(36 days)
K874469A, K935213, K903497A
No
The document describes a standard electrical muscle stimulator and electromyography device with no mention of AI or ML capabilities, training data, or performance metrics typically associated with AI/ML.
Yes
The device description and intended use clearly state that it is for treating various medical conditions, including muscle spasms, disuse atrophy, and stroke rehabilitation, which are all therapeutic applications.
Yes
The device description states, "The MyoTrac Infiniti is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves." Monitoring and displaying bioelectric signals and electrical activity of nerves are diagnostic functions.
No
The device description explicitly states it is an electrical muscle stimulator and an electromyography device, which are hardware components. The performance studies also mention safety and EMC testing, which are typically associated with hardware devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The MyoTrac Infiniti system is described as an electrical muscle stimulator and an electromyography device. It works by applying electrical stimulation to muscles and monitoring the electrical signals produced by muscles and nerves.
- Intended Use: The intended uses listed are related to treating muscle conditions, stimulating nerves, and providing biofeedback. These are all direct interactions with the patient's body, not tests performed on samples taken from the body.
Therefore, the MyoTrac Infiniti system falls under the category of a therapeutic or diagnostic device that interacts directly with the patient, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Indications for use:
- Biofeedback, Relaxation and Muscle Reeducation. ●
- Relaxation of Muscle Spasms. .
- Prevention or retardation of disuse atrophy. .
- Increasing local blood circulation. .
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. .
- . Maintaining or increasing range of motion.
- Stroke Rehab by Muscle re-education. .
The MyoTrac Infiniti system is indicated for the ongoing treatment of the following conditions: Relaxation of Muscle Spasms, Prevention of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion and Stroke Rehab by Muscle Re-education. It is also used for relaxation & Muscle Re-Education purposes.
Product codes (comma separated list FDA assigned to the subject device)
IPF, HCC
Device Description
The MyoTrac Infiniti device is an electrical muscle stimulator for contraction of muscles as indicated below.
The MyoTrac Infiniti is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves. The indications for use are muscle re-education, relaxation and biofeedback.
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)
Non-clinical tests were performed consisted of verification of the product specification, system validation, safety and EMC testing. Device equivalency is determined by a direct comparison of the device functional and hardware specifications of MyoTrac Infiniti system with the legally marketed predicate devices, Automove AM800 EMG triggered stimulator and Sys STIM 208 powered muscle stimulator. Such a comparison table is present in the above section
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
K874469A, K935213, K903497A
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).
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
DEC 2 9 2005
Premarket Notification 510(k) Summary
| Date Prepared: | 20-10-2005 |
|---|---|
| Applicant: | Thought Technology Ltd |
| 2180 Belgrave Avenue | |
| Montreal Quebec | |
| Canada H4A 2L8 | |
| Contact: | Suresh Sugirtharaja |
| Design Coordinator | |
| Tel: | 489-8251 x127 |
| Fax: | 489-8255 |
1
| Device Name | ||
|---|---|---|
| Trade Name: | MyoTrac Infiniti System | |
| Common Name: | Powered muscle stimulator and biofeedback device | |
| Classification Name: | 89IPF, 84HCC | (882.5050 and 890.5850) |
| ClassII | ||
| Predicate Devices | ||
| Trade Name: | Danmeter AutoMove AM800 EMG Triggered Stimulator | |
| (K972997) | ||
| Classification Name: | 89IPF, 84HCC, ClassII | |
| Trade Name: | Mettler Electronics Corp Sys STIM 208 powered muscle | |
| stimulator (K031017) | ||
| Classification Name: | 89IPF, ClassII |
Description of Device:
The MyoTrac Infiniti device is an electrical muscle stimulator for contraction of muscles as indicated below.
The MyoTrac Infiniti is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves. The indications for use are muscle re-education, relaxation and biofeedback.
Intended Use
Indications for use:
- Biofeedback, Relaxation and Muscle Reeducation. ●
- Relaxation of Muscle Spasms. .
- Prevention or retardation of disuse atrophy. .
- Increasing local blood circulation. .
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. .
- . Maintaining or increasing range of motion.
- Stroke Rehab by Muscle re-education. .
2
Technical Characteristics Comparison to Predicate Device
MyoTrac Infiniti is compared to AutoMove AM800 (K972997) and Sys STM 208 (K031017). The technical specifications of the MyoTrac Infiniti substantially fall within the range of the AutoMove AM800. The differences are that the MyoTrac Infiniti is able to deliver more charge per pulse and more power density than the AutoMove AM800 but still with in the range of Sys STIM 280 and power density limits specified by 21 CFR 890 5850 (Powered Muscle Stimulator) and outputs EMG RMS vs. EMG peak from the AutoMove AM800. These differences should not affect the safety or effectiveness of the device.
| | PROPOSED DEVICE
MyoTrac Infiniti | Danmeter AutoMove AM800
EMG Triggered Stimulation
K972997 | SYS STIM 208
K031017 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Intended Use | Muscle Stimulation and
EMG Biofeedback | Muscle Stimulation and
EMG Biofeedback | Powered Muscle
Stimulation |
| Primary Functions | Delivery of stimulation and
reading of Electromyography | Delivery of stimulation and
reading of Electromyography | Delivery of stimulation |
| Stimulator Output | 0 - 100mA at 500ohms | 0 -60mA at 2.5Kohms | 0-184mA at 500 ohms |
| Waveform | Asymmetrical Balanced Pulsed
Current | Biphasic, alternating and
monophasic Current | Asymmetrical Biphasic
Rectangle with zero net
DC |
| Maximum Phase
Charge | 60μC | 31μC | 56μC |
| Frequency | 2 – 100 Hz | 10 - 100 Hz | 1-80Hz |
| Peak pulse intensity | 100mA | 60mA | 184mA |
| Pulse Width | 50 - 400μs | 100 – 400 μs | 200-800μS |
| Ramps | 0 - 10sec on and off ramp | 0.5 sec to 10 sec | |
| Duty Cycle | On(sec): 2 -20
Off(sec): 2-50 | On(sec): 2-20
Off(sec): 2-50 | ON 0.375 to 3.75sec
OFF 0.375 to 3.75sec |
| Session Duration
(min) | 1 to 120 minutes | 10 to 800 minutes or continue | |
| Programmable
features | Frequency, Current intensity,
pulse width, ramp up and down,
session length, threshold
trigger by the patient and the
physician. | Frequency, Current, Pulse
width, ramp up and down,
session duration, threshold for
trigger and duty cycle. By
patient or physician. | |
| Surface Electrodes | K874469A AxelGaard
electrodes for EMG or Stim.
K935213 Electrodes Uni-Gel
for EMG only
K903497A Triode Electrodes
for EMG only
K903497A Single Electrodes
for EMG only | PALS FLEX electrodes -
AxelGaard - K8764469A | |
| Current Density (full
output) | Axelgaard Model 895220
0.24mA/cm²
Axelgaard Model 895340
0.08mA/cm² | 0.5 mA/ cm² | 0.132mA/ cm² |
| Power Density (full
output @ 500ohms) | Axelgaard Model 895220
16mW/cm² | 13mW/cm² | 12mW/ cm² |
3
| | Axelgaard Model 895340
5.3mW/cm² | | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------|
| EMG Ranges in μV | 0-5, 0-10, 5-10, 0-20, 5-20, 10-
20, 0-50, 10-50, 0-100, 50-100,
0-200, 50-200, 100-200, 0-500,
100-500, 0-1000, 0-2000 | 2 - 2000μV | N/A |
| EMG Bandwidth | 20 – 500 Hz | 50 – 1000 Hz | N/A |
| EMG Signal
Processing | Root Mean Square (RMS) | Peak | N/A |
| EMG Detection | Bipolar | Bipolar | N/A |
| Work Period (sec) | 2 – 20 seconds | 2 - 20 seconds | 0.375 to 3.75sec |
| Rest Period (sec) | 2 - 50 seconds | 2 - 50 seconds | 0.375 to 3.75sec |
| Session Duration
(min) | 1-120 minutes | 1 – 30 minutes | 0-60minutes |
| Feedback Modes | Line Graph, Bar Graphs, Digital
Display | Bar Graphs, Digital Displays | Digital |
。
4
Performance Data
Non-clinical tests were performed consisted of verification of the product specification, system validation, safety and EMC testing. Device equivalency is determined by a direct comparison of the device functional and hardware specifications of MyoTrac Infiniti system with the legally marketed predicate devices, Automove AM800 EMG triggered stimulator and Sys STIM 208 powered muscle stimulator. Such a comparison table is present in the above section
Biocompatibility:
The Axelgaard EMG/Stimulation electrodes (K874469A), Thought Technology single, triode and Uni-gel Electrodes for EMG (K903497A & K935213) have been laboratory tested for the safety of the materials and were found to be safe under the standard required for each test.
Conclusion:
The MyoTrac Infiniti system is safe and effective for its intended use. The MyoTrac Infiniti system is substantially equivalent to the predicate devices.
End of 510(k) Summary
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.
Public Health Service
DEC 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thought Technology Limited c/o Mr. Robert Mosenkis CITECH 5200 Butler Pike Plymouth Meeting, PA 19462
Re: K053266/S1
Trade/Device Name: MyoTrac Infiniti System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, HCC Dated: December 14, 2005 Received: December 16, 2005
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) premarket notification of intent to narket the device indication indical we nave revewed your Section 910(t) promantee is substantially equivalent (for the indications for referenced above and nave decemined are as a see as a see a marketed in interstate winners the use stated in the enclosure) to regally manufacture Medical Device Amendments, or to devices that prior to May 26, 1970, the chacinon auto of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal Food, Drug, May may have been reclassified in accordance with the premarket approval application (PMA). You may, Act (Act) that do not require apploval of a provisions of the Act. The general therefore, market the device, subject to the genirements for annual registration, listing of devices, good controls provisions of the necesses institutions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in h If your device is classified (see ao re) into Existing major regulations affecting your device can be may be subject to such additional volts of Environs. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Sous ents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination as fithe Assurance Flease be advised that 1 177 - 15 usualled of aevice complies with other requirements of the Act or any FDA has made a decommation administered by other Federal agencies. You must comply with all
Federal statutes and regulations administered by other Federal (1) CED Box 807) Federal statutes and regulations administered by on the segistration and listing (21 CFR Part 807); the rive s requirements) in the manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2- Mr. Robert Mosenkis
This letter will allow you to begin marketing your device as described in your section 510(k) I his letter will anow you to begin marketing your arrial equivalence of your deversits vour develop premarket notification: The PDA midnig of substanted vice 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), please If you desire specific advice for your do not on one one as not the regulation entitled, contact the Office of Comphalled at (210) 210 - 120 - 120 .97). You may obtain other "Misbranding by relerence to preharter nothedron" (2) Cfrom the Division of Small Manufacturers, general information on your responsionnies and its tool-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Вавда Виелино
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The MyoTrac Infiniti system is indicated for the ongoing treatment of the The Myo Frac Immit System is Indiation of Muscle, Spasms, Prevention of Musical rollowing conditions: Notaxation of more of culation, immediate post-surgical disuse atropity, increasing lood blood on us thrombosis, Maintaining or increasing stimulation of call muselou to problem to re-education. It is also used for range of motion anxation & Muscle Re-Ec ucation purposes.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/ OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS: LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Mulkerson
: Vision Sign-Off) Orvision of General, Restorative and Neurological Devices
Number K053266
Page 12 of 27
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