Who is the manufacturer of MYOTRAC INFINITI ELECTRICAL STIMULATOR?

Thought Technology , Ltd. filed the 510(k) submission for MYOTRAC INFINITI ELECTRICAL STIMULATOR (K053434).

What is the FDA product code for MYOTRAC INFINITI ELECTRICAL STIMULATOR?

KPI. It is classified under 21 CFR 876.5320 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for MYOTRAC INFINITI ELECTRICAL STIMULATOR?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MYOTRAC INFINITI ELECTRICAL STIMULATOR?

Pathway CTS 2000 Pelvic Floor Training System (K023906); InCare PRS Pelvic Floor Therapy System (K974048); K.E.A.T (K002154); Evadri Bladder Control System (K050483); Detrusan 500 Incontinence Therapy System (K994109).

Who can help prepare an FDA 510(k) submission like MYOTRAC INFINITI ELECTRICAL STIMULATOR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MYOTRAC INFINITI ELECTRICAL STIMULATOR

K053434 · Thought Technology , Ltd. · KPI · Mar 15, 2006 · Gastroenterology, Urology

Device Facts

Record ID	K053434
Device Name	MYOTRAC INFINITI ELECTRICAL STIMULATOR
Applicant	Thought Technology , Ltd.
Product Code	KPI · Gastroenterology, Urology
Decision Date	Mar 15, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5320
Device Class	Class 2
Attributes	Therapeutic, 3rd-Party Reviewed

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.

Device Story

MyoTrac Infiniti is a non-implanted electrical muscle stimulator and electromyography (EMG) device. It inputs bioelectric signals via vaginal or rectal EMG/stimulation sensors; processes signals using Root Mean Square (RMS) calculations; and outputs stimulation pulses or visual biofeedback (line graphs, bar graphs, digital displays, animations). Used in clinical settings by healthcare providers for pelvic floor muscle re-education, incontinence treatment, and neuromuscular rehabilitation. Providers monitor EMG activity to guide therapy; stimulation parameters (frequency, intensity, pulse width) are adjustable by clinicians, with optional feature locking for patient safety. Benefits include improved urinary control, muscle strengthening, and rehabilitation of muscle function.

Clinical Evidence

Bench testing only. Evidence consists of verification of product specifications, system validation, safety testing, and EMC testing. Biocompatibility of patient-contacting electrodes (vaginal/rectal sensors) was confirmed through laboratory testing against applicable standards.

Technological Characteristics

Non-implanted electrical stimulator and EMG biofeedback device. Features bipolar EMG detection with RMS signal processing. Stimulation parameters: 12.5-200 Hz frequency, 0-100mA intensity, 0.2-1ms pulse width. Connectivity includes vaginal/rectal sensors. Powered by 1.5V battery or medical Class II power adapter. Software performs signal processing and display of biofeedback data.

Indications for Use

Indicated for patients requiring treatment for stress, urge, or mixed urinary incontinence; muscle spasms; disuse atrophy; poor local blood circulation; post-surgical venous thrombosis prevention; range of motion maintenance; or stroke rehabilitation. Used for EMG biofeedback and muscle re-education.

Regulatory Classification

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).

Predicate Devices

Pathway CTS 2000 Pelvic Floor Training System (K023906)
InCare PRS Pelvic Floor Therapy System (K974048)
K.E.A.T (K002154)
Evadri Bladder Control System (K050483)
Detrusan 500 Incontinence Therapy System (K994109)

Submission Summary (Full Text)

{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 Page of

MYOTRAC INFINITI ELECTRICAL STIMULATOR

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MYOTRAC INFINITI ELECTRICAL STIMULATOR

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Device Story

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Submission Summary (Full Text)

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