CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON

K030231 · Sorin Group Italia S.R.L. · DWF · Apr 18, 2003 · Cardiovascular

Device Facts

• Record ID: K030231
• Device Name: CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
• Applicant: Sorin Group Italia S.R.L.
• Product Code: DWF · Cardiovascular
• Decision Date: Apr 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Coronary Artery Perfusion Cannula with Self-Inflating Balloon is indicated for use in delivery of cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass surgery.

Device Story

The Coronary Artery Perfusion Cannula with Self-Inflating Balloon is a surgical device used during cardiopulmonary bypass. It consists of a single-lumen vinyl tube with a proximal female luer connector and a distal, pre-molded self-inflating vinyl cuff. The cuff is positioned over a hole in the tubing to facilitate the infusion of cardioplegia solution. The device is available in five cuff diameters (4, 5, 6, 7, and 8 mm) and two configurations (straight and right angle). It is intended for use by surgeons in an operating room setting to deliver cardioplegia solution directly into the coronary arteries, aiding in myocardial protection during bypass procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Single-lumen vinyl tube; pre-molded self-inflating vinyl cuff; female luer connector. Available in 4-8 mm cuff diameters; straight or right-angle configurations. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring direct delivery of cardioplegia solution to the coronary arteries.

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

• California Medical Laboratories, Inc. Aortic Root Cannula

Submission Summary (Full Text)

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K030231

# APR 1 8 2003

#### Summary of Safety and Effectiveness

# DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Vitalcor's, Inc. devices are substantially equivalent to the cited predicate device based in fact that both devices have the same stated intended use, have very similar technologic characteristics, including material, dimensional specifications and performance characteristics.

#### COMPANY AND CONTACT PERSON

Vitalcor, Inc. 100 E. Chestnut Avenue Westmont, Illinois 60559 William Huck President

#### DEVICE NAME

Coronary Artery Perfusion Cannula with Self-Inflating Balloon

#### NAME OF PREDICATE OR LEGALLY MARKETED DEVICE

- The claim of substantial equivalence is based upon the following device: California Medical Laboratories, Inc. Aortic Root Cannula ●
#### DESCRIPTION OF DEVICE

The Coronary Artery Perfusion Cannula with Self-Inflating Balloon consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tubing for purposes of receiving the infused cardioplegia solution. The subject device is provided for in five sizes based upon the diameter of the cuff consisting of 4, 5, 6, 7 & 8 mm in diameter. Furthermore, the cannula is pre-shaped into two configurations both straight and right angle.

## STATEMENT OF INTENDED USE

The Coronary Artery Perfusion Cannula with Self-Inflating Balloon is indicated for use in delivery of cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass surgery.

# STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES

California Medical Laboratories is indicated for use in delivery of cardioplegia solution during cardiopulmonary bypass surgery.

# STATEMENT OF COMPARISON OF TECHNOLOGIC CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE

Vitalcor's, Inc devices have technologic characteristics including material, dimensional and performance characteristics, which are substantially equivalent to the predicate device.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with three stripes extending from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 8 2003

Vitalcor, Inc. c/o William C. Huck President 100 East Chestnut Avenue Westmont, IL 60559

Re: K030231

Trade/Device Name: Coronary Artery Perfusion Cannula with Self-Inflating Balloon Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: January 17, 2003 Received: January 22, 2003

Dear Mr. Huck:

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, Drug, 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 -- William C. Huck

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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

l.

ram D. Zuckerman, M.D. Director Division of Cardiovascualr Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known): Ko302 31

Coronary Artery Perfusion Cannula with Self-Inflating Balloon Device Name:

Indications For Use:

The Coronary Artery Perfusion Cannula with Self-Inflating Balloon is indicated for use in delivery of cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass surgery.

Concurrence of CDRH, Office of Device Evaluation (ODE)

V. Oertle

ardiovascular D

**510(k) Number** K030231

**Prescription Use**
801.109

OR Over-The-Counter Use _ _ _ _ _ _ Per 21 CFR