The AFFINITY® 38 µ Arterial Filter with Trillium™ Biopassive Surface is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.

Device Description

The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is a single use device designed to filter microemboli from the blood in the extracorporeal circuits during cardiopulmonary bypass surgery. The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is coated with a non-leaching biopassive surface.

AI/ML Overview

This K013084 submission for the AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is a "SPECIAL 510(k)" for a modification to an existing device (AFFINITY® 38 µ Arterial Blood Filter, K952532) by adding a Trillium™ Biopassive Surface coating. The submission primarily relies on demonstrating substantial equivalence to predicate devices, rather than conducting a de novo effectiveness study with defined acceptance criteria and associated performance results in tables.

Therefore, many of the requested sections below cannot be fully populated as the provided document does not contain such detailed effectiveness study information. The focus is on the technological characteristics comparison and biocompatibility/in vitro bench testing to show that the new coating does not significantly affect safety and effectiveness compared to the predicate devices.

Here's the information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the format of a table for an effectiveness study. Instead, it states that "biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the AFFINITY® 38 // Arterial Blood Filter with Trillium™ did not significantly affect safety and effectiveness."

The tests performed were:

Coating Characteristics
Physical Characteristics
Performance Characteristics

The overall "performance" is implicitly deemed acceptable as it allows for substantial equivalence. The document doesn't provide specific numerical targets or results for these characteristics.

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

The document does not specify sample sizes for any test sets or the provenance of the data (country of origin, retrospective/prospective). The studies mentioned are "biocompatibility and in vitro bench testing," which typically involve laboratory tests rather than human subject data in the way clinical studies do.

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 applicable and not provided in the document. The evaluation of material characteristics and in-vitro performance generally relies on scientific and engineering testing, not expert consensus for ground truth on a test set in the clinical sense.

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. Adjudication methods are typically relevant for clinical studies involving reader interpretation, which is not what was performed for this device modification.

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

This is not applicable as the device is an arterial blood filter, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.

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

This is not applicable as the device is an arterial blood filter, not a software algorithm.

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

The "ground truth" for this submission is based on scientific and engineering standards and tests for material properties, biocompatibility, and filter performance (e.g., flow rates, filtration efficiency – though not detailed in the summary). It's essentially an engineering and laboratory-based ground truth, comparing the modified device's characteristics to those of the predicate devices and accepted material standards.

8. The sample size for the training set

This is not applicable. This device is not an AI/ML algorithm that requires a training set.

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

This is not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary

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K013084

SEP 2 7 2001

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

Marie L. Holm. Associate Product Regulations Manager, Regulatory Affairs

DEVICE NAME

AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface

NAME OF PREDICATED OR LEGALLY MARKETED DEVICE

AFFINITY® 38 µ Arterial Blood Filter (K952532) AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)

DESCRIPTION OF DEVICE

The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is coated with a non-leaching biopassive surface.

STATEMENT OF INTENDED USE

The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.

STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE

The AFFINITY® 38 // Arterial Blood Filter is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.

AFFINITY® 38 µ Arterial Filter with Trillium™ Biopassive Surface

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STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON

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

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

This "SPECIAL 510(k)" is being submitted for a modification to the AFFINITY® 38 u Arterial Blood Filter. The modification to the current AFFINITY® 38 u Arterial Blood Filter is to coat the primary blood contact surfaces with Trillium™.

The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is being compared to the following Marketed Devices:

. AFFINITY® 38 µ Arterial Blood Filter (K952532)
AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (K973760)

The AFFINITY® 38 u Arterial Blood Filter with Trillium™ Biopassive Surface Trillium™ has the same indications statement and intended uses as the:

AFFINITY® 38 u Arterial Blood Filter (K952532) .
The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface has "no new technological characteristics (e.g., materials and manufacturing processes)" from the AFFINITY® 38 µ Arterial Blood Filter. The technological characteristic is solely the coating material of the blood pathway:
Trillium™ .
The technological characteristic of the Trillium™ Biopassive Surface is common to other medical devices (hollow fiber oxygenators) currently in commercial distribution as follows:
AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (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® 38 u Arterial Blood Filter with Trillium™ Biopassive Surface is

AFFINITY® 38 u Arterial Filter with Trillium™ Biopassive Surface

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substantially equivalent to other marketed extracorporeal cardiopulmonary devices.

The biocompatibility and in vitro bench testing demonstrated that when ompaged The predicate devices, the AFFINITY® 38 // Arterial Blood Filter with Trillium™ to the predicate donooo, the Aignificantly affect safety and effectiveness and are Diopaorro Garraco ent to other commercially distributed extracorporeal Substantially oquivaloritions to othe in vitro bench testing included analysis of:

Coating Characteristics .
Physical Characteristics .
Performance Characteristics .

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

SEP 2 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marie L. Holm Associate Product Regulations Manager Medtronic Perfusion Systems 7611 Northland Drive N Minneapolis, MN 55428-1088

Re: K013084

Trade Name: AFFINITY® 38 µ Arterial Filter with Trillium™ Biopassive Surface Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary bypass arterial line blood filter Regulatory Class: II Product Code: DTM Dated: September 11, 2001 Received: September 14, 2001

Dear Ms. Holm:

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 for assumer 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 he 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); good manufacturing practice requirements as set

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Page 2 - Ms. Marie L. Holm

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rorth in also quand byovisions (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) 594-4586. 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,

Valla Tuh
Thomas E. Dillard III

James E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510 (k) Number if known: _ LO13084

Device Name: AFFINITY® 38 µ Arterial Filter with Trillium™ Biopassive Surface

Indications for Use:

The AFFINITY® 38 µ Arterial Filter with Trillium™ Biopassive Surface is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013084

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter use _________________________________________________________________________________________________________________________________________________________

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.”