(86 days)
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.
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.
The provided document is a 510(k) summary for a medical device called the "Coronary Artery Perfusion Cannula with Self-Inflating Balloon." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance), or training set information.
Instead, the document focuses on:
- Claim of Substantial Equivalence: The key assertion is that the new device is substantially equivalent to a predicate device (California Medical Laboratories, Inc. Aortic Root Cannula) based on similar intended use and technologic characteristics (material, dimensional specifications, and performance characteristics).
- Intended Use: Both the new device and the predicate device are indicated for use in the delivery of cardioplegia solution during cardiopulmonary bypass surgery.
- Technological Characteristics: A general statement that the new device's characteristics are "substantially equivalent" to the predicate.
In summary, this 510(k) submission relies on a comparison to an existing device rather than presenting new performance data against pre-defined acceptance criteria from a study.
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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
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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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
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.(b)
Classification. Class II (performance standards).