(96 days)
K02906, K03410, K0304, K0254, K. Park Server (TS Par
No
The summary describes a device for electrical stimulation and EMG biofeedback, with no mention of AI or ML technologies in its description, intended use, or performance studies.
Yes
The device is indicated for treatment of various conditions like urinary incontinence, muscle spasms, prevention of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles, maintaining or increasing range of motion, and stroke rehab by muscle re-education. These are all therapeutic uses.
Yes
The device is indicated for "assessing EMG activity of the pelvic floor and accessory muscles" and to "monitor and display the bioelectric signals produced by muscles," which are diagnostic functions.
No
The device description explicitly states it is a "non-implanted electrical stimulator" and an "electromyography device," indicating it includes hardware components for electrical stimulation and EMG signal acquisition.
Based on the provided information, the MyoTrac Infiniti system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- MyoTrac Infiniti Function: The description clearly states that the MyoTrac Infiniti is a non-implanted electrical stimulator and an electromyography device. It works by applying electrical stimulation to muscles and monitoring the electrical activity produced by muscles and nerves.
- Intended Use: The intended uses described involve treating conditions like urinary incontinence, muscle spasms, disuse atrophy, and for biofeedback and muscle re-education. These are all in vivo (within the living body) applications, not the analysis of specimens taken from the body.
Therefore, the MyoTrac Infiniti system falls under the category of a therapeutic and diagnostic device used directly on the patient, not an IVD.
N/A
Intended Use / Indications for Use
The MyoTrac Infiniti system is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscle through reflexive mechanisms, strengthening of pelvic floor muscle. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles.
The MyoTrac Infiniti system is also indicated for the ongoing treatment of the following conditions: 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 and Stroke Rehab by Muscle re-education. It is also used for Biofeedback, Relaxation & Muscle Re-Education purposes.
Product codes (comma separated list FDA assigned to the subject device)
KPI, IPF, HCC
Device Description
The MyoTrac Infiniti device is a non-implanted electrical stimulator for urinary incontinence, it is intended to re-train the urinary continence mechanisms by way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. The device is indicated for treatment of patients with stress incontinence, urge incontinence or mixed incontinence (a combination of stress and urge incontinence). The indications for this use and labeling will be a subset of the overall indications for use. The MyoTrac Infiniti is an electrical muscle stimulator for contraction of muscles as well.
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 EMG biofeedback.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor, abdominal or gluteal muscles, calf muscles
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; Pathways CTS 2000 pelvic floor training system (K023906), InCare PRS Pelvic Floor Therapy System (K974048), Evadri Bladder Control System (K050483), K.E.A.T (K002154) and Detrusan 500 Incontinence Therapy System (K994109).
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.
K023906, K974048, K050483, K002154, K994109
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.
K02906, K03410, K0304, K0254, K. Park Server (TS Par
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
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).
0
K os3434
page 1 of 8
MAR 1.5 2006
Premarket Notification 510(k) Summary
| Date Prepared: | 03-07-2006 |
|---|---|
| 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
K053434
Page 2 of 8
Intended Use
Indications for use:
The MyoTrac Infiniti system is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscle through reflexive mechanisms, strengthening of pelvic floor muscle. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles.
The MyoTrac Infiniti system is also indicated for the ongoing treatment of the following conditions: 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 and Stroke Rehab by Muscle re-education. It is also used for Biofeedback, Relaxation & Muscle Re-Education purposes.
2
chnical Characteristics Comparison to Predicate Do
This device is compared to Patimosystem (K02906), hCare PRS Pelvi Floor Theray System
(K03410), The technical (K0304), K. S. T. (K0254), K. S. Parisen (K. Park Server (TS Par
| PROPOSED
DEVICE
Trac Infiniti | Pathway CTS2000
K023906 | InCare PRS
K974048 | K.E.A.T
K002154 | Evadri Bladder
Control System
K050483 (Predicate
with AC power
source) | Detrusan 500
(K994109) | Frequency | Peak pulse intensity | Pulse Width | Ramps | Duty Cycle | Session Duration (min) | Programmable features | Vaginal EMG/Stim Probe | Vaginal EMG Probe | Id Probe
Muscle
and
red by
al. | Pathway Anal
EMG/Stimulation
Sensor K993976 | InCare Anal
STIM/EMG Probe
K930530 | Unknown | Urostym Anal
STIM/EMG Probe
K993721 | Power
Density (full
output @
500ohms) | | EMG Ranges
in μV | EMG
Bandwidth | EMG Signal
Processing | EMG
Detection | Work Period
(sec) | Rest Period
(sec) | Session
Duration (min) | Feedback
Modes |
|------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------|-------------------------------|----------------------------|-------------------------------------------|-----------------------------------------------------------|-------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------|---------------------------------------------------|------------------------------------------|-------------|-------------------------------------------|----------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------|---------------------------|------------------|----------------------|----------------------|---------------------------|-----------------------------------------------------------------------------|
| Treatment of
urinary
incontinence | Treatment of
urinary
incontinence | Treatment of urinary
incontinence | Treatment of (stress,
urge & mixed) urinary
incontinence | Treatment of urinary
incontinence | Treatment of urinary
incontinence | 12.5, 50, 100, 200 Hz | 100mA | 0.2, ms | 0 - Duty Cycle on and off ramp. | On (sec): 2 - 20
Off (sec): 2 - 50 | 1-120 minutes | Frequency, Current intensity, pulse width, ramp up and down, session length, by the patient and the physician.
Physicians can lock the features for the patient with the exception of the current intensity. | Saint-Cloud Probe for vaginal Muscle Stimulation and Biofeedback, manufactured by Saint-Cloud International.
Femelex Probe for vaginal Muscle stimulation and Biofeedback manufactured by PhysioMed. | Thought Technology Ltd Vaginal Probe for | y Ltd
be for | Unknown | Unknown | N/A | Unknown | St - Cloud Vaginal
22.84mW/cm² | Femelex
11.32mW/cm²
St - Cloud Rectal
194mW/cm² | 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 | 20 - 500 Hz | Root Mean Square
(RMS) | Bipolar | 2 - 20 seconds | 2 - 50 seconds | 1-120 minutes | Line Graph, Bar
Graphs, Digital
Display, Signal
linked animations |
| EMG Biofeedback | EMG Biofeedback | EMG Biofeedback | Delivery of stimulation | EMG Biofeedback | Delivery of stimulation | 12.5, 50, 100, 200 Hz | 100mA | 0.3ms fixed | 2 sec on ramp, 1 sec off ramp | On(sec): 1-80
Off(sec): 0-80 | 0-30 | None by Patient: Frequency, Duty cycle, Session Length by physician. | Pathway Vaginal EMG/Stimulation Sensor K993976 | Unknown | 2 | 2.31 cm² | 7.98 cm² | 7.854 cm² | Unknown | Pathway Vaginal
EMG/Stim Sensor:
7.79 mW/cm² | Pathway Anal
EMG/Stim Sensor:
8.49 mW/cm² | 0 - 5, 0 - 30, 0-
100, 0 - 1000μV
ranges | 20 - 500 Hz | Root Mean Square
(RMS) | Bipolar | 1 - 80 seconds | 0 - 80 seconds | 1 - 60 minutes | Line Graph, Bar
Graphs, Digital
Displays, Signal
linked Animations |
| Delivery of
stimulation
and reading of
Electromyography | Delivery of
stimulation and
reading of
Electromyography | Delivery of stimulation
and reading of
Electromyography | 6V Rechargeable
lithium-ion battery | Isolated AC to DC
power adapter,
115/230VAC
switchable input to
6VDC output | Main Powered | 12.5, 50, 100, 200 Hz | 30V | 0.3, 1 ms | On Ramp: 20%, 40%, 60%, 80%, 100% of ON Time, No OFF Ramp | On(sec): 1-80
Off(sec): 0-80 | 0-30 | None by Patient: Frequency, Duty cycle, Session Length by physician. | InCare Vaginal STIM/EMG probe K891773 | Unknown | y | 2.12 cm² | 1.99 cm² | Unknown | Unknown | InCare Vaginal
STIM/EMG
47mW/cm² | In Care Anal
STIM/EMG
239mW/cm² | 0-5, 0-10, 0-25, 0-
100, 0-250, 0-500 μV
ranges | 100 - 500 Hz | Root Mean Square
(RMS) | Bipolar | 1 - 80 seconds | 0 - 80 seconds | 1 - 60 minutes | Unknown |
| 1.5V
one or
Rechargeable NiMH
battery pack | Unknown | Unknown | 0-100mA | 0-30Vdc 1% or 5%
increment | 0-30V | 12.5, 50 Hz | 100mA | 0.3ms fixed | Unknown | ON: 5 sec OFF 5sec
ON: 5sec OFF: 10sec | 0-30 | unknown | Hollister Vaginal STIM Probe K891773 | N/A | 2.45 | Pathway Vaginal
EMG/Stim Sensor:
43m A/cm² | InCare Vaginal
STIM/EMG
3mA/ cm² | 12.73mA/cm² | Unknown | 81.02 mW/cm² | Unknown | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| -15W
Medical Class II
power adapter
500mA | Asymmetrical
Balanced Pulsed
Current
28μC | 0-30VDC | Balanced
Symmetrical Biphasic | Balanced Biphasic,
no DC component | Square Symmetrical
Balanced Biphasic | 10, 12.5, 20, 50, 100, 200 Hz | 0-30Vdc 1% or 5% increment | 0.3, 1 ms | Unknown | ON: 1-80 sec
OFF: 0-80 sec | 1-30min | Unknown | Unknown | N/A | Vaginal
cm² | Pathway Anal
EMG/Stim Sensor:
47m A/cm² | In Care Anal
STIM/EMG
18mA/ cm² | Unknown | 16.4mA/cm² | Unknown | 120 mW/cm² | 0-5, 0-10, 0-25, 0-50,
0-100, 0-250, 0-200 | 20-500 Hz | Root Mean Square
(RMS) | Bipolar | 1 - 80 sec | 0 - 80 sec | 1 - 60 min | Unknown |
| Symmetrical
Balanced Pulsed | | 60μC | Unknown | Unknown | 64μC | 1-100Hz | 30V | 0.01-0.4ms
1/12th of the intensity (V) | | On(sec): 1 - 60
Off(sec): 0-60 | 0-30min | None by Patient: Pulse Width, Frequency, Duty cycle, Session Length by physician. | Urostym Vaginal STIM/EMG Probe K990041 | Unknown | Unknown | 120 mW/cm² | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | | | | | |
K053434
Page 3 of 8
3
K053434
Page 4 of 8
4
K053454
page 5 of 8
5
.
K053434
Page 6 of 8
6
K053434
Page 2 of 8
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; Pathways CTS 2000 pelvic floor training system (K023906), InCare PRS Pelvic Floor Therapy System (K974048), Evadri Bladder Control System (K050483), K.E.A.T (K002154) and Detrusan 500 Incontinence Therapy System (K994109). Such a comparison table is present in the above section.
Biocompatibility:
The Thought Technology Vaginal EMG Sensor (K932149B), Thought Technology Rectal EMG Sensor (K932149B), St-Cloud Vaginal EMG/Stimulator Electrode, St-Cloud Rectal EMG/Stimulator Electrode, Physiomed Femilex Vaginal EMG/Stimulator Electrode, 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
7
K053434
Page 8 of 8
Device Name
Trade Name: Common Name: Classification Name: MvoTrac Infiniti System Non Implanted Electrical Continence Device 78 KPI. 84HCC ClassII (876.5320, 882.5050 and 890.5850)
Predicate Devices
Classification Name:
Classification Name:
Trade Name:
Trade Name:
Pathway CTS 2000 Pelvic Floor Training System (K023906) Classli, 78 KPI, 84HCC
InCare PRS Pelvic Floor Therapy System (K974048) ClassII, 78 KPI, 84HCC
Trade Name: Classification Name: K.E.A.T (K002154) ClassII, 78 KPI
Trade Name: Classification Name: Evadri Bladder Control System (K050483) ClassII, 78 KPI, 84HCC
Trade Name: Classification Name: Detrusan 500 Incontinence Therapy System (K994109) ClassII, 78 KPI
Description of Device:
The MyoTrac Infiniti device is a non-implanted electrical stimulator for urinary incontinence, it is intended to re-train the urinary continence mechanisms by way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. The device is indicated for treatment of patients with stress incontinence, urge incontinence or mixed incontinence (a combination of stress and urge incontinence). The indications for this use and labeling will be a subset of the overall indications for use. The MyoTrac Infiniti is an electrical muscle stimulator for contraction of muscles as well.
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 EMG biofeedback.
8
Image /page/8/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the edge. Inside the circle is a stylized image of an eagle with its wings spread, with three wavy lines below it. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR ! 5 2006
Thought Technology, Ltd. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298
Re: K053434
Trade/Device Name: MyoTrac InfinitiTM System Regulation Number: 21 CFR §876.5320 Regulation Name: Non-implanted electrical implanted continence device Product Code: KPI Regulation Number: 21 CFR §890.5850 Regulation Name: Powered muscle stimulator Product Code: IPF Regulation Number: 21 CFR §882.5050 Regulation Name: Biofeedback device Product Code: HCC Regulatory Class: II Dated: February 27, 2006 Received: February 28, 2006
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
9
This letter will allow you to begin marketing your device as described in your Section 510(k) This leter with anow you to ogen mating of substantial equivalence of your device to a legally premarket notification: "The 1197 mining sification 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), please If you desire specific ad not of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation on your responsibilities under the Act from the 807.77). I ou may obtain one general national 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/industry/support/index.html
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known): K053434
Device Name: MyoTrac Infiniti System
Indications for Use:
The MyoTrac Infiniti system is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscle through reflexive mechanisms, strengthening of pelvic floor muscle. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles.
The MyoTrac Infiniti system is also indicated for the ongoing treatment of the following conditions: 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 and Stroke Rehab by Muscle re-education. It is also used for Biofeedback, Relaxation & Muscle Re-Education 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)
David le. Syverson
(Division Sign-Off)
(Division Sign-Off) ion of Reproductive, Abdomina and Radiological Device 510(k) Number
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