(86 days)
Not Found
Not Found
No
The description focuses on the mechanical components and function of a cannula, with no mention of AI or ML.
Yes
The device is used for delivery of cardioplegia solution during surgery, which directly treats a condition during a medical procedure.
No.
The device is a perfusion cannula used for delivering cardioplegia solution, not for diagnosing conditions.
No
The device description clearly outlines physical components (vinyl tube, luer connector, cuff) and their physical characteristics (sizes, shapes), indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside of the body (in vitro).
- Device Function: The Coronary Artery Perfusion Cannula with Self-Inflating Balloon is a surgical device used directly within the body during cardiopulmonary bypass surgery. Its purpose is to deliver a solution (cardioplegia) to the coronary arteries.
- Lack of Specimen Testing: The device does not involve the collection or testing of any biological specimens.
Therefore, based on its intended use and function, this device falls under the category of a surgical or interventional device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
DWF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
California Medical Laboratories, Inc. Aortic Root Cannula
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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.
2
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
3
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