(44 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, deep learning, or any related terms, nor does it describe any features or performance metrics typically associated with AI/ML-powered devices.
No
The device is intended for diagnostic purposes (MR imaging) and pre-operative information, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "for diagnostic purposes".
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the device includes hardware components or is purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "MR imaging of peripheral blood vessels in the lower extremity". This describes an in vivo diagnostic procedure (imaging within the living body), not an in vitro diagnostic procedure (testing samples outside the body).
- Input Imaging Modality: The input is "MR imaging", which is an in vivo imaging technique.
- Anatomical Site: The anatomical site is the "lower extremity", again indicating an in vivo application.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device is used to directly image the body.
N/A
Intended Use / 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.
Product codes
KCY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
MR imaging
Anatomical Site
lower extremity
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the left side of the eagle. The eagle symbol is composed of three curved lines that resemble the wings and body of an eagle. The text is written in uppercase letters and is evenly spaced around the circle.
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.
Image /page/0/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo. The word "Centennial" is below the letters "FDA". There are three stars below the word "Centennial".
1
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__