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.

Device Description

The Affinity Fusion Hollow Fiber Oxygenator with Integrated Arterial Filter and Balance Biosurface is a single use, microporous, hollow fiber, gas exchange device with plasma-resistant fiber and integrated heat exchanger. The oxygenator is coated on its primary blood contacting surfaces with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface. The focus of the submission is on demonstrating substantial equivalence to a predicate device (Affinity NT Oxygenator 511T), rather than establishing de novo performance criteria with a clinical study. Therefore, the information requested regarding acceptance criteria and studies proving the device meets those criteria in the traditional sense of a clinical trial (e.g., sample size for test set, number of experts for ground truth, MRMC studies) is largely not applicable in this context.

Instead, the submission relies on in vitro testing to show that the new device performs comparably to the predicate device and meets established performance specifications and standards for cardiopulmonary bypass oxygenators and arterial bloodline filters.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various in vitro tests conducted. It states that "The Affinity Fusion Oxygenator passed each test mentioned in the table below." This implies that the acceptance criteria for each test were met, demonstrating functional/performance and physical/mechanical characteristics. However, specific numerical acceptance criteria (e.g., "gas transfer efficiency must be >X%") and the exact numerical results obtained ("gas transfer efficiency was Y%") are not provided in this summary.

Test	Test Classification	Outcome
Gas Transfer	Functional/Performance	Passed (Implied: Met established specifications for gas transfer)
Heat Exchanger Performance	Functional/Performance	Passed (Implied: Met established specifications for heat exchange)
High Flow Blood Trauma	Functional/Performance	Passed (Implied: Met established specifications for blood trauma)
Min Flow Blood Trauma	Functional/Performance	Passed (Implied: Met established specifications for blood trauma)
Time to Prime	Functional/Performance	Passed (Implied: Met established specifications for priming time)
Gross Air Handling	Functional/Performance	Passed (Implied: Met established specifications for air removal)
Filtration Efficiency	Functional/Performance	Passed (Implied: Met established specifications for filtration)
Cap Pulls	Physical/Mechanical	Passed (Implied: Met established specifications for cap integrity)
Integrity	Physical/Mechanical	Passed (Implied: Met established specifications for overall integrity)
Port Break and Tube Pull	Physical/Mechanical	Passed (Implied: Met established specifications for port/tube strength)
Luer port design - sampling port	Physical/Mechanical	Passed (Implied: Met established specifications for luer port design)
Luer port design - air purge line	Physical/Mechanical	Passed (Implied: Met established specifications for luer port design)
Balance Coverage/Leaching	Functional/Performance	Passed (Implied: Met established specifications for coating)
Particulate Shedding	Functional/Performance	Passed (Implied: Met established specifications for particulate matter)

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

Sample Size: Not explicitly stated. The tests were "in vitro testing," meaning laboratory bench tests rather than tests on human subjects. The number of devices or test runs for each in vitro test is not specified.
Data Provenance: In vitro testing, conducted in a laboratory setting. No country of origin for patient data or retrospective/prospective classification is applicable as it's not a clinical study.

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

Not Applicable. As this was in vitro performance testing against established standards and specifications, there was no "ground truth" established by human experts in the way it would be for diagnostic device evaluation (e.g., radiologists interpreting images). The "ground truth" here is the adherence to performance standards and specifications outlined in the referenced guidance documents and ISO standards.

4. Adjudication Method for the Test Set:

Not Applicable. No human interpretation or adjudication in the context of expert consensus was involved for these in vitro tests. The results were likely measured objectively by instruments and compared against predetermined numerical or pass/fail criteria.

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

No. This type of study is relevant for diagnostic imaging devices or algorithms where human readers' performance is being evaluated. The Affinity Fusion Oxygenator is a medical device for cardiopulmonary bypass; therefore, an MRMC study is not applicable.

6. Standalone (Algorithm Only) Performance:

Not Applicable. This concept applies to AI/software as a medical device. The Affinity Fusion Oxygenator is a physical device, not an algorithm. Its "standalone" performance refers to its operational characteristics during in vitro testing.

7. Type of Ground Truth Used:

For in vitro testing, the "ground truth" is defined by:
- Relevant requirements of "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff issued on November 13, 2000."
- ISO 7199 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)."
- ISO 15675 "Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters."
  The device's performance was measured against the specifications and requirements laid out in these regulatory and international standards.

8. Sample Size for the Training Set:

Not Applicable. The device did not involve machine learning or an algorithm that required a "training set" of data.

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

Not Applicable. As there was no training set, this information is not relevant.

Summary

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K122827

1 4 2012

510(k) Summary of Safety and Effectiveness

Date Prepared:	September 12, 2012
	DEC 1
Applicant:	Medtronic, Inc.
	Medtronic Perfusion Systems
	7611 Northland Drive
	Brooklyn Park, MN 55428
	Establishment Registration No. 2184009
Contact Person:	Mary Donlin
	Senior Regulatory Affairs Specialist
	Phone: (763) 526-9172
	Fax: (763) 367-8147
	E-mail:mary.e.donlin@medtronic.com
Trade Name:	Affinity Fusion® Oxygenator with Integrated Arterial Filter andBalance® Biosurface
Common Name:	Oxygenator
Classification Name:	Cardiopulmonary bypass oxygenator
Classification:	Class II, 21 CFR 870.4350

Product Code:

DTZ

Name of Predicate Device: Affinity NT Oxygenator 511T (K973760)

Device Description:

Intended Use:

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Contraindications:

Do not use this device for any purpose other than indicated.

Comparison to the Predicate Device:

The Affinity Fusion Oxygenator Model BB811 has the same intended use and principles of operation and technology when compared to the predicate device. The design incorporated an integrated heat exchanger and an integrated arterial filter. The material used to manufacture the housing of the oxygenator is a copolvester material that is Bisphenol A-free (BPA free).

Intended Use:

The Affinity Fusion Oxygenator has the same intended use as the predicate Affinity NT oxygenator (K973760) with the addition of the filtering capability due to the integration of arterial filter within the fiber bundle assesmbly.

Design and Materials: .

The design and the materials of the Affinity Fusion Oxygenator and the predicate device are essentially the same. The design of the oxygenator device is similar in that they each contain a heat exchanger for temperature control, and a fiber bundle assembly for gas transfer. The device is manufactured with various adhesives and urethanes. The housing of the Affinity Fusion oxygenator is made of a Bisphenol A-free (BPA-free) Eastman Tritan TM Copolyester, MX731, which differs from the polycarbonate material used in the predicate devices. The Affinity Fusion oxygenator Model BB811 is provided with Balance Biosurface coating. Balance is a biocompatible surface coating that increases the thromboresistance of the blood contact surfaces. Balance is a heparin free version of Trillium coating. Trillium coating is available on the Affinity NT Hollow Fiber Oxygenator.

• Principles of Operation and Technology:

The principles of operation of the subject device and the predicate devices are essentially identical. Blood is pumped into the heat exchanger device whereby blood temperature is controlled with the use of essentially a water bath. After the blood exits the heat exchanger, it enters the oxygenator device through the fiber bundle assembly through which the gas transfer occurs (i.e., introduction of oxygen; removal of carbon dioxide). The transfer process occurs via diffusion across the walls of the hollow fiber membranes contained within the oxygenator.

• Performance:

In vitro testing was carried out in accordance with the relevant requirements of "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and

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FDA Staff issued on November 13, 2000, " ISO 7199 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)"; and ISO 15675 "Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters".

In vitro testing was carried out to demonstrate both the substantial equivalence with the predicate device and also to comply with safety and effectiveness requirements.

Testing supplied in the 510(k) premarket notification includes performance tests, physical and mechanical integrity tests that demonstrate compliance with performance specifications.

The tests that were performed are listed in the following summary table. The Affinity Fusion Oxygenator passed each test mentioned in the table below.

Test	Test Classification	Test Title
1.	Functional/Performance	Gas Transfer
2.	Functional/Performance	Heat Exchanger Performance
3.	Functional/Performance	High Flow Blood Trauma
4.	Functional/Performance	Min Flow Blood Trauma
5.	Functional/Performance	Time to Prime
6.	Functional/Performance	Gross Air Handling
7.	Functional/Performance	Filtration Efficiency
8.	Physical/Mechanical	Cap Pulls
9.	Physical/Mechanical	Integrity
10.	Physical/Mechanical	Port Break and Tube Pull
11.	Physical/Mechanical	Luer port design - sampling port
12.	Physical/Mechanical	Luer port design - air purge line
13.	Functional/Performance	Balance Coverage/Leaching
14.	Functional/Performance	Particulate Shedding

Conclusion:

The data included in this submission is sufficient to provide reasonable assurance of the safety and effectiveness of the device and the Affinity Fusion® Oxygenator with Integrated Arterial Filter is substantially equivalent to the legally marketed predicate device, Affinity NT Oxygenator 511T (K973760).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract caduceus or a symbol representing health and human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

DEC 14 2012 .

Medtronic Cardiovascular Mary E. Donlin. Senior Regulatory Affairs Specialist 8200 Coral Street NE Mailstop MVS83 Mounds View, MN 551112

Re: K122827

Trade/Device Name: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface

Regulation Number: 21 CFR 870.4350

Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ

Dated: September 12, 2012

Received: September 18, 2012

Dear Ms. Donlin:

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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Page 2 - Ms. Mary E. Donlin

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic ford in the quality systems (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 n you desire specific davide in your avers offices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Tou may of Small Manufacturers, International and Consumer Assistance 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,

Matthew G. Hillebrenner

for

Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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4.0 Indications for Use Statement

K122827 510(k) Number (if known):

Device Name:

Affinity Fusion® Oxygenator with Integrated Arterial Filter and Balance® Biosurface

Indications for Use:

× Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number	K122827

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.”