CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE

K122811 · Medtronic, Inc. · DTL · Oct 12, 2012 · Cardiovascular

Device Facts

• Record ID: K122811
• Device Name: CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
• Applicant: Medtronic, Inc.
• Product Code: DTL · Cardiovascular
• Decision Date: Oct 12, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

Medtronic Comector Components with Balance Biosurface are intended for use in the extracorporeal cardiopulmonary perfusion bypass circuit to interconnect tubing and the primary devices of the bypass circuit.

Device Story

Connector components (Y-type, straight, reducer, adapter/luer) used in extracorporeal cardiopulmonary bypass circuits; function to interconnect tubing and primary bypass devices. Components feature smooth blood-contacting surfaces to provide continuous fluid flow path. Used in surgical settings during cardiopulmonary bypass procedures. Operated by perfusionists or surgical staff. Benefit provided by Balance Biosurface coating to improve hemocompatibility within the bypass circuit.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, performance testing, and comparison to the predicate device.

Technological Characteristics

Polycarbonate components with Balance Biosurface coating. Configurations include Y-type, straight, reducer, and adapter (luer). Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.

Regulatory Classification

Identification

A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

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

Submission Summary (Full Text)

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K 122811

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## 510(k) Summary

OCT 1 2 2012

Date Prepared:

Submitter :

September 12, 2012

Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establishment Registration Number: 2184009

Contact Person:

Jacqueline A Hauge Senior Regulatory Affairs Specialist Medtronic Perfusion Systems Phone: [phone] Fax: . [phone] Email: [e-mail]

Alternate Contact: Susan Fidler Senior Regulatory Affairs Manager Medtronic Perfusion Systems Phone: [phone] Fax: [phone] Email: [e-mail]

#### Device Name and Classification

Tubing, Connectors and Accessories with Balance® Biosurface Trade Name: Common Name: Cardiopulmonary bypass adapter, tubing, connector, stopcock, manifold or fitting Regulation Number: 21 CFR 870.4290 . DTL and DWF Product Codes: Product Classification: Class II

| Predicate Device | |
|------------------|--|
|------------------|--|

K113845

Tubing, Connectors and Accessories with Balance® Biosurface

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#### Device Description

Medtronic Comector Components with Balance Biosurface are intended for use in the extracorporeal circuit during cardiopulmonary bypass surgery. These components are primarily used to interconnect tubing and the primary devices of the bypass circuit. The lumen of the Connector Components with Balance Biosurface consist of smooth blood-contacting surfaces which provide a continuous pathway for the flow of blood and/or other fluids during cardiopulmonary bypass surgical procedures. The Connector Components with Balance Biosurface are comprised of polycarbonate and Balance Biosurface materials and provided in Ytype, straight, reducer and adapter (luer) configurations.

### Intended Use

Medtronic Comector Components with Balance Biosurface are intended for use in the extracorporeal cardiopulmonary perfusion bypass circuit to interconnect tubing and the primary devices of the bypass circuit.

## Comparison to Predicate

When compared to the predicate device (K113845), the Medtronic Connector Components with Balance Biosurface presented in this submission have the same:

- Intended Use
- Technological characteristics
- Operating principle
- Design features .
- Performance
- Biological safety
- Base materials prior to coating
- Coating materials
- Packaging materials and configurations
- Method of sterilization and sterility assurance level
- Shelf life

#### Conclusion

Medtronic has demonstrated that Connector Components with Balance Biosurface for use in extracorporeal cardiopulmonary bypass perfusion systems (tubing sets/packs) are substantially equivalent to the predicate device based upon design, test results, and indications for use. The fundamental scientific principle, labeling and intended use are unchanged from the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

OCT 1 2 2012

Medtronic, Inc.
c/o Ms. Jacqueline Hauge
Senior Regulatory Affairs Specialist
7611 Northland Dr.
Minneapolis, MN 55428

Re: K122811

Trade/Device Names: Connector Components with Balance Biosurface Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting Regulatory Class: Class II Product Code: DTL Dated: September 12, 2012 Received: September 13, 2012

Dear Ms. Hauge:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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.

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

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Page 2 - Ms. Jacqueline Hauge

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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

510(k) Number (if known):

Device Name: Connector Components with Balance™ Biosurface

Indications For Use:

Medtronic Connector Components with Balance™ Biosurface are indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Cardiovascular Devices