The AF100 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 AF100 with Balance Biosurface (BB851) is coated with a nonleaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.

AI/ML Overview

The provided text describes the K122760 submission for the Medtronic Affinity® AF100 Arterial Filter with Balance® Biosurface. Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets in the provided document. However, the study aimed to verify the performance characteristics through pre-clinical bench testing. The reported "performance" is that the device passed these tests, indicating it met Medtronic's internal criteria for safety and effectiveness, and thus demonstrated substantial equivalence to the predicate device.

Acceptance Criteria (Inferred from tests performed)	Reported Device Performance (Implied by conclusion)
Device functions without causing excessive blood damage.	Passed Blood Damage Testing
Device maintains acceptable blood flow without excessive pressure loss.	Passed Pressure Drop testing
Device withstands operational pressures and physical stresses.	Passed Structural Integrity testing, Burst Pressure testing
Device effectively handles and removes air.	Passed Air Handling Capabilities
Device effectively filters microemboli larger than its specified micron size.	Passed Filtration Efficiency
Device's coating remains intact and functional.	Passed Coating Integrity
Device's initial blood volume requirement is within acceptable limits.	Passed Priming Volume testing
Device does not shed an unacceptable amount of particles into the bloodstream.	Passed Particulate Shedding testing

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

Sample Size: Not specified. The document only mentions "Pre-clinical bench testing."
Data Provenance: The nature of "pre-clinical bench testing" implies that the data was generated in a controlled laboratory environment, likely at Medtronic, Inc. It is not patient data, so "country of origin" is not applicable in the same way as clinical studies. It is implicitly "prospective" bench testing, as it was conducted to verify the device's performance for this submission.

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

This section is not applicable. The device's performance was evaluated through physical and chemical bench tests, not through expert review of data such as medical images or clinical outcomes. Therefore, "ground truth" in the clinical sense, established by medical experts, was not required. The "ground truth" was determined by the objective results of the bench tests against predefined specifications.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments. Since this study involved pre-clinical bench testing with objective measurements, an adjudication method was not needed.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to establish substantial equivalence with the predicate devices."

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

This question is not applicable as the device is a physical medical device (an arterial filter), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth was established through objective measurements and results from pre-clinical bench tests. These tests evaluated the physical and functional properties of the device against internal specifications and engineering standards for blood-contacting medical devices.

8. The Sample Size for the Training Set

This question is not applicable. As the device is a physical medical product, not an algorithm, there is no "training set."

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

This question is not applicable for the same reason as point 8.

Summary

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K122760

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7 2012 DEC

510(k) Summary of Safety and Effectiveness

Date Prepared:	September 10, 2012
Applicant:	Medtronic, Inc.
	7611 Northland Drive
	Minneapolis, MN 55428
	Establish Registration Number: 2184009
Contact Person:	Julia A. Nelson
	Principal Regulatory Affairs Specialist
	Phone: (763) 514-9844
	Fax: (763) 367-8361
	E-mail: julia.a.nelson@medtronic.com
Trade Name:	Affinity® AF100 Arterial Filter with Balance® Biosurface
Common Name:	Arterial Filter
Classification Name:	Cardiopulmonary bypass arterial line blood filter
Classification:	Class II, 21 CFR 870.4260
Product Code:	DTM
Name of Predicate Device:	Affinity Arterial Filter with Trillium (20µm) Model 353T(K033468)
Device Description:

The AF100 is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

Intended Use:

The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

Contraindications:

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

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K122760
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Comparison to Predicate Devices:

A comparison of Affinity AF100@Arterial Filter with Balance® Biosurface to the predicate device indicates the following similarities:

. Same intended use
Same technological characteristics .
Same operating principle .
Same design features .
Similar materials with the exception of the housing material of the AF100 device. The . AF100 housing is made of a Bisphenol A-free (BPA-free) copolyester material, which differs from the polycarbonate material used in the predicate device.
. Same shelf life

Summary of Performance Data

Pre-clinical bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence with the predicate devices.

The following performance tests were conducted:

Blood Damage Testing ●
Pressure Drop
Structural Integrity
Air Handling Capabilities
Filtration Efficiency
Burst Pressure
Coating Integrity
Priming Volume
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® AF100 Arterial Filter with Balance® Biosurface is substantially equivalent to the legally marketed predicate device, Affinity Arterial Filter with Trillium (20um) Model 353T (K033468).

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered in the image and is the only element present.

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

DEC 7 2012

Medtronic Cardiovascular Julia A. Nelson, Principal Regulatory Affairs Specialist 8200 Coral Street NE Mailstop MVS83 Mounds View. MN 551112

Re: K122760

Trade/Device Name: Affinity AF100 Arterial Filter with Balance Biosurface Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTM Dated: September 10, 2012 Received: September 12, 2012

Dear Ms. Nelson:

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. Julia A. Nelson

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 11 10 http://www.fda.gov/AboutFDA/CentersOffices/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 note the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 I va inay 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,

Kenneth J!

for

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

Enclosures

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Indications for Use Statement

K122760 510(k) Number (if known):

Device Name:

Affinity® AF100 with Balance® Biosurface

Indications for Use:

The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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

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.”