Medtronic 96530-121 Addendum

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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