(67 days)
No
The device description and performance studies focus on electrical stimulation and impedance measurements, with no mention of AI or ML technologies.
Yes
The device is described with "Intended Use / Indications for Use" for treating medical diseases and conditions to relieve pain, and for neuromuscular stimulation for conditions like muscle spasms, disuse atrophy, and circulation. These uses align with the definition of a therapeutic device.
No
The device description and intended use indicate that the MEDSTAR 150 is a therapeutic device designed to relieve pain and stimulate muscles, not to diagnose medical conditions.
No
The device description explicitly states it is a "DC battery powered device that generates small pulses of electrical current" delivered through "lead cables to electrodes placed on the skin." This describes hardware components, not a software-only device.
Based on the provided information, the MEDSTAR 150 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used for adjunctive therapy in the treatment of medical diseases and conditions to relieve pain and for neuromuscular stimulation. These are applications that involve direct interaction with the patient's body for therapeutic purposes.
- Device Description: The device description explains that it generates electrical pulses delivered through electrodes placed on the skin to activate underlying nerves and muscle. This is a description of a device that acts on the body, not on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body. The MEDSTAR 150 is a therapeutic device that delivers electrical stimulation to the body.
N/A
Intended Use / Indications for Use
Interferential Stimulation is used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:
- . Symptomatic relief and management of chronic pain and/or
- . an adjunctive treatment in the management of post surgical and posttraumatic acute pain.
When used for neuromuscular stimulation, the standard indications for use are:
- 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; and
- Maintaining or increasing rang of motion
The MEDSTAR 150 should only be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:
- symptomatic relief and management of chronic pain and/or .
- an adjunctive treatment in the management of post surgical and posttraumatic acute ● pain.
When used for neuromuscular stimulation, the standard indications for use are:
- 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; ● and
- Maintaining or increasing rang of motion .
Product codes
IPF, LIH
Device Description
The MEDSTAR 150 is a DC battery powered device that generates small pulses of electrical current. These small pulses of electrical current are delivered through lead cables to electrodes placed on the skin. These electrical pulses pass through the skin and activate underlying nerves and muscle.
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
FUNCTIONAL SAFETY TESTING:
Was performed with a signal generator voltmeter, 20 ohm resistor, and alligator clip wires. The signal generator was set to 1000 Hz and V ¡ was set at approximately 2 volts. The voltage drop across the electrodes (V2) was measured and the impedance of the electrodes calculation is as follows:
Impedance (Z) = V7/V1 x R Where V2 and V; are the voltage meter readings.
Refer to section 6 for further details.
CONCLUSION:
The MEDSTAR 150 is substantially equivalent to 4000+ Interferential Powered Muscle Stimulator in intended use, design and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
A. 510(k) Summary
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K013081 |
|---|---|
| SUBMITTER: | MedNet Services, Inc. |
| 2855 Anthony Lane, Suite B-10 | |
| St. Anthony, MN 55418 | |
| Phone: 612-788-6228 | |
| Fax: 612-788-6228 | |
| CONTACT PERSON: | David L. Mathews |
| TITLE: | President |
| DATE PREPARED: | September 11, 2001 |
| TRADE NAME: | MEDSTAR™ 150 |
| COMMON NAME: | Powered Muscle Stimulator (89IPF) |
| CLASSIFICATION: | 21 CFR 890.5850, Powered Muscle |
| Stimulator Class II | |
| PRODUCT CODE: | IPF, LIH |
| PREDICATE DEVICE (S): | 4000+ Interferential Powered Muscle Stimulator, |
| K950783 |
DEVICE DESCRIPTION:
The MEDSTAR 150 is a DC battery powered device that generates small pulses of electrical current. These small pulses of electrical current are delivered through lead cables to electrodes placed on the skin. These electrical pulses pass through the skin and activate underlying nerves and muscle.
INTENDED USE:
Interferential Stimulation is used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:108
1
K013081
2 OF 2
- . Symptomatic relief and management of chronic pain and/or
- . an adjunctive treatment in the management of post surgical and posttraumatic acute pain.
When used for neuromuscular stimulation, the standard indications for use are:
- 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; and
- Maintaining or increasing rang of motion
FUNCTIONAL SAFETY TESTING:
Was performed with a signal generator voltmeter, 20 ohm resistor, and alligator clip wires. The signal generator was set to 1000 Hz and V ¡ was set at approximately 2 volts. The voltage drop across the electrodes (V2) was measured and the impedance of the electrodes calculation is as follows:
Impedance (Z) = V7/V1 x R Where V2 and V; are the voltage meter readings.
Refer to section 6 for further details.
CONCLUSION:
The MEDSTAR 150 is substantially equivalent to 4000+ Interferential Powered Muscle Stimulator in intended use, design and performance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2001
Mr. David L. Mathews President MedNet Services, Inc. 2855 Anthony Lane, Suite B-10 St. Anthony, Minnesota 55418
Re: K013081
Trade/Device Name: MEDSTAR™ 150 Interferential and Powered Muscle Stimulator Regulation Number: 890.5850 and unclassified Regulation Name: Powered muscle stimulator and Interferential current therapy Regulatory Class: II Product Code: IPF, LIH Dated: September 11, 23001 Received: September 14, 2001
Dear Mr. Mathews:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 20, 1970, in easondance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, diereleve, mains 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 (PMA), it If your device is elassinod (600 as controls. Existing major regulations affecting your device can may oe subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advisou that I Drivisantes over device complies with other requirements of the Act that I DI Has made a cond regulations administered by other Federal agencies. You must or any I odetar states and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Part 607), adoning (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. David L. Mathews
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and h your finding of substantial equivalence of your device to a legally premated predicated. " cresults 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 21 CFR Part 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" (21CFR Part 807.97). regaration childred, which on your responsibilities under the Act may be obtained from the O wision 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/dsma/dsmamain.html
Sincerely vours.
Mark M Mullener
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NOV 2 0 2001
Indications For Use Page
510(k) Number (if known): Not yet assigned.
Device Name: MEDSTAR 150
Indications For Use:
The MEDSTAR 150 should only be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:
- symptomatic relief and management of chronic pain and/or .
- an adjunctive treatment in the management of post surgical and posttraumatic acute ● pain.
When used for neuromuscular stimulation, the standard indications for use are:
- 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; ● and
- Maintaining or increasing rang of motion .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Minh N Mulkerson
510(k) Nu: K013081