STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35

K023622 · Stockert Instrumente GmbH · DWF · Nov 21, 2002 · Cardiovascular

Device Facts

• Record ID: K023622
• Device Name: STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35
• Applicant: Stockert Instrumente GmbH
• Product Code: DWF · Cardiovascular
• Decision Date: Nov 21, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Stöckert Pediatric Aortic Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary bypass up to six hours or less.

Device Story

Stöckert Pediatric Aortic Cannulae are sterile, single-use, wire-reinforced aortic cannulae; used in clinical settings for cardiopulmonary bypass. Device consists of a cannula tube with a curved distal tip; helically wound stainless steel wire encapsulated within the outer wall provides kink resistance. Diameters range from 4.5 to 10.5 Fr; length is 22 cm. Operated by surgical staff to facilitate arterial perfusion during bypass. Device returns blood from extracorporeal circuit to patient; supports bypass duration up to six hours.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by in-vitro performance and biocompatibility testing.

Technological Characteristics

Wire-reinforced aortic cannula; stainless steel wire reinforcement; 4.5 to 10.5 Fr diameter; 22 cm length; curved distal tip; sterile; single-use; non-pyrogenic.

Indications for Use

Indicated for pediatric patients requiring arterial blood return from an extracorporeal circuit during cardiopulmonary bypass procedures lasting six hours or less.

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

• Jostra Arterial Perfusion Cannulae
• Research Medical Inc. Pediatric Aortic Cannula

Submission Summary (Full Text)

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510(k) Pre-Market Notification: Stöckert Pediatric Aortic Cannulae (11/19/02)

1623622

## NOV 2 1 2002

| 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: | September 5, 2002 |
| DEVICE TRADE NAME: | Stöckert Pediatric Aortic Cannulae, A272-15 through A272-35 |
| COMMON/USUAL NAME: | Cardiovascular Aortic Cannulae |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Vascular Catheter, Cannula or Tubing |
| PREDICATE DEVICE: | Jostra Arterial Perfusion Cannulae |
| DEVICE DESCRIPTION: | |

The Stöckert Pediatric Aortic Cannulae, A272-15 through A272-35 are sterile, non-pyrogenic devices, for single use only, and are not to be resterilized by the user. The devices are wire reinforced aortic cannulae with a curved distal tip.

The cannulae are comprised of two components, the cannula tube and the curved tip. Encapsulated within the cannula outer wall is a helically wound stainless steel wire which allows the cannula tube to resist kinking. The devices range in diameter from 4.5 to 10.5 Fr and have an overall length of 22 cm.

## INDICATIONS FOR USE

The Stöckert Pediatric Aortic Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary bypass up to six hours or less.

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

In-vitro performance and biocompatibility tests demonstrate substantial equivalence of the Stöckert Pediatric Aortic Cannulae to the Research Medical Inc. Pediatric Aortic Cannula. The devices share the same intended use and overall design features (flexible tapered aortic cannula with a distal tip including suture ring, and without an attached connector).

## 510(k) Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2002

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

Re: K023622

Stöckert Pediatric Aortic Cannulae (Models A272-15 through A272-35) Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: October 28, 2002 Received: October 29, 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. Iisting 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 - Ms. Lynne Leonard

Enclosure

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), 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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

Dna Alunhurfor

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

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## Indications For Use

510(k) Number (If known):

Device Name:

Stöckert Pediatric Aortic Cannulae (Models A272-15 through A272-35)

K 023622

Indications For Use:

The Stöckert Pediatric Aortic Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary bypass up to six hours or less.

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