(67 days)
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No
The provided text does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing that would typically indicate the use of AI/ML in a medical device. The description focuses on the device's intended use as an electrical stimulator with standard indications.
Yes
The listed indications for use, such as "Relaxation of muscle spasms," "Prevention or retardation of disuse atrophy," and "Symptomatic relief of chronic intractable pain," are all therapeutic applications.
No
The provided 'Intended Use / Indications for Use' section lists therapeutic purposes such as muscle relaxation, prevention of atrophy, increasing blood circulation, muscle re-education, increasing range of motion, prevention of venous thrombosis, and pain relief. None of these indications describe the process of identifying or diagnosing a disease or condition.
No
The intended use describes the device as a "combination" device and lists indications for use that are typically associated with electrical stimulation hardware (High Volt Pulsed Galvanic Stimulators, Neuromuscular Electrical Stimulators, Interferential Stimulators). There is no mention of the device being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Indications: The listed indications for use (relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, immediate postsurgical stimulation of calf muscles, and symptomatic relief of pain) are all related to physical stimulation and therapy applied directly to the body. They do not involve the analysis of biological specimens.
Therefore, this device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is a 'combination' device and has the same indications for use as two different types of predicate devices.
High Volt Pulsed Galvanic Stimulators and Neuromuscular Electrical Stimulators share the same indications for use as listed below.
- 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
Interferential Stimulators have one additional indication for use:
Symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post traumatic and post-surgical pain relief.
Prescription Use
(Per 21 CFR 801.109)
Product codes (comma separated list FDA assigned to the subject device)
IPF, LIH
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
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Anatomical Site
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1998
Mr. Robert R. Thauer Vice President of Operations Vision Quest Industries, Inc. 1675 Scenic Avenue Costa Mesa, California 92626
Re: K982388 Trade Name: Surgi Stim Requlatory Class: II Product Codes: IPF and LIH July 6, 1998 Dated: Received: July 9, 1998
Dear Mr. Thauer:
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 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 895. ನ್ನ 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device 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 regulations.
1
Page 2 - Mr. Robert R. Thauer
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asboing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets produced of mits 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,
Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use
This device is a 'combination' device and has the same indications for use as two different types of predicate devices.
High Volt Pulsed Galvanic Stimulators and Neuromuscular Electrical Stimulators share the same indications for use as listed below.
- 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 ●
Interferential Stimulators have one additional indication for use:
Symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post traumatic and post-surgical pain relief.
Prescription Use
(Per 21 CFR 801.109)
bcolly
(Division Division of General Rest 510(k) Number