AFFINITY FUSION RECIRCULATION LINE MODEL RCL841

K122913 · Medtronic, Inc. · DWF · Oct 19, 2012 · Cardiovascular

Device Facts

• Record ID: K122913
• Device Name: AFFINITY FUSION RECIRCULATION LINE MODEL RCL841
• Applicant: Medtronic, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Oct 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2

Intended Use

The Affinity Fusion Recirculation Line is intended for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

Device Story

Affinity Fusion Recirculation Line consists of 0.6 cm (1/4 in) flexible tubing with Y connector and female luer ports; provides fluid path from recirculation port of Affinity Fusion Oxygenator with Integrated Arterial Filter to venous reservoir. Used during cardiopulmonary bypass procedures (up to 6 hours) to facilitate circuit setup and priming. Operated by perfusionists or clinical staff in surgical settings. Device ensures continuous flow path; aids in circuit management; benefits patient by maintaining integrity of extracorporeal circulation.

Clinical Evidence

Bench testing only. No clinical data required to establish substantial equivalence. Performance verified via integrity testing, burst testing, dust cap pull-off testing, and tube pull-off testing.

Technological Characteristics

Flexible 0.6 cm (1/4 in) tubing with Y connector and female luer ports. Designed for cardiopulmonary bypass circuit integration. Class II device (21 CFR 870.4350).

Indications for Use

Indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Tubing, Connectors and Accessories with Balance® Biosurface (K113845)

Submission Summary (Full Text)

{0}------------------------------------------------

K122913

# 510(k) Summary of Safety and Effectiveness

| Date Prepared: | September 17, 2012 |
|---------------------------|-----------------------------------------------------------------------|
| Applicant: | Medtronic, Inc. |
| | Medtronic Perfusion Systems |
| | 7611 Northland Drive |
| | Brooklyn Park, MN 55428 |
| | Establishment Registration No. 2184009 |
| Contact Person: | Mary Donlin |
| | Senior Regulatory Affairs Specialist |
| | Phone: [phone] |
| | Fax: [phone] |
| | E-mail:[e-mail] |
| Trade Name: | Affinity Fusion® Recirculation Line |
| Common Name: | Cardiopulmonary bypass tubing |
| Classification Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| Classification: | Class II, 21 CFR 870.4350 |
| Product Code: | DWF |
| Name of Predicate Device: | Tubing, Connectors and Accessories with Balance® Biosurface (K113845) |

### Device Description:

The recirculation line consists of a 0.6 cm (1/4 in) flexible line with Y connector and female luer ports. The recirculation line provides a path from the recirculation port of the Affinity Fusion® Oxygenator with Integrated Arterial Filter to the venous reservoir. It is configured for maximum flexibility to facilitate ease of circuit set up and priming.

## Intended Use:

The Affinity Fusion Recirculation Line is intended for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

## Contraindications:

None.

{1}------------------------------------------------

## Comparison to the Predicate Device:

A comparison of Affinity Fusion® Recirculation Line to the predicate device indicates the following similarities:

- Same intended use .
- Same technological characteristics .
- Same operating principle .
- Same design features .
- Same materials .
- 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:

- Integrity Testing .
- Burst Testing .
- Dust Cap Pull-Off Testing �
- Tube Pull-Off Testing .

#### Conclusion:

The data included in this submission is sufficient to provide reasonable assurance of the safety and effectiveness of the device and the Affinity Fusion® Recirculation Line is substantially equivalent to the legally marketed predicate device, Tubing, Connectors and Accessories with Balance® Biosurface (KI13845).

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. 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 eagle or bird symbol, with three wing-like shapes extending upwards and a curved body below.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

OCT 19 2012

Medtronic, Inc. c/o Ms. Mary Donlin Senior Regulatory Affairs Specialist 7611 Northland Drive Brooklyn Park, MN 55428

#### Re: K122913

Affinity Fusion® Recirculation Line Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: September 19, 2012 Received: September 21, 2012

#### Dear Ms. Donlin:

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

{3}------------------------------------------------

Page 2 - Ms. Mary Donlin

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 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/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 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.

A. Killer

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

Enclosure

{4}------------------------------------------------

# 4.0 Indications for Use Statement

510(k) Number (if known): _ K1229 l 3

Device Name:

Affinity Fusion® Recirculation Line

Indications for Use:

The recirculation line is indicated for use in connecting tubing and/ or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

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)

W.S. Wheeler

(Division Sign-Off) (Division Sign-off)
Division of Cardiovascular Devices

510(k) Number_K122913