(44 days)
This device is intended for use in MR imaging of peripheral blood yessels in the lower extremity for patients with suspected peripheral vascular disease for diagnostic purposes and pre-operative information.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
The letter states that the device, an "MRI Compatible Thigh Tourniquet," has been determined to be substantially equivalent to legally marketed predicate devices. This determination is based on the indications for use provided by the applicant.
Therefore, I cannot extract the requested information as it is not present in the provided document.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN - 7 2007
Ms. Erin Buethe Product Manager of MRI Devices TopSpins®, Inc. 403 Riverview Dr. ANN ARBOR MI 48107
Re: K071140
Trade/Device Name: MRI Compatible Thigh Tourniquet Regulation Number: 21 CFR §878.5910 Regulation Name: Pneumatic tourniquet Regulatory Class: I Product Code: KCY Dated: April 17, 2007 Received: April 24, 2007
Dear Ms. Buethe:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 (OS) 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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PREMARKET NOTIFICATION OF MRI COMPATIBLE THIGH TOURNIQUET STATEMENT OF INDICATIONS FOR USE
This device is intended for use in MR imaging of peripheral blood yessels in the lower extremity for patients with suspected peripheral vascular disease for diagnostic purposes and pre-operative information.
Prescription Use
Hubert Lerner and
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number__
§ 878.5910 Pneumatic tourniquet.
(a)
Identification. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.