STOCKERT V172-28 VENOUS FEMORAL CANNULA

K022321 · Stockert Instrumente GmbH · DWF · Oct 9, 2002 · Cardiovascular

Device Facts

• Record ID: K022321
• Device Name: STOCKERT V172-28 VENOUS FEMORAL CANNULA
• Applicant: Stockert Instrumente GmbH
• Product Code: DWF · Cardiovascular
• Decision Date: Oct 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stöckert V172-28 Venous Femoral Cannula is intended to be used to cannulate the inferior vena cava and the right atrium via femoral access during cardiopulmonary bypass surgery for periods up to six hours.

Device Story

Stöckert V172-28 Venous Femoral Cannula is a sterile, single-use, wire-reinforced PVC cannula (28 Fr, 90 cm) designed for femoral vessel cannulation during cardiopulmonary bypass. It features a non-wire reinforced proximal end for circuit connection and two sets of side holes for drainage from the right atrium and inferior vena cava/hepatic veins. An included obturator seals side holes during insertion to prevent blood leakage; it is removed and discarded post-insertion. Used in surgical settings by clinicians to facilitate extracorporeal circulation. Benefits include providing an alternative access route to superior/inferior vena cava cannulation.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included pressure drop, blood trauma, leak, and kink resistance.

Technological Characteristics

Polyvinyl chloride (PVC) wire-reinforced cannula; 28 Fr diameter; 90 cm length; includes removable obturator; non-wire reinforced proximal end for 1/2" connector; sterile, non-pyrogenic, single-use.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring cannulation of the inferior vena cava and right atrium via femoral access for up to six hours.

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

• Medtronic DLP Venous Femoral Cannula

Submission Summary (Full Text)

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510(k) Pre-Market Notification: Stöckert V172-28 Venous Femoral Cannula

KO22321 PG1 of 2

510(K) SUMMARY

OCT 0 9 2002

| SUBMITTER: | Stöckert Instrumente GmbH<br>Lindberghstr.25<br>D-80939 Munich Germany |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT: | COBE Cardiovascular, Inc.<br>14401 W. 65th Way<br>Arvada, Colorado 80004-3599 USA |
| CONTACT PERSON: | Shawn Riedel<br>Regulatory and Quality Assurance Manager<br>COBE Cardiovascular, Inc.<br>Arvada, Colorado USA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| DATE PREPARED: | 11 July 2002 |
| DEVICE TRADE NAME: | Stöckert V172-28 Venous Femoral Cannula |
| COMMON/USUAL NAME: | Cardiovascular Femoral Cannula |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Vascular Catheter, Cannula or<br>Tubing |
| PREDICATE DEVICE: | Medtronic DLP Venous Femoral Cannula |

## DEVICE DESCRIPTION:

The Stöckert V172-28 Venous Femoral Cannula is a sterile, non-pyrogenic device, for single use only, and is not to be resterilized by the user. The device is a polyvinyl chloride (PVC) wire reinforced Cannula with a non-wire reinforced proximal end for connecting the device to a cardiopulmonary bypass circuit. The Stöckert V172-28 Cannula is intended to be used to cannulate the femoral vessels during cardiopulmonary bypass surgery. During use, the cannula is inserted into the vena femoralis and advanced into the right atrium, allowing blood from the systemic circulation to enter the extracorporeal circuit. Insertion of the cannula into the vena femoralis during cardiopulmonary bypass surgery is an alternative method for insertion of a cannula into the superior or inferior vena cava.

The Stöckert V172-28 Cannula is 28 Fr and 90 cm in length, with a flexible proximal end that can accommodate a 1/2" connector. The cannula tube contains two sets of side holes, one set for drainage from the right atrium and one set for drainage from the inferior vena cava and hepatic veins. An obturator is provided with each cannula, which seals the inside of the cannula tube in the areas of the side holes to prevent blood leakage from the cannula during insertion. After insertion, the obturator is removed and discarded by the user.

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# INDICATIONS FOR USE

The Stöckert V172-28 Venous Femoral Cannula is intended to cannulate the inferior vena cava and the right atrium via femoral access during cardiopulmonary bypass surgery for periods up to six hours.

# STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The Stöckert V172-28 Venous Femoral Cannula are substantially equivalent to the Medtronic DLP Venous Femoral Cannula. The following tests were performed to demonstrate substantial equivalency of the devices:

- 1. Pressure Drop
- 2. Blood Trauma
- 3. Leak
- 4. Kink Resistance

## TRUTHFUL AND ACCURATE STATEMENT

A statement attesting to the truthfulness and accuracy of the information contained in this submission is attached as Appendix 11.

## FURTHER INFORMATION

In the event that additional information is required, please contact the following individual at COBE Cardiovascular, Inc. the applicant of this 510(k) notification, submitting on behalf of the manufacturer and specification holder of the product, Stöckert Instrumente GmbH. Munich, Germany:

> Shawn Riedel Manager, Regulatory and Quality Assurance COBE Cardiovascular, Inc. 14401 West 65" Way Arvada, Colorado 80004-3599 USA Phone: [phone] Fax: [phone] Email: shawn.riedel(@cobecv.com

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 9 2002

Stöckert Instrumente GmbH c/o Mr. Shawn Riedel COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599

Re: K022321

Stöckert V172-28 Venous Femoral Cannula Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: II (two) . Product Code: DWF Dated: July 12, 2002 Received: July 17, 2002

Dear Mr. Riedel:

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.

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Page 2 - Mr. Shawn Riedel

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. 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,

4.

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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KØ22321
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Indications For Use

510(k) Number (If known): K020321

Device Name:

Stöckert V172-28 Venous Femoral Cannula

Indications For Use:

The Stöckert V172-28 Venous Femoral Cannula is intended to be used to cannulate the inferior vena cava and the right atrium via femoral access during cardiopulmonary bypass surgery for periods up to six hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Division of Cardiovascular & Respiratory Devices
510(k) Number K022332

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