(243 days)
Torc Body is indicated to be used for:
- Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
- Strengthening, toning and firming of buttocks & thighs.
Torc Body, the Powered Muscle Stimulator, is intended to improve tone and strengthen the muscles of the abdomen, buttocks, and thighs and to firm the abdomen muscles. The modified Torc Body, as described in this submission, is an upgrade from its previous version; which includes User- Friendly GUI, Internal power supply, and a wheeled console allowing clinicians to navigate and operate the device effortlessly. We intend to market this device to clinicians, as a prescription device. For ease of use and operation for the clinicians, we have 3 modes (suggestive): CLASSIC VECTOR, POWER SEQUENCE, DYNAMIC ROTATION. The modified device generates electrical stimulation to contract the muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.
The provided FDA 510(k) summary for the Torc Body device (K192039) primarily focuses on demonstrating substantial equivalence to a predicate device (K131291) through a comparison of technical characteristics and compliance with voluntary standards. It does not contain information about clinical studies with specific acceptance criteria related to device performance in terms of diagnostic accuracy, sensitivity, specificity, or human perception improvement.
Therefore, many of the requested details about acceptance criteria and clinical study design for device performance, especially those related to AI/algorithm performance and human perception, are not available in this document. The Torc Body is a "Powered Muscle Stimulator," and its performance is evaluated based on its electrical output characteristics and safety, rather than complex diagnostic or image interpretation tasks.
However, based on the provided text, I can infer the acceptance criteria by looking at the "Comparison" column in the tables, where the modified device's characteristics are judged against the predicate device. The general acceptance criterion is substantial equivalence, meaning the modified device performs as designed and its changes do not affect safety and effectiveness compared to the predicate device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a powered muscle stimulator demonstrating substantial equivalence, the "acceptance criteria" are generally that the modified device's technical specifications and safety aspects are comparable to or within acceptable deviations from the predicate device, or meet relevant safety standards. The "performance" refers to these technical specifications.
| Characteristic | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) | Reported Device Performance (Modified Device, K192039) |
|---|---|---|
| Intended Use | Identical to Predicate (Improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen; Strengthening, toning and firming of buttocks & thighs) | Identical |
| Fundamental Scientific Principles | Identical to Predicate | Identical |
| Safety and Effectiveness | Changes do not affect safety and effectiveness. | Demonstrated via compliance with voluntary standards (IEC 60601-1, IEC 60601-1-2, IEC60601-2-10, ISO 14971, ISO 13485:2016, 21CFR820, IEC 62366, ISO 15233, ISO 10993-1) and comparison of technical characteristics. "No new safety or performance issues were raised during testing." |
| Output Waveform(Classic Vector Mode) | Symmetrical Biphasic, comparable maximum output voltage/current, pulse width, frequency, phase duration, net charge, current density, power density. | Waveform: Symmetrical Biphasic (Identical) Shape: Step Sine Wave (Modified from Square Wave, functionally equivalent)Max Output Voltage: S.6 Vpp @ 500Ω (± 10%), 62.4 Vpp @ 2KΩ (± 10%), 66 Vpp @ 10KΩ (± 10%) (Negligible difference)Max Output Current: 103.2 mA pp @ 500 Ohm, 31.2 mA pp @ 2K Ohm, 6.6 mA pp @ 10K Ohm (Negligible difference)Pulse Width: 124.7 μS (± 10%) @500Ω (Less than predicate, but sinewave with 50% duty cycle implies similar stimulation strength)Frequency: 4010 Hz (± 10%) @500Ω, Resultant: 1 – 100 Hz (Higher, but resultant frequency is virtually identical due to interferential effect)Phase Duration: 124.7 μS (Less than predicate, but sinewave with 50% duty cycle implies similar stimulation strength)Net Charge: 0 μC @500Ω (Identical)Max Phase Charge: 6.435 μC (Less than predicate, but sinewave with 50% duty cycle implies similar stimulation strength)Max Current Density: 1.15 mA/cm² (Negligible difference)Max Power Density: 0.0295 W/cm² (Negligible difference) |
| Output Waveform(Power Sequence Mode) | Symmetrical Biphasic, comparable maximum output voltage/current, pulse width, frequency, phase duration, net charge, current density, power density, ON/OFF times. | Waveform: Symmetrical Biphasic (Identical)Shape: Square Wave (Identical)Max Output Voltage: 50.8 Vpp @ 500Ω (± 10%), 64 Vpp @ 2KΩ (± 10%), 65.6 Vpp @ 10KΩ (± 10%) (Negligible difference)Max Output Current: 101.6 mA pp @ 500 Ohm, 32 mA pp @ 2K Ohm, 6.56 mA pp @ 10K Ohm (Negligible difference)Pulse Width: 350 μS (± 10%) @ 500Ω (Identical)Frequency: 99.91 Hz (± 10%) @ 500Ω (Negligible difference)Phase Duration: 350 μS (± 10%) (Identical)Net Charge: 0 μC @500Ω (Identical)Max Phase Charge: 35.56 μC @ 500 Ω Load (Negligible difference)Max Current Density: 1.13 mA/cm² (Negligible difference)Max Power Density: 0.0287 W/cm² (Negligible difference)ON Time: 6 seconds (Virtually identical to 5.5s)OFF Time: 4 seconds (Virtually identical to 5.5s) |
| Output Waveform(Dynamic Rotation Mode) | Symmetrical Biphasic, comparable maximum output voltage/current, pulse width, frequency, phase duration, net charge, current density, power density. | Waveform: Symmetrical Biphasic (Identical)Shape: Modulated Sine Wave (Modified from Square Wave, functionally equivalent)Max Output Voltage: 51.2 Vpp @ 500Ω (± 10%), 63.2 Vpp @ 2KΩ (± 10%), 65.6 Vpp @ 10KΩ (± 10%) (Negligible difference)Max Output Current: 102.4 mA pp @ 500 Ohm, 31.6 mA pp @ 2K Ohm, 6.56 mA pp @ 10K Ohm (Negligible difference)Pulse Width: 124.9 μS (± 10%) @ 500Ω (Less than predicate, but sinewave with 50% duty cycle implies similar stimulation strength)Frequency: 4002 Hz (± 10%) @ 500Ω, Resultant: 1 – 100 Hz (Higher, but resultant frequency is virtually identical due to interferential effect)Phase Duration: 124.9 μS (± 10%) (Less than predicate, but sinewave with 50% duty cycle implies similar stimulation strength)Net Charge: 0 μC @500Ω (Identical)Max Phase Charge: 6.4 μC (Less than predicate, but sinewave with 50% duty cycle implies similar stimulation strength)Max Current Density: 1.14 mA/cm² (Negligible difference)Max Power Density: 0.0291 W/cm² (Negligible difference) |
| Other Device Features (e.g., Power source, Display, Console, Class) | Comparable or enhanced without adverse impact. | Power source: Internal medical grade power supply (Modified from AC/DC adaptor & rechargeable battery; tested to be safe).Display: 12" LCD (Modified from 5.7" LCD; improved visual/wide angle view).Console: Wheeled console (Modified from non-wheeled; enhanced navigation/operation).Prescription/OTC: Prescription (Modified from OTC; change in marketing, not performance).Weight/Dimension: Increased due to wheeled console (Modified, but functional).Compliance with Voluntary Standards: YES (Identical). |
2. Sample Size Used for the Test Set and Data Provenance
The document states "The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared Torc Body device."
- Sample Size: Not specified. This typically refers to the number of physical units subjected to bench testing or the number of measurements taken. The document does not provide these details.
- Data Provenance: The testing appears to be bench testing conducted by the manufacturer (Johari Digital Healthcare Ltd). No information about country of origin of data or retrospective/prospective nature is applicable as it's not a clinical study on human subjects or pre-existing datasets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This device is a powered muscle stimulator, and its performance is evaluated through engineering and electrical safety bench tests against specifications and voluntary standards, not by expert interpretation of clinical data in the way a diagnostic AI would be.
4. Adjudication Method for the Test Set
- Not applicable. There's no "ground truth" established by experts in the context of a diagnostic decision to adjudicate. The "ground truth" here is adherence to engineering specifications and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not a diagnostic device or a device involving human interpretation of medical cases. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is a hardware muscle stimulator with software controls; it's not an algorithm intended for diagnostic interpretation to be evaluated in a standalone performance test in the typical sense of AI/ML. Its performance is inherent in its electrical output and safety characteristics.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence is:
- Predicate Device Specifications: The technical specifications (output voltage, current, pulse width, frequency, etc.) of the legally marketed predicate device (K131291).
- Voluntary Standards: Compliance with international safety and quality standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, ISO 13485, IEC 62366, ISO 15233, and ISO 10993-1.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 29, 2020
Johari Digital Healthcare Limited Pooja Johari Founder and Director Marketing G-582, 584 EPIP, Boranada Jodhpur, Rajsthan 342008 India
Re: K192039
Trade/Device Name: Torc Body Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 24, 2019 Received: December 30, 2019
Dear Pooja Johari:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K192039
Device Name Torc Body
Indications for Use (Describe)
Torc Body is indicated to be used for:
- Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
- · Strengthening, toning and firming of buttocks & thighs.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510 (k) Summary As required by 21 CFR 807.92(c)
| Device Name | Torc Body |
|---|---|
| Submitters name/contact details | Nisha JohariJohari Digital Healthcare LtdG-582, 584 EPIP, Boranada,Jodhpur - India - 342008Contact number: + 1-888-412-3160 |
| Summary Preparation Date | 20-Mar-2020 |
| Device Trade Name | Torc Body |
| Device / Proprietary Name | Torc Body |
| Common Name | Stimulator, Muscle, Powered, for Muscle Conditioning |
| Classification Name | Powered Muscle Stimulator,Stimulator, Muscle, Powered, For Muscle Conditioning |
| Classification Regulation | 21 CFR 890.5850, Class II |
| Classification Product Code | NGX |
Legally marketed Predicate Device
| Device Trade Name | Torc Body |
|---|---|
| Classification Name | Powered Muscle Stimulator,Stimulator, Muscle, Powered, For Muscle Conditioning |
| 510(K) No | K131291 |
| Address and Registration | Johari Digital Healthcare LtdG-582, 584 EPIP, Boranada,Jodhpur - India - 342008 |
| Contact Person: | Nisha Johari |
| Contact Number: | +91-9829954228 |
| FDA Registration | 8040537 |
{4}------------------------------------------------
Device Description
Torc Body, the Powered Muscle Stimulator, is intended to improve tone and strengthen the muscles of the abdomen, buttocks, and thighs and to firm the abdomen muscles.
The modified Torc Body, as described in this submission, is an upgrade from its previous version; which includes User- Friendly GUI, Internal power supply, and a wheeled console allowing clinicians to navigate and operate the device effortlessly. We intend to market this device to clinicians, as a prescription device. For ease of use and operation for the clinicians, we have 3 modes (suggestive):
- . CLASSIC VECTOR is only necessary for non-active patients. It creates a twisting motion to warm up, build blood circulation and slowly build a tolerance to muscle contractions.
- POWER SEQUENCE contracts the muscles, holds it and then relaxes it to increase strength and muscle endurance.
- DYNAMIC ROTATION - Fast, sequential contractions of the muscles which leads to toning and firming.
The modified device generates electrical stimulation to contract the muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks
While redesigning the Torc Body, complete care and considerable measures have been taken to retain its safety and effectiveness. Torc Body device complies with voluntary standards.
Intended Use
Torc Body is indicated to be used for:
- . Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
- Strengthening, toning and firming of buttocks & thighs.
The device safety and efficacy was demonstrated by performance data and comparison of technical characteristics between the modified device and the predicate device.
Substantial Equivalence:
The intended use and indication for use of the modified device are the same as the predicate device (Torc Body , K131291). The modification made to the device include:
- User Friendly GUI- LCD with wide angle view that significantly facilitates the use of the device.
- Power Supply- Internal power supply in place of external AC/DC adaptor and rechargeable battery. Wheeled Console- Allows clinicians to navigate and operate the device effortlessly
- Prescriptive device- we intend to market this device to clinicians, we propose making it a prescription device.
{5}------------------------------------------------
Comparison of Technological Characteristics
A comparison below given below identifies all the changes between the modified and the predicate device:
| Device Features | Modified Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(K) Number | K192039 | K131291 | N/A |
| Device Name,Model | Torc Body | Torc Body | Design revision updatedto V2.0 |
| Manufactured For | 7E LLC | 7E LLC | Identical |
| Manufactured By | Johari DigitalHealthcare Ltd. | Johari DigitalHealthcare Ltd. | Identical |
| Classification Name | Powered musclestimulator | Powered musclestimulator | Identical |
| Product Code | NGX | NGX | Identical |
| Regulation Number | 21 CFR 890.5850 | 21 CFR 890.5850 | Identical |
| Panel | Physical Medicine | Physical Medicine | Identical |
| Class | Class II | Class II | Identical |
| Prescription/OTC | Prescription | OTC | Modified;We intend to market thisdevice to clinicians andpropose making it aprescription device. |
| Indication for use | Improvement ofabdominal tone,for strengtheningof the abdominalmuscles, fordevelopment offirmer abdomen.Strengthening,toning andfirming ofbuttocks &thighs. | Improvementof abdominaltone, forstrengtheningof theabdominalmuscles, fordevelopmentof firmerabdomen.Strengthening,toning andfirming ofbuttocks &thighs. | Identical |
| Target population | It is to be used byadults only. | It is to be used byadults only. | Identical |
| Power source | 100-240AC,50/60Hz, 75VA | AC/DC Adaptor &24V DC Ni MHRechargeableBattery | Modified;The modified device usesan internal medical grade |
| Method of LineCurrent Isolation | (a) AC Power supplyis converted to DCPower supplythrough a medicalgrade PSU, whichhas isolation of2XMOPP (IEC60601-1)(b) Isolation thrutransformer inbetween device andpatient | (a) AC Powersupply isconverted to DCPower supplythrough Adaptor,which uses atransformer inbetween the Lowand High voltagesides. Hence thereis insulation ofmains fromCircuitry.(b) The deviceoperates on Ni-Mhrechargeablebattery | power supply, in place ofAC/DC adaptor andrechargeable batteryused in the predicatedevice. The internalpower supply complieswith all necessaryvoluntary standards.Modified;The new version of TorcBody has 2XMOPP levelisolation as required bythe IEC standards. |
| Patient LeakageCurrentNormal conditionSingle Faultcondition | Normal condition =less than$100\mu A$Single faultcondition = less than$300\mu A$ | Normal condition= less than $100\mu A$Single faultcondition = lessthan $300\mu A$ | Identical |
| Components | Main unit, 8 selfadhesive electrodes, 4 electrode leadwires, , 1 AC PowerCord | Main unit, 8electrodes, 4electrode leadwires, 6 elasticbelts (2 large, 2medium, 2 small),1 AC Adapter. | Modified;The modified device hasan internal medical gradepower supply with an ACpower cord; thepredicate device has arechargeable batterywith an AC adapter. |
| Display | 12" LCD | 5.7" LCD | Modified; |
| Modified for better visualwhich gives a wide viewangle. | |||
| Number of OutputModes | 03(Classic Vector,Power Sequence,Dynamic Rotation) | 03(ABS, BTS, CVL) | Modified;Name of the modes(Classic Vector, PowerSequence, DynamicRotation) has beenmodified for a clearunderstanding of theclinician. |
| Number of OutputChannels | 2 (Two) | 2 (Two) | Identical |
| Synchronous orAlternating? | Synchronous(a) Output 1 to 2 arecompletely isolated.Only power supplyand ground arecommon | Synchronous(a) Output 1 to 2are completelyisolated. Onlypower supply andground arecommon | Identical |
| Method of ChannelIsolation | Transformer | Transformer | Identical |
| Regulated CurrentorRegulated Voltage | Tran conductance | Tran conductance | Identical |
| Software/Firmware/MicroprocessorsControls? | YES | YES | Identical |
| Automatic OverloadTrip? | YES | YES | Identical |
| Automatic No-LoadTrip | NO | NO | Identical |
| Automatic Shut off? | YES | YES | Identical |
| Patient OverrideControl? | YES | YES | Identical |
| Indicator Display:On/Off Status? | YES | YES | Identical |
| Low Battery? | N/A | YES | Modified;The modified device doesnot have a battery and,therefore, does not have |
| a battery indicatordisplay. | |||
| Voltage/CurrentLevel? | YES | YES | Identical |
| Timer Range(minutes) | 1 – 60 MinutesIn step of 1 minute | 1 – 60 MinutesIn step of 1minute | Identical |
| Compliance withVoluntaryStandards? | YESIEC 60601-1, IEC60601-1-2,IEC60601-2-10,and ISO14971 | YESIEC 60601-1, IEC60601-1-2,IEC60601-2-10,and ISO14971 | Identical |
| Compliance With 21CFR 898 | YES, the electrodecable can never beplugged in the ACsocket, not evenaccidentally | YES, the electrodecable can never beplugged in the ACsocket, not evenaccidentally | Identical |
| Weight | 32.66 Kgs | 3.0 KG | Modified;The modified device hasbeen upgraded to awheeled console. |
| Dimension(L X B X H) | 14″(L) X 17.5″ (W) X40″(H) | 8.2″(L) x 6.0″ (W) x4.0" (H) | Modified;The modified device hasbeen upgraded to awheeled console. |
| Housing Materialand construction | ABS Plastic Body | ABS Plastic Body | Identical |
| OperatingTemperature | Temperature: +15°Cto +35°C | Temperature:+15°C to +35°C | Identical |
| Relative Humidity:30 % to 75 % (non-condensing)Barometric | Relative Humidity:30 % to 75 % (non-condensing)Barometric | ||
| pressure:700 hPa to 1060 hPa | pressure:700 hPa to 1060 hPa | ||
| Transport andstorageenvironment | Temperature: +5°Cto +45°CRelative Humidity:10% to 85% (non-condensing) | Temperature:+5°C to +45°CRelative Humidity:10% to 85% (non-condensing) | Identical |
Basic Device Characteristics – Comparison with Predicate Device
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
Comparison
Output Specification – Comparion with Predicate Devcies
| Characteristics | MODIFIED DEVICE | PREDICATE DEVICE | Comparison |
|---|---|---|---|
| Torc Body (K192039) | Torc Body (K131291) | ||
| Output Waveform | Classic Vector | ABS-6 | N/A |
| Waveform | Symmetrical Biphasic | Symmetrical Biphasic | Identical |
| Shape | Step Sine Wave | Square Wave | Modified;The modified devices uses sinewave |
| Maximum OutputVoltage | 51.6 Vpp @ 500Ω(± 10%)62.4 Vpp @ 2KΩ(± 10%)66 Vpp @ 10KΩ(± 10%) | 51 Vpp @ 500Ω(± 10%)63 Vpp @ 2KΩ(± 10%)66 Vpp @ 10KΩ(± 10%) | Modified;The difference between the devices at 500 and 2KΩ values is negligible. |
| Maximum OutputCurrent | 103.2 mA pp @ 500 Ohm31.2 mA pp @ 2K Ohm6.6 mA pp @ 10K | 102 mA pp @ 500 Ohm31.5 mA pp @ 2K Ohm6.6 mA pp @ 10K | Modified;The difference between the devices at 500 |
Mode: Classic Vector
| sinewave | |||
|---|---|---|---|
| Maximum OutputVoltage | 51.6 Vpp @ 500Ω(± 10%)62.4 Vpp @ 2KΩ(± 10%)66 Vpp @ 10KΩ(± 10%) | 51 Vpp @ 500Ω(± 10%)63 Vpp @ 2KΩ(± 10%)66 Vpp @ 10KΩ(± 10%) | Modified;The differencebetween the twodevices at 500Ωand 2KΩ values, isnegligible. |
| Maximum OutputCurrent | 103.2 mA pp @ 500Ohm31.2 mA pp @ 2KOhm6.6 mA pp @ 10KOhm | 102 mA pp @ 500Ohm31.5 mA pp @ 2KOhm6.6 mA pp @ 10KOhm | Modified;The differencebetween the twodevices at 500Ωand 2KΩ values, isnegligible. |
| Pulse Width | 124.7 μS (± 10%)@500Ω | 350 μS (± 10%) | Modified;The pulse width isless than thepredicate device,however thewaveshape issinewave withduty cycle of 50%,which implies thatthe strength ofthe stimulation isessentially the |
| same in both | |||
| devices. | |||
| Frequency | 4010 Hz (± 10%)@500ΩResultant: 1 – 100 Hz | 99 Hz (± 10%) | Modified;The pulse rate ishigher in themodified device,but due to theinterferentialeffect theresultantfrequency is only1 – 100 Hz(sweeping), whichis virtuallyidentical to thepredicate devciewith frequency(99 Hz). |
| For Interferentialmodes only:-Beat frequency | N/A | N/A | Identical |
| For multiphasicWaveform- SymmetricalPhases? | Yes | Yes | Identical |
| - Phase duration | 124.7 μS | 350 μS | Modified;The phaseduration is lessthan the predicatedevice, howeverthe waveshape issinewave withduty cycle of 50%,which implies thatthe strength ofthe stimulation isessentially thesame in bothdevices. |
| Net charge | 0 μC @500Ω (BeingBiphasic in naturethe net charge wouldbe Zero) | 0 μC @500Ω (BeingBiphasic in naturethe net charge wouldbe Zero) | Identical |
| MaximumPhase Charge | 6.435 μC | 35.7 μC | Modified; |
| The phase chargeis less than thepredicate device,however thewaveshape issinewave withduty cycle of 50%,which implies thatthe strength ofthe stimulation isessentially thesame in bothdevices. | |||
| MaximumCurrent Density | 1.15 mA/cm²*measured with 50 x 90mmrectangular electrodes | 1.14 mA/cm²*measured with 50 x 90mmrectangular electrodes | Modified;The differencebetween thevalues of bothdevices isnegligible. |
| MaximumPower Density | 0.0295 Watt/cm²*measured with 50 x 90mmrectangular electrodes | 0.0289 Watt/cm²*measured with 50 x 90mmrectangular electrodes | Modified;The differencebetween thevalues of bothdevices isnegligible. |
| Burst Mode-Pulses Per Burst-Burst Per second-Burst Duration-Duty Cycle | N/A | N/A | Identical |
| ON Time | N/A | 5.5 seconds | Modified;Modified devicedoes not have ONtime. |
| OFF Time | N/A | 5.5 seconds | Modified;Modified devicedoes not have OFFtime. |
| Additional Features | Sweep Frequency 1-100 Hz | N/A | The modifieddevice has featureof sweepfrequency |
| Characteristics | MODIFIED DEVICETorc Body (K192039) | PREDICATE DEVICETorc Body (K131291) | Comparison |
| Output Waveform | Power Sequence | ABS-6 | N/A |
| Waveform | Symmetrical Biphasic | Symmetrical Biphasic | Identical |
| Shape | Square wave | Square Wave | Identical |
| Maximum OutputVoltage | 50.8 Vpp @ 500Ω(± 10%)64 Vpp @ 2KΩ(± 10%)65.6 Vpp @ 10KΩ(± 10%) | 51 Vpp @ 500Ω(± 10%)63 Vpp @ 2KΩ(± 10%)66 Vpp @ 10KΩ(± 10%) | Modified;The differencebetween thevalues of bothdevices atdifferent isnegligible. |
| Maximum OutputCurrent | 101.6 mA pp @ 500Ohm32 mA pp @ 2K Ohm6.56 mA pp @ 10KOhm | 102 mA pp @ 500Ohm31.5 mA pp @ 2KOhm6.6 mA pp @ 10KOhm | Modified;The differencebetween thevalues of bothdevices isnegligible. |
| Pulse Width | 350 μS (± 10%) @500Ω | 350 μS (± 10%) | Identical |
| Frequency | 99.91 Hz (± 10%) @500Ω | 99 Hz (± 10%) | Modified;The differencebetween thevalues of bothdevices isnegligible. |
| Beat frequencyFor multiphasicWaveformSymmetrical Phases? | N/A | N/A | Identical |
| Phase duration | Yes, SymmetricalBiphasic350 μS (± 10%) | Yes, SymmetricalBiphasic350 μS (± 10%) | Identical |
| Net charge | 0 μC @500Ω (BeingBiphasic in naturethe net charge wouldbe Zero) | 0 μC @500Ω (BeingBiphasic in naturethe net charge wouldbe Zero) | Identical |
| Maximum PhaseCharge | 35.56 μC @ 500 ΩLoad | 35.7 μC @ 500 ΩLoad | Modified; |
| Maximum Currentdensity | 1.13 mA/cm²*measured with 50 x 90mmrectangular electrodes | 1.14 mA/cm²*measured with 50 x 90mmrectangular electrodes | The differencebetween thevalues of bothdevices isnegligible.Modified; |
| Maximum PowerDensity | 0.0287 Watt/cm²*measured with 50 x 90mmrectangular electrodes | 0.0289 Watt/cm²*measured with 50 x 90mmrectangular electrodes | The differencebetween thevalues of bothdevices isnegligible.Modified; |
| Burst Mode-Pulses Per Burst-Burst Per second-Burst Duration-Duty Cycle | N/A | N/A | Identical |
| ON Time | 6 seconds | 5.5 seconds | Modified;The differencebetween thevalues of bothdevices is virtuallyidentical. |
| OFF Time | 4 seconds | 5.5 seconds | Modified;The differencebetween thevalues of bothdevices is virtuallyidentical. |
| Additional Features | Identical. |
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
Mode: Power Sequence
{13}------------------------------------------------
Mode: Dynamic Rotation
| Characteristics | MODIFIED DEVICETorc Body (K192039) | PREDICATE DEVICETorc Body (K131291) | Comparison |
|---|---|---|---|
| Output Waveform | Dynamic Rotation | ABS-6 | N/A |
| Waveform | Symmetrical Biphasic | SymmetricalBiphasic | Identical |
{14}------------------------------------------------
| Shape | Modulated Sine Wave | Square Wave | Modified; |
|---|---|---|---|
| Maximum OutputVoltage | 51.2 Vpp @ 500Ω(± 10%)63.2 Vpp @ 2KΩ(± 10%)65.6 Vpp @ 10KΩ(± 10%) | 51 Vpp @ 500Ω(± 10%)63 Vpp @ 2KΩ(± 10%)66 Vpp @ 10KΩ(± 10%) | Modified;The differencebetween the twodevices values atdifferent loadvalues isnegligible. |
| Maximum OutputCurrent | 102.4 mA pp @ 500Ohm31.6 mA pp @ 2KOhm6.56 mA pp @ 10KOhm | 102 mA pp @ 500Ohm31.5 mA pp @ 2KOhm6.6 mA pp @ 10KOhm | Modified;The differencebetween the twodevices values atdifferent loadvalues isnegligible |
| Pulse Width | 124.9 μS (± 10%) @500Ω | 350 μS (± 10%) | Modified;The pulse width isless than thepredicate device,however thewaveshape issinewave withduty cycle of 50%,which implies thatthe strength ofthe stimulation isessentially thesame in bothdevices. |
| Frequency | 4002 Hz (± 10%) @500ΩResultant: 1 – 100 Hz | 99 Hz (± 10%) | Modified;The pulse rate ishigher in themodified device,but due to theinterferentialeffect theresultantfrequency is only |
| 1 – 100 Hz(sweeping), whichis virtuallyidentical to thepredicate devciewith frequency(99 Hz). | |||
| Beat frequency | NA | NA | Identical |
| For multiphasicWaveformSymmetricalPhases? | Yes, SymmetricalBiphasic | Yes, SymmetricalBiphasic | Identical |
| Phase duration | 124.9 μS (± 10%) | 350 μS (± 10%) | Modified;The phaseduration is lessthan the predicatedevice, howeverthe waveshape issinewave withduty cycle of 50%,which implies thatthe strength ofthe stimulation isessentially thesame in bothdevices. |
| Net charge | 0 μC @500Ω (BeingBiphasic in nature thenet charge would beZero) | 0 μC @500Ω (BeingBiphasic in naturethe net chargewould be Zero) | Identical |
| Maximum PhaseCharge | 6.4 μC | 35.7 μC | Modified;The phase chargeis less than thepredicate device,however thewaveshape issinewave withduty cycle of 50%,which implies thatthe strength ofthe stimulation isessentially thesame in bothdevices. |
| Maximum Currentdensity | 1.14 mA/cm²*measured with 50 x 90mmrectangular electrodes | 1.14 mA/cm²*measured with 50 x 90mmrectangular electrodes | Modified;The differencebetween thevalues of bothdevices isnegligible. |
| Maximum PowerDensity | 0.0291 Watts/cm²*measured with 50 x 90mmrectangular electrodes | 0.0289 Watts/cm²*measured with 50 x 90mmrectangular electrodes | Modified;The differencebetween thevalues of bothdevices isnegligible. |
| Burst Mode-Pulses Per Burst-Burst Per second-Burst Duration-Duty Cycle | NA | NA | Identical |
| ON Time | NA | 5.5 seconds | Modified;Modified devicedoes not have ONtime. |
| OFF Time | NA | 5.5 seconds | Modified;Modified devicedoes not have OFFtime. |
| Additional Features | Sweep Frequency 1-100 Hz | - | The modifieddevice has featureof sweepfrequency. |
{15}------------------------------------------------
{16}------------------------------------------------
Although there are minor differnces observed between the individual mode parameters of modified Torc Body and the predicate device, no difference found raised any questions regarding safety and effectiveness of the modified device. The primary change from the predicate Torc Body device to Torc Body Version 2.0 is that the new device model provides an internal power supply instead of a rechargeable battery; a user-friendly GUJ; and a wheeled console. We are also proposing to change the type of use from Over the Counter to Prescription.
There are no changes to the indications for use, fundamental scientific principles, performance specifications, or operation of the device.
{17}------------------------------------------------
User-Friendly GUI: The modified Torc Body device has a larger touch screen LCD, which gives a wide-angle view that significantly facilitates the use of the device.
Power Supply: The modified Torc Body device is equipped with an internal medical grade power supply, instead of an AC/DC adaptor and rechargeable battery (predicate device). Testing under voluntary standards has been carried out to make sure the power supply is safe and there are no new risks with this change.
Wheeled Console: The Torc Body has been upgraded to a modern, sleek, wheeled console which allows clinicians to navigate and operate the device effortlessly.
Prescription Device: As a manufacturer, we understand that the modified Torc Body device is based on the same technology and intended for the same use as its predicate device and that the modifications will not affect safety and effectiveness. However, as we intend to market this device to clinicians, we propose making it a prescription device.
The fundamental scientific technology is not changed in the modified device, and the change is solely considered for ease of use to the clinician. The modified device generates the same stimulation to contract the muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks. The clinician can increase or decrease the intensity as per the desired stimulation.
While redesigning the Torc Body, complete care and considerable measures have been taken to retain its safety and effectiveness. The modified Torc Body device complies with voluntary standards, hence the modified device is substantially equivalent to the predicate device.
Non-Clinical Testing
The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared Torc Body device. The modified device Torc Body met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared device. No new safety or performance issues were raised during testing.
Non-Clinical Bench Testing:
- Reliability Testing
- Compliance Testing (IEC60601-1, IEC60601-1-2
- Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
- Quality System Regulation (21CFR820)
- Application of usability engineering to medical devices (IEC 62366)
- Application of risk management to medical devices (ISO 14971)
- Symbols to be used with medical device labels, labelling and information to be supplied (ISO 15233)
- Biological evaluation of medical devices (ISO 10993-1)
{18}------------------------------------------------
CONCLUSION
The information and testing presented in this traditional 510(k) demonstrate that the modified Torc Body device performs as designed and is substantially equivalent to the predicate device (K131291). The changes made do not affect the safety and effectiveness of the device.
§ 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).