MADTRONIC DLP ARTERIAL CANNULAE

K991066 · Medtronic Vascular · DWF · Sep 14, 1999 · Cardiovascular

Device Facts

• Record ID: K991066
• Device Name: MADTRONIC DLP ARTERIAL CANNULAE
• Applicant: Medtronic Vascular
• Product Code: DWF · Cardiovascular
• Decision Date: Sep 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product is intended for use with cardiopulmonary bypass as an arterial return cannula.

Device Story

Cardiovascular cannula used during cardiopulmonary bypass; facilitates arterial return. Device consists of thin-wall cannula body with beveled tip, fabricated from polyurethane or wire-reinforced polyvinyl chloride; terminates in 3/8" barbed connector. Includes plastic, blunt-tip introducer with porous plug to aid insertion and minimize blood loss during priming; introducer features port for 0.038" guidewire. Used by clinicians in surgical settings. Modifications include increased radius of introducer tip to improve penetration force characteristics.

Clinical Evidence

Bench testing only. Laboratory assessment measured force required for cannula introducer to penetrate an aqueous, semi-solid matrix. Results verified that increasing the radius of the introducer tip significantly increased penetration force.

Technological Characteristics

Materials: Polyurethane or wire-reinforced polyvinyl chloride. Components: Cannula body, beveled tip, 3/8" barbed connector, plastic blunt-tip introducer with porous plug. Features: 0.038" guidewire compatibility. Energy source: None (mechanical).

Indications for Use

Indicated for use as an arterial return cannula during cardiopulmonary bypass procedures.

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 Arterial Cannula Family (K880421)

Submission Summary (Full Text)

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K991066

# Medtronic @

SEP 1 4 1999

Medtronic, Inc.
Medtronic DLP
620 Watson SW, P.O. Box 409
Grand Rapids, MI 49501-0409 Telephone: [phone] Toll Free: [phone] Fax: [phone]

## 510(k) Summary [As Required by 21 CFR 807.92]

| Submitter: | James Balun<br>Medtronic DLP<br>620 Watson, S.W.<br>Grand Rapids, Michigan 49504 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | [phone] |
| FAX Number: | [phone] |
| Date Summary Prepared: | March 26, 1999 |
| Trade Name of Device: | Medtronic DLP Arterial Cannula Family (Including Descending Arch and<br>Elongated One-Piece Arterial Models) |
| Common Name of Device: | Cardiovascular cannula |
| Classification Name of Device: | "Cardiopulmonary bypass vascular cannula",<br>Class II at 21 CFR 870.4210 |
| Predicate Substantially Equivalent Device: | Medtronic DLP Arterial Cannula Family,<br>Cleared under 510(k) Number K880421 on April 28, 1988,<br>Class II at 21 CFR 870.4210 |
| Description of Device: | These Medtronic DLP Arterial Cannulae feature a thin-wall cannula body with<br>a beveled tip which is fabricated from either polyurethane or wire-reinforced<br>polyvinyl chloride. The proximal end of the cannula terminates in a barbed<br>3/8" connector. A plastic, blunt tip introducer with a porous plug is provided to<br>aid in insertion of the cannula and prevent excessive blood loss during priming.<br>The introducer includes a port which enables insertion along a 0.038"<br>guidewire. |

・・ 510(k) Summary Medtronic DLP Arterial Cannula Family

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991066

#### These products are intended for use with cardiopulmonary bypass as arterial Intended Use of Device: return cannulae.

### Comparison to Predicate Devices:

No change to the intended use of these cannulae is being implemented in conjunction with the proposed device modifications. The proposed modifications include:

- Blunting, i.e., increasing the radius, of the tip of the introducer; and (1)
- Revisions to the Warnings section of the Directions for Use. (2)

#### Summary of Non-Clinical Performance Data:

A laboratory assessment of the force which must be applied to the cannula introducer in order to penetrate an aqueous, semi-solid matrix was performed. This assessment verified that increasing the radius of the introducer tip significantly increased the amount of force required to penetrate this test material.

#### Conclusion of Non-Clinical Testing:

The result of this laboratory test supports an assertion that the Medtronic DLP Arterial Canhula Family which has been modified as described above is as safe and effective as the original cannula which was cleared for marketing in April 1988.

4 1 1 1 1 510(k) Summary Medtronic DLP Arterial Cannula Family

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.

Mr. James Balun Principal Product Regulation Manager Medtronic, Inc. Medtronic DLP 620 Watson SW, P.O. Box 409 Grand Rapids, MI 49501-0409

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1999

K991066 Re :

Medtronic DLP Arterial Cannula Family (DLP Descending Arch Arterial Cannula, product codes 70321, 70324, 71321, and 71324, and DLP Elongated One-Piece Arterial Cannula, product codes 77420, 77422, 77520, and 77522) Regulatory Class: II Product Code: DWF Dated: July 16, 1999 Received: July 19, 1999

Dear Mr. Balun:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 requlations.

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Page 2 - Mr. James Balun

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), or 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 807.97). Other general information on your responsibilities 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,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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(991066 510(k) Number (if known):

Medtronic DLP Arterial Cannula Family (Including Descending Arch and Elongated One-Piece Models) Device Name:

Indications For Use:

This product is intended for use with cardiopulmonary bypass as an arterial return cannula.

(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

Division of Cardiovascular, Respiratory,

510(k) Number_ 1066600 106

(Division Sign-Off)

and Neurological Devices

Over-The-Counter Use

(Optional Format 1-2-96)