Model Numbers
Device Description
FDA-Cleared Indications for Use
96820-108
Bio-Medicus™
These devices are to be used by a trained physician only.
Supplement: Temporary modification to indications for use for
cannulae
96820-108, 96820-110, 96820-112, 96820-114
96830-108, 96830-110, 96830-112, 96830-114
96570-115, 96570-117, 96570-119, 96570-121, 96570-123, 96570-125
96670-115, 96670-117, 96670-119, 96670-121, 96670-123, 96670-125, 96670-127, 96670-129
96530-115, 96530-117, 96530-119, 96530-121, 96530-123, 96530-125
96600-115, 96600-117, 96600-119, 96600-121, 96600-123, 96600-125, 96600-127, 96600-129
Background
On April 6, 2020 the United States Food and Drug Administration (FDA) published the following
guidance:
Devices during the Coronavirus Disease 2019 (COVID-19) Pubic Health Emergency.”
Under this guidance, the FDA is allowing temporary, limited modifications to the indications of certain
FDA-cleared or FDA-approved cardiopulmonary devices without prior submission of premarket
notification. These modifications are allowed, due to the public health emergency related to COVID-19,
when they do not create an undue risk. This indication modification is in effect for the duration of the
public health emergency related to COVID-19, as declared by the Department of Health and Human
Services (HHS).
Indications for use
“Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass
In accordance with the FDA guidance, the devices listed below have a modified indication for use during
the COVID-19 public health emergency. This indication modification has not been cleared or approved
by the FDA, but shall apply temporarily to the device models listed in this supplement:
The device can be used for longer than 6 hours in an extracorporeal membrane oxygenation (ECMO)
circuit to treat patients who are experiencing acute respiratory or acute cardiopulmonary failure.
The table below shows the part numbers, device descriptions, and FDA-cleared indications for use for
the various cannulae granted the above modified indication.
96820-110
96820-112
96820-114
96830-108
96830-110
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Pediatric Femoral
Cannulae and
Introducers
Cannulae are used to cannulate vessels, perfuse vessels
or organs, and/or connect with accessory extracorporeal
equipment. The cannula introducer is intended to
facilitate proper insertion and placement of the
appropriately-sized cannula within the vessel for
Model Numbers
Device Description
FDA-Cleared Indications for Use
96830-112
96830-114
cardiopulmonary bypass. These products are intended
for use up to 6 hours.
96570-115
96670-129
Bio-Medicus Adult
These devices are to be used by a trained physician only.
96530-115
96600-129
Bio-Medicus
These devices are to be used by a trained physician only.
96570-117
96570-119
96570-121
96570-123
96570-125
96670-115
96670-117
96670-119
96670-121
96670-123
96670-125
96670-127
96530-117
96530-119
96530-121
96530-123
96530-125
96600-115
96600-117
96600-119
96600-121
96600-123
96600-125
96600-127
Femoral Cannulae
and Introducers
Cannula Kits
Cannulae are used to cannulate vessels, perfuse vessels
or organs, and/or connect with accessory extracorporeal
equipment. The cannula introducer is intended to
facilitate proper insertion and placement of the
appropriately-sized cannula within the vessel for
cardiopulmonary bypass. The Bio-Medicus cannula (18
cm (7.09 in) tip length models) may be used in either the
femoral position as an arterial delivery cannula or in the
jugular position as a venous return cannula. These
products are intended for use up to 6 hours.
Cannulae are used to cannulate vessels, perfuse vessels
or organs, and/or connect with accessory extracorporeal
equipment. The cannula introducer is intended to
facilitate proper insertion and placement of the
appropriately-sized cannula within the vessel for
cardiopulmonary bypass. The Bio-Medicus cannula (18
cm (7.09 in) tip length models) may be used in either the
femoral position as an arterial delivery cannula or in the
jugular position as a venous return cannula. These
products are intended for use up to 6 hours.
Device performance
There are no changes to device performance as described in the instructions for use for these devices.
Summary of durability testing
Medtronic conducted in vitro testing and reliability and life testing on these devices. The testing showed
no failures.
Medtronic also conducted functional testing to demonstrate product reliability using worst case
pediatric and adult cannulae models, following environmental conditioning, aging, and simulated use
conditioning at maximum flow rates for up to 6 hours of use. All devices met the performance
requirements with no failures.
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Summary of clinical performance
A literature search and review1 were conducted to assess the published evidence specific to the use of
Bio-Medicus Adult Femoral Cannulae and Introducers and Cannula Kits, and Bio-Medicus Pediatric
Femoral Cannulae and Introducers in ECMO or extracorporeal life support (ECLS) since the first CE mark
in 2014. Nine articles reported on case studies of 44 patients using Bio-Medicus cannulae in an
ECMO/ECLS setting. The length of time these patients were on ECMO ranged from days to months.
Nineteen of the 44 ECMO-treated patients were COVID-19 patients. Erik Osborn et al
their experience with 15 COVID-19 patients demonstrates that ECMO can be successfully employed as a
support modality for COVID-19 related acute respiratory distress syndrome. Loforte A. et al
from 4 COVID-19 patient experiences that if the conservative treatment is not effective, veno-venous
ECMO support might be considered. The evidence from these 9 case reports confirmed that ECMO use is
beneficial and no performance or safety issues due to the use of Medtronic Bio-Medicus cannulae were
reported.
The clinical performance and safety data of Bio-Medicus cannulae derived from Medtronic field
experience data (including Bio-Medicus Adult Femoral Cannulae and Introducers and Cannula Kits, and
Bio-Medicus Pediatric Femoral Cannulae and Introducers) and published scientific literature (including
all Bio-Medicus adult and pediatric cannulae and not limited to these models) were evaluated and
4
documented in a Clinical Evaluation Report (CER)
. The CER confirms the performance and safety of BioMedicus Adult Femoral Cannulae and Introducers and Cannula Kits, and Bio-Medicus Pediatric Femoral
Cannulae and Introducers.
No new or increased risks or other clinical concerns were identified in this clinical evidence review for
the Medtronic Bio-Medicus Adult Femoral Cannulae and Introducers and Cannula Kits, and Bio-Medicus
Pediatric Femoral Cannulae and Introducers.
Medtronic conducted blood trauma testing comparing a reference catheter, which is qualified for
ECMO/ECLS long-term use, to the Bio-Medicus Adult Femoral Cannulae and Introducers and Cannula
Kits, and Bio-Medicus Pediatric Femoral Cannulae and Introducers. The design, geometry, flow rate
performance, and manufacturing methods used for the Bio-Medicus Adult Femoral Cannulae and
Introducers and Cannula Kits, and Bio-Medicus Pediatric Femoral Cannulae and Introducers are the
same as the reference device. The results of the blood trauma testing demonstrate that the Bio-Medicus
Adult Femoral Cannulae and Introducers and Cannula Kits, and Bio-Medicus Pediatric Femoral Cannulae
and Introducers have equivalent hemocompatibility as the reference device.
Medtronic also conducted biocompatibility testing of the blood-contacting materials used in the BioMedicus Adult Femoral Cannulae and Introducers and Cannula Kits, and Bio-Medicus Pediatric Femoral
Cannulae and Introducers for prolonged use. The results of the biocompatibility testing demonstrate
that the Bio-Medicus Adult Femoral Cannulae and Introducers and Cannula Kits, and Bio-Medicus
Pediatric Femoral Cannulae and Introducers meet ISO 10993-1 as recommended by FDA guidance
2
reported that
3
concluded
1
The literature search and review were conducted to access the products in scope of this documentation only.
2
Data on file
3
Data on file
4
Data on file
Page 3 of 5
document “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management process.’”
Potential risks
Possible complications include those normally associated with ECMO, ECLS, anticoagulation, and largebore venous and arterial catheterization.
The following potential adverse effects are associated with the use of the devices: abrasion, air
embolism, anaphylaxis, bleeding or hematoma at the cannulation site, death, delayed procedure,
dissection, exsanguination, foreign-material embolism, hemolysis, hypercarbia, hypervolemia,
hypotension, hypovolemia, hypoxia, infection, irritation, ischemia or lower limb ischemia, major blood
loss, minor blood loss, neurological dysfunction, organ dysfunction, perforation, sensitization,
thromboembolism, thrombus formation, tissue damage, toxicity, vessel damage. Vessel damage and
complications at the puncture site may occur if the instructions for use are not followed.
Clinical signs or observations that suggest device changeout is necessary
These clinical observations may necessitate or predict the need for device replacement throughout the
duration of use:
Decreased blood flow due to a clot, obstruction, or other factor that cannot be managed by
•
catheter repositioning
Significant or uncontrolled blood loss from the catheter
•
Entrained air in the catheter or connectors
•
Mechanical injury to access vessels (perforation, tearing, dissection), injury at or above the site
•
of insertion, and tissue damage during the insertion and placement of the catheter
Mechanical failure due to kinking of the catheter, or material failure due to incorrect suturing
•
Hemorrhage related to bleeding, catheter malposition, or dislodgement around the insertion
•
site
Heart, vessel, or lung damage; anemia; liver or kidney failure; and stroke
•
Note: The benefits of catheterization for extracorporeal circulation must be weighed against the risk of
systemic anticoagulation and subsequent propensity for hemorrhage.
Warning: Only physicians with previous training and experience in cannulation, Seldinger technique and
extracorporeal life support should replace these devices. It is the responsibility of the physician to
determine the proper steps to follow based on the patient’s individual clinical need.
Use conditions
The intended patient population are those experiencing acute respiratory failure or acute
cardiopulmonary failure. The duration of use is likely to extend beyond the labeled 6-hour indication
when used in an ECMO circuit. There are no other changes to the intended use as described in the
instructions for use for these devices. There are no changes to the contraindications as described in the
instructions for use for these devices.
There are no changes to the recommended catheters by flow index as shown in Table 1 and Table 2.
2
Table 1. Recommended catheter for flow index 2.5 L/min/m
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Body surface area (m2)
Index matched flow
requirements (L/min)
Return
Drainage
0.2
0.5
96820-108
96830-110
0.6
1.5
96820-112
96830-114
1.0
2.5
96820-014
96570-119
1.4
3.6
96570-117
96670-123
1.8
4.6
96570-119
96670-125
2.2
5.6
96570-121
96670-127
2.6
6.5
96570-123
96670-129
Body surface area (m2)
Index matched flow
requirements (L/min)
Return
Drainage
0.2
0.3
96820-108
96830-108
0.6
0.9
96820-110
96830-112
1.0
1.5
96820-112
96830-114
1.4
2.2
96820-114
96570-117
1.8
2.8
96570-115
96570-119
2.2
3.4
96570-117
96670-121
2.6
3.9
96570-117
96670-123
Table 2. Recommended catheter for flow index 1.5 L/min/m
2
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
M013394C001 B
© 2021 Medtronic
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