MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)

K022272 · Medtronic Cardiac Surgical Products · DWF · Jan 8, 2003 · Cardiovascular

Device Facts

• Record ID: K022272
• Device Name: MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)
• Applicant: Medtronic Cardiac Surgical Products
• Product Code: DWF · Cardiovascular
• Decision Date: Jan 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery.

Device Story

Venous cannula for cardiopulmonary bypass; collects blood from right side of heart via superior and inferior vena cava. Modified version of existing Medtronic single stage venous cannulae; incorporates malleable wire/tube assembly embedded within cannula wall. Allows surgeon to shape cannula body into preferred position. Used in surgical setting by cardiac surgeons. Benefits include improved positioning flexibility during bypass procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted in accordance with ISO 10993-1 for externally communicating devices in contact with circulating blood for limited (<24 hour) duration.

Technological Characteristics

Cardiovascular cannula with embedded malleable wire/tube assembly. Materials biocompatibility per ISO 10993-1. Externally communicating device, limited contact duration (<24 hours).

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring venous blood collection from the right side of the heart via the superior and inferior vena cava.

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 Single Stage Venous Cannulae (K845045)

Submission Summary (Full Text)

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KO22272

Section 2: 510(k) Summary and Certification

JAN 0 8 2003

510(k) Summary

# > Medtronic

Medtronic Cardiac Surgical Products

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

| Submitter: | Roger Brink<br>Medtronic Cardiac Surgical Products<br>620 Watson SW<br>Grand Rapids, MI 49504 |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| Date Summary Prepared: | July 11, 2002 |
| Trade Name of Device: | Medtronic DLP Malleable Single Stage Venous<br>Cannula |
| Common Name of Device: | Cardiovascular cannula |
| Classification Name of Device: | "Cardiopulmonary bypass vascular cannula,"<br>Class II at 21 CFR 870.4210 |
| Predicate Substantially<br>Equivalent Devices: | Medtronic DLP Single Stage Venous Cannulae,<br>Class II at 21 CFR 870.4210, cleared under 510(k)<br>Number K845045 |
| Description of Device: | The Medtronic DLP Malleable Single Stage Venous<br>Cannulae represent modified versions of existing<br>Medtronic Single Stage Venous Cannulae. The proposed<br>change involves the incorporation of a malleable wire/tube<br>assembly embedded within the wall of the cannula. This<br>malleable wire/tube assembly allows the cannula body to<br>be shaped into a surgeon preferred position. |
| Intended Use of Device: | These cannulae are intended for collection of venous<br>blood from the right side of the heart via the superior and<br>inferior vena cava during cardiopulmonary bypass surgery. |
| Comparison to Existing Predicate Devices | The Medtronic DLP Malleable Single Stage Venous Cannulae are substantially<br>equivalent to existing Medtronic DLP Single Stage Venous Cannulae. The existing |
| 510(k) Premarket Submission | Malleable Single Stage Venous Cannulae<br>Confidential |
| Medtronic, Inc. | |

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cannulae have been modified to include a malleable wire/tube assembly embedded within the cannula body. The indications for use for both the existing and modified devices are identical, and the addition of wire / tube assembly does not represent a change to the fundamental scientific technology of the devices.

#### Summary of Non-Clinical Performance Data

Material biocompatibility was conducted in accordance with the ISO 10993-1 standard. Under this standard these cannulae are categorized as externally communicating devices in contact with circulating blood for a limited (<24 hour) contact duration.

#### Conclusions of Non-Clinical Tests

The results of the non-clinical tests summarized above support an assertion that the Medtronic DLP Malleable Single Stage Venous Cannulae are as safe and effective as the existing Medtronic DLP Single Stage Venous Cannulae.

| 510(k) Premarket Submission<br>Medtronic, Inc. | Malleable Single Stage Venous Cannulae | Confidential |
|------------------------------------------------|----------------------------------------|--------------|
| Medtronic Cardiac Surgical Products | 7/11/02 | 7 |

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 8 2003

Medtronic, Inc. c/o Mr. Roger W. Brink Director, QA/RA Medtronic Cardiac Surgical Products 620 Watson SW Grand Rapids, MI 49504

Re: K022272

Trade Name: Medtronic Malleable Single Stage Venous Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Catheter, Cannula or Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: October 18, 2002 Received: October 21, 2002

Dear Mr. Brink:

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. Drue, 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. Roger W. Brink

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) you may obtain. 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,

KalaTeh

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

1022272

Device Name: Medtronic Malleable Single Stage Venous Cannulae

Indications for Use:

These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

| 510(k) Number | K022272 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Ov er-The-Counter Use |
|------------------------------------------|----|-----------------------|
|------------------------------------------|----|-----------------------|

(Optional Format 1-2-96)

| 510(k) Premarket Submission<br>Medtronic, Inc. | Malleable Single Stage Venous Cannulae | Confidential |
|------------------------------------------------|----------------------------------------|--------------|
|------------------------------------------------|----------------------------------------|--------------|

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Medtronic Cardiac Surgical Products