Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir

K191444 · Medtronic, Inc. · DTZ · Sep 27, 2019 · Cardiovascular

Device Facts

• Record ID: K191444
• Device Name: Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir
• Applicant: Medtronic, Inc.
• Product Code: DTZ · Cardiovascular
• Decision Date: Sep 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Affinity NT oxygenator 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 uncoated Affinity NT cardiotomy/venous reservoir (CVR) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine CPB procedures up to 6 hours in duration.

Device Story

The Affinity NT Oxygenator (Models 511B and 541B) is a cardiopulmonary bypass device used in extracorporeal perfusion circuits. It functions by oxygenating venous blood, removing carbon dioxide, and regulating blood temperature via integrated heat exchange. The 541B model includes an uncoated cardiotomy/venous reservoir for collecting venous and suctioned blood. The device is operated by perfusionists in clinical settings such as the operating room during cardiac surgery. It provides essential life support by maintaining gas exchange and hemodynamic stability during procedures lasting up to 6 hours. The Balance biosurface is applied to the oxygenator to improve hemocompatibility.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing.

Technological Characteristics

The device consists of an oxygenator with a Balance biosurface and an optional uncoated cardiotomy/venous reservoir. It utilizes a hollow-fiber membrane for gas exchange and an integrated heat exchanger for thermal regulation. The device is designed for extracorporeal perfusion circuits. It is a mechanical device without software or electronic components.

Indications for Use

Indicated for patients undergoing routine cardiopulmonary bypass (CPB) procedures requiring blood oxygenation, carbon dioxide removal, and temperature regulation for up to 6 hours. The reservoir is indicated for collection of venous and cardiotomy suctioned blood during these procedures.

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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September 27, 2019

Medtronic, Inc. Harsh Dharamshi Senior Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, Minnesota 55428

Re: K191444

Trade/Device Name: Affinity NT Oxygenator with Balance Biosurface (Model 511B), Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (Model 541B) Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II Product Code: DTZ Dated: August 28, 2019 Received: August 29, 2019

Dear Harsh Dharamshi:

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 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, and prohibitions 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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K191444

Device Name

Affinity NT Oxygenator with Balance biosurface (Model 511B)

Indications for Use (Describe)

The Affinity NT oxygenator 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.

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

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# Indications for Use

510(k) Number (if known) K191444

Device Name

Affinity NT Oxygenator with Balance biosurface and uncoated cardiotomy/venous reservoir (541B)

Indications for Use (Describe)

The Affinity NT oxygenator 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 uncoated Affinity NT cardiotomy/venous reservoir (CVR) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine CPB procedures up to 6 hours in duration.

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."