3T VESSEL CANNULAS

K020768 · 3t Medical Systems, LLC · DWF · Aug 23, 2002 · Cardiovascular

Device Facts

• Record ID: K020768
• Device Name: 3T VESSEL CANNULAS
• Applicant: 3t Medical Systems, LLC
• Product Code: DWF · Cardiovascular
• Decision Date: Aug 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2

Intended Use

3T Medical Systems vessel cannulas are indicated for use during open-heart surgery or in vascular surgery to help check for leaks in a harvested vein which will be used for a graft.

Device Story

3T Vessel Cannulas are surgical instruments used during open-heart or vascular procedures. Device facilitates leak testing of harvested veins intended for use as grafts. Cannula inserted into harvested vein; saline or other fluid introduced to pressurize vessel; clinician visually inspects for leaks. Device aids in ensuring graft integrity prior to implantation. Used in clinical surgical settings by surgeons or surgical staff.

Clinical Evidence

No clinical data provided; substantial equivalence based on device design and intended use.

Technological Characteristics

Cardiopulmonary bypass vascular cannula (21 CFR 870.4210). Class II device. Mechanical design for fluid delivery to harvested vessels.

Indications for Use

Indicated for patients undergoing open-heart or vascular surgery requiring vein graft leak testing.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

AUG 2 3 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3T Medical Systems, LLC c/o Mr. Robert P. Eaton Manager 12553 South Wamblee Valley Road Conifer, CO 80433

Re: K020768

3T Vessel Cannulas Regulation Number: 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing. Regulatory Class: Class II (two) Product Code: DWF Dated: June 12, 2002 Received: June 14, 2002

Dear Mr. Eaton:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

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Page 2 - Mr. Robert P. Eaton

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 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,

Elias Mallis

for
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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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3T Medical Systems, LLC (Regulatory Office) 12553 South Wamblee Valley Road Conifer, Colorado 80433

## INDICATIONS FOR USE STATEMENT

510 (k) Number: K020768

Device Name: 3T Vessel Cannulas

Indications For Use: 3T Medical Systems vessel cannulas are indicated for use during open-heart surgery or in vascular surgery to help check for leaks in a harvested vein which will be used for a graft.

Prescription Use
(Per 21 CFR 801.109)

Elias Mallis

(Division Sign-Off) Division of Cardiovascular and Respiratory Devices

510(k) Number Ko20768