PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA

K983791 · Edwards Lifesciences Research Medical · DWF · Jun 11, 1999 · Cardiovascular

Device Facts

• Record ID: K983791
• Device Name: PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA
• Applicant: Edwards Lifesciences Research Medical
• Product Code: DWF · Cardiovascular
• Decision Date: Jun 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Peripheral Retrograde Cardioplegia Cannula is indicated for use in the delivery of blood or cardioplegic solution. Placement of the cannula may be performed either through the jugular vein or intraoperatively.

Device Story

Peripheral Retrograde Cardioplegia Cannula (PRC-012-MIB) is a triple-lumen radiopaque cannula used for delivering blood or cardioplegic solution during cardiac procedures. Device features a distal tip with multiple infusion holes and a separate pressure-monitoring lumen terminating at a 3-way stopcock. A manually inflated/deflated silicone occlusion balloon surrounds the distal body proximal to flow holes. Cannula length is approximately 50cm. Used by clinicians in surgical settings; provides controlled delivery of cardioplegic agents to the heart. Benefits include localized delivery of cardioplegic solution to support myocardial protection during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Triple-lumen radiopaque cannula; silicone occlusion balloon (manual inflation/deflation); 50cm usable length; sterile, non-pyrogenic; 3-way stopcock for pressure monitoring.

Indications for Use

Indicated for delivery of blood or cardioplegic solution via jugular vein or intraoperative placement.

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

• Retroplegia Cannula, RC-014-MIB (K880103)
• Heartport Endosinus Catheter (K961270)

Submission Summary (Full Text)

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# JUN 1 1 1999

83791

## IV. 510(k) Summary

#### A. Submitter / 510(k) Sponsor

John W. Smith, Manager of Regulatory Affairs

Baxter Research Medical, Inc. 6864 South 300 West Midvale, Utah 84047 USA

Phone [phone]

Fax [phone]

#### B. Device Name

Peripheral Retrograde Cardioplegia Cannula, PRC-012-MIB

Classified by FDA under 21 CFR § 870.4210, Cardiopulmonary bypass vascular catheter, cannula, or tubing.

#### C. Predicate Devices

| Predicate Device A: | Retroplegia Cannula, RC-014-MIB |
|---------------------|--------------------------------------|
| Manufacturer: | Baxter Research Medical, Inc. (BRMI) |
| 510(k) Number: | K880103 |

| Predicate Device B: | Heartport Endosinus Catheter |
|---------------------|------------------------------|
| Manufacturer: | Heartport, Inc. |
| 510(k) Number: | K961270 |

#### D. Device Description

The BRMI Peripheral Retrograde Cannula is a triple lumen radiopaque cannula. The distal tip contains multiple infusion holes and a separate pressure monitoring lumen that terminates at a 3-way stopcock.

A soft, low-pressure, manually inflated and deflated silicone occlusion balloon surrounds the distal body (proximal to the flow holes).

The cannula has approximately 50cm of usable lumen length.

Each Peripheral Retrograde Cannula is individually packaged sterile and non-pyrogenic in a sealed, peel-type pouch.

#### E. Intended Use

The Peripheral Retrograde Cardioplegia Cannula is indicated for use in the delivery of blood o'r cardioplegic solution.

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Placement of the cannula may be performed either through the jugular vein or intraoperatively.

## Summary of Comparison, Proposed and Predicate Devices F.

The proposed device is substantially equivalent to the cited predicate devices in intended use, technology, materials, and design.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 11 1999

Mr. John W. Smith Manager, Regulatory Affairs Baxter Healthcare Corporation 6864 South 300 West Midvale, UT 84047-1051

Re: K983791 Peripheral Retrograde Cardioplegia Cannula Requlatory Class: II (Two) Product Code: DWF Dated: March 23, 1999 Received: March 25, 1999

Dear Mr. Smith:

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 Requlations, 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 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 Please note: this response to your premarket Federal Reqister. 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 - Mr. John W. Smith

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), 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 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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#### D. Indications for Use Statement

510(k) Number (if known):

K983791

Peripheral Retrograde Cardioplegia Cannula Device Name:

# Indications for use:

The Peripheral Retrograde Cardioplegia Cannula is indicated for use in the delivery of blood or cardioplegic solution.

Placement of the cannula may be performed either through the jugular vein or intraoperatively.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vera E. Eagler
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

Prescription Use X

(Per 21 CFR 801.109)

.

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________