(214 days)
For Ultrasound: Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. Ultrasound can provide therapeutic deep heating between 40° and 45 °C.
For VMS, Russian, Monophasic Hi-Volt:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For Microcurrent, Interferential and Premodulated:
- Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions
Not Found
This document is an FDA 510(k) clearance letter for various Vectra devices (Vectra 2C, 4C, 2S, 4S, Pro 2, and Pro 4), which are indicated for physical therapy applications such as ultrasound and electrical stimulation. However, the provided text does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document primarily states that the devices are substantially equivalent to legally marketed predicate devices, allowing them to proceed to market. It outlines general controls, regulations, and contact information for the manufacturer.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This information would typically be found in the 510(k) submission summary or detailed study reports, which are not provided in the given text. The FDA letter is an outcome of the review process, not the detailed review itself.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1999
Ms. Cheryl G. Dyer Requlatory Compliance Specialist Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 37343-0489 Hixson, Tennessee
Re: K982317 Vectra 2C and Vectra 4C Trade Names: Product Codes: GZJ, LIH, IPF, IMG, and IMI K982321 Vectra 2S and Vectra 4S Trade Names: GZJ, LIH, and IPF Product Codes: K982324 Vectra Pro 2 and Vectra Pro 4 Trade Names: Product Codes: GZJ, LIH, IPF, IMG, and IMI Regulatory Class: II December 10, 1999 Dated: Received: December 11, 1999
Dear Ms. Dyer:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory
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Page 2 - Ms. Cheryl G. Dyer
action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ho. Marle N. Milkeran
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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Image /page/2/Picture/1 description: The image shows the logo for Chattanooga Group, Inc. The logo consists of a stylized letter "C" on the left, with the words "Chattanooga" above the words "Group, Inc." on the right. The letter "C" is made up of black and white shapes, and the words are in a simple, sans-serif font.
INDICATIONS
For Ultrasound
Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. Ultrasound can provide therapeutic deep heating between 40° and 45 °C.
For VMS, Russian, Monophasic Hi-Volt
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation I
- Muscle re-education
- 피 Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis L
For Microcurrent, Interferential and Premodulated
- Symptomatic relief of chronic, intractable pain a
- Management of pain associated with post-traumatic or post-operative conditions
Mark M Milluson
fo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K98 2324
Prescription Use
(Per 21 CFR 801.109)
4717 Adams Road P.O. Box 489 Hixson, TN 37343-0489 Phone: 423-870-2281 Fax: 423-870-7404
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).