Medtronic CYTO-KIT-USM Instructions for Use

en

Instructions for Use

CYTO-KIT-USM

Cytosponge™*

Cell Collection Kit

Cytosponge™*

Cell Collection Kit

Quick Reference Guide

1. Remove the Cytosponge™* cell collection device from the box. Do not use if

the pouch has been damaged or the packaging has been compromised.

2. Check the Specimen Jar with Preservative. Do not use if the seal is not intact or

the preservative has leaked.

3. Seat patient in an upright position.

4. Peel open the Cytosponge™* cell collection device pouch and remove the

device.

Note: For further details, and a complete list of contraindications, warnings, and
cautions, please refer to the Cytosponge™* cell collection device instructions for
use.

5. Detach capsule from the retainer card and carefully unwind the string from the

card.

6. Prepare the capsule and string for swallowing by bundling the string against

the capsule. Hold the capsule between your thumb and index finger and fold
the string back and forth in 2 cm lengths against the capsule. Use your thumb
and index finger to hold the folds adjacent to the capsule as you go. Stop
bundling when there is approximately 10 cm of string remaining from the
retainer card.

Caution

Do not wrap the string around the capsule.

Note: Bundling the string like an accordion will help to avoid tangles and knots
when swallowed.

7. Instruct the patient to open his or her mouth and extend his or her tongue.

Place capsule and string bundle in the patient’s mouth at the back of his or her
tongue.

8. Hold the retainer card so that approximately 10 cm of string remains outside of

the patient’s mouth.

9. Have the patient drink 150-250 mL of room temperature water to swallow the

capsule and string.

Note: Drinking water will help ensure that the string will properly travel down the
throat and the capsule will reach the stomach.

10. Check the patient’s mouth to ensure that all of the bundled string has been

Caution

Keep the Specimen Jar with Preservative out of reach of the patient.

swallowed. If there is excess string still present, have the patient drink
additional water and continue swallowing.

11. Set a timer for 7 min., 30 sec. Start the timer after the capsule and string have

been swallowed.

12. Prepare the Specimen Jar with Preservative prior to retrieving the

Cytosponge™* cell collection device by breaking the seal and removing the lid.

Note: For further details, and a complete list of contraindications, warnings, and

Caution

Center the string to the middle of the throat before pulling.

cautions, please refer to the Specimen Jar with Preservative instructions for use.

13. After 7 min., 30 sec. has elapsed, tilt the patients head back slightly, grip the

retainer card and string, and in a smooth, quick, and continuous fashion pull
the string until the sponge exits the patient’s mouth.

Note:

• Failure to wait the entire time period may result in inadequate samples.

• Removal of the Cytosponge™* cell collection device may trigger a brief

pharyngeal reflex; pulling smoothly, quickly, and continuously will lessen the
patient’s discomfort upon removal.

• Increased resistance may be encountered as the sponge passes the lower

esophageal sphincter and upper esophageal sphincter. This can potentially
require a slight increase of force to be exerted on the string.

14. Immediately place the Cytosponge™* cell collection device in the Specimen Jar

with Preservative.

15. Cut the string near the sponge and discard the retainer card and excess string.

16. Close the Specimen Jar with Preservative. Then label the jar according to

laboratory procedures.

17. Place the jar in the biohazard bag with the absorbent pad and seal the bag,

leaving little air in the bag.

Cytosponge™*

CYTO-201

Cell Collection Device

Indications for Use

The Cytosponge™* cell collection device is indicated for use in the collection and
retrieval of surface cells in the esophagus for cytological and histological analyses.

Do not use if package is opened or damaged

Target Population

Patient’s aged 18 and over.

Intended User Group

The Cytosponge™* device is to be administered by healthcare professionals such as
medical doctors, registered nurses, and other qualified health professionals trained
in use of the device.

General Warnings and Cautions

Warning

Use of this device has not been studied in, or may be more difficult, less effective,
or less well tolerated in patients under 18 years of age.

Use of this device in patients taking anti-thrombotic drugs which cannot be
temporarily stopped before and after the procedure is contraindicated.

Potential complications include:

• Aspiration

• Mucosal laceration or perforation requiring secondary intervention

• Major and minor bleeding

• Airway obstruction

• Infection

Warning

• Intestinal obstruction

• Tissue damage

treat any of the potential complications listed above.

The sponge may detach from the string during removal of the device.

In the event of the separation of the sponge and suture, an endoscopic retrieval
procedure (e.g. use of a Roth Net™* retriever) may be necessary.

• Allergic reaction

• Dysphagia

• Pain

Secondary intervention including endoscopy and/or surgery may be required to

Warning

In the event that a serious incident has occurred related to device use,

immediately report the event to Covidien, the competent authorities, and any

other regulators as required.

Caution

Inspect the device packaging and expiration date before use. Do not use the
device if the inner pouch or device is damaged.

Never attempt to sterilize the device. Sterilization of the device may lead to

infection, allergic reaction, pain, and respiratory disorders.

changes in material characteristics which may impact the integrity of the device
and compromise device performance. This product is for single-use only. Do not
reuse. Reuse of the device can cause cross contamination leading to patient

Caution

Only trained healthcare professionals should use the device.

Store in a cool, dry, well-ventilated area away from direct heat.

Contraindications

• Patients with symptoms of dysphagia or history of swallowing disorders

• Patients with known or suspected anatomical abnormalities of the esophagus

or stomach

• Patients that have undergone esophageal or gastric dilation, ablation, biopsy,

mucosal resection, or other invasive medical procedures within the previous
two months

• Pregnancy

• Patients with known or suspected portal hypertension and/or gastric or

Warning

Failure to discontinue anti-thrombotic agents before and after the procedure

lead to transfusion therapy for hemostasis or death.

esophageal varices

• Patients taking anti-thrombotic drugs (e.g. anticoagulants, antiplatelet agents)

that cannot be temporarily discontinued

may lead to higher rates of intra- and post-treatment bleeding and may possibly

Note: For patients currently on anti-thrombotic agents, the health care provider
responsible for the administration of the Cytosponge™* device should consult with
the specialist(s) responsible for the management of the anti-thrombotic agent
and/or refer to professional society guidelines addressing the management of these
medications regarding the proper protocol for discontinuation and resumption of
these medications.

Materials Required (not provided)

1. Room temperature water

2. Timer

3. Collection container

4. Preservative media

5. Scissors

Directions for Use

1. The patient should not eat or drink during the four hours prior to the

procedure.

2. Remove the retaining card with the device from the outer pouch.

3. Detach the capsule from the retaining card by pushing against the stringless

side of the capsule.

4. Carefully unwind the string from the retaining card ensuring it does not tangle,

knot, or kink.

5. Prepare the capsule and string for swallowing by bundling the string against

the capsule. Hold the capsule between the thumb and index finger. Fold the
string back and forth in 2 cm lengths against the capsule. Use the thumb and
index finger to hold the folds adjacent to the capsule. Stop bundling when
there is approximately 10 cm of string remaining from the retainer card.

Caution

Do not wrap the string around the capsule.

Note: Bundling the strong like an accordion will help to avoid tangles and knots
when swallowed.

6. Seat the patient in an upright position. Instruct the patient to open their

mouth and extend his or her tongue. Gently place the capsule and bunched
string on the back of the patient’s tongue.

Note: If it is easier for the patient, they can place the capsule and string in their own
mouth.

Hold the retainer card so that approximately 10 cm of string remains outside of
the patient’s mouth. Provide 150 to 250 mL of room temperature water for the
patient to drink. Instruct the patient to swallow the capsule and bunched
string with all the water.

Note: Drinking water will help ensure that the string will properly travel down the
esophagus and the capsule will reach the stomach.

7. Instruct the patient to open his or her mouth. If excess or bunched string is

detected, instruct the patient to drink additional water to facilitate capsule
advancement. Repeat until there is no evidence of excess or bunched string at
the back of the patient’s mouth.

8. Once the patient has swallowed the capsule and no excess string is detected in

Caution

Center the string to the middle of the throat before pulling.

the mouth, set the timer for 7 min., 30 sec. This period of time will allow the
capsule to dissolve in the stomach and the sponge to expand.

Note: Failure to wait the entire period may result in inadequate samples.

Note: If desired, xylocaine spray may be used on the back of the patient’s throat 2

minutes before retrieval of the device.

9. After the 7 min., 30 sec. time period has elapsed, grip the retainer card and

string, then gently and continuously pull the string until the sponge exits the
patient’s mouth.

Note: Removal of the Cytosponge™* cell collection device may trigger a brief
pharyngeal reflex; pulling smoothly, quickly, and continuously will lessen the
patient’s discomfort upon removal.

Note: Increased resistance may be encountered as the sponge passes the lower
esophageal sphincter and the upper esophageal sphincter. This can potentially
require a slight increase of force to be exerted on the string.

Note: Esophageal spasm can result in increased resistance. If increased resistance is
encountered, discontinue pulling on the string and allow the patient to relax for
several minutes before resuming the retrieval process.

Warning

Do not continue pulling the string if increased resistance remains. Excessive
force can result in harm to the patient or failure of the device

10. Immediately place the sponge portion of the device within a collection

container and media. Cut the string near the sponge.

11. Close the collection container and label it according to laboratory procedures.

Note: An alcohol-based fixative shown to preserve cells and small tissue fragments
in suspension appropriate for cytological and histological examination is
recommended. In previous Cytosponge™* cell collection device studies, cytological
samples obtained with the Cytosponge™* device were preserved using an alcohol-

based fixative system. Performance standards have not been established for the use
of Cytosponge™* cell collection device samples with other preservative media.

12. Discharge the patient as appropriate per standard procedures. Instruct patient

to contact treating physician immediately for significant chest pain, throat
pain, difficulty swallowing, fever, bleeding, abdominal pain, difficulty
breathing, vomiting, or other warning signs provided by the physician.

Clinical Performance Information

In a Covidien sponsored post-market study in a population of individuals with
confirmed Barrett’s esophagus (BE), sample adequacy was measured by the
presence of columnar cells. Presence of columnar cells in a Cytosponge™* sample

indicated that the Cytosponge™* device had reached the stomach and thus was
able to collect cells sample from the stomach and along the whole length of the
esophagus including the distal esophagus where possible abnormalities such as
Barrett’s esophagus

1

can usually be found. Samples were processed with paraffin,
stained and evaluated by a qualified pathologist. Cytological samples obtained with
the Cytosponge™* cell collection device were preserved in BD CytoRich™*
preservative fluid.

1

American Gastroenterological Association, Spechler SJ, Sharma P, Souza RF, Inadomi JM, Shaheen NJ

American Gastroenterological Association medical position statement on the management of
Barrett's esophagus. Gastroenterology. 2011 Mar; 140(3):1084-91. doi: 10.1053/j.gastro.2011.01.030.

Criteria

For purposes of this investigation, an adequate sample was one in which at least
one group of columnar cells was present. No minimal size is required for a group; a
group of columnar cells can consist of two cells that are clearly columnar. Sample
adequacy was presented as a proportion of subjects who fulfilled this definition
after up to two total administrations of the Cytosponge™* device.

Results

Sixty-eight subjects met the inclusion criteria for sample adequacy. Four out of 68
samples were inadequate. Two of the four patients repeated the Cytosponge™*
device swallow and met the criteria for sample adequacy.

Conclusion

Sixty-four of 68 Cytopsponge™* samples were adequate after one administration.
Sixty-six of 68 Cytosponge™* samples or 97% were sample adequate
after two administrations.

Note: A minimum of six to 10 well-visualized and preserved epithelial cells (at least
six cells per cluster) in total are necessary to ensure an adequate sampling of the
esophageal mucosa

2

. In addition to the overall number of epithelial cells, a
minimum of two columnar type cells are necessary to ensure that the device has
reached the stomach prior to retrieval.

2

College of American Pathologists Cytopathology Committee Special Section, August 2003 Defining

Adequacy in Non-gynecologic Cytology.

Note: A negative or normal result does not exclude the presence of columnar
epithelium (Barrett’s Esophagus).

Clinical Benefits

In clinical studies, cells collected by the Cytosponge™* device have been shown to
provide sample adequate cells, which when used with a biomarker, exposed
abnormal cells.

3,4

3

Case 1: Lao-Sirieix P, et al. Evaluation of a minimally invasive Cytosponge esophageal cell collection
system in patients with Barrett’s esophageal cell collection system in patients with Barrett’s
esophagus. Gastroenterology 2015: 148 (4): S1 S- 16 [AGA Abstract].

4

Case 2: A study of the adequacy and accuracy of Cytosponge: first report in an American population
with Barrett’s esophagus and GERD. Gastroenterology 2019; 156 (6): S1, S222-S223 [AGA Abstract].

Product Disposal

After use, this product may be a potential biohazard. Handle and dispose of in
accordance with accepted medical practice and applicable local, state, and federal
laws and regulations.

California Proposition 65 Statement

For information regarding California Proposition 65, please refer to

www.covidien.com/caprop65

.

Part No. PT00117485

COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive

May be covered by US Patents: www.covidien.com/patents

6422 PJ Heerlen, The Netherlands.

Product of USA (from US and foreign materials ).

www.covidien.com

REV 2020 / 07 - 5

Results for Life are U.S., and internationally registered trademarks of
Covidien AG. TM* brands are trademarks of their respective owner.
Other brands are trademarks of Covidien company.

©2014, 2020 Medtronic.

Coviden llc,

15 Hampshire Street, Mansfield, MA 02048 USA.

Medtronic B.V., Earl Bakkenstraat 10,

[phone]

Specimen Jar with Preservative

Components:

1. Specimen jar

2. CytoRich™* red preservative fluid

Do not use if package is opened or damaged

Note: The specimen jar comes prefilled with preservative.

Indications for Use

The specimen jar is indicated for use in the transport of cells and small tissue
fragments.

The CytoRich™* red preservative fluid is indicated to preserve cells and small tissue

Warning

Cytologic specimens may contain infectious agents. Users should use

appropriate biohazard precautions when handling samples.

Keep specimen jar with preservative out of reach of the patient.

fragments in suspension for cytological and histological examination and is
compatible with immunohistochemical staining. This preservative lyses red blood
cells and solubilizes proteins, producing results similar to those obtained with
samples processed with neutral buffered saline.

appropriate personal protective equipment, including gloves, and follow

Caution

Do not pipette by mouth since accidental ingestion may lead to toxicity.

Do not allow any reagents to come in contact with open wounds as this may
cause irritation.

Wear powder-free gloves, lab coat, and eye protection during laboratory
procedures.

Follow appropriate biohazard precautions when handling cell and tissue
specimens.

Do not ingest (preservative contains alcohols other than ethanol and
formaldehyde).

CytoRich™* Red Preservative Fluid

CytoRich™* red preservative fluid is a hemolytic fixative and is commonly used for
cytology and small biopsy processing. The active ingredients of the preservative
include alcohols, formaldehyde, non-toxic demulcents, emollients, and buffers.

Summary and Explanation

1. CytoRich™* red preservative fluid is not indicated for use as a fixative for

cervicovaginal cytology screening.

2. CytoRich™* red preservative fluid is sold for use as a fixative for diagnostic non-

cervicovaginal cytology, including cells and small tissue samples. This may
include, but is not limited to, scrapings, brushings, sputum, washings, fine­needle aspirates, and other non-cervicovaginal samples.

3. Cells and small tissue samples fixed in CytoRich™* red preservative fluid may

be processed using general cytology protocols, including automated slide
processors, centrifugation methods, and cell block methods.

Mechanisms of Hemolysis and Fixation

CytoRich™* red preservative fluid lyses red blood cells, cross-links soluble globulin
proteins, and alcohol fixes cells and small tissue fragments. One milliliter of
CytoRich™* red preservative fluid is sufficient to fix 25 to 50 microliters of whole
blood (via lysis of red blood cells and stabilization of soluble proteins).

1. Alcohol and osmotic lysis contribute to selectively emulsify and further disrupt

red blood cell membranes. Rare individuals may have red blood cells with
hemoglobinopathy, which may lyse slowly or resist complete lysis. Lysis is
resisted by senescent red blood cells.

2. Globulin proteins collected found within blood plasma and interstitial tissue

fluids are cross-linked by formaldehyde prior to being denatured by alcohols in
solution, thereby preventing the formation of protein super-aggregates
(flocculent precipitates).

3. Cells may appear to be alcohol fixed due to the ability of alcohol to transport

more easily than formaldehyde through other cell membranes into the cells’
cytoplasm and nucleoplasm.

4. Subsequently, formaldehyde can cross-link intercellular junctions and

intracellular proteins. This allows for cells and tissue fragments to maintain
long-term stability in suspension.

Storage, Stability, and Specimen Transport Requirements

1. The Specimen Jar with Preservative should be stored at room temperature

(15°C to 30°C).

2. The shelf life is indicated on the product labels.

3. Specimens fixed and contained within the Specimen Jar and Preservative are

stable for at least 30 days.

4. Morphological stability has been demonstrated for specimens stored in

CytoRich™* red preservative fluid for up to six months at room temperature.

5. CytoRich™* red preservative fluid is appropriate for transporting fixed samples

within a temperature range of approximately -5°C to +45° C.

Directions for Use

1. Break seal on specimen jar safety seal.

2. Remove lid by turning lid counterclockwise.

3. Place specimen in the Specimen Jar with Preservative and replace lid. Align

threads and turn clockwise until lid is secured tightly.

4. Do not over tighten.

5. Do not cross thread.

General Specimen Preparation – Background

One millimeter of CytoRich™* red preservative fluid is sufficient to fix 25 to 50
microliters of whole blood (via lysis of red blood cells and stabilization of soluble
proteins). Using this ration as a baseline, one milliliter of CytoRich™* red

preservative fluid is sufficient to fix 50 microliters of aqueous cell slurry (clearing of
red blood cells and protein).

Recommended Cytosponge™* Specimen Preparation – IHC Method

1. After placing the Cytosponge™* in the Specimen Jar with Preservative, shake

the specimen jar vigorously to loosen the cells from the Cytosponge™*.
Insufficient shaking may result in an excess of cells remaining trapped in the
Cytosponge™* mesh.

2. Transfer the CytoRich™* red preservative fluid containing the cells to an

appropriate 50 mL centrifuge tube.

3. Centrifuge the cells for 10 minutes at 3000 times the gravity.

4. If cells are still in suspension, repeat the centrifugation for 10 minutes at 3000

times gravity.

5. Decant and properly discard the supernatant solution.

6. Create a cell block using a plasma thrombin method to form a cell clot for best

visualization of cellular morphology.

Limitations of the Procedure

1. Cytosponge™* cell collection device samples should be placed in the

Specimen Jar with Preservative as soon as possible after collection.

2. A specimen that has degraded prior to fixation may not be adequate for

evaluation and assay performance.

3. The preservative should not be used to fix tissue fragments with an average

diameter in excess of 5 millimeters.

Symbol Descriptions and Matrix

Symbol

Description

Non-sterile
Single use

For prescription use only

Do not use if package is damaged
Consult instructions for use

Caution, consult accompanying documents

Symbol

Description

Medical device

In vitro diagnostic medical device

Sufficient for 26 ml

Store at room temperature

Keep dry

Made from 100% recycled fibers. Minimum 35% post-consumer content.

Symbol

Description

CE mark

Authorized representative in the European Community
Catalog number

Manufacturer

Use-by date
Batch code

COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive

Other brands are trademarks of Covidien company.

Product of USA (from US and foreign material s).

www.covidien.com

REV 10/2020

In Vitro Diagnostic

Medical Device

Part No. PT00117486

Results for Life are U.S., and internationally registered trademarks of
Covidien AG. ™* brands are trademarks of their respective own er.

May be covered by US Patents: www.covidien.com/patents

©2014, 2020 Medtronic.

26 mL

Coviden llc,

15 Hampshire Street, Mansfield, MA 02048 USA.

[phone]