The Affinity Fusion Oxygenator with Integrated Arterial Filter and 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 procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass 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 to the patient for blood volume replacement.

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.

Device Description

The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood 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. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Cortiva BioActive Surface or Balance Biosurface bonded to the blood contacting surface of the integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

AI/ML Overview

The provided text is a 510(k) Summary for the Medtronic Affinity Fusion Oxygenator System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a novel device. Therefore, much of the requested information about a specific study proving the device meets acceptance criteria is not explicitly provided in this type of regulatory submission.

However, I can extract the relevant information that is available and clarify what is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics relevant to an "AI system" or "medical device performance" in the general sense, as typically sought in such a request. Instead, it refers to "predetermined requirements" and "improved bond performance" for specific components.

The "performance" referred to in this document primarily relates to the device meeting its intended function as an oxygenator and arterial filter during cardiopulmonary bypass. The summary states that "Operation and performance qualification... were completed" and that "the manufacturing process consistently produces product that meets predetermined requirements."

Aspect of Performance/Criteria	Reported Device Performance / Evaluation Outcome
Overall Performance	- "No newly emerging hazards or risks were identified." - "Modifications... result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate device."
Manufacturing Process	"Consistently produces product that meets predetermined requirements under challenge and normal operating conditions."
Pressure Integrity	Evaluated as part of OQ/PQ. (Specific criteria/results not detailed)
Burst (Strength)	Evaluated as part of OQ/PQ. (Specific criteria/results not detailed)
Torque (TMA bond)	"Improved bond performance relative to the current material."
Insertion Depth (TMA)	Evaluated as part of OQ/PQ. (Specific criteria/results not detailed)
Biocompatibility	New material is "biocompatible per the ISO 10993 standard and does not require new biocompatibility testing."
TMA Seal (non-patient contacting)	"Verified through the part specifications, along with random sampling and statistical modeling."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of an AI/algorithm evaluation. For the physical device modifications, it mentions "random sampling and statistical modeling" for the TMA seal, but no specific sample sizes or data provenance (country, retrospective/prospective) are provided for these manufacturing/design evaluations.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to the provided document. The submission pertains to modifications of a physical medical device (oxygenator) and its manufacturing process, not to an AI/algorithm that requires expert-established ground truth from a dataset.

4. Adjudication Method

This information is not applicable to the provided document, as it does not describe an AI/algorithm evaluation requiring adjudication of ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable to the provided document. The submission is for a physical medical device and does not involve AI assistance to human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable to the provided document. The submission is for a physical medical device and does not involve an AI algorithm.

7. Type of Ground Truth Used

This information is not applicable in the context of an AI/algorithm. For the physical device, the "ground truth" or verification is based on engineering specifications, performance testing (pressure integrity, burst, torque, insertion depth), and biocompatibility standards (ISO 10993).

8. Sample Size for the Training Set

This information is not applicable to the provided document, as it does not describe an AI/algorithm that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable to the provided document, as it does not describe an AI/algorithm.

Summary of what the document does provide:

The document describes a 510(k) premarket notification for the Affinity Fusion Oxygenator System, which involves modifications to a legally marketed predicate device (K203111). The core of the submission is to demonstrate substantial equivalence to this predicate device.

The study presented is not a classic "clinical trial" or "AI validation study" but rather a series of engineering and qualification tests to ensure that the modifications (specifically, changes to the Temperature Monitoring Adapter (TMA) insert component material and insertion depth, and different bioactive surfaces) do not alter the fundamental performance, safety, or efficacy of the device.

Key points from the document regarding "proof" and "acceptance":

Proof of Meeting Acceptance Criteria: The proof is based on "Operation and performance qualification (OQ/PQ)" and "Design Characterization" activities. These activities evaluate various physical properties and manufacturing consistency.
Acceptance Criteria (Implied): The implied acceptance criteria are that the modified device's performance (e.g., pressure integrity, burst, torque, insertion depth, biocompatibility) meets internal predetermined requirements and does not introduce new hazards compared to the predicate device. For example, the TMA bond evaluation "indicated improved bond performance relative to the current material," suggesting a performance target was met or exceeded. Biocompatibility was accepted based on the new material already being used in another cleared device and conforming to ISO 10993.
Study Design: The study is a non-clinical engineering and bench testing evaluation rather than a clinical trial or AI performance study. It's focused on validating the impact of specific component changes.
Conclusion: The manufacturer concluded, and the FDA agreed by clearing the device, that these modifications maintain substantial equivalence to the predicate device, meaning it is as safe and effective as a device already on the market.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

Medtronic Inc. Aj Thakkar Sr. Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, Minnesota 55428 04/06/2023

Re: K230640

Trade/Device Name: Affinity Fusion™ Oxygenator System Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: March 7, 2023 Received: March 8, 2023

Dear Aj Thakkar:

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 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

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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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Kathleen M. Digitally signed by Grunder -S Date: 2023.04.06 for Nicole Gillette 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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510(k) Number (if known)

Device Name

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

Indications for Use (Describe)

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

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)

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 PRAStaff@fda.hhs.gov

"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."

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510(k) Number (if known)

Device Name

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

Indications for Use (Describe) Oxygenator with Integrated Arterial Filter

Cardiotomy/Venous Reservoir

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 to the patient for blood volume replacement.

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)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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."

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510(k) Number (if known)

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 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)
Prescription Use (Part 21 CFR 801 Subpart D)	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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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."

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510(k) Number (if known)

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) Oxygenator with Integrated Arterial Filter

Cardiotomy/Venous Reservoir

The Affinity Fusion cardiotomy/venous reservorr 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 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)
Prescription Use (Part 21 CFR 801 Subpart D)
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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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."

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510(k) Summary

Submitter

Date Prepared:	March 7, 2023
Applicant:	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establishment Registration Number: 2184009
Contact Person:	Aj ThakkarSenior Regulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: 508-452-4897Email: aj.thakkar@medtronic.com
Alternate Contact:	Ryan CalabreseVP, Regulatory AffairsMedtronic Perfusion SystemsPhone: 763-526-3515Email: ryan.s.calabrese@medtronic.com

Device

ModelNos.	Trade Name	Common Name	ClassificationName	Class	ClassificationPanel	Regulation(21 CFR)	ProductCode
CB811	Affinity FusionOxygenator withIntegrated ArterialFilter and Cortiva™BioActive Surface	Oxygenator	Cardiopulmonarybypass oxygenator	Class II	Cardiovascular	870.4350870.4260	DTZDTM
CB841	Affinity FusionOxygenator withIntegrated ArterialFilter and Cortiva™BioActive Surface andCardiotomy/Venous ReservoirWith Balance™ Biosurface	Oxygenator	Cardiopulmonarybypass oxygenatorandCardiopulmonarybypass bloodreservoir	Class II	Cardiovascular	870.4350870.4260870.4400	DTZDTMDTN
BB811	Affinity FusionOxygenator withIntegrated Arterial Filterand Balance Biosurface	Oxygenator	Cardiopulmonarybypass oxygenator	Class II	Cardiovascular	870.4350	DTZ

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BB841	Affinity FusionOxygenator withIntegrated Arterial FilterAnd Cardiotomy/VenousReservoir with BalanceBiosurface	Oxygenator	Cardiopulmonarybypass oxygenatorandCardiopulmonarybypass bloodreservoir	Class II	Cardiovascular	870.4350870.4260870.4400	DTZDTMDTN
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Predicate Device

Trade Name	510(k)	Clearance Date
Affinity Fusion Oxygenator	K203111	September 16, 2021

No reference devices were used in this submission.

Device Description

Principles of Operation

Affinity Oxygenators are designed to be an integral part of the cardiopulmonary heart bypass circuit for use during cardiac surgery. The Affinity Oxygenators are 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.

The oxygenator is composed of the "fiber bundle" which is the gas exchange portion of an oxygenator. The "fiber bundle" is comprised of tiny hollow tubes, or "hollow fibers" that consist of a microporous membrane that allows for gas exchange. Blood flows over the outside surfaces of the hollow fibers while fresh gas is delivered to the inside of the fibers allowing for gas exchange.

Blood that comes from the patient is delivered through a pump to the oxygenator and other auxiliary devices, and back to the patient. The oxygenator can be connected to a heater/cooler device, recirculation circuit, cardioplegia circuit, and the main blood path. The oxygenator is under constant fluid pressure. There is pressure exerted on the blood-side of the device from the blood pump and patient, the water-

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side of the device due to the flow of the heater-cooler for water, and the gas-side of the device due to the flow of gases through the device. The water-side of the oxygenator is connected to a heater/cooler device to enable temperature control of the blood.

Indications for Use

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

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

Oxygenator with Integrated Arterial Filter

Cardiotomy/Venous Reservoir

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

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

Oxygenator with Integrated Arterial Filter

Cardiotomy/Venous Reservoir

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 vacuumassisted 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 to the patient for blood volume replacement.

Comparison of Technological Characteristics with the Predicate Device

A comparison of the modified product to the currently marketed predicate products (K203111) indicates the following similarities:

Intended Use / Indications for use
Contraindications
. Operating Principle
Mechanism of action
Performance
. Shelf Life
Packaging configuration and Materials
Sterilization process and requirements
Did not require clinical data to verify safety and efficacy

When compared to the predicate devices, the Affinity Fusion Oxygenator Devices presented in this submission have the following differences:

Temperature Monitoring Adapter (TMA) insert component material and insertion depth

Performance Data

Operation and performance qualification, biocompatibility rationale and the design characterization activities were completed, and they have led to the conclusion that no newly emerging hazards or risks were identified.

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Operation Qualification and Performance Qualification (OQ/PQ)

Operation qualification and performance qualification was carried out to provide objective evidence that the manufacturing process consistently produces product that meets predetermined requirements under challenge and normal operating conditions respectively, including pressure integrity, burst, torgue and insertion depth testing.

Design Characterization

The bond between the new material and adhesive was evaluated utilizing the interfacial surface, geometry, material and adhesive compatibility. This evaluation indicated improved bond performance relative to the current material. The PQ torque data for the new TMA serves as an approximation of the long-term shelf-life performance of the TMA bond.

Biocompatibility Assessment

A biocompatibility assessment was carried out to demonstrate that new material, which is currently used in the Affinity Pixie CVR Oxygenator, is biocompatible per the ISO 10993 standard and does not require new biocompatibility testing. The unique interaction of the new material with the adhesive is non-patient contacting. The new TMA creates a seal preventing contact with the circulating blood volume, and this interference fit has been verified through the part specifications, along with random sampling and statistical modeling.

Conclusion

Medtronic has demonstrated through testing completed that the modifications made to the Affinity Fusion Oxygenator System described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate device.

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.”