Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface

K183490 · Medtronic, Inc. · DTZ · Apr 12, 2019 · Cardiovascular

Device Facts

• Record ID: K183490
• Device Name: Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface
• Applicant: Medtronic, Inc.
• Product Code: DTZ · Cardiovascular
• Decision Date: Apr 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. The Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

Device Story

Extracorporeal perfusion circuit components for cardiopulmonary bypass (CPB). Devices include oxygenators, integrated arterial filters, and cardiotomy/venous reservoirs (CVR). Inputs: venous blood, cardiotomy suctioned blood. Operation: blood flows through oxygenator for gas exchange (O2/CO2) and heat exchanger for temperature control; integrated filters remove microemboli; CVR collects venous/suctioned blood and supports vacuum-assisted venous drainage (VAVD). Used in OR by perfusionists/surgeons. Outputs: oxygenated, temperature-regulated blood returned to patient. Benefits: maintains physiological gas exchange and temperature during open-heart surgery; provides filtration and blood salvage capabilities. Surface coatings (Trillium, Cortiva, Balance) enhance biocompatibility.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and performance characteristics consistent with established predicate devices for cardiopulmonary bypass.

Technological Characteristics

Hollow fiber oxygenators with integrated heat exchangers, arterial filters, and venous reservoirs. Materials include biocompatible polymers with optional surface coatings (Trillium Biosurface, Cortiva BioActive Surface, Balance Biosurface). Connectivity: None (mechanical/fluidic). Sterilization: Ethylene oxide. Operation: Passive fluid flow driven by external pump systems. Form factor: Integrated modular units for CPB circuits.

Indications for Use

Indicated for patients undergoing routine cardiopulmonary bypass (CPB) procedures requiring extracorporeal blood oxygenation, CO2 removal, and temperature regulation for up to 6 hours. Includes filtration of microemboli. Specific models include integrated cardiotomy/venous reservoirs for venous/cardiotomy suctioned blood collection and post-operative autologous blood collection.

Regulatory Classification

Identification

A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

April 12, 2019

Wendy Pinor Principal Regulatory Affairs Specialist 7611 Northland Dr Minneapolis, Minnesota 55428

Re: K183490

Trade/Device Name: Affinity NT™ Oxygenator (Model 511), Affmity® NT Oxygenator with Plasma Resistant Fiber (PRF) with Trillium™ Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T-R), Affinity® NT Integrated Trillium™ CVR/Membrane Oxygenator (Model 541TT), Affinity® NT Integrated Trillium™ CVR/Membrane Oxygenator (Model 541TT-R), Affinity NTTM Oxygenator with Cortiva™ BioActive Surface (Model CB511), Affinity NTTM Integrated Uncoated CVR/Oxygenator with CortivaTM BioActive Surface (Model CB541), Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface (Model BB811), Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface (Model CB811), Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BB841), and Affinity Fusion™ Oxygenator with Integrated Arterial Filter and CortivaTM BioActive Surface and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model CB841) Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II

Product Code: DTZ Dated: January 16, 2019 Received: January 17, 2019

Dear Wendy Pinor:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database

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located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K183490

Device Name

Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface (Model BB811)

Indications for Use (Describe)

The Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.

The Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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{3}------------------------------------------------

510(k) Number (if known) K183490

#### Device Name

Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BB841)

#### Indications for Use (Describe)

The Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.

The Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

The Affinity Fusion™ Cardiotomy/Venous Reservoir with Balance™ Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum-assisted venous drainage (VAVD) procedures.

The Affinity Fusion™ Cardiotomy/Venous Reservoir with Balance™ Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood volume replacement.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size:14px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:14px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{4}------------------------------------------------

510(k) Number (if known) K183490

Device Name

Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface (Model CB811)

Indications for Use (Describe)

The Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.

The Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------|
| <span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{5}------------------------------------------------

510(k) Number (if known) K183490

#### Device Name

Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model CB841)

#### Indications for Use (Describe)

The Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.

The Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

The Affinity Fusion™ Cardiotomy/Venous Reservoir with Balance™ Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum-assisted venous drainage (VAVD) procedures.

The Affinity Fusion™ Cardiotomy/Venous Reservoir with Balance™ Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood volume replacement.

Type of Use (Select one or both, as applicable)

| <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------|
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{6}------------------------------------------------

510(k) Number (if known) K183490

Device Name Affinity NT™ Oxygenator (Model 511)

#### Indications for Use (Describe)

The Affinity NT™ Oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.

Type of Use (Select one or both, as applicable)

| <span></span> Prescription Use (Part 21 CER 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------|-----------------------------------------------------------|
|------------------------------------------------------------|-----------------------------------------------------------|

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{7}------------------------------------------------

510(k) Number (if known) K183490

Device Name

Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with Trillium™ Biosurface (Model 511T)

Indications for Use (Describe)

The Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with Trillium™ Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{8}------------------------------------------------

510(k) Number (if known) K183490

#### Device Name

Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541)

Indications for Use (Describe)

The Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{9}------------------------------------------------

510(k) Number (if known) K183490

Device Name

Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R)

Indications for Use (Describe)

The Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{10}------------------------------------------------

510(k) Number (if known) K183490

Device Name

Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T)

Indications for Use (Describe)

The Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Plasma Resistant Fiber [PRF] Oxygenator with Trillium Biosurface) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|--|
| <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{11}------------------------------------------------

510(k) Number (if known) K183490

Device Name

Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T-R)

Indications for Use (Describe)

The Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Plasma Resistant Fiber [PRF] Oxygenator with Trillium Biosurface) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Type of Use (Select one or both, as applicable)

| <div><span style="font-size: 10pt;"></span><span style="font-family: Wingdings;">X</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|----------------------------------------------------------------------------------------------------------------------------------------------|
| <div><span style="font-size: 10pt;"></span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{12}------------------------------------------------

510(k) Number (if known) K183490

Device Name

Affinity® NT Integrated Trillium™ CVR/Membrane Oxygenator (Model 541TT)

Indications for Use (Describe)

The Affinity® NT Integrated Trillium™ CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Oxygenator with Trillium™ Biosurface) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Type of Use (Select one or both, as applicable)

| <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------|
|---------------------------------------------------------------------------|--------------------------------------------------------------------------|

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{13}------------------------------------------------

510(k) Number (if known) K183490

Device Name

Affinity® NT Integrated Trillium™ CVR/Membrane Oxygenator (Model 541TT-R)

Indications for Use (Describe)

The Affinity® NT Integrated Trillium™ CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Oxygenator with Trillium™ Biosurface) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{14}------------------------------------------------

510(k) Number (if known) K183490

Device Name

Affinity NTTM Oxygenator with CortivaTM BioActive Surface (Model CB511)

Indications for Use (Describe)

The Affinity NT™ Oxygenator with Cortiva™ BioActive Surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.

Type of Use (Select one or both, as applicable)

| <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------|
| <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{15}------------------------------------------------

510(k) Number (if known) K183490

Device Name

Affinity NTTM Integrated Uncoated CVR/Oxygenator with Cortiva™ BioActive Surface (Model CB541)

Indications for Use (Describe)

The Affinity NT™ Integrated Uncoated CVR/Oxygenator with Cortiva™ BioActive Surface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------|--|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |
| <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]