(187 days)
PGS 3000
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of these technologies.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device offers "therapeutic relief" for several conditions, such as muscle spasm and disuse atrophy.
No
The device is described as a stimulator used for therapeutic relief, relaxation of muscle spasm, prevention of disuse atrophy, increasing blood circulation, and maintaining/increasing range of motion. These are all therapeutic actions, not diagnostic ones.
No
The provided 510(k) summary does not contain enough information to definitively determine if the Impulse HVG Stimulator is a software-only medical device. The description is minimal and does not specify the device's components or how it achieves its intended use. The name "Stimulator" suggests a hardware component is likely involved in delivering the therapeutic effect.
Based on the provided information, the Impulse HVG Stimulator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended uses listed (relaxation of muscle spasm, prevention of disuse atrophy, increasing local blood circulation, maintaining or increasing range of motion) are all therapeutic applications applied directly to the patient's body. IVDs are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
- Device Description: The description "Impulse HVG Stimulator" suggests a device that delivers electrical impulses, consistent with a therapeutic stimulator, not a device for analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information.
- Using reagents or assays.
- Mentioning laboratory settings or procedures.
Therefore, the Impulse HVG Stimulator is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Impulse HVG Stimulator can be used to treat and provide therapeutic relief for the following indications:
- relaxation of muscle spasm
- prevention or retardation of disuse atrophy
- increasing local blood circulation, and
- maintaining or increasing range of motion
The Impulse HVG has the same intended medical uses as the listed predicate device (PGS 3000).
Product codes
1022
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
PGS 3000
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a bird or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1997
Mr. John P. Landino President Sterling Medical Technologies, Inc. 801 Jupiter Road, Suite 102 Plano, Texas 75074
K970847 Re : Impulse HVG Regulatory Class: II Product Code: 1022 August 18, 1997 Dated: Received: August 21, 1997
Dear Mr. Landino:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 device, subject to the general controls provisions The general controls provisions of the Act 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 Requlations, 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 regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 regulations.
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Page 2 - Mr. John P. Landino
This letter will allow you to begin marketing your device as described in your 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 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 device, 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,
Ascollifa
Celra M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a black rectangular box with the words "INDICATIONS FOR USE" written in bold, black letters inside. The words are centered within the box. The box is a simple, clean design, with a clear and easy-to-read font.
ア
Prescribing Information
The Impulse HVG Stimulator can be used to treat and provide therapeutic relief for the following indications:
- relaxation of muscle spasm
- prevention or retardation of disuse atrophy
- increasing local blood circulation, and
- maintaining or increasing range of motion
The Impulse HVG has the same intended medical uses as the listed predicate device (PGS 3000).
Prescription U.
(Per 21 CFR 801.109)
(Per 21 CFR 801.109)
Prescription Use.
focoele
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