The AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

Device Description

The AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface is a single use device designed to filter microemboli from the blood in the extracorporeal circuits during cardiopulmonary bypass surgery. The AFFINITY 20 µ Arterial Blood Filter with Trillium" Biosurface is coated with a nonleaching biosurface.

AI/ML Overview

This document describes a Special 510(k) submission for a modification to the Medtronic AFFINITY® 20 µ Arterial Blood Filter. The modification involves coating the blood contact surfaces of the filter with Trillium™ Biosurface. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

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

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

The provided text does not explicitly state quantitative acceptance criteria or detailed reported device performance in a tabular format as would typically be found in a clinical study report. It states that "biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed arterial filters."

The types of tests performed included:

Coating Characteristics
Physical Characteristics
Performance Characteristics

Without specific numerical targets for these characteristics and the corresponding results, a detailed table cannot be created. The acceptance criteria essentially appear to be "not significantly affecting safety and effectiveness" and "substantially equivalent" to the predicate devices based on these categories of testing.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document primarily describes in vitro bench testing rather than a study involving human or animal subjects that would typically have a "test set" in the context of device performance in a clinical scenario. Therefore, information about human subject sample size, country of origin, or retrospective/prospective nature of the data is not applicable in the context of this submission. The tests were likely conducted on manufactured device units.

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 section is not applicable. The submission relies on "biocompatibility and in vitro bench testing" to demonstrate substantial equivalence. These tests typically involve laboratory measurements and comparisons to engineering specifications or predicate device performance, not expert-established ground truth in the way clinical diagnostic studies would.

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

This section is not applicable. As mentioned above, the evaluation is based on in vitro bench testing, not on clinical assessments that would require adjudication of findings.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in the provided text. This device is a medical filter, not a diagnostic imaging or AI-driven system.

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

This section is not applicable. The device is a physical filter, not an algorithm.

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

The concept of "ground truth" as typically used in diagnostic or AI studies is not directly applicable here. For the in vitro bench testing, the "ground truth" refers to established scientific methods and engineering specifications for device performance, as well as the observed performance of the predicate devices. The aim was to show that the modified device's characteristics (coating, physical, and performance) were comparable to the predicate device and met scientific standards.

8. The sample size for the training set

This section is not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

This section is not applicable for the same reasons as #8.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

COMPANY AND CONTACT PERSON

Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Tel: (763) 391-9183 FAX: (763) 391-9603

Michele Pyfferoen, Requlatory Affairs Specialist, Requlatory Affairs

DEVICE NAME

AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface

NAME OF PREDICATED OR LEGALLY MARKETED DEVICE

AFFINITY® 20 µ Arterial Blood Filter (K994208) AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biosurface (K973760)

DESCRIPTION OF DEVICE

The AFFINITY 20 µ Arterial Blood Filter with Trillium" Biosurface is coated with a nonleaching biosurface.

STATEMENT OF INTENDED USE

STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE

The AFFINITY® 20 µ Arterial Blood Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON

Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".

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DETERMINATION OF SUBSTANTIAL EQUIVALENCE

This "SPECIAL 510(k)" is being submitted for a modification to the AFFINITY® 20 µ Arterial Blood Filter. The modification to the current AFFINITY® 20 µ Arterial Blood Filter is to coat the blood contact surfaces with Trillium".

The AFFINITY®20 µ Arterial Blood Filter with Trillium™ Biosurface is being compared to the following Marketed Devices:

AFFINITY® 20 u Arterial Blood Filter (K994208) .
AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biosurface (K973760) ●

The AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface Trillium™ has the same indications statement and intended uses as the:

AFFINITY® 20 µ Arterial Blood Filter (K994208) .
The AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface has "no new technological characteristics (e.g., materials and manufacturing processes)" from the AFFINITY® 20 µ Arterial Blood Filter. The technological characteristic is solely the coating material of the blood contact surface:
Trillium™ .
The technological characteristic of the Trillium™ Biosurface is common to other medical devices (hollow fiber oxygenators) currently in commercial distribution as follows:
AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biosurface (K973760) .
This technological characteristic "could affect the safety and effectiveness of the device". However, these "technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are acceptable scientific methods which exist for assessing effects of these new technological characteristics".

"Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the AFFINITY" 20 µ Arterial Blood Filter with Trillium™ Biosurface is substantially equivalent to other marketed arterial filters.

The biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed arterial filters. The in vitro bench testing included analysis of:

Coating Characteristics .
Physical Characteristics .
. Performance Characteristics

Special 510 (k) Notification	AFFINITY® 20 μ Arterial Filter with	Confidential
Medtronic, Inc.	Trillium™ Biosurface	Page 17
Medtronic Perfusion Systems

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Public Health Service

NOV 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Perfusion Systems c/o Ms. Michele Pyfferoen 7611 Northland Drive Minneapolis, MN 55428

Re: K033468

AFFINITY® 20μ Arterial Filter with Trillium™ Biosurface Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II (two) Product Code: 74 DTM Dated: October 31, 2003 Received: November 3, 2003

Dear Ms. Pyfferoen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Michele Pyfferoen

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

Enclosure

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510(k) Number (if known) K 033468

Device Name:

AFFINITY® 20μ Arterial Filter with Trillium™ Biosurface

Indications for Use:

The AFFINITY® Arterial Filter with Trillium™ Biosurface is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

O.M.

vascular Devices

Ko 33468 510(k) Number

(Optional Format 3-10-98)

Regulation Number and Section

§ 870.4260 Cardiopulmonary bypass arterial line blood filter.

(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”