BTL-703-2
Device Facts
| Record ID | K200382 |
|---|---|
| Device Name | BTL-703-2 |
| Applicant | Btl |
| Product Code | NGX · Physical Medicine |
| Decision Date | Jan 6, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
BTL-703-2 is indicated to be used for: - Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. - Strengthening, toning and firming of buttocks, thighs and calves. - Improvement of muscle tone and firmness, for strengthening muscles in arms.
Device Story
Non-invasive therapeutic device; delivers electromagnetic stimulation and bipolar radiofrequency (RF) energy to targeted tissue. Main unit with two applicators enables hands-free simultaneous treatment; applicators secured by fixation belts. User interface features large color touch-screen for parameter setting and step-by-step therapy guidance. Electromagnetic field interacts with body tissues to achieve muscle stimulation; bipolar RF provides surface warming (below 40°C) to enhance patient comfort. Used in clinical settings by trained operators. Output affects muscle tone and firmness; benefits include improved abdominal tone and muscle strengthening in specified body areas.
Clinical Evidence
Bench testing only. Device evaluated for electrical safety and performance per IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971, and ISO 10993 (cytotoxicity, irritation, sensitization). No clinical data presented.
Technological Characteristics
System console with electromagnetic field and bipolar RF generators, computer, and touch-screen control panel. Two output channels. Electromagnetic field intensity 0.5–2.0 T; pulse repetition 1–150 Hz; pulse duration 190–280 µs; biphasic sinusoidal waveform. RF frequency 27.12 MHz; total power 60 W (2x30 W). Includes overheating protection sensors. Class II, BF electrical protection. Software-controlled.
Indications for Use
Indicated for improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen, and strengthening, toning, and firming of buttocks, thighs, calves, and arms.
Regulatory Classification
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.
Predicate Devices
- 799-2L (K190456)
Reference Devices
- BTL-899 (K192224)
Submission Summary (Full Text)
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January 6, 2021
BTL David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K200382
Trade/Device Name: BTL-703-2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 10, 2020 Received: December 14, 2020
Dear David Chmel:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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.
Amber Ballard, PhD Assistant 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
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### Indications for Use
510(k) Number (if known) K200382
Device Name BTL-703-2
Indications for Use (Describe) BTL-703-2 is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, toning and firming of buttocks, thighs and calves.
- · Improvement of muscle tone and firmness, for strengthening muscles in arms.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☑</span> |
|----------------------------------------------|-------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | □ |
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Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares, with the letters "BTL" inside the leftmost square. To the right of the squares is the text "BTL Industries" in a dark gray, sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.
# 510(k) Summary
# General Information
| Sponsor: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: +1-866-285-1656<br>Fax: +1-888-499-2502 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| | Fax: +1-888-499-2502 |
| Applicant: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: +1-866-285-1656<br>Fax: +1-888-499-2502 |
| Contact Person: | David Chmel<br>BTL Industries, Inc.<br>chmel@btlnet.com |
| Summary Preparation<br>Date: | 31 December 2020 |
## Device Name
| Trade/Proprietary Name: | BTL-703-2 |
|------------------------------|--------------------------------------------------|
| Primary Classification Name: | Stimulator, Muscle, Powered, Muscle Conditioning |
| Classification Regulation: | 21 CFR 890.5850, Class II |
| Classification Product Code: | NGX |
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Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares with the letters "BTL" inside the leftmost square. To the right of the logo is the text "BTL Industries" in a dark gray sans-serif font. The text is aligned horizontally with the logo.
#### Legally Marketed Predicate Device
The BTL-703-2 is a state-of-the-art device with accessories combining electromagnetic and high frequency energy, and is substantially equivalent to the following product, which is already cleared for distribution in the USA under the following 510(k) Premarket Notification number:
- 799-2L (K190456) ●
#### Reference Device BTL-899
The reference device has been added to this section because it is technologically similar to the BTL-703-2 device. Both devices are tracked internally under a common project number, P899. Hence, all test reports and technical documentation refer to this number.
#### Product Description
The BTL-703-2 is a non-invasive therapeutic device is comprised of a main unit and applicators that deliver electromagnetic and radiofrequency to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators.
The BTL-703-2 is equipped with a large color touch-screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch-screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
#### Indications for Use
BTL-703-2 is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, toning and firming of buttocks, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms. ●
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### Non-clinical Testing
The BTL-703-2 device has been thoroughly evaluated for electrical safety. The device has been found to comply with the following applicable medical device safety standards:
| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for basic safety<br>and essential performance |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safety<br>and essential performance - Collateral standard: Electromagnetic disturbances<br>– Requirements and tests |
| IEC 62304 | Medical device software - Software lifecycle processes |
| ISO 14971 | Medical devices – Application of risk management to medical devices |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation and testing within<br>a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices – Part 10: Tests for irritation and skin<br>sensitization |
### Technological Characteristics
The BTL-703-2 device has similar indications for use and technological characteristics and principles of operation to its predicate device. The BTL-703-2 device and its predicate are comprised of a system console and applicators. The system console consists of the electromagnetic field and radiofrequency generators, computer, and a touch-screen control panel.
The generated electromagnetic field is intenact with the tissues of the human body in order to achieve muscle stimulation. The radiofrequency is providing a low degree of warming of the applicators and thus enhance the patient's comfort during the treatment.
The mechanism of action and technological similarities and differences between the BTL-703-2 device and the predicate device are described below in the comparison table. The differences do not raise any new types of safety or effectiveness questions.
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# Comparison with the Predicate Devices
| 510(k)<br>number<br>Device name<br>Company<br>name | K200382<br>BTL-703-2<br>BTL Industries, Inc. | K190456<br>BTL 799-2L<br>BTL Industries, Inc. | Reference Device<br>K192224<br>BTL-899<br>BTL Industries, Inc. | Significant<br>difference |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Product<br>Code<br>and<br>Regulation | Physical Medicine<br>21 CFR 890.5850<br>NGX – Stimulator,<br>Muscle, Powered,<br>Muscle Conditioning | Physical Medicine<br>21 CFR 890.5850<br>NGX - Stimulator,<br>Muscle, Powered,<br>Muscle Conditioning | General & Plastic Surgery<br>21 CFR 878.4400<br>GEI - Electrosurgical,<br>Cutting & Coagulation &<br>Accessories | None |
| Indications<br>for Use | BTL-703-2 is indicated<br>to be used for:<br>Improvement of<br>abdominal tone,<br>strengthening of<br>the abdominal<br>muscles,<br>development of<br>firmer abdomen.Strengthening,<br>toning and firming<br>of buttocks, thighs<br>and calves.Improvement of<br>muscle tone and<br>firmness, for<br>strengthening<br>muscles in arms. | BTL 799-2L is<br>indicated to be used<br>for:<br>Improvement of<br>abdominal tone,<br>strengthening of<br>the abdominal<br>muscles,<br>development of<br>firmer abdomen.Strengthening,<br>toning and firming<br>of buttocks, thighs<br>and calves.Improvement of<br>muscle tone and<br>firmness, for<br>strengthening<br>muscles in arms. | BTL-899 is indicated to<br>be used for:<br>Non-invasive<br>lipolysis (breakdown<br>of fat) of the<br>abdomen.Reduction in<br>circumference of<br>the abdomenThe BTL-899 is intended<br>for use with Skin Type I to<br>Skin Type III. | Not<br>Significantly<br>different |
| Basic<br>Technology | Electromagnetic<br>stimulation<br>accompanied by<br>bipolar radiofrequency | Electromagnetic<br>stimulation | Electromagnetic<br>stimulation<br>accompanied by<br>bipolar radiofrequency | Not<br>Significantly<br>different<br>Please see the<br>discussion and |
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| | | | | conclusion<br>below |
|---------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Clinical Use | Prescription use | Prescription use | Prescription use | None |
| Electrical<br>Protection | Class II, BF | Class II, BF | Class II, BF | None |
| User<br>Interface | Touch screen | Touch screen | Touch screen | None |
| Firmware<br>Controlled | Yes | Yes | Yes | None |
| Number of<br>outputs<br>channels | 2 | 2 | 2 | Not<br>Significantly<br>different |
| Number of<br>output<br>modes* | 1 | 1 | 1 | None |
| Number of<br>Magnetic<br>coils<br>in the<br>Applicator | 1 | 1 | 1 | None |
| Magnetic<br>Field<br>Intensity (on<br>the coil<br>surface) | 0.5 to 1.8 T<br>for app:<br>BTL-899-AP-C-1 | 0.5 to 1.8 T<br>for app:<br>BTL 299-6 | 0.5 to 1.8 T<br>for app:<br>BTL-899-AP-C-1 | None |
| Magnetic<br>Field<br>Intensity (on<br>the coil<br>surface) | 0.7 to 2.0 T<br>for app:<br>BTL-899-AP-C-2 | 0.7 to 2.0 T<br>for app:<br>BTL 299-7 | N/A | None |
| Maximum<br>magnetic | 908 mT | 980 mT | 908 mT | None |
| field<br>intensity at<br>applicator<br>center<br>surface | for app: BTL-899-AP-<br>C-1 | for app:<br>BTL 299-6 | for app: BTL-899-AP-<br>C-1 | None |
| Maximum<br>magnetic<br>field<br>intensity at<br>applicator<br>center<br>surface | 1238 mT<br>for app: BTL-899-AP-<br>C-2 | 1220 mT<br>for app:<br>BTL 299-7 | 1238 mT | None |
| Pulse<br>Repetition<br>Rate -<br>supported<br>by the<br>device | 1 – 150 Hz | 1 – 150 Hz | 1 – 150 Hz | None |
| Pulse<br>Duration | $280 \mu s \pm 20\% \mu s$<br>for app:<br>BTL-899-AP-C-1 | $280 \mu s \pm 20\% \mu s$<br>for app:<br>BTL 299-6 | $280 \mu s \pm 20\% \mu s$<br>for app:<br>BTL-899-AP-C-1 | None |
| Pulse<br>Duration | $190 \mu s \pm 20\% \mu s$<br>for app:<br>BTL-899-AP-C-2 | $190 \mu s \pm 20\% \mu s$<br>for app:<br>BTL 299-7 | N/A | None |
| Waveform | Biphasic | Biphasic | Biphasic | None |
| Shape | Sinusoidal | Sinusoidal | Sinusoidal | None |
| RF Type | Bipolar | N/A | Bipolar | Not<br>Significantly<br>different<br>Please see<br>discussion on<br>basic technology<br>below |
| Total RF<br>Power | 60 W (2x30) | N/A | 60 W (2x30) | Not<br>Significantly<br>different<br>Please see<br>discussion on<br>basic technology<br>below |
| RF<br>Frequency | 27.12 Mhz | N/A | 27.12 Mhz | Not<br>Significantly<br>different<br>Please see<br>discussion on<br>basic technology<br>below |
| Overheating<br>Protection<br>Sensor | Yes | N/A | Yes | Not<br>Significantly<br>different |
| Selection of<br>parameters | Yes | Yes | Yes | None |
| Application | Hands-free, applicator<br>fixed by fixation belt | Hands-free,<br>applicator fixed by<br>fixation belt | Hands-free, applicator<br>fixed by fixation belt | Not<br>Significantly<br>different |
| Therapy<br>Time | Up to 30 min | Up to 60 min | Up to 30 min | Not<br>Significantly<br>different |
| Energy<br>Source | 100 - 240 V AC, 50-<br>60 Hz | 100 - 240 V AC, 50-<br>60 Hz | 100 - 240 V AC, 50-<br>60 Hz | None |
| Maximum<br>Output<br>Voltage | N/A | N/A | N/A | N/A |
| Maximum<br>Output<br>Current | N/A | N/A | N/A | N/A |
| Maximum<br>Current<br>Density<br>(mA/cm²) | N/A | N/A | N/A | N/A |
| Maximum<br>Phase<br>Charge,<br>(mC) | N/A | N/A | N/A | N/A |
| Maximum<br>Power<br>Density*<br>(W/cm²) | N/A | N/A | N/A | N/A |
| System<br>Dimensions<br>(W×H×D) | 23 x 39 x 29 in<br>(592 x 985 x 730 mm) | 23 x 55 x 23 in<br>(580x1380x580 mm) | 23 x 39 x 29 in<br>(592 x 985 x 730 mm) | Not<br>Significantly<br>different |
| System<br>Weight | 85 kg | 44 kg | 85 kg | Not<br>Significantly<br>different |
| Ambient<br>Storage<br>Temperature | 14 °F to 131 °F (-10°C<br>to +55°C) | 14 °F to 131 °F (-<br>10°C to +55°C) | 14 °F to 131 °F (-10°C<br>to +55°C) | None |
| Relative<br>Storage<br>Humidity | 10% to 85% | 10% to 85% | 10% to 85% | None |
| Environment<br>al<br>Specificatio<br>ns | For indoor use only | For indoor use only | For indoor use only | None |
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Image /page/8/Picture/0 description: The image contains the logo for BTL Industries. The logo consists of three interconnected blue squares with the letters "BTL" inside. To the right of the logo, the words "BTL Industries" are written in a dark gray sans-serif font.
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Image /page/9/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares that are nested inside each other. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font.
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### Substantial Equivalence
The BTL-703-2 is indicated for improvement of abdominal tone, strengthening of the abdominal muscles and development of firmer abdomen, as well as for strengthening, toning and firming of buttocks, thighs and calves. These indications are the same as the predicate device's indications.
The predicate device BTL-799L utilizes electromagnetic stimulation in order to achieve therapeutic effect. The proposed device BTL-703-2 also utilizes electromagnetic stimulation for its main therapeutic effect; however, the device is also equipped with a bipolar radiofrequency generator. The radiofrequency is warming the applicators' surface to below 40℃ thus enhancing the patient's comfort during the treatment.
The BTL-703-2 electromagnetic technology is identical to FDA cleared predicate device BTL 799-2L. The bipolar radiofrequency technology has also been cleared by FDA in a number of devices, for example BTL-899 (K192224).
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Image /page/11/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares on the left side. To the right of the squares is the text "BTL Industries" in a dark gray, sans-serif font.
Any differences between the predicate device and BTL-703-2 have no significant influence on the safety or effectiveness of the BTL-703-2 device. Therefore, the BTL-703-2 is substantially equivalent to the predicate device.
### Conclusion
Based upon the intended use and known technical information provided in this pre-market notification, the BTL-703-2 device has been shown to be substantially equivalent to the currently marketed predicate devices.
