TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE

K012538 · Medtronic Vascular · DWF · Aug 23, 2001 · Cardiovascular

Device Facts

• Record ID: K012538
• Device Name: TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
• Applicant: Medtronic Vascular
• Product Code: DWF · Cardiovascular
• Decision Date: Aug 23, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2

Intended Use

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

Device Story

Device consists of biocompatible polyvinyl chloride (PVC) tubing and molded connectors used in extracorporeal circuits during cardiopulmonary bypass surgery. Components are coated with Trillium™ Biopassive Surface, a polymer containing non-leaching heparin, to improve hemocompatibility. Used by perfusionists or surgical staff in clinical settings to interconnect catheters, cannulae, and oxygenators. The coating is intended to reduce blood trauma and adverse reactions associated with extracorporeal circulation. Device is a passive component; no active processing or software involved.

Clinical Evidence

Bench testing only. Testing included coating leaching analysis and physical/performance characteristics: spallation, pressure decay/integrity, kink resistance, blood trauma, and pull strength.

Technological Characteristics

Biocompatible PVC tubing and molded connectors. Surface modified with Trillium™ Biopassive Surface (non-leaching heparin-containing polymer). Passive device; no energy source, software, or connectivity.

Indications for Use

Indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery. No specific patient population or contraindications provided.

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

• Intersept Blood Tubing Packs (K800178)
• Affinity Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)

Submission Summary (Full Text)

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# AUG 2 3 2001

## Summary of Safety and Effectiveness

## Company and Contact Person

Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Tel: [phone] Fax: [phone]

Marie Holm, Associate Product Regulations Manager, Regulatory Affairs

### Device Name

Tubing and Connectors with Trillium™ Biopassive Surface

## Name of Predicated or Legally Marketed Device

Intersept Blood Tubing Packs (K800178) mensept Drood Tubing Packs (115001773)
Affinity Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)

#### Description of Device

The tubing consists of biocompatible polyvinyl chloride tubing in various lengths (see Appendix I). This tubing will be used in the extracorporeal circuit during I cardiopulmonary bypass to interconnect the catheters and cannula with an oxygenator and other accessory bypass equipment.

The connectors consist of molded fittings for use in interconnecting tubing, cannula and/or other extracorporeal devices (see Appendix I).

Tubing and connectors are coated with Trillium™ Biopassive Surface (a polyment containing non-leaching heparin).

#### Statement of Intended Use

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

### Statement of Intended Use of Predicate Device

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

| Special 510(k) Notification<br>Medtronic, Inc. | Tubing and Connectors with Trillium™<br>Biopassive Surface | Confidential |
|------------------------------------------------|------------------------------------------------------------|--------------|
| Medtronic Perfusion Systems | Appendix III | 17 |

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### Statement of Technological Characteristics and Comparison

Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".

### Determination of Substantial Equivalence

This "SPECIAL 510(k)" is being submitted for a modification to various Medtronic tubing and connectors. The modification to the current tubing and connectors is to coat the blood contact surfaces with Trillium™

The Medtronic Tubing and Connectors with Trillium™ Biopassive Surface are being compared to the following marketed devices:

Tubing and connectors described in (K800178) Affinity Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)

The tubing and connectors with Trillium™ Biopassive Surface have the same indications statement and intended uses as the:

Tubing and connectors described in (K800178)

The tubing and connectors with Trillium™ Biopassive Surface have no "new technological characteristics (e.g., materials and manufacturing processes)" from the currently marketed tubing and connectors.

The technological characteristic of the Trillium™ Biopassive Surface is used in other cardiopulmonary devices currently in commercial distribution as follows:

Affinity Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)

This technological characteristic "could affect the safety and effectiveness of the device". However, these "new technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are acceptable scientific methods which exist for assessing effects of these new technological characteristics".

"Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the tubing and connectors with Trillium™ Biopassive Surface are substantially equivalent to other marketed tubing and connectors.

The biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the tubing and connectors with Trillium™ Biopassive Surface does not significantly affect safety and effectiveness and are substantially equivalent to other

| Special 510(k) Notification | Tubing and Connectors with Trillium™ | Confidential |
|-----------------------------|--------------------------------------|--------------|
| Medtronic, Inc. | Biopassive Surface | |
| Medtronic Perfusion Systems | Appendix III | 18 |

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commercially distributed cardioplegia delivery system. The in vitro bench testing included analysis of:

Coating Characteristics:

Coating Leaching

Physical/Performance Characteristics:

Spallation Pressure Decay/Pressure Integrity Kink Resistance Blood Trauma Pull Strength

| Special 510(k) Notification | Tubing and Connectors with Trillium™ | Confidential |
|-----------------------------|--------------------------------------|--------------|
| Medtronic, Inc. | Biopassive Surface | |
| Medtronic Perfusion Systems | Appendix III | 19 |

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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 with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

AUG 2 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marie Holm Associate Product Regulations Manager Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428

K012538 Re:

> Tubing and Connectors with Trillium™ Biopassive Surface Regulation Number: 870.4210 Regulatory Class: II (two) Product Code: DWF Dated: August 6, 2001 Received: August 7, 2001

Dear Ms. Holm:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Marie Holm

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

lR

James E. Dillard III Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number if known: __KO12538_____________________________________________________________________________________________________________________________________________

Device Name: Medtronic Tubing and Connectors with Trillium™ Biopassive Surface

## Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012338

Prescription Use _

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Per 21 CFR 801.109