(207 days)
The CATHEFFECTS Desai VectorCath™ Mapping System is intended to aid in the determination and analysis of abnormal heart activity. The device is used in conjunction with a 5-electrode catheter to record endocardial potentials to aid in the determination of the direction of the cardiac wavefront and the possible location of the wavefront's source.
Not Found
This document (K012089) is an FDA 510(k) clearance letter for the Desai VectorCath Mapping System. It does not contain details about acceptance criteria or a study proving the device meets those criteria.
The letter primarily:
- Acknowledges receipt and review of the 510(k) premarket notification.
- Determines the device is substantially equivalent to legally marketed predicate devices.
- Grants permission to market the device, subject to general controls and applicable additional controls.
- Provides contact information for regulatory questions.
The "Indications For Use" section on page 2 describes the intended purpose of the device but does not specify performance metrics or study results.
Therefore, based solely on the provided text, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets those criteria. This information would typically be found in the 510(k) submission itself, not in the clearance letter.
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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2002
Mr. Shawn Fojtik Chief Operating Officer CathEffects, L.L.C. 1100 Melody Lane, Suite 108 Roseville, CA 95678
Re: K012089
Trade Name: Desai VectorCath Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer. Regulatory Class: II (two) Product Code: DQK Dated: October 17, 2001 Received: November 5, 2001
Dear Mr. Fojtik:
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 - Mr. Shawn Fojtik
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 or any 1 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
K. Don Miller
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ of
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Desai VectorCath™ Mapping System
- The CATHEFFECTS Desai VectorCath™ Mapping System is intended Indications For Use: to aid in the determination and analysis of abnormal heart activity. The device is used in conjunction with a 5-electrode catheter to record endocardial potentials to aid in the determination of the direction of the cardiac wavefront and the possible location of the wavefront's source.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use /
OR
Over-The-Counter Use __
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012089
241
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).