(218 days)
Not Found
Not Found
No
The device description and performance studies focus on traditional electrical stimulation parameters and comparison to a predicate electrical stimulator, with no mention of AI or ML.
Yes
Explanation: The device is intended for "adjunctive therapy for the treatment of medical diseases and conditions" and is indicated for "stimulating neuromuscular tissues for bulk muscle excitation in the legs or arms for rehabilitative purposes," which are therapeutic applications.
No
Explanation: The device is described as a Magnetic Muscle Stimulator System intended for therapeutic use to stimulate neuromuscular tissues for rehabilitation, not for diagnosing medical conditions.
No
The device description explicitly states the system consists of a stimulator Control Unit and a Treatment Wand, which are hardware components.
Based on the provided information, the Neotonus MS-101 Magnetic Muscle Stimulator System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "stimulating neuromuscular tissues for bulk muscle excitation in the legs or arms for rehabilitative purposes." This involves direct interaction with the patient's body to treat a condition, not analyzing samples taken from the body.
- Device Description: The device description details a system that generates a magnetic field applied to the skin to stimulate muscles. This is a physical therapy device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device does not perform tests or provide diagnostic information based on these samples.
Therefore, the Neotonus MS-101 is a therapeutic device, specifically a muscle stimulator, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Neotonus MS-101 Magnetic Muscle Stimulator System is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The Neotonus MS-101 is indicated for use in stimulating neuromuscular tissues for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Indications for Use for Muscle Stimulators:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
Product codes
89IPF
Device Description
The MS-101 Magnetic Muscle Stimulator System consists of a stimulator Control Unit and a Treatment Wand. The Control Unit is used to generate a voltage signal that periodically charges a "C" shaped magnetic coil which is held against the patient's skin nearest the muscle group to be stimulated. Controls are available to vary the pulse frequency (1-55 Hz), pulse amplitude (0-100%), on-cycle "Duty" period (1-30 sec) and off-duty "Rest" period (0-60 sec).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
legs or arms, calf muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
under medical supervision
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical study was conducted to compare the physiological effect of the MS-101 to that of the RICH-MAR electrical stimulator. The knee extensor muscles of nine healthy volunteers with varying degrees of muscle tone were stimulated using both the MS-101 and the electrical muscle stimulator. The study showed that:
- The skeletal muscle responses evoked by the MS-101 were comparable to those evoked using the RICH-MAR electrical stimulator.
- Both types of stimulation evoked the classic sigmoidal relationships between stimulus amplitude and muscle torque and between stimulus frequency and muscle torque.
- Both types of stimulation evoked the classic muscle fatigue and increased one-. half relaxation time with repeat contractions.
- The MS-101 is substantially equivalent to electromyostimulation for muscle rehabilitation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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).
0
510(k) Summary
Neotonus, Inc. MS-101 Magnetic Muscle Stimulator System
- Sponsor 1.
Neotonus, Inc. 810-A Franklin Court Marietta, GA 30067
Tony J. Morris Contact Person: President
May 21, 1998 Date Prepared:
Devicc Name 2.
Classification Name: Powered Muscle Stimulator, 21 CFR 890.5850, Product Code 89IPF, Class II MS-101 Magnetic Muscle Stimulator System Proprietary Name:
Intended Use 3.
The Neotonus MS-101 Magnetic Muscle Stimulator System is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The Neotonus MS-101 is indicated for use in stimulating neuromuscular tissues for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Indications for Use for Muscle Stimulators:
- Relaxation of muscle spasms 8
- Prevention or retardation of disuse atrophy 4
- Increasing local blood circulation .
- Muscle re-education .
- Immediate post-surgical stimulation of call muscles to prevent venous . thrombosis
- Maintaining or increasing range of motion .
4. Device Description
The MS-101 Magnetic Muscle Stimulator System consists of a stimulator Control Unit and a Treatment Wand. The Control Unit is used to generate a voltage signal that
and the comments of the management one offer and the county of the market of the many
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periodically charges a "C" shaped magnetic coil which is held against the patient's skin nearest the muscle group to be stimulated. Controls are available to vary the pulse frequency (1-55 Hz), pulse amplitude (0-100%), on-cycle "Duty" period (1-30 sec) and off-duty "Rest" period (0-60 sec).
Basis For Substantial Equivalence ર્ડ
The MS-101 is substantially equivalent to electrical stimulators used for muscle renabilitation and the indications as stated above. In particular, the MS-101 is substantially equivalent to the RICII-MAR Theratouch electrical muscle stimulator. A clinical study was conducted to compare the physiological effect of the MS-101 to that of the RICH-MAR electrical stimulator. The knee extensor muscles of nine healthy volunteers with varying degrees of muscle tone were stimulated using both the MS-101 and the electrical muscle stimulator. The study showed that:
- . The skelctal muscle responses evoked by the MS-101 were comparable to those evoked using the RICH-MAR electrical stimulator.
- . Both types of stimulation evoked the classic sigmoidal relationships between stimulus amplitude and muscle torque and between stimulus frequency and muscle torque.
- Both types of stimulation evoked the classic muscle fatigue and increased one-. half relaxation time with repeat contractions.
- The MS-101 is substantially equivalent to electromyostimulation for muscle rehabilitation.
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 1998
Mr. James R. Veale Vice President, Regulatory Services Medical Device Consultants, Inc. Representing Neotonus, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K973929 Neotonus MS-101 Magnetic Muscle Stimulator System Regulatory Class: II Product Code: IPF Dated: February 18, 1998 Received: February 20, 1998
Dear Mr. Veale:
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, qood 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. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Frid 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. 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 requlations.
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Page 2 - Mr. James R. Veale
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 requlation (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 gener 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,
Jacotte
Celia 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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510(k) Number (it known): K973929
Device Name: NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM
Indications For Use:
The Neotonus MS-101 Magnetic Muscle Stimulator System is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The Neotonus MS-101 is indicated for use in sumulating neuromuscular tiasucs for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Indications for Usc for Muscle Stimulators:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy t
- Increasing local blood circulation レ
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANCITITUR PAGE 16 NECESSARY
Concurrence of CDRH, Office of Donco Evaluation (ODE)
Prescription Use (Fer 21 CFR 801.109
OR
Over-the-Counter Use
(Optional Format 1-2-96)
Robert J. De Luca