(451 days)
truSculpt flex 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.
truSculpt flex is an electrical muscle stimulator, which generates electrical impulses that are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. The device contracts muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.
truSculpt flex consists of a console with a touchscreen control panel and eight handpiece pairs. All system functions are controlled through the console. During a treatment session, one or more handpiece pairs are secured to the patient using disposable hydrogel pads and transparent silicone belts, and electrical stimulation is delivered to the treatment area at the selected treatment mode and intensity.
The provided text describes a 510(k) premarket notification for the truSculpt flex device, a powered muscle stimulator. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Torc Body, K192039) through a comparison of technological characteristics and non-clinical bench testing.
However, the document does not contain any information about clinical studies that would involve a test set, human subjects, expert consensus for ground truth, or MRMC studies demonstrating improvement with AI assistance. It explicitly states:
"The device safety and efficacy was demonstrated by performance data and a comparison of technical characteristics between the modified device and the predicate device." (Page 6)
"The information and testing presented in this traditional 510(k) demonstrate that the truSculpt flex device performs as designed and intended, and is substantially equivalent to the predicate device (K192039). The changes made do not affect the safety and effectiveness of the device." (Page 16)
The submission details non-clinical bench testing to demonstrate compliance with various standards (e.g., IEC, ISO, CFR 820), reliability testing, and a comparison of output specifications between the modified and predicate devices. It emphasizes that fundamental scientific technology has not changed and reported differences in individual mode parameters are within acceptable limits as per regulatory guidance.
Therefore, an exhaustive answer to your request, based only on the provided text, would indicate the absence of information for many of your criteria concerning clinical performance studies.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for clinical performance in the way one might expect for an image-based diagnostic AI device. Instead, the acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device (Torc Body, K192039) through:
- Identical Indications for Use: "Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. Strengthening, toning and firming of buttocks & thighs." (Page 6)
- Identical Fundamental Scientific Technology: "The fundamental scientific technology has not changed in the modified device." (Page 4) and "There are no changes to the indications for use, fundamental scientific principles, performance specifications, or operation of the device." (Page 16)
- Compliance with applicable voluntary standards and regulations: (IEC 60601-1, IEC 60601-1-2, IEC60601-2-10, ISO 14971, ISO 13485:2016, 21CFR820, IEC 62366, ISO 15233, ISO 10993-1). (Page 16)
- Bench testing demonstrating safety and performance: "The truSculpt flex device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared device. No new safety or performance issues were raised during testing." (Page 16)
- Output specifications within acceptable limits: Minor differences in mode parameters are noted but are deemed to be "within the limits as per 'Guidance Document for Powered Muscle Stimulator 510(k)s', issued on June 9, 1999, ANSI/AAMI NS4:2013 (R2017) standard for electrical stimulators." (Page 16)
Since this is a substantial equivalence claim based on technical characteristics and bench testing, there are no reported "device performance" metrics in terms of clinical accuracy (e.g., sensitivity, specificity, AUC) from a clinical study on a test set. The performance is implied by its adherence to safety standards and comparable electrical output to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical bench testing and a comparison to a predicate device, not a clinical study involving human test subjects or a "test set" of patient data for performance evaluation in the context of an AI/diagnostic device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set or human-established ground truth is mentioned for this device's 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No MRMC study was performed as this is not an AI/diagnostic imaging device and is not described as involving human "readers" or AI assistance in clinical interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical powered muscle stimulator, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of a clinical test set. The "ground truth" for this 510(k) submission is primarily based on:
- Engineering specifications and measurements: Comparing the electrical output parameters (voltage, current, pulse width, frequency, etc.) of the modified device to the predicate device and ensuring they fall within acceptable ranges as per relevant standards (e.g., ANSI/AAMI NS4:2013).
- Compliance with recognized voluntary standards: Meeting the requirements of standards like IEC 60601-1, ISO 14971, etc., which are inherently designed to ensure basic safety and performance.
8. The sample size for the training set
Not applicable. The document does not describe the use of machine learning or AI models with training sets.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
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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.
December 3, 2022
Johari Digital Healthcare Limited Pooja Johari Founder and Director Marketing G-582, 584 EPIP, Boranda Jodhpur, Rajasthan 342012 India
Re: K212866
Trade/Device Name: truSculpt flex Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 28, 2022 Received: November 4, 2022
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
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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); 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 medical devices and radiation-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,
Heather L. Dean -S
Heather Dean, Ph.D. Assistant Director, Acute Injury Devices Team 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
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Indications for Use
510(k) Number (if known) K212866
Device Name truSculpt flex
Indications for Use (Describe)
truSculpt flex 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) |
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510 (k) Summary
| Device Name | truSculpt flex muscle stimulator |
|---|---|
| Submitters name/contact details | Nisha JohariJohari Digital Healthcare LtdG-582- 584 EPIP, Boranada,Jodhpur – India – 342012Contact number: + 91-9829954228 |
| SummaryPreparation Date | 28-Oct-2022 |
| Device Trade Name | truSculpt flex |
| Device / ProprietaryName | truSculpt flex |
| Common Name | Stimulator, Muscle, Powered, for Muscle Conditioning |
| Classification Name | Powered Muscle Stimulator,Stimulator, Muscle, Powered, For Muscle Conditioning |
| ClassificationRegulation | 21 CFR 890.5850, Class II |
| ClassificationProduct 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 | K192039 |
| Address andRegistration | Johari Digital Healthcare LtdG-582, 584 EPIP, Boranada,Jodhpur – India – 342012 |
| Contact Person: | Nisha Johari |
| FDA Registration | 8040537 |
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Device Description
truSculpt flex is an electrical muscle stimulator, which generates electrical impulses that are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. The device contracts muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.
truSculpt flex consists of a console with a touchscreen control panel and eight handpiece pairs. All system functions are controlled through the console. During a treatment session, one or more handpiece pairs are secured to the patient using disposable hydrogel pads and transparent silicone belts, and electrical stimulation is delivered to the treatment area at the selected treatment mode and intensity.
The fundamental scientific technology has not changed in the modified device. Changes are solely considered for ease of use for the clinicians. 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 device, complete care and considerable measures have been taken to retain its safety and effectiveness. The truSculpt flex device complies with voluntary standards.
The modified device, as described in this submission, is an upgrade from its previous version. Modifications include the addition of two outputs; change in electrode size and type; addition of adhesive hydrogel pads and reusable silicone belts; and renaming of treatment modes.
With respect to the previously cleared device, the modified device has two treatment types:
-
Classic In Classic mode, the treatment duration is 45 minutes.
- A flex+ - In flex+ mode, the treatment duration is 15 minutes.
For ease of use and operation for the clinicians, we have 3 modes (suggestive):
- . PREP mode creates a twisting motion to warm up and stretch the muscles and to slowly build a tolerance to muscle contractions. PREP mode is available for Classic treatments only.
Image /page/4/Picture/13 description: The image shows a diagram of a muscle being stimulated by two electrical devices. The devices are labeled with the numbers 1 and 2. The muscle is shown in a reddish-brown color, and the electrical stimulation is shown as yellow beams emanating from the devices. The devices are connected to the muscle by wires.
Fig:- Prep Mode
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• TONE mode contracts the muscles, holds it, and then relaxes to increase strength and muscle endurance. TONE mode is available for Classic and flex+ treatments.
Image /page/5/Picture/3 description: The image shows a diagram of a muscle stimulation device. The device consists of two white pads with yellow tops, labeled "1" and "2", placed on a brown surface. Yellow beams are shown emanating from the pads, targeting a muscle underneath. The pads are connected to wires, with a red wire attached to pad "1" and a black wire attached to pad "2".
Fig:- Tone Mode
• SCULPT mode uses fast, sequential contractions of the muscles which leads to toning and firming. SCULPT mode is available for Classic and flex+ treatments
Image /page/5/Picture/6 description: The image shows a medical device used for muscle stimulation. Two white devices with yellow labels marked "1" and "2" are positioned above a muscle. Yellow beams are emitted from the devices, targeting the muscle below. The setup suggests a therapeutic or diagnostic application involving targeted muscle stimulation.
Fig:- Sculpt Mode
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truSculpt flex in action- Interaction with patient
The device contracts muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.
Image /page/6/Picture/4 description: The image shows a person lying down with electrodes attached to their legs and abdomen. The electrodes are connected to wires that run to a machine in the background. The electrodes are placed on the person's skin with a clear plastic sheet. The electrodes are numbered 2, 3, 5, 6, and others.
Where
-
- Reusable silicone belts (cummerbunds)
-
- Electrodes ( Handpiece )
-
- Adhesive hydrogel pads
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 device, complete care and considerable measures have been taken to retain its safety and effectiveness. The truSculpt flex device complies with voluntary standards.
Intended Use
truSculpt flex 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 a 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 , K192039).
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Comparison of Technological Characteristics
A comparison given below identifies all the changes between the modified and the predicate device:
| Basic Device Characteristics – Comparison with Predicate Device | |||
|---|---|---|---|
| Device Features | Modified device | Predicate Device | Comparison | ||
|---|---|---|---|---|---|
| 510(K) Number | K212866 | K192039 | N/A | ||
| Device Name, Model | truSculpt flex | Torc Body | Design revision updated | ||
| Manufactured For | 7e Wellness Corporation | 7e Wellness Corporation | Identical | ||
| Manufactured By | Johari Digital Healthcare Ltd. | Johari Digital Healthcare Ltd. | Identical | ||
| Classification Name | Powered muscle stimulator | Powered muscle stimulator | 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 | Prescription | Identical | ||
| Indication for use | Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. Strengthening, toning and firming of buttocks & thighs. | Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. Strengthening, toning and firming of buttocks & thighs. | Identical | ||
| Target population | It is to be used by adults only | It is to be used by adults only. | Identical | ||
| Power source | 100-240AC, 50/60Hz, 75VA | 100-240AC, 50/60Hz, 75VA | Identical | ||
| Method of Line Current Isolation | (a) AC Power supply is converted to DC Power supply through a medical-grade PSU, which has isolation of 2XMOPP (IEC60601-1)(b) Isolation thru transformer between device and patient | (a) AC Power supply is converted to DC Power supply through a medical-grade PSU, which has isolation of 2XMOPP (IEC60601-1)(b) Isolation thru transformer between device and patient | Identical | ||
| Device Features | Modified device | Predicate Device | Comparison | ||
| Patient LeakageCurrentNormal condition | Normal condition = lessthan100μΑ | Normal condition = lessthan100μΑ | Identical | ||
| Single Faultcondition | Single fault condition =less than 300μΑ | Single fault condition = lessthan 300μA | |||
| Components | Main unit,8 Stainless steel reusableelectrodes pairs (16electrodes)4 electrode lead wires1 AC Power Cord4 Hydrogel pads2 reusable silicone belts(cummerbunds) | Main unit,8 self adhesive electrodes ,4 electrode lead wires,1 AC Power Cord | Modified;-The modifieddevice has twoadditionaloutputs (4channels), hencethe number ofelectrodes hasbeen increasedfrom 8 to 16.- The modifieddevice hasstainless steelelectrodes, whichdo not have anyexpiry and aremore reliable,cost-effective,andenvironmentallyfriendly thansingle-useelectrodes.-Hydrogel padsare being addedto facilitateattachment ofelectrodes topatient's skin andto enhanceenergy coupling.- Silicone beltsare being addedto secure | ||
| Device Features | Modified device | Predicate Device | Comparison | ||
| Display | 12" LCD | 12" LCD | electrodes in place.Identical | ||
| Number of OutputModes | 03(Prep, Tone, Sculpt) | 03(Classic Vector, PowerSequence, DynamicRotation) | Modified;Renamed treatment modesfor usability. | ||
| Number of OutputChannels | 4Synchronous(a) Outputs 1 to 4 arecompletely isolated. Onlypower supply and groundare common. | 2Synchronous(a) Outputs 1 to 2 arecompletely isolated. Onlypower supply and groundare common. | ModifiedThe number of outputs is beingincreased from two to four toprovide enhancedcustomization and flexibility tothe clinician.The modified device has beentested against EMI/EMC &safety standards as per the IEC60601-1 requirements.All the test reports areavailable under section017_ElectromagneticCompatability & Electrical Safety | ||
| 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-Load | NO | NO | Identical | ||
| Device Features | Modified device | Predicate Device | Comparison | ||
| Trip | |||||
| Automatic Shut off? | YES | YES | Identical | ||
| Patient OverrideControl? | YES | YES | Identical | ||
| Indicator Display:On/Off Status? | YES | YES | Identical | ||
| Low Battery? | N/A | N/A | Identical | ||
| Voltage/CurrentLevel? | YES | YES | Identical | ||
| Timer Range(minutes) | 45 Minutes – For ClassicMode15 Minutes – For Flex+mode | 1 – 60 MinutesIn step of 1 minute | ModifiedThe modifieddevice hasprefixedtreatment timeof:15 minutes and45 minutes | ||
| Compliance withVoluntaryStandards? | YESIEC 60601-1,IEC 60601-1-2,IEC60601-2-10, &ISO14971 | YESIEC 60601-1,IEC 60601-1-2,IEC60601-2-10, & ISO14971 | Identical | ||
| Compliance With 21CFR 898 | YES, the electrode cablecan never be plugged inthe AC socket, not evenaccidentally | YES, the electrode cablecan never be plugged in theAC socket, not evenaccidentally | Identical | ||
| Weight | 32.66 Kgs | 32.66 Kgs | Identical | ||
| Dimension(L X B X H) | 14"(L) X 17.5" (W) X40"(H) | 14"(L) X 17.5" (W) X 40"(H) | Identical | ||
| Housing Materialand construction | ABS Plastic Body | ABS Plastic Body | Identical | ||
| OperatingTemperature | Temperature: +15°C to+35°C | Temperature: +15°C to+35°C | Identical | ||
| Relative Humidity: 30 %to 75 % (non-condensing) | Relative Humidity: 30 % to75 % (non-condensing) | ||||
| Barometric pressure:700 hPa to 1060 hPa | Barometric pressure:700 hPa to 1060 hPa | ||||
| Transport andstorage | Temperature: +5°C to+45°C | Temperature: +5°C to+45°C | Identical | ||
| Device Features | Modified device | Predicate Device | Comparison | ||
| Relative Humidity: 10% to 85% (non-condensing) | Relative Humidity: 10% to 85% (non-condensing) |
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Comparison of output specification
Mode: Prep
| S.No. | Parameters | MODIFIED DEVICEtruSculpt flex | PREDICATE DEVICETorc Body (K192039) |
|---|---|---|---|
| Mode Name | Prep | Classic Vector | |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Step Sine Wave | Step Sine Wave |
| 3. | Maximum Output | 100 Vpp @ 500Ω (± 10%) | 51.6 Vpp @ 500Ω (± 10%) |
| Voltage | 125 Vpp @ 2KΩ (± 10%) | 62.4 Vpp @ 2KΩ (± 10%) | |
| 133 Vpp @ 10KΩ (± 10%) | 66 Vpp @ 10KΩ (± 10%) | ||
| 4. | Maximum Output | 200 mA @ 500 Ohm | 103.2mA @ 500 Ohm |
| Current | 62.5 mA @ 2K Ohm | 31.2 mA @ 2K Ohm | |
| 13 mA @ 10K Ohm | 6.6 mA @ 10K Ohm | ||
| 5. | Pulse Width | 125 μS (± 10%) @500Ω | 124.7 μς (± 10%) @500Ω |
| 6. | Frequency | Channel1:4000 Hz (± 10%) @500ΩChannel 2:4001 – 4100 Hz (± 10%) @500Ω | Channel1:4000 Hz (± 10%) @500ΩChannel 2:4001 – 4100 Hz (± 10%) @500Ω |
| 7. | For Interferentialmodes only:- Beatfrequency | Resultant: 1 – 100 Hz | Resultant: 1 – 100 Hz |
| 8. | For multiphasicWaveform- SymmetricalPhases?- Phase duration | Yes125 μS | Yes124.7 μς |
| 9. | Net charge | 0 μC @500Ω (Being Biphasic innature the net charge would beZero) | 0 μC @500Ω (Being Biphasic innature the net charge would beZero) |
| 10. | Maximum PhaseCharge | 12.5 μC | 6.45 μC |
| 11. | Maximum CurrentDensity | 2.88 mA/cm²*measured with 59 x 599mm square electrodes | 1.15 mA/cm²*measured with 50 x 90mm rectangularelectrodes |
| 12. | Maximum PowerDensity | 0.144 Watt/cm²*measured with 59 x 59mm squareelectrodes | 0.0295 Watt/cm²*measured with 50 x 90mm rectangularelectrodes |
| 13. | Burst Mode- Pulses Per- Burst | N/A | N/A |
| S.No. | Parameters | MODIFIED DEVICE | PREDICATE DEVICE |
| truSculpt flex | Torc Body (K192039) | ||
| - Burst Per- second- Burst Duration- Duty Cycle | |||
| 14. | ON Time | N/A | N/A |
| 15. | OFF Time | N/A | N/A |
| 16. | Additional Features | Sweep Frequency 1- 100 Hz | Sweep Frequency 1- 100 Hz |
| S.No. | Parameters | MODIFIED DEVICEtruSculpt flex | PREDICATE DEVICETorc Body (K192039) |
| Output Waveform | Tone | Power Sequence | |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Square wave | Square Wave |
| 3. | Maximum Output | 70 Vpp @ 500Ω (± 10%) | 51 Vpp @ 500Ω (± 10%) |
| Voltage | 125 Vpp @ 2KS2 (± 10%) | 63 Vpp @ 2KΩ (± 10%) | |
| 150 Vpp @ 10KΩ (± 10%) | 66 Vpp @ 10KΩ (± 10%) | ||
| 4. | Maximum Output | 140 mA@ 500 Ohm | 102 mA @ 500 Ohm |
| Current | 62.5 mA @ 2K Ohm | 31.5 mA @ 2K Ohm | |
| 15 mA @ 10K Ohm | 6.6 mA @ 10K Ohm | ||
| ഗ് | Pulse Width | 350 µS (± 10%) @ 500Ω | 350 uS (+ 10%) |
| 6. | Frequency | 99 Hz (± 10%) @ 500Ω | 99 Hz (± 10%) |
| 7. | Beat frequency | N/A | N/A |
| 8. | For multiphasic | ||
| Waveform | |||
| SymmetricalPhases? | Yes, Symmetrical Biphasic | Yes, Symmetrical Biphasic | |
| Phase duration | 350 µS (± 10%) | 350 uS (+ 10%) | |
| 9. | Net charge | 0 µC @500Ω (Being Biphasic in | 0 µC @500Ω (Being Biphasic in |
| nature the net charge would be | nature the net charge would | ||
| Zero) | be Zero) | ||
| 10. | Maximum Phase | 24.50 µC @ 500 Ω Load | 17.85 µC @ 500 Ω Load |
| Charge | |||
| 11. | Maximum Current | 2.02 mA/cm2 | 1.14 mA/cm² |
| density | *measured with 59 x 59 mm square electrodes | *measured with 50 x 90mm rectangularelectrodes | |
| 12. | Maximum Power | 0.070 Watts/cm2 | 0.029584 Watt/cm² |
| Density | *measured with 59 x 59 mm square electrodes | *measured with 50 x 90mm rectangularelectrodes | |
| 13. | Burst Mode | N/A | N/A |
| Pulses Per Burst | |||
| Burst Per | |||
| second | |||
| Burst Duration | |||
| Duty Cycle | |||
| 14. | ON Time | 6 seconds | 6 seconds |
| 15. | OFF Time | 4 seconds | 4 seconds |
| 13 | Additional | ||
| Features | |||
| S.No. | Parameters | MODIFIED DEVICE | PREDICATE DEVICE |
| truSculpt flex | Torc Body (K192039) | ||
| Output | Sculpt | Dynamic Rotation | |
| Waveform | |||
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Modulated Sine Wave | Modulated Sine Wave |
| 3. | Maximum Output | 100 Vpp @ 500Ω (± 10%) | 51.2 Vpp @ 500Ω (± 10%) |
| Voltage | 125 Vpp @ 2KΩ (± 10%) | 63.2 Vpp @ 2KΩ (± 10%) | |
| 135 Vpp @ 10KΩ (± 10%) | 66 Vpp @ 10KΩ (± 10%) | ||
| 4. | Maximum Output | 200 mA @ 500 Ohm | 102.4 mA @ 500 Ohm |
| Current | 62.5 mA @ 2K Ohm | 31.6 mA @ 2K Ohm | |
| 13.5 mA @ 10K Ohm | 6.56 mA @ 10K Ohm | ||
| 5. | Pulse Width | 125 μS (± 10%) @ 500Ω | 124.9 μS (± 10%) @ 500Ω |
| 6. | Frequency | 4000 Hz (± 10%) @ 500ΩResultant: 1 – 100 Hz | 4002 Hz (± 10%) @ 500ΩResultant: 1 - 100 Hz |
| 7. | Beat frequency | N/A | N/A |
| 8. | For multiphasic | ||
| Waveform | |||
| Symmetrical | Yes, Symmetrical Biphasic | Yes, Symmetrical Biphasic | |
| Phases? | |||
| Phase duration | 125 μS (± 10%) | 124.9 μS (± 10%) | |
| 9. | Net charge | 0 μC @500Ω (Being Biphasic innature the net charge would beZero) | 0 μC @500Ω (Being Biphasic innature the net charge wouldbe Zero) |
| 10. | Maximum PhaseCharge | 12.5 μC | 6.4 μC |
| 11A. | Maximum | 2.88 mA/cm²*measured with 59 x 599mm square electrodes | 1.14 mA/cm²*measured with 50 x 90mm rectangularelectrodes |
| 12A. | Maximum PowerDensity | 0.144 Watt/cm²*measured with 59 x 59mm square electrodes | 0.0291 Watts/cm² |
| 13. | Burst ModePulses Per | N/A | N/A |
| Burst | |||
| Burst Per | |||
| second | |||
| Burst Duration | |||
| Duty Cycle | |||
| 14. | ON Time | N/A | N/A |
| 15. | OFF Time | N/A | N/A |
| 13 | AdditionalFeatures | Sweep Frequency 1- 100 Hz | Sweep Frequency 1- 100 Hz |
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Traditional 510(K) — K212866
truSculpt flex 510(K) Summary
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Mode: Tone
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Mode: Sculpt
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There are no changes to the indications for use, fundamental scientific principles, performance specifications, or operation of the device. Although there are minor differences observed between the individual mode parameters of truSculpt flex and the predicate device, no differences found raised any questions regarding the safety and effectiveness of the modified device as the observed deviation in values is within the limits as per "Guidance Document for Powered Muscle Stimulator 510(k)s", issued on June 9, 1999, ANSI/AAMI NS4:2013 (R2017) standard for electrical stimulators.
The fundamental scientific technology is not changed in the modified device, and the changes are solely considered for ease of use for the clinician. The truSculpt flex 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.
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 truSculpt flex device 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)
CONCLUSION
The information and testing presented in this traditional 510(k) demonstrate that the truSculpt flex device performs as designed and intended, and is substantially equivalent to the predicate device (K192039). 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).