TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE

K113845 · Medtronic, Inc. · DTL · Jan 25, 2012 · Cardiovascular

Device Facts

• Record ID: K113845
• Device Name: TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
• Applicant: Medtronic, Inc.
• Product Code: DTL · Cardiovascular
• Decision Date: Jan 25, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Indications for Use

The Medtronic Custom Perfusion System is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery procedures.

Device Story

Tubing, connectors, and accessories used in cardiopulmonary bypass circuits to connect primary system components. Devices feature Balance™ Biosurface, a non-leaching biocompatible coating designed to reduce platelet adhesion and activation while preserving platelet function. Used in clinical settings during bypass surgery; operated by perfusionists or surgical staff. The coating is heparin-free. Benefits include improved hemocompatibility within the extracorporeal circuit.

Clinical Evidence

Bench testing only. Performance data included verification of Balance™ Biosurface coverage and leaching, hemolysis, WBC retention, platelet retention/activation, kallikrein generation, tubing kink resistance, pressure integrity, pressure decay, tubing pull force, tubing life, tubing spallation, biocompatibility assessment, packaging/sterilization assessment, and shelf-life verification. All tests passed.

Technological Characteristics

Cardiopulmonary bypass tubing, connectors, and accessories. Features Balance™ Biosurface, a non-leaching, heparin-free biocompatible coating. Mechanical characteristics include kink resistance, pressure integrity, and spallation resistance. Sterilization and packaging methods remain consistent with previously cleared predicate devices.

Indications for Use

Indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery 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

• Intersept Custom Tubing Pack (K800178)
• Bio-Medicus Tubing Connectors (K883956)
• Signature Custom Tubing Pack (K924529)
• Trillium Coated Tubing and Connectors (K012538)
• Affinity Pixie™ Arterial Filter with Balance™ Biosurface (K100646)

Submission Summary (Full Text)

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K113845 pa 10+ 3

JAN 2 5 2012

# 510(k) Summary of Safety and Effectiveness

| Date Prepared: | December 22, 2011 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Medtronic, Inc.<br>Medtronic Perfusion Systems<br>611 Northland Drive<br>Minneapolis, MN 55428 |
| Contact Person: | Kevin T. Lam<br>Senior Regulatory Affairs Specialist<br>Medtronic Perfusion Systems<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| | Alternate contact:<br>Sue Fidler<br>Senior Regulatory Affairs Manager<br>Medtronic Perfusion Systems<br>Phone: [phone] |

Fax:

#### Device Name and Classification:

| Trade Name: | Tubing, Connectors and Accessories with Balance™ Biosurface |
|--------------------|---------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass adapter tubing, connector, stopcock, manifold or fitting |
| Regulation Number: | 21 CFR 870.4290 |
| Product Code: | DWF and DTL |
| Product Code: | Class II |

763-367-8360

E-Mail: [e-mail]

### Predicate Devices

Intersept Custom Tubing Pack (K800178) Bio-Medicus Tubing Connectors (K883956) Signature Custom Tubing Pack (K924529) Trillium Coated Tubing and Connectors (K012538) Affinity Pixie™ Arterial Filter with Balance™ Biosurface (K100646)

## Device Description

Tubing, Connectors, and Accessories with Balance™ Biosurface are used in cardiopulmonary bypass for connecting the primary devices of the bypass circuit. The

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K113845 pg 2 of 3

functionality and intended use of these devices are the same as those for the coated (Trillium® Biosurface) and uncoated tubing, connectors, and accessories that are FDA cleared. Balance™ Biosurface has been previously FDA cleared (K100646) and is commercially available. Balance™ Biosurface is a non-leaching biocompatible surface that reduces platelet adhesion and activation and preserves platelet function.

#### Intended Use

There is no change to the indication for use for these devices/components.

The Medtronic Custom Perfusion System is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery procedures.

#### Comparison to Predicate Devices

A comparison of the modified product and the currently marketed tubing, connectors, and accessories with Trillium® Biosurface (K012538), Intersept Custom Tubing Pack (K800178), Bio-Medicus Tubing Connectors (K883956), and Signature Custom Tubing Pack (K924529) indicates the following similarities to the product which received 510/k) clearance:

- ◆ Same intended use
- . Same technological characteristics
- Same operating principle .
- Same design features (with the exception that Balance™ Biosurface will not contain . heparin in the coating)
- Same base materials prior to coating .
- Same shelf life .

A comparison of the modified product and the currently marketed Affinity Pixie™ Arterial Filter with Balance™ Biosurface (K100646) indicates the following similarities to the product which received 510(k) clearance:

- Same Balance™ Biosurface coating .
#### Summary of Performance Data

Verification and validation testing has demonstrated that the tubing, connectors, and accessories with Balance™ Biosurface are substantially equivalent to the predicates. The following performance tests were conducted:

| Verification/Validation | Results |
|------------------------------------------|---------|
| Balance™ Biosurface coverage | Pass |
| Balance™ Biosurface leaching | Pass |
| Hemolysis | Pass |
| White Blood Cell (WBC) Retention | Pass |
| Platelets Retention/ Platelet Activation | Pass |
| Kallikrein Generation | Pass |
| Tubing kink resistance | Pass |

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| Pressure integrity | Pass |
|----------------------------------------|-------------------------------------------------|
| Pressure decay | Pass |
| Tubing pull force | Pass |
| No tubing pull off during static force | Pass |
| Tubing Life | Pass |
| Tubing Spallation | Pass |
| Biocompatibility Assessment | Pass - no impact to biocompatibility |
| Packaging and Sterilization Assessment | Pass - no impact to packaging and sterilization |
| Shelf-Life Verification | Pass |

## Conclusion

Medtronic has demonstrated that the tubing, connectors, and accessories with Balance™ Biosurface for use in custom perfusion system are substantially equivalent to the predicate devices based upon design, test results and indications for use. The fundamental scientific principle, labeling and the intended use are unchanged as a result of these device modifications.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

JAN 2 5 2012

Medtronic, Inc. c/o Mr. Kevin T. Lam Senior Regulatory Affairs Specialist Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428

Re: K113845

Trade/Device Name: Tubing, Connectors, and Accessories 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: December 22, 2011 Received: December 28, 2011

Dear Mr. Lam:

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

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### Page 2 - Mr. Kevin T. Lam

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/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 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,

M.A. Killebrew

്യം 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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K113845

# Indications for Use Statement

510(k) Number (if known): _K113845

Device Name: Tubing, Connectors, and Accessories with Balance™ Biosurface

Indications for Use:

This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery procedures.

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)

.y. Kleban

(Division Sian-Off) (Division of Cardiovascular Devices

k11 3845 510(k) Number_