Supplement: Temporary modification to indications for use for
System Part
Device
Description
FDA-Cleared Indications for Use
560BCS1
Bio-Console
TM
560
The Medtronic centrifugal blood pumping system is
extracorporeal support devices
560BCS1, ACM100, ACM200, ACM300, BD38, BD14
560A, HC150A, 95184-001, 95185-001, AP40AST
AP40, CBAP40, BBAP40
95244, 95134, CB2980POLY, CB4627, DP38T, DP38PT
Background
On April 6, 2020 the United States Food and Drug Administration (FDA) published the following
guidance: “Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass
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, in light of the public health emergency, 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
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 system part numbers, device descriptions, and FDA-cleared indications for
use for the various cardiopulmonary devices granted the above modified indication.
Numbers*
ACM100
ACM200
ACM300
BD38
BD14
Extracorporeal
Blood Pumping
Console with
accessories:
Autoclamp
Bubble detector
(adult)
intended to pump blood through the extracorporeal
bypass circuit for extracorporeal support for periods
appropriate to cardiopulmonary bypass procedures (up
to 6 hours).
Page 1 of 7
System Part
Numbers*
Device
Description
FDA-Cleared Indications for Use
560A
External
Drive
The Medtronic external drive motor 560A is indicated for
HC150A
Emergency Hand
Refer to the Affinity CP centrifugal blood pump IFU for
95184
-
001
TX50 Adult Flow
The
Bio-Probe™ blood flow monitoring system is to be
AP40AST
Affinity CP Adapter
Refer to the Affinity
CP centrifugal blood pump IFU for
AP40
Affinity CP
The Affinity CP centrifugal blood pump is used to pump
CBAP40
Affinity CP
The Affinity CP centrifugal blood pump with Cortiva
Bubble detector
(pediatric)
95185-001
Motor for Affinity
TM
CP Centrifugal
Blood Pump
Crank for Affinity CP
Centrifugal Blood
Pump
Transducer
TX50P Pediatric
Flow Transducer
Centrifugal Blood
Pump**
use with the Affinity CP centrifugal blood pump.
indications for use.
used with an appropriate model Bio-Console
extracorporeal blood pumping console to measure
directly the blood flow in the extracorporeal perfusion
circuit.
indications for use.
blood through the extracorporeal bypass circuit for
extracorporeal circulatory support for periods
appropriate to cardiopulmonary bypass (up to 6 hours).
It is also indicated for use in extracorporeal support
systems (for periods up to 6 hours) not requiring
complete cardiopulmonary bypass (for example,
valvuloplasty, circulatory support during mitral valve
reoperation, surgery of the vena cava or aorta, liver
transplants).
Centrifugal Blood
Pump with
CortivaTMBioActive
Surface**
The Affinity CP centrifugal blood pump is driven by the
external drive motor or the emergency handcrank.
The Affinity CP centrifugal blood pump is intended for
use with pump speed controllers approved by Medtronic
or may be used with the StöckertTMand Sorin
centrifugal pump systems or the SarnsTMand Terumo
TM
TM
centrifugal systems by attaching the Affinity CP adapter.
bioactive surface is used to pump blood through the
extracorporeal bypass circuit for extracorporeal
circulatory support for periods appropriate to
cardiopulmonary bypass (up to 6 hours).
Page 2 of 7
System Part
Numbers*
Device
Description
FDA-Cleared Indications for Use
It is
also indicated for use in extracorporeal support
BBAP40
Affinity CP
The Affinity CP centrifugal blood pump with Balance
95244
Adult Bio
-
Probe
Refer to the Bio
-
Probe blood flow monitoring system
systems (for periods up to 6 hours) not requiring
complete cardiopulmonary bypass (for example,
valvuloplasty, circulatory support during mitral valve
reoperation, surgery of the vena cava or aorta, liver
transplants).
The Affinity CP centrifugal blood pump with Cortiva
bioactive surface is driven by the external drive motor or
the emergency handcrank.
The Affinity CP centrifugal blood pump with Cortiva
bioactive surface is intended for use with pump speed
controllers approved by Medtronic or may be used with
the Stöckert and Sorin centrifugal pump systems or the
Sarns and Terumo centrifugal systems by attaching the
Affinity CP adapter.
Centrifugal Blood
Pump with
Balance
TM
Biosurface1**
biosurface is used to pump blood through the
extracorporeal bypass circuit for extracorporeal
circulatory support for periods appropriate to
cardiopulmonary bypass (up to 6 hours).
It is also indicated for use in extracorporeal support
systems (for periods up to 6 hours) not requiring
complete cardiopulmonary bypass (for example,
valvuloplasty, circulatory support during mitral valve
reoperation, surgery of the vena cava or aorta, liver
transplants).
The Affinity CP centrifugal blood pump with Balance
biosurface is driven by the external drive motor or the
emergency handcrank.
The Affinity CP centrifugal blood pump with Balance
biosurface is intended for use with pump speed
controllers approved by Medtronic or may be used with
the Stöckert and Sorin centrifugal pump systems or the
Sarns and Terumo centrifugal systems by attaching the
Affinity CP adapter.
1
Technology licensed under agreement from BioInteractions, Limited, United
Kingdom.
Flow Probe, 3/8”**
95134
Pediatric Bio-Probe
Flow Probe, 1/4”**
operator manual for indications for use.
Page 3 of 7
Loading...