AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE

K122760 · Medtronic, Inc. · DTM · Dec 7, 2012 · Cardiovascular

Device Facts

• Record ID: K122760
• Device Name: AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
• Applicant: Medtronic, Inc.
• Product Code: DTM · Cardiovascular
• Decision Date: Dec 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4260
• Device Class: Class 2
• Attributes: Therapeutic

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 Arterial Filter with Balance Biosurface is a single-use, sterile, blood-contacting device used during cardiopulmonary bypass surgery. It functions as an inline filter within the extracorporeal circuit to remove particulate and gaseous microemboli from blood. The device features a nonleaching biocompatible surface coating designed to reduce platelet activation and adhesion, thereby preserving platelet function. The housing is constructed from a BPA-free copolyester. It is operated by perfusionists or surgical staff in an OR setting. By filtering microemboli, the device aims to reduce the risk of embolic complications for the patient during bypass procedures.

Clinical Evidence

Bench testing only. No clinical data was required to establish substantial equivalence. Performance testing included blood damage testing, pressure drop, structural integrity, air handling capabilities, filtration efficiency, burst pressure, coating integrity, priming volume, and particulate shedding.

Technological Characteristics

Single-use arterial blood filter; BPA-free copolyester housing; Balance Biosurface (nonleaching biocompatible coating); ethylene oxide sterilization; inline cardiopulmonary bypass circuit integration.

Indications for Use

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

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 Trillium (20µm) Model 353T (K033468)

Submission Summary (Full Text)

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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: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| 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<br>(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.

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.

#### 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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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 [phone] or [phone] 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