STOCKERT CORONARY PERFUSION CANNULAE

K022280 · Stockert Instrumente GmbH · DWF · Oct 11, 2002 · Cardiovascular

Device Facts

• Record ID: K022280
• Device Name: STOCKERT CORONARY PERFUSION CANNULAE
• Applicant: Stockert Instrumente GmbH
• Product Code: DWF · Cardiovascular
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stöckert Coronary Perfusion Cannulae are intended to be used to cannulate the coronary ostium and to deliver cardioplegic solution during cardiopulmonary surgery for periods of up to six hours.

Device Story

Stöckert Coronary Perfusion Cannulae are manual surgical instruments used during cardiopulmonary bypass. Device consists of flexible PVC or malleable stainless steel body with soft silicone tip; includes 1/4" barbed tubing connector or luer lock. Available in various tip diameters (3.0-5.0 mm; 9-15 Fr) and lengths (14 cm or 26 cm). Operated by surgeons in OR to cannulate coronary ostium for cardioplegic solution delivery. Provides direct access for myocardial protection during surgery.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence established via in-vitro performance and biocompatibility testing.

Technological Characteristics

Materials: PVC or stainless steel body, silicone tip. Dimensions: 3.0-5.0 mm tip diameter; 14 cm or 26 cm length. Connectivity: 1/4" barbed tubing or luer lock. Non-powered, manual surgical instrument.

Indications for Use

Indicated for patients undergoing cardiopulmonary surgery requiring coronary ostium cannulation and cardioplegic solution delivery 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 Coronary Ostial Perfusion Cannulae

Submission Summary (Full Text)

{0}------------------------------------------------

510(k) Pre-Market Notification: Stöckert Coronary Perfusion Cannulae

## OCT 1 1 2002

### 510(k) Summarv

| SUBMITTER: | Stöckert Instrumente GmbH<br>Lindberghstrasse 25<br>D-80939 Munich, Germany |
|----------------------|-------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mr. Helmut Höfl<br>Director, Quality and Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | May 10, 2002 |
| DEVICE TRADE NAME: | Stöckert Coronary Perfusion Cannulae |
| COMMON/USUAL NAME: | Antegrade Cardioplegia Cannulae |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Vascular Catheter, Cannula or Tubing |
| PREDICATE DEVICE: | Medtronic DLP Coronary Ostial Perfusion Cannulae |

DEVICE DESCRIPTION:

The Stöckert Coronary Perfusion Cannulae are comprised of either a flexible plastic (PVC) or a malleable stainless steel body, with a soft silicone tip and either a ¼" barbed tubing connector or a luer lock. They are offered in various tip outer diameters ranging from 3.0 to 5.0 mm (9 to 15 Fr). The P605, P607, P615, and P617 Series Stöckert Coronary Perfusion Cannulae are 26 cm long. The P606, P616, and P618 Series Stöckert Coronary Perfusion Cannulae are 14 cm long.

### INDICATIONS FOR USE

The Stöckert Coronary Perfusion Cannulae are intended to be used to cannulate the coronary ostium and to deliver cardioplegic solution during cardiopulmonary surgery for periods of up to six hours.

### STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

In-vitro performance and biocompatibility tests demonstrate substantial equivalency of the Stöckert Coronary Perfusion Cannulae to the Medtronic DLP Coronary Ostial Perfusion Cannulae. The devices share the same intended use, design features, and performance characteristics.

{1}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three parallel lines that curve to form the shape of the bird's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 1 2002

Stöckert Instrumente GmbH c/o Ms. Lynne Leonard Leonard Regulatory Consulting 20193 Goins Drive Morrison, CO 80465

Re: K022280

Stöckert Coronary Perfusion Cannulae Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: July 11, 2002 Received: July 15, 2002

Dear Ms. Leonard:

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 mav publish further announcements concerning your device in the Federal Register.

{2}------------------------------------------------

Page 2 - Ms. Lynne Leonard

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,

R. Zaleski M.D.

Bram D. Zuckerman, M.D. -Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Pre-Market Notification: Stöckert Coronary Perfusion Cannulae

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

#### Indications For Use

510(k) Number (If known): K022280

Device Name:

:

Stöckert Coronary Perfusion Cannulae

Indications For Use:

The Stöckert Coronary Perfusion Cannulae are intended to be used to cannulate the coronary ostium and to deliver cardioplegic solution during cardiopulmonary surgery for periods of 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)

Division of Cardiovascular & Respiratory Devices
510(k) Number K022880

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________