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 six 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 Oxygenator with Integrated Arterial Filter and Carmeda Bio-Active 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 six hours in duration.

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

Device Description

Affinity Fusion Oxygenators with Integrated Arterial Filter and with Balance Biosurface or Carmeda BioActive Surface are single-use, microporous, hollow-fiber, gas exchange device with plasma-resistant fiber and integrated heat exchanger and arterial filter. The oxygenators are bonded on their primary blood contacting surfaces with either Balance Biosurface or Carmeda BioActive Surface.

The device is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood. The device is also used to cool or warm the blood during routine cardiopulmonary bypass procedures up to six hours in duration. The integrated filter is designed to filter from the extracorporeal circuit microemboli larger than the specified micron size (25u). The filtration functionality is achieved through the progressively tighter fiber spacing within the fiber bundle assembly (FBA) inside the oxygenator.

The purpose of this Special 510(k) Notification was to notify the FDA of an alternate material formulation for the luer caps used on the recirculation, cardioplegia and sampling ports of the Affinity Fusion Oxygenator with Integrated Filter and with either Balance Biosurface or Carmeda BioActive Surface.

AI/ML Overview

This document describes a Special 510(k) Notification for the Medtronic Affinity Fusion Oxygenator with Integrated Arterial Filter, with either Balance™ Biosurface or Carmeda® BioActive Surface. The purpose of this notification is to advise the FDA of an alternate material formulation for the luer caps used on the recirculation, cardioplegia, and sampling ports of the device.

Given that this is a Special 510(k) focusing on a minor material change to luer caps and states that "Clinical testing was not required to establish substantial equivalence," the typical comprehensive device performance study structure (including detailed acceptance criteria, sample sizes for test and training sets, expert involvement, and ground truth establishment) is not present in the provided text in the way it would be for a novel device or a significant modification that impacts clinical performance.

However, I can extract the relevant information regarding the performance data that was required and what was concluded regarding substantial equivalence, and then explain why other typical study details are absent.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria for the performance tests in the format of a table with specific thresholds. It confirms that the tests were conducted and the device continued to meet the substantial equivalence requirements.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility standards met with new luer cap material.	Biocompatibility testing was conducted and found acceptable.
Positive pressure integrity maintained with new luer cap material.	Positive pressure integrity testing was conducted and found acceptable.
All other performance characteristics (e.g., oxygenation, CO2 removal, heat exchange, filtration efficiency, operating principle, overall design, dimensions) remain unchanged and equivalent to the predicate device.	Bench testing verified these characteristics are unchanged and equivalent to the predicate device despite the luer cap material change.

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

Sample Size: Not explicitly stated for either biocompatibility or positive pressure integrity tests. The document only mentions that "bench testing was used."
Data Provenance: The tests were "bench testing," meaning in-vitro, laboratory-based testing conducted by Medtronic. The origin of any specific biological materials (if used in biocompatibility) or external data is not specified. It is prospective testing performed on the modified device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The "ground truth" in this context refers to engineering specifications and regulatory standards for biocompatibility and pressure integrity, not a clinical interpretation by medical experts. These are objective, measurable parameters.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed (biocompatibility, positive pressure integrity) involve objective measurements against established engineering and regulatory requirements, not subjective interpretation requiring an adjudication panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. This type of study is conducted for diagnostic or image-interpretation devices to assess human reader performance with and without AI assistance. The Affinity Fusion Oxygenator is a therapeutic device (extracorporeal perfusion circuit component), not an AI-based diagnostic tool.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done:

No. This also relates to AI-based diagnostic algorithms. The performance of the oxygenator itself (oxygenation, CO2 removal, heat exchange, filtration) is assessed in a standalone context on the bench, but it's not an algorithm, so the terminology doesn't fit. The "algorithm-only" concept typically refers to the diagnostic output of an AI system without human medical interaction.

7. The Type of Ground Truth Used:

For Biocompatibility: Established international and national standards for biological evaluation of medical devices (e.g., ISO 10993 series), ensuring the new material does not induce harmful biological responses.
For Positive Pressure Integrity: Established engineering specifications for the device's structural integrity, ensuring it can withstand operational pressures without leakage or failure.
For other performance characteristics: Established engineering specifications and performance benchmarks derived from the predicate device's cleared performance, ensuring oxygenation efficiency, CO2 removal rate, heat exchange capabilities, and filtration efficacy remain consistent.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable for the same reason as point 8.

Summary of the Study and Conclusion:

The study described here is a bench-testing verification of a minor material change to a previously cleared medical device (Affinity Fusion Oxygenator). The primary goal was to demonstrate that changing the luer cap material does not adversely affect the device's fundamental performance characteristics, safety, or effectiveness.

The document states:
"Bench testing was used to verify the performance characteristics of these devices. Clinical testing was not required to establish substantial equivalence."
And
"The following performance tests were conducted:

Biocompatibility
Positive pressure integrity"

The conclusion is that:
"In summary, the information included in this submission demonstrates that with changes made to the Affinity Fusion Oxygenators with Integrated Filter and with Balance Biosurface or Carmeda BioActive Surface are substantial equivalent to the legally marketed predicate versions."

This means that the implied acceptance criteria for these tests were successfully met, affirming that the modified device, despite the new luer cap material, maintains the same performance and safety profile as the predicate devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

Medtronic, Inc. Lisa Stone Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112

Re: K142784

Trade/Device Name: Affinity Fusion® Oxygenator with Integrated Arterial Filter and with Balance TM Biosurface or Carmeda® BioActive Surface Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: September 26, 2014 Received: September 26, 2014

Dear Ms. Stone:

This letter corrects our substantially equivalent letter of October 24, 2014.

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.

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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 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 yours.

M.A. Hillebrand

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142784

Device Name

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface

Indications for Use (Describe)

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."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740

Affinity Fusion Oxygenators Medtronic Confidential

KXXXXXXX 1-26

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142784

Device Name

Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bio-Active Surface

Indications for Use (Describe)

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carneda Bio-Active 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 six 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)

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."

FORM FDA 3881 (8/14)

PSC Publishing Services (301) 443-6740

Affinity Fusion Oxygenators Medtronic Confidential

Image /page/3/Picture/21 description: The image contains two lines of text. The first line reads "KXXXXXXX", with the letter K followed by a series of X's. The second line reads "1-27", which appears to be a numerical range or identifier. The text is presented in a clear, legible font.

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Summary of Safety and Effectiveness

Date Prepared:	September 23, 2014
Applicant:	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveBrooklyn Park, MN 55428Establishment Registration No. 2184009
Contact Person:	Lisa StonePrincipal Regulatory Affairs SpecialistMedtronic, Inc.Coronary and Structural Heart Disease Management8200 Coral Sea Street NE, MVS 83Mounds View, MN 55112Phone: (763) 514-9866Fax: (763) 367-8147Email: lisa.j.stone@medtronic.com
Trade Name:	Affinity Fusion® Oxygenator with Integrated Arterial Filterand with Balance™ Biosurface or Carmeda® BioActiveSurface
Common Name:	Oxygenator
Classification Name:	Cardiopulmonary Bypass Oxygenator
Classification:	Class II, 21 CFR 870.4350
Product Code:	DTZ
Name of Predicate Device:	Affinity Fusion® Oxygenator with Integrated Arterial Filterand with Balance™ Biosurface, Model BB811 (K122827)
	Affinity Fusion® Oxygenator with Integrated Arterial Filterand with Carmeda® BioActive Surface, Model CB811(K123314)

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Device Description

Intended Use

There were no changes to the intended use of the devices as related to the change purposed in this Special 510(k) Notification. The current Indications for Use statement is noted below:

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

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

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda 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 six hours in duration.

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

Comparison to the Predicate Device

The Affinity Fusion Oxygenators with Integrated Filter and with Balance Biosurface or Carmeda BioActive Surface are substantially equivalent to the previous versions (predicate) of these devices.

The modified oxygenators have the following similarities to the predicate devices which received 510(k) clearance:

Same intended use/indications ●
Same operating principle ●
Same fundamental technological characteristics
Same overall design, dimensions and performance ●
Substantially equivalent materials All materials are the same except for the protective o luer caps used on the recirculation, cardioplegia and sampling ports. These caps have undergone a minor formulation change.
Same packaging materials and design ●
Same sterilization requirements ●

Summary of Performance Data

Bench testing was used to verify the performance characteristics of these devices. Clinical testing was not required to establish substantial equivalence.

The following performance tests were conducted:

Biocompatibility
Positive pressure integrity

Conclusion

In summary, the information included in this submission demonstrates that with changes made to the Affinity Fusion Oxygenators with Integrated Filter and with Balance Biosurface or Carmeda BioActive Surface are substantially equivalent to the legally marketed predicate versions.

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.”