BTL 799-2T

K182106 · BTL Industries, Inc. · NGX · Oct 23, 2018 · Physical Medicine

Device Facts

• Record ID: K182106
• Device Name: BTL 799-2T
• Applicant: BTL Industries, Inc.
• Product Code: NGX · Physical Medicine
• Decision Date: Oct 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BTL 799-2T 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 and thighs. · Improvement of muscle tone and firmness, for strengthening muscles in arms.

Device Story

Non-invasive therapeutic device; produces electromagnetic field interacting with human body tissues to induce neuromuscular stimulation. System console includes electromagnetic field generators, computer, and touch-screen control panel; two outputs allow simultaneous treatment via two applicators. Used in clinical settings by healthcare providers; user guided by on-screen instructions to set therapy parameters (intensity, time). Device induces electrical current in neuromuscular tissue to initiate action potential, resulting in muscle contraction. Output affects muscle tone and firmness; benefits include improved abdominal tone and strengthened muscles in abdomen, buttocks, thighs, and arms.

Clinical Evidence

Bench testing only. Device evaluated for electrical safety and performance per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, IEC 62366, IEC 62304, ISO 14971, and ISO 10993 (parts 1, 5, 10).

Technological Characteristics

System console with electromagnetic field generators, computer, and touch-screen. Magnetic field intensity 0.5-1.8 T; pulse repetition 1-150 Hz; pulse duration 280 ± 20% µs. Class II, BF electrical protection. Indoor use only. Firmware-controlled. Sterilization not specified; biocompatibility per ISO 10993.

Indications for Use

Indicated for improvement of abdominal tone, strengthening abdominal muscles, development of firmer abdomen, and strengthening, toning, and firming of buttocks, thighs, 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

• BTL 799-2 (K180813)
• Body Control System "4M" (K092476)

Submission Summary (Full Text)

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October 23, 2018

BTL Industries, Inc. David Chmel VP of Operations 362 Elm Street Marlborough, MA 01752

Re: K182106

Trade/Device Name: BTL 799-2T Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: July 31, 2018 Received: August 3, 2018

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.

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182106

Device Name BTL 799-2T

Indications for Use (Describe)

BTL 799-2T 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 and thighs.

· Improvement of muscle tone and firmness, for strengthening muscles in arms.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| 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 nested squares with the letters "BTL" inside, followed by the text "BTL Industries" in a sans-serif font. The squares and text are a dark blue-gray color, and the background is white.

# 510(k) Summary

# General Information

| Sponsor: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: [phone]<br>Fax: [phone] |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person: | David Chmel<br>BTL Industries, Inc.<br>[e-mail] |
| Summary Preparation<br>Date: | October 02, 2018 |

### Device Name

| Trade/Proprietary Name: | BTL 799-2T |
|------------------------------|-----------------------------|
| Primary Classification Name: | Stimulator, Muscle, Powered |
| Classification Regulation: | 21 CFR 890.5850, Class II |
| Classification Product Code: | NGX |

### Legally Marketed Predicate Devices

The BTL 799-2T is a state-of-the-art electromagnetic device with accessories, and is substantially equivalent to the current products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification number:

- primary predicate 799-2 (K180813) .
- secondary predicate Body Control System "4M" (K092476) .

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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 diamond shapes on the left, with the letters "BTL" inside the diamonds. To the right of the diamond shapes, the words "BTL Industries" are written in a gray, sans-serif font.

# Product Description

The BTL 799-2T is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The device two outputs enable simultaneous treatment by two applicators.

The BTL 799-2T is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user stepby-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.

### Intended Use

BTL 799-2T 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 and thighs.
- . Improvement of muscle tone and firmness, for strengthening muscles in arms.

# Non-clinical Testing

The BTL 799-2T 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<br>safety and essential performance |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Electromagnetic disturbances - Requirements and tests |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard: Usability |
| IEC 60601-2-10 | Medical Electrical Equipment – Part 2-10: Particular Requirements for<br>the Basic Safety and Essential Performance of Nerve and Muscle<br>Stimulators |

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Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares on the left side, with the letters "BTL" visible within the squares. To the right of the squares, the words "BTL Industries" are written in a dark gray, sans-serif font.

| IEC 62366 | Medical devices - Application of usability engineering to medical<br>devices |
|--------------|---------------------------------------------------------------------------------------------------------------|
| IEC 62304 | Medical device software – Software life cycle processes |
| ISO 14971 | Medical devices – Application of risk management to medical devices |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation and<br>testing within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices – Part 5: Tests for in vitro<br>cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices – Part 10: Tests for irritation<br>and skin sensitization |

# Technological Characteristics

The BTL 799-2T device is technologically identical to the primary predicate device BTL 799-2 (K180813). The BTL 799-2T device and its predicates are comprised of a system console and applicator(s). The system console consists of the electromagnetic field generators, computer, and the touch-screen control panel.

Generated electromagnetic field is intended to interact with the tissues of the human body to achieve muscle stimulation.

The technological similarities and differences between the BTL 799-2T device and the predicate devices are described bellow in the comparison table. The differences do not raise any new types of safety or effectiveness questions.

| 510(k) number | Not Assigned | K180813 | K092476 |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | BTL 799-2T | BTL 799-2 | Body Control System<br>"4M" |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | SPORT-ELEC S.A. |
| Product Code<br>and Regulation | Physical Medicine<br>21 CFR 890.5850<br>NGX - Stimulator, Muscle,<br>Powered, Muscle<br>Conditioning | Physical Medicine<br>21 CFR 890.5850<br>NGX - Stimulator, Muscle,<br>Powered, Muscle<br>Conditioning | Physical Medicine<br>21 CFR 890.5850<br>NGX - Stimulator, Muscle,<br>Powered, Muscle<br>Conditioning |
| 510(k) number | Not Assigned | K180813 | K092476 |
| Device name | BTL 799-2T | BTL 799-2 | Body Control System<br>"4M" |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | SPORT-ELEC S.A. |
| Intended Use | BTL 799-2T is indicated to<br>be used for:<br>• Improvement of<br>abdominal tone,<br>strengthening of the<br>abdominal muscles,<br>development of firmer<br>abdomen.<br>• Strengthening, Toning<br>and Firming of buttocks<br>and thighs.<br>• Improvement of muscle<br>tone and firmness, for<br>strengthening muscles<br>in arms. | BTL 799-2 is indicated to be<br>used for:<br>• Improvement of<br>abdominal tone,<br>strengthening of the<br>abdominal muscles,<br>development of firmer<br>abdomen.<br>• Strengthening, Toning<br>and Firming of buttocks<br>and thighs. | Body Control System 4M is<br>indicated for the<br>improvement of muscle tone<br>and firmness, for<br>strengthening muscles in<br>arms, abdomen, thighs and<br>buttocks areas.<br>Contraindicated use on<br>injured or otherwise<br>impaired muscles<br>Not intended for use in any<br>therapy or for the treatment<br>of any medical conditions or<br>diseases |
| Principle of Action | Initiating action potential of<br>nerves results in muscle<br>contraction | Initiating action potential of<br>nerves results in muscle<br>contraction | Initiating action potential of<br>nerves results in muscle<br>contraction |
| Clinical Use | Prescription use | Prescription use | Over-the-counter use |
| Electrical<br>Protection | Class II, BF | Class II, BF | Class II, BF |
| User Interface | Touch screen | Touch screen | LCD screen |
| Firmware<br>Controlled | Yes | Yes | Yes |
| Type of Energy | Magnetic field | Magnetic field | Electrical |
| Number of outputs | 2 | 2 | 2 |
| Number of<br>Magnetic Coils<br>in the Applicator | 1 | 1 | N/A |
| Magnetic Field<br>Intensity | 299-6 applicator: 0.5-1.8 T | 299-6 applicator: 0.5-1.8 T | N/A |
| 510(k) number | Not Assigned | K180813 | K092476 |
| Device name | BTL 799-2T | BTL 799-2 | Body Control System<br>"4M" |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | SPORT-ELEC S.A. |
| Pulse Repetition<br>Rate | 1 - 150 Hz | 1 – 150 Hz | 0,25-160 Hz |
| Pulse Duration | 280 ± 20% µs | 280 ± 20% µs | 70 - 360 µs |
| Selection of<br>parameters<br>(Intensity, Time) | Yes | Yes | Yes |
| Therapy Time | Up to 60 min | Up to 60 min | Up to 40 min |
| Energy Source | 100 - 240 V AC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz | 3.7 V Rechargeable battery<br>pack |
| System<br>Dimensions<br>(W×H×D) | 500×1380×580 mm<br>(20×55×23 in) | 500×1380×580 mm<br>(20×55×23 in) | 84x126x30xmm<br>(3x5x1 in) |
| Ambient<br>Temperature | -10°C to +55°C | -10°C to +55°C | 0°C to +45°C |
| Relative Humidity | 10% to 85% | 10% to 85% | 10% to 90% |
| Environmental<br>Specifications | For indoor use only | For indoor use only | For indoor use only |

# Comparison with the Predicate Device

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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares, each rotated 45 degrees, with the letters "BTL" inside. To the right of the square logo is the text "BTL Industries" in a gray, sans-serif font.

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Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares on the left side, with the letters "B", "T", and "L" inside each square, respectively. To the right of the squares is the text "BTL Industries" in a dark gray, sans-serif font.

# Substantial Equivalence

The technological characteristics of the BTL 799-2T device are identical to the primary predicate BTL 799-2 and substantially equivalent to the secondary predicate Body Control System "4M".

The BTL 799-2T technology is already cleared. It is using mechanism of neuromuscular stimulation by the current induced in the tissue. The subject device induced current of 28-30 mA is identical to the primary predicate. The already cleared device areas of application are abdomen, buttocks and thighs muscles. The same type of mechanism of action is applied to the same type muscles newly also in area of arms. Since only the application area is being extended, the difference does not rise any new questions of safety and effectiveness.

The main difference between BTL 799-2T and secondary predicate Body Control System "4M" is in the energy type used to stimulate the tissues. The BTL 799-2T device is inducing stimulation current by magnetic field, the Body Control System "4M" is stimulating

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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares, each containing the letters "BTL" in white. To the right of the square logo is the text "BTL Industries" in a dark gray sans-serif font. The overall design is clean and modern.

neuromuscular tissue via the direct current flow. In both cases there is an induction of electrical stimulus in the neuromuscular tissue which represents identical mechanism of action. Therefore this difference does not rise any new questions of safety and effectiveness.

The differences between the predicate devices and BTL 799-2T device have no significant influence on safety or effectiveness of the BTL 799-2T device. Therefore, the BTL 799-2T device is substantially equivalent to the predicate devices.

## Conclusion

Based upon the intended use and known technical information provided in this pre-market notification, the BTL 799-2T device has been shown to be substantially equivalent to currently marketed predicate devices.