AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE

K123351 · Medtronic Perfusion Systems · DTM · Mar 19, 2013 · Cardiovascular

Device Facts

• Record ID: K123351
• Device Name: AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
• Applicant: Medtronic Perfusion Systems
• Product Code: DTM · Cardiovascular
• Decision Date: Mar 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4260
• Device Class: Class 2

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.

Device Story

The Affinity AF100 is an arterial blood filter used during cardiopulmonary bypass surgery to remove particulate and gaseous microemboli from the extracorporeal circuit. The device features a nonleaching heparin-based Carmeda BioActive Surface to enhance blood compatibility and reduce thromboresistance. It is a single-use, sterile, ethylene oxide-sterilized device. The housing is constructed from a BPA-free copolyester. During surgery, blood flows through the filter, which traps microemboli; this process helps mitigate potential embolic complications for the patient. The device is operated by perfusionists or surgical staff within the clinical setting of an operating room.

Clinical Evidence

No clinical data. Substantial equivalence was established through pre-clinical bench testing, including blood damage testing, pressure drop, structural integrity, air handling capabilities, filtration efficiency, burst pressure, coating integrity, priming volume, and particulate shedding.

Technological Characteristics

Arterial line blood filter; BPA-free copolyester housing; Carmeda BioActive Surface (heparin coating); ethylene oxide sterilization; single-use; nonpyrogenic; non-toxic.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures (up to 6 hours duration) requiring removal of particulate and gaseous microemboli.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Affinity Arterial Filter with Carmeda® BioActive Surface (20µm) Model CB353 (K001138)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

MAR 1 9 2013

| Date Prepared: | March 12, 2013 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Medtronic, Inc.<br>Medtronic Perfusion Systems<br>7611 Northland Drive<br>Minneapolis, MN 55428<br>Establish Registration Number: 2184009 |
| Contact Person: | Julia A. Nelson<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail:[e-mail] |
| 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)<br>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 [phone] or [phone] 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