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.

Model 511T:

The Affinity NT Oxygenator 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 (CPB) procedures up to 6 hours in duration.

Device Description

The device listed in this 510(k) Notification is single use, non-toxic, non-pyrogenic, and is supplied sterile in packaging.

The Medtronic Affinity NT Oxygenator is a single use device designed to oxygenate and remove carbon dioxide from the blood and with the heat exchanger and arterial filter cools or warms the blood during extracorporeal circulation. The oxygenator has either a blood contacting Trillium™ Biosurface or is uncoated.

Affinity NT Oxygenator is designed to be an integral part of the cardiopulmonary heart lung bypass circuit for use during cardiac surgery. Blood that comes from the patient is delivered through a blood pump to the oxygenator and other auxiliary devices, and then back to the patient.

The purpose of this 510(k) Notification is to notify the FDA of a labeling change to the disinfectant warning on the Instructions for Use to allow for disinfectant use in the water path of the oxygenator as well as report previous changes for the Affinity NT Oxygenator models included in this submission.

AI/ML Overview

The request concerns a 510(k) submission for the Medtronic Affinity NT Oxygenator (Models 511 and 511T). This document is a regulatory notice granting 'substantial equivalence' and does not describe a study evaluating an AI/ML device or its performance against acceptance criteria in the manner requested (e.g., in terms of clinical performance, ground truth, expert consensus, MRMC studies, etc.).

The device is a cardiopulmonary bypass oxygenator, which is a physical medical device, not an AI/ML product. The performance data provided is related to its mechanical integrity and basic function rather than diagnostic or analytical performance.

Therefore, many of the requested fields are not applicable to this type of device and submission.

Here's the relevant information that can be extracted, and an explanation for why other fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Testing	Acceptance Criteria	Reported Device Performance
Pressure Integrity	Water path must withstand 45 PSI pressure for 6 hours without leaking	Pass
Burst	Water path burst testing should be comparable to that of control devices	Pass
Port Break	Water path break force shall be comparable to that of the control device	Pass

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided document for the mechanical tests.
Data Provenance: Not specified. Testing was conducted internally by Medtronic. It is a pre-market submission, so the data is prospective relative to the submission but does not involve patient data in these physical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for these physical tests is based on observable mechanical performance (e.g., does it leak, does it burst at a comparable pressure, does the port break at a comparable force) under controlled laboratory conditions, not expert interpretation of complex data.

4. Adjudication method for the test set:

Not applicable. Results are objective pass/fail based on predetermined physical thresholds or comparison to a predicate device's physical thresholds.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" for the performance tests (Pressure Integrity, Burst, Port Break) is based on objective physical measurements and adherence to predefined engineering specifications or comparison to the physical properties of a predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 06, 2016

Medtronic Cardiac and Vascular Group Renee Cveykus Principal Regulatory Affairs Specialist 8200 Coral Sea St. NE Mounds View, MN 55112

Re: K162896

Trade/Device Name: Affinity NT Oxygenator (Model 511), Affinity NT Oxygenator with Trillium Biosurface (Model 511T) Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTR Dated: October 14, 2016 Received: October 17, 2016

Dear Ms. Cveykus:

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. 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 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 (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M.A. Hilleman

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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Indications for Use

510(k) Number (if known)

K162896

Device Name Affinity NT Oxygenator

Indications for Use (Describe)

Model 511:

Model 511T:

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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5.1 510(k) Summary

Date Prepared:	October 14, 2016
Submitter:	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establishment Registration Number: 2184009
Contact Person:	Renee L. CveykusPrincipal Regulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: (763) 505-3059Fax: (763) 367-0401Email: renee.l.cveykus@medtronic.com
Alternate Contact:	Susan C. FidlerSr. Regulatory Affairs ManagerMedtronic Perfusion SystemsPhone: (763) 514-9839Fax: (763) 367-8360Email: susan.c.fidler@medtronic.com

Proprietary Name:

Proprietary Name:
Models	Description
511	Affinity NTTM Oxygenator
511T	Affinity NTTM Oxygenator with TrilliumTM Biosurface

Device Name and Classification:

Trade Name:	Affinity NTTM Oxygenator with TrilliumTM Biosurface
Common Name:	Oxygenator
Classification Name:	Cardiopulmonary bypass Oxygenator
Classification Panel:	Cardiovascular
Regulation Number:	21 CFR 870.4350
Product Code:	DTZ
Classification:	Class II

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Predicate Device:

Medtronic Affinity NT Oxygenators (K143073). The scope of this predicate submission is below and included both uncoated and Trillium coated models.

Product Family	Model	Description
Affinity NT Oxygenator	511	Affinity NT Oxygenator
	511T	Affinity NT Oxygenator with Trillium Biosurface

Device Description

The device listed in this 510(k) Notification is single use, non-toxic, non-pyrogenic, and is supplied sterile in packaging.

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Indications for Use

There is no change to the intended use of the devices within the scope of the proposed change in this Traditional 510(k) Notification. The current Indications for Use statements for these devices are listed below:

The Affinity NT Oxygenator (Model 511) 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 NT Oxygenator with Trillium Biosurface (model 511T) 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.

Comparison to Predicate Devices

The Affinity NT Oxygenator has the same intended use, design and materials, and principles of operation and technology when compared to the predicate Affinity NT Oxygenator.

Intended Use: The intended use is the same as the predicate device. ●
Design: The design is the same as the predicate device.
Materials: The materials of the Affinity NT Oxygenator are the same as the predicate device.
Principles of Operation and Technology: The principles of operation are the same as the predicate device.
Performance: The performance of the device is the same as the predicate device. ●

Summary of Performance Data

Testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:

Testing	Description	Result
Pressure Integrity	Water path must withstand 45 PSI pressure for 6 hours without leaking	Pass
Burst	Water path burst testing should be comparable to that of the control devices	Pass
Port Break	Water path break force shall be comparable to that of the control device	Pass

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An analysis was also completed to characterize the physical properties of the materials used to construct the water side of the heat exchanger.

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Conclusion

In summary, the information provided within the submission demonstrates that the Affinity NT Oxygenator Uncoated or with Trillium Biosurface is substantially equivalent to the marketed predicate devices.

Regulation Number and Section

§ 870.4350 Cardiopulmonary bypass oxygenator.

(a)
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.(b)
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.”