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 Carmeda BioActive Surface (CB851) is coated with a nonleaching bioactive surface (heparin) to enhance blood compatibility and provide thromboresistant blood-contacting surfaces. 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 is a 510(k) Summary for a medical device (Affinity® AF100 Arterial Filter with Carmeda® BioActive Surface) seeking a determination of substantial equivalence to a predicate device. This type of regulatory submission in the U.S. FDA context focuses on comparing a new device to an already legally marketed one, rather than presenting a detailed study proving the new device's independent efficacy against acceptance criteria in the way clinical trials for novel devices do.

Therefore, many of the requested elements pertaining to a clinical study (like sample size for test sets and training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of document because it describes pre-clinical bench testing for substantial equivalence, not a clinical effectiveness study.

Here's a breakdown of the information that is available and a note on what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "performance tests" that were conducted to demonstrate substantial equivalence to the predicate device. However, it does not specify quantitative "acceptance criteria" for each test or detailed "reported device performance" against those criteria. It only states that these tests were conducted to "verify the performance characteristics."

Performance Test	Acceptance Criteria (Not explicitly stated)	Reported Device Performance (Not explicitly stated)
Blood Damage Testing	Not specified	Verified performance characteristics
Pressure Drop	Not specified	Verified performance characteristics
Structural Integrity	Not specified	Verified performance characteristics
Air Handling Capabilities	Not specified	Verified performance characteristics
Filtration Efficiency	Not specified	Verified performance characteristics
Burst Pressure	Not specified	Verified performance characteristics
Coating Integrity	Not specified	Verified performance characteristics
Priming Volume	Not specified	Verified performance characteristics
Particulate Shedding	Not specified	Verified performance characteristics

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable. Performance was verified through pre-clinical bench testing, not a clinical test set with human data. The document does not specify the number of devices or trials performed for each bench test.
Data Provenance: Not applicable, as this was pre-clinical bench testing. There is no mention of country of origin or whether it was retrospective or prospective in a clinical sense.

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

Not applicable. This was pre-clinical bench testing of a physical device, not an AI/diagnostic device requiring expert ground truth for image or data interpretation.

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

Not applicable. This was pre-clinical bench testing, not a study involving human readers or expert adjudication.

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:

Not applicable. This device is an arterial filter for cardiopulmonary bypass, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is a physical arterial filter, not an algorithm.

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

For pre-clinical bench testing, "ground truth" would equate to established engineering and material science standards and measurement techniques for evaluating physical properties (e.g., pressure, filtration size, material strength). The document implies that industry standards and validated methods were used to conduct the described performance tests, but it does not detail them.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device that requires a training set.

Summary of Device Acceptance & Study:

The "acceptance criteria" for this submission are primarily demonstrating substantial equivalence to the predicate device (Affinity Arterial Filter with Carmeda® BioActive Surface (20µm) Model CB353, K001138).

The study that "proves the device meets the acceptance criteria" is a series of pre-clinical bench tests. These tests were conducted to verify that despite a change in housing material (from polycarbonate to Bisphenol A-free (BPA-free) copolyester), the new device maintains similar technological characteristics, operating principles, design features, and performance as the predicate device. The conclusion of the submission states: "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 FDA's letter confirms that based on the provided information, the device is deemed "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for market clearance under the 510(k) pathway.

Summary

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510(k) Summary of Safety and Effectiveness

MAR 1 9 2013

Date Prepared:	March 12, 2013
Applicant:	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establish Registration Number: 2184009
Contact Person:	Julia A. NelsonPrincipal Regulatory Affairs SpecialistPhone: (763) 514-9844Fax: (763) 367-8360E-mail:julia.a.nelson@medtronic.com
Trade Name:	Affinity® AF100 Arterial Filter with Carmeda® BioActive Surface
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 Carmeda® BioActive Surface (20µm)Model CB353 (K001138)
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.

The AF100 with Carmeda BioActive Surface (CB851) is coated with a nonleaching bioactive surface (heparin) to enhance blood compatibility and provide thromboresistant blood-contacting surfaces. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.

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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Comparison to Predicate Devices:

A comparison of Affinity AF100 Arterial Filter with Carmeda® BioActive Surface 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:

Pursuant to the statutory requirements under Section 513(i)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act), this new device, the Affinity AF100 Arterial Filter with Carmeda® BioActive Surface is substantially equivalent to the legally marketed predicate device, Affinity Arterial Filter with Carmeda® BioActive Surface (20μm) Model CB353 (K001138).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 19, 2013

Medtronic CardioVascular c/o Julia A. Nelson, MS. RAC Principal Regulatory Affairs Specialist 8200 Coral Street NE Mailstop MVS83 Mounds View, MN 55112

Re: K123351

Trade Name: Affinity® AF100 Arterial Filter with Carmeda® Bioactive Surface Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II Product Code: DTM Dated: February 28, 2013 Received: March 1, 2013

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

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Page 2 - Ms. Julia Nelson

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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 Division 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 Gillillebrenner

for 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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Indications for Use Statement

510(k) Number (if known): _ K123351

Device Name:

Affinity® AF100 with Carmeda® BioActive Surface

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)

Matthew G則illebrenner

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.”