STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP

K994209 · Cobe Cardiovascular, Inc. · DWF · Jun 14, 2000 · Cardiovascular

Device Facts

• Record ID: K994209
• Device Name: STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Jun 14, 2000
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stockert V142 Series Venous Cannulae with Lighthouse Tip are intended to be used for cannulating the superior or the inferior vena cava during standard cardiopulmonary bypass surgery.

Device Story

The Stockert V142 Series Venous Cannulae are sterile, single-use, wire-reinforced catheters designed for venous drainage during cardiopulmonary bypass surgery. The device consists of a cannula tube with an integrated, helically wound stainless steel wire to prevent kinking and a distal open 'lighthouse' tip to facilitate blood flow. It is available in sizes ranging from 28 Fr to 36 Fr with a length of 40 cm. The device is operated by a surgeon or perfusionist in an operating room setting. It functions as a passive conduit for venous return from the patient to the cardiopulmonary bypass circuit. By providing a kink-resistant pathway for blood drainage, the device supports the maintenance of extracorporeal circulation during cardiac procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Single-stage, wire-reinforced venous cannula. Materials: stainless steel wire encapsulated in cannula wall. Dimensions: 40 cm length, 28-36 Fr sizes. Connectivity: 3/8" connector. Sterilization: sterile, non-pyrogenic, single-use.

Indications for Use

Indicated for cannulation of the superior or inferior vena cava in patients undergoing standard cardiopulmonary bypass surgery.

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

• Baxter Research Medical Inc. Single Stage Venous Return Cannula Wire Reinforced with Lighthouse Tip

Submission Summary (Full Text)

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510(k) Pre-Market Notification: Stockert Venous Cannulae with Lighthouse Tip

K 994209

27

| | JUN 1 4 2000 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary | |
| SUBMITTER: | Stockert Instrumente GmbH<br>Division of Sorin Biomedica SpA<br>Lilienthalalle 5-7<br>D-80939 Munich Germany |
| APPLICANT: | COBE Cardiovascular, Inc.<br>Division of Sorin Biomedica SpA<br>14401 W. 65th Way<br>Arvada, Colorado 80004-3599 USA |
| CONTACT PERSON: | Lynne Leonard<br>Regulatory Affairs Manager<br>COBE Cardiovascular, Inc.<br>Arvada, Colorado USA<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | November 22, 1999 |
| DEVICE TRADE NAME: | Stockert V142 Series Venous Cannulae with Lighthouse Tip |
| COMMON/USUAL NAME: | Cardiovascular Venous Cannulae |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Vascular Catheter, Cannula or Tubing |
| PREDICATE DEVICE: | Baxter Research Medical Inc. Single Stage Venous Return Cannula<br>Wire Reinforced with Lighthouse Tip |

#### DEVICE DESCRIPTION:

The Stockert V142 Series Venous Cannulae with Lighthouse Tip are sterile, non-pyrogenic devices, for single use only, and are not to be resterilized by the user. The devices are single stage, wire reinforced venous cannulae with a distal open lighthouse tip. They are intended to be used to can, ulate the venous vessels during cardiopulmonary bypass surgery.

The product will be offered for sale in various french sizes ranging from 28 Fr to 36 Fr.

The Stockert Venous Cannulae with Lighthouse Tip are composed of two components, the cannula tube and the lighthouse tip. Encapsulated within the cannulae outer wall is a helically wound stainless steel wire which allows the cannula tube to resist kinking. The length of the device is, 40 cm.

#### INDICATIONS FOR USE

The Stockert V142 Series Venous Cannulae with Lighthouse Tip are intended to be used for cannulating the major venous vessels during cardiopulmonary bypass surgery.

## STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The Stockert Venous Cannulae with Lighthouse Tip are substantially equivalent to the Baxter Research Medical Inc. Single Stage Venous Return Cannula Wire Reinforced with Lighthouse Tip. The devices are both single stage, wire reinforced venous return cannulae with an open lighthouse tip on the distributed and

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without a connector on the proximal end. The Stockert Venous Cannulae are 40 cm in length, accept a 3/8" connector, and will be offered in sizes from 28 Fr. The Baxter RMM Venous Cannual cre 35 to 40 cm in length, accept a 3/8" connector, and are offered in sizes from 26 Fr to 40 Fr.

The following tests were performed to demonstrate substantial equivalency of the Stockert V142 Series Venous Cannulae with Lighthouse Tip to the Baxter Research Medical Inc. Single Stage Venous Return Cannula Wire Reinforced with Lighthouse Tip:

- 1. Pressure Drop
- 2. Blood Trauma
- ന് Leak
- 4. Kink Resistance
- 5. Bond Strength
- હ. Dimensional Inspection Post-sterilization and Post-aging

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a human figure or a symbol representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 4 2000

Ms. Lynne Leonard Requlatory and Clinical Affairs Manager COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599

Re: K994209 Stockert V142 Series Venous Cannulae with Light Regulatory Class: II (two) Product Code: DWF Dated: May 12, 2000 Received: May 15, 2000

Dear Ms. Leonard:

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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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. Leonard

This letter will allow you to begin marketing your device as described in rnis feecer were notification. The FDA finding of substantial your of the premains wire to a legally marketed predicate device results equivalence or 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 Additionally, for questions on the promotion and [phone]. (Jos) of your device, please contact the Office of Compliance at Also, please note the regulation entitled, "Misbranding [phone]. by reference to premarket notification" (21CFR 807.97). Other general by reference to promresponsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Brian E. Harvey

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

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# Indications For Use

510(k) Number (if known): K994209

Device Name:

Stockert V142 Series Venous Cannulae with Lighthouse Tip

Indications For Use:

The Stockert V142 Series Venous Cannulae with Lighthouse Tip are intended to be used for cannulating the superior or the inferior vena cava during standard cardiopulmonary bypass surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Beve R. Couperle E. Hany
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

C(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use