AFFINITY® Pediatric Arterial Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gascous microemboli.

Device Description

The AFFINITY® Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. These devices are available both in an uncoated and a Carmeda coated option. The Carmeda coating is a BioActive Surface that is non-leaching and provides a thromboresistant blood contact surface.

AI/ML Overview

This document is a 510(k) Summary for the Medtronic AFFINITY® Pediatric Arterial Filter. It describes the device, its intended use, comparison to predicate devices, and the performance data that supports its substantial equivalence. The document does not contain information about an AI/ML device. Therefore, I cannot provide details on acceptance criteria and study designs relevant to AI/ML.

However, based on the provided text, I can infer the acceptance criteria and the study that proves the device meets the acceptance criteria for this non-AI medical device.

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

The document does not explicitly state numerical acceptance criteria for each test. Instead, it relies on demonstrating "substantial equivalence" to a predicate device (Terumo AF02) to prove satisfactory performance. The "reported device performance" is implicitly that it met or matched the performance characteristics of the predicate device.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Filtration Efficiency	Must be substantially equivalent to or better than the Terumo AF02 pediatric arterial filter.	Demonstrated substantial equivalence to the Terumo AF02.
Air Handling Capabilities	Must be substantially equivalent to or better than the Terumo AF02 pediatric arterial filter.	Demonstrated substantial equivalence to the Terumo AF02.
Effect on Cellular Blood	Must be substantially equivalent to or better than the Terumo AF02 pediatric arterial filter, indicating minimal adverse impact.	Demonstrated substantial equivalence to the Terumo AF02.
Components
Pressure Drop	Must be substantially equivalent to or better than the Terumo AF02 pediatric arterial filter (i.e., not cause excessive pressure).	Demonstrated substantial equivalence to the Terumo AF02.
Structural Integrity	Must be substantially equivalent to or better than the Terumo AF02 pediatric arterial filter, ensuring device robustness.	Demonstrated substantial equivalence to the Terumo AF02.
Priming Volume	Must be substantially equivalent to or better than the Terumo AF02 pediatric arterial filter.	Demonstrated substantial equivalence to the Terumo AF02 (implies a suitable priming volume for pediatric applications).

2. Sample sized used for the test set and the data provenance

The document states, "Functional testing was used to establish the performance characteristics... Clinical testing was not required." This indicates that the testing was benchtop or laboratory-based functional testing.

Sample size: Not explicitly stated. It would typically involve a specific number of manufactured units of the device tested under controlled laboratory conditions, as well as units of the predicate device for comparison.
Data provenance: Laboratory data. It does not mention country of origin or whether it was retrospective or prospective, but functional testing is inherently prospective, as it involves newly conducted experiments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as this is a traditional medical device (hardware) and not an AI/ML device where expert ground truth labeling would be required. The "ground truth" for functional testing is typically defined by engineering specifications and validated test methods.

4. Adjudication method for the test set

This information is not applicable for a functional performance study of a physical device. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI/ML evaluations to resolve discrepancies in expert interpretations.

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

No, a MRMC comparative effectiveness study was not done. This type of study applies to diagnostic imaging or AI devices involving human interpretation, which is not the case for this arterial filter.

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

No, this is not an algorithm or AI device. Therefore, a standalone algorithm performance evaluation is not applicable.

7. The type of ground truth used

The "ground truth" for this device's performance evaluation was based on established engineering and performance specifications for cardiopulmonary bypass arterial filters, demonstrated by comparison to a legally marketed predicate device (Terumo Capiox Arterial Filter, AF02, Pediatric). The implicit ground truth is that the device must perform at least as well as the predicate device across the specified functional characteristics.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device and thus does not have a "training set."

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

This information is not applicable as this is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" in bold, sans-serif font on the right. The graphic depicts a human figure in motion within a circle, suggesting movement and activity.

JUL - 3 2007

1071253

510(k) Summary

Date Prepared:

April 25, 2007

Submitter:

Medtronic 7611 Northland Drive Brooklyn Park, MN 55428

Contact Person:

Jessica Sixberry Senior Regulatory Affairs Specialist Phone: (763) 391-9136 Fax: (763) 391-9100 Email: jessica.m.sixberry@medtronic.com

Device Name and Classification:

Trade Name:	Affinity® Pediatric Arterial Filter
Common Name:	Cardiopulmonary bypass arterial line blood filter
Regulation Number:	21 CFR 870.4260
Product Code:	DTM
Classification:	Class II

Predicate Devices

Terumo Capiox Arterial Filter, AF02, Pediatric (K943917) Medtronic Affinity® Arterial Filter (K952532) Medtronic Affinity® Arterial Filter, Carmeda® Coated (K000379)

Device Description

Indications for Use

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

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Comparison to Predicate Devices

The AFFINITY® Pediatric Arterial Filter has the same technological characteristics when compared to the existing devices. This device utilizes the design features and materials of the adult Medtronic AFFINITY® Arterial Filter but meets the performance characteristics of the Terumo Pediatric arterial filter CAPIOX AF02.

. Intended Use: The AFFINITY® Pediatric Arterial Filter has the same intended use as the Medtronic AFFINITY® Arterial Filter.
Principles of Operation and Technology: The AFFINITY® Pediatric Arterial Filter uses ♪ the same technologies in operation of the of the AFFINITY® Arterial Filter. The AFFINITY® Pediatric Arterial Filter is a miniaturized version of the AFFINITY® Arterial Filter. Air removal and filtration are accomplished in the same manner. Both filters are also made from the same materials.
Performance: The AFFINITY® Pediatric Arterial Filter was compared to the Terumo . AF02 for performance characteristics as this is also a pediatric filter. The comparisons demonstrated that these were substantially equivalent in performance.

Summary of Performance Data

Functional testing was used to establish the performance characteristics of the modifications of this device from previously marketed devices. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:

t Filtration Efficiency
Air Handling Capabilities .
Effect of Device on Cellular Blood Components .
Pressure Drop .
Structural Integrity .
Priming Volume .

Conclusion

Medtronic has demonstrated that the AFFINITY® Pediatric Arterial Filter is substantially equivalent to the predicate devices based upon design, test results, and indications for use. Any noted differences do not raise new issues of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 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 symbol of three human profiles facing to the right, with three curved lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 2007 JUL

Medtronic, Inc. c/o Ms. Jessica Sixberry Senior Regulatory Affairs Specialist Medtronic Perfusion Systems 7611 Northland Drive Brooklyn Park, MN 55428

Re: K071253

Affinity Pediatric Arterial Filter Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary bypass arterial line blood filter Regulatory Class: Class II Product Code: DTM Dated: April 25, 2007 Received: May 4, 2007

Dear Ms. Sixberry:

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. Jessica Sixberry

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 agencics. 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), please contact the Office of Compliance at (240) 2760120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ashley D. Boam

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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510(k) Number (if known): K071253

Device Name: AFFINITY® Pediattic Arterial Blood Filter, also available with CARMEDA® Bioactive Surfacc

Indications for Use: AFFINITY® Pediatric Arterial Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gascous microemboli.

Prescription Use Per 21 CFR 801.109

Qver-The-Counter Usc _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anhue Boam fa BDZ

liovascular Devices

510(k) Number K071253

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.”