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 procedures up to 6 hours in duration.

Device Description

The device listed in this 510(k) Notification is a 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 a blood contacting Cortiva™ -BioActive Surface.

The Affinity NT Hollow Fiber Oxygenator (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 procedures up to 6 hours in duration.

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 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 model included in this submission.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Medtronic Affinity NT Oxygenator with Cortiva™ Bioactive Surface. It focuses on demonstrating substantial equivalence to a predicate device, specifically regarding a labeling change and previous modifications.

This document does not contain information on acceptance criteria for device performance related to a study proving the device meets those criteria, nor does it describe a study like a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study. The content of this document suggests that the device in question is a medical device (oxygenator) rather than an AI/ML powered device, which is relevant to why such information is absent.

Therefore, many of the requested details cannot be extracted from this document, especially those pertaining to AI/ML device performance and ground truth establishment.

However, I can provide information based on the performance tests conducted to verify the device's characteristics, as described:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Water path must withstand 45 PSI pressure for 6 hours without leaking	Pass
Water path burst testing should be comparable to that of the control devices	Pass
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 (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The tests described are engineering/mechanical performance tests, not clinical evaluations requiring expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the document. The performance tests are objective engineering measurements.

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

An MRMC study was not done, and this device is not an AI-powered device. Clinical testing was explicitly stated as not required to establish substantial equivalence for this submission.

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

A standalone performance evaluation of an algorithm was not done, as this is not an AI-powered device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance tests appears to be engineering specifications and measurements. For example, the water path resistance to pressure is a quantitative engineering specification.

8. The sample size for the training set

This information is not applicable and not provided in the document, as this is not an AI/ML device that requires a training set.

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

This information is not applicable and not provided in the document.

Summary

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

September 21, 2016

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

Re: K162016

Trade/Device Name: Affinity NT Oxygenator with Cortiva™ Bioactive Surface Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTR Dated: July 20, 2016 Received: July 21, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/ResourcesforYou/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. Willehemen

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)

K162016

Device Name Affinity NT Oxygenator with Cortiva™ BioActive Surface

Indications for Use (Describe)

Model CB511:

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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Date Prepared:	July 19, 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:

Models	Description
CB511	Affinity NT Oxygenator with Cortiva™ BioActive Surface

Device Name and Classification:

Trade Name:	Affinity NT Oxygenator with Cortiva™ BioActive Surface
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)

Device Description

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

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 statement for this device is listed below:

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

1 Note: Product Name changed from Affinity NT Oxygenator with Carmeda® BioActive Surface to Affinity NT Oxygenator with Cortiva™ BioActive Surface (Submitted to File K143073/A002 dated June 15, 2016).

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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 hourswithout leaking	Pass
Burst	Water path burst testing should be comparable to that ofthe control devices	Pass
Port Break	Water path break force shall be comparable to that of thecontrol device	Pass

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

Conclusion

Medtronic has demonstrated that the modification made to the Affinity NT Oxygenator with Cortiva™ BioActive Surface is substantially equivalent to the predicate devices based upon design, test results, and indications for use.

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.”