(156 days)
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No
The document does not mention AI, ML, or any related concepts, and the device description suggests fixed parameters with only amplitude control.
Yes
The device is described as "muscle re-education" and for "therapy for the indicated medical conditions," which aligns with the definition of a therapeutic device designed to treat or alleviate medical conditions.
No
The device description and intended use indicate that the Stim-8 is used for muscle stimulation for therapeutic purposes (e.g., relaxation of muscle spasms, prevention of disuse atrophy), not for diagnosing medical conditions.
No
The device description explicitly states it is a "compact, battery powered muscle stimulator" that provides "transcutaneous electrical pulses," indicating it is a hardware device that delivers electrical stimulation.
Based on the provided information, the Stim-8 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The Stim-8 is used for stimulating muscles for therapeutic purposes (relaxation, preventing atrophy, increasing circulation, etc.). This is a direct interaction with the patient's body for treatment.
- Device Description: It's a muscle stimulator that provides transcutaneous electrical pulses. This is a physical intervention.
- Lack of In Vitro Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Stim-8 does not perform any such analysis of biological samples.
The Stim-8 is a therapeutic medical device, specifically an electrical muscle stimulator.
N/A
Intended Use / Indications for Use
The Stim-8 is used for stimulation of muscles for the purposes of 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 range of motion.
Product codes
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Device Description
The Stim-8 is a compact, battery powered muscle stimulator. It is used to repetitively contract skeletal muscles by providing transcutaneous electrical pulses to areas of the body that require therapy for the indicated medical conditions. The parameters of the Stim-8 cannot be set by the user. Four channels are available on the Stim-8. Each channel operates independently and if desired one, two, three or four channels may be used simultaneously. The only controllable parameters are the amplitude intensity controls of the stimulation.
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
Non-clinical tests: (b) (1) Comparisons of stimulation outputs for the Stim-8 and the predicate NeuroTech-16 Program System Controller show similar results that are suitable for muscle stimulation. To minimize potential electrical and mechanical hazards, BMR adheres to recognised and established industry practice and all devices are subject to final performance testing. The Stim-8 is designed and tested to EN 60601-1-2 (IEC 601-1-2). (2) Clinical tests: No clinical testing was performed. (3) Test conclusions: Testing of the stimulation output parameters of the Stim-8 indicate that the device is safe, that it provides appropriate stimulation output for effective muscle stimulation and that it performs as well as or better than the legally marketed predicate device identified in section (3) of this Summary.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
510(k) Notification for Stim-8: Appendix IX
510(k) Summary of Safety and Effectiveness
This summary is submitted in compliance with the FDA interim rule 21 CFR 807.92.
(1) Submitted by: (a)
BMR Ltd., Research & Development, 16 22 Merchants Road, Galway. Republic of Ireland
- 353 91 566911 Telephone: + 353 91 566907 Fax ::
Contact Person:
Position/ Title:
Date of preparation:
Trade name of device:
A
t
(2)
Common name:
Classification name:
Identification of predicate (3) or legally marketed device: Stim-8
Muscle Stimulator
12 December, 1995
Isaac Finnegan
Powered muscle stimulator; $890.5850
Design Engineer - Regulatory Affairs
NeuroTech-16 Program System Controller Model 280 (NeuroTech Inc., 510(k) # K860315)
116
1
Description of device: (4)
The Stim-8 is a compact, battery powered muscle stimulator. It is used to repetitively contract skeletal muscles by providing transcutaneous electrical pulses to areas of the body that require therapy for the indicated medical conditions. The parameters of the Stim-8 cannot be set by the user. Four channels are available on the Stim-8. Each channel operates independently and if desired one, two, three or four channels may be used simultaneously. The only controllable parameters are the amplitude intensity controls of the stimulation.
Intended uses: (5)
The Stim-8 is used for stimulation of muscles for the purposes of 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 range of motion.
These uses are similar to the predicate marketed device identified in section (3) of this summary.
(6) Technological comparison
is similar the NeuroTech-16 Program System The Stim-8 Controller in that both utilize microprocessor controlled stimulation parameters. Output for either device is suitable for muscle stimulation using standard skin surface electrodes. Both devices are similar in basic operational design and use the impedance of the output transformer to achieve a near net zero charge into the skin. The Stim-8 is effectively a more limited, portable version of the NeuroTech-16 Program System Controller with a replaceable battery.
2
Non-clinical tests: (b) (1)
Comparisons of stimulation outputs for the Stim-8 and the predicate NeuroTech-16 Program System Controller show similar results that are suitable for muscle stimulation. To minimize potential electrical and mechanical hazards, BMR adheres to recognised and established industry practice and all devices are subject to final performance testing. The Stim-8 is designed and tested to EN 60601-1-2 (IEC 601-1-2).
(2) Clinical tests:
No clinical testing was performed.
- (3) Test conclusions:
Testing of the stimulation output parameters of the Stim-8 indicate that the device is safe, that it provides appropriate stimulation output for effective muscle stimulation and that it performs as well as or better than the legally marketed predicate device identified in section (3) of this Summary.