RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014

K991170 · Edwards Lifesciences Research Medical · DWF · Jul 2, 1999 · Cardiovascular

Device Facts

• Record ID: K991170
• Device Name: RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014
• Applicant: Edwards Lifesciences Research Medical
• Product Code: DWF · Cardiovascular
• Decision Date: Jul 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Retrograde Cardioplegia Cannula with Duraflo Treatment is indicated for use in the delivery of blood or cardioplegic solution. Extracorporeal circuit components with the Duraflo treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

Device Story

Dual-lumen cannula for retrograde cardioplegia delivery; features distal infusion holes and separate pressure monitoring lumen. Includes soft, self-inflating, low-pressure balloon proximal to flow holes; balloon inflates via differential pressure during infusion and deflates spontaneously when flow stops. Supplied with introducer stylet. Device treated with Duraflo (heparin coating) to reduce thrombogenicity. Used by surgeons during cardiopulmonary bypass procedures to deliver cardioplegic solution to the heart. Benefits include localized delivery of cardioplegia and reduced blood-contact surface activation via heparin coating.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-lumen cannula with integrated self-inflating balloon. Materials include proprietary Duraflo heparin coating. Sterile, non-pyrogenic, single-use. Mechanical inflation mechanism via differential pressure. No software or electronic components.

Indications for Use

Indicated for patients undergoing cardiopulmonary surgery requiring delivery of blood or cardioplegic solution intraoperatively. For short-term use only (< 6 hours) when a heparin-treated blood path is desired.

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 (K880103)
• Extracorporeal Circuit with Duraflo II Heparin Treatment (K932208)

Submission Summary (Full Text)

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K991170 Page 1 of

Retrograde Cardioplegia Cannula with Duraflo Treatment

# 510(k) Summary IV.

# Submitter / 510(k) Sponsor A.

John W. Smith, Manager of Regulatory Affairs Baxter Research Medical, Inc. 6864 South 300 West Midvale, Utah 84047 USA

Phone [phone]

Fax [phone]

## B. Date Prepared

1999-06-30

## C. Device Name

Retrograde Cardioplegia Cannula with Duraflo Treatment, DII-RC-014

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

# D. Predicate Devices

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

Extracorporeal Circuit with Duraflo II Heparin Treatment Predicate Device B: Baxter Healthcare Corporation Manufacturer: 510(k) Number: K932208

# E. Device Description

The Baxter Research Medical Retrograde Cardioplegia Cannula with Duratio Treatment is a dual lumen cannula. The distal tip contains multiple infusion holes and an opening into the separate pressure monitoring lumen. A soft, low-pressure, self-inflating balloon surrounds the distal body (proximal to the flow holes). Inflation is accomplished via the differential pressure that occurs within the cannula during influsion. The balloon will deflate spontaneously when flow is stopped. The cannula is furnished with an introducer stylet. Each device is Individually packaged sterile and non-pyrogenic in a sealed, peed-type pouch.

The device is treated with Baxter Healthcare Corporation's proprietary Heparin coating, Duraflo.

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#### Intended Use F.

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

Extracorporeal circuit components with the Duraflo treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

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

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

The proposed device consists of a device identical to the device cited as predicate Device A, which has been treated with the Duraflo treatment included in Predicate Device B.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

# JUL : 2 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K991170 Retrograde Cardioplegia Cannula with Duraflo Treatment Regulatory Class: II (Two) Product Code: DWF April 6, 1999 Dated: Received: April 7, 1999

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the Retrograde Cardioplegia Cannula with Duraflo Treatment, Model Number DII-RC-014, 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 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 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), promotion, or advertising, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Callahan

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): K991170

> Retrograde Cardioplegia Cannula with Duraflo Treatment Device Name:

# Indications for use:

The Retrograde Cardioplegia Cannula with Duratio Treatment is indicated for use in the delivery of blood or cardioplegic solution intraoperatively.

Extracorporeal circuit components with the Duraflo treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

This device is for short-term use only (< 6 h).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Caroline Henry Leon

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 491170 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_