BTL 799-2

K180813 · BTL Industries, Inc. · NGX · Jun 14, 2018 · Physical Medicine

Device Facts

• Record ID: K180813
• Device Name: BTL 799-2
• Applicant: BTL Industries, Inc.
• Product Code: NGX · Physical Medicine
• Decision Date: Jun 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

BTL 799-2 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 and thighs.

Device Story

Non-invasive therapeutic device; generates electromagnetic field to interact with human body tissues; induces action potentials in nerves to cause muscle contraction. Used for strengthening, toning, and firming abdomen, buttocks, and thighs. System consists of console with electromagnetic field generators, computer, and touch-screen control panel; two outputs allow simultaneous treatment using two applicators. Operated by clinician in clinical setting; user guided step-by-step via touch-screen interface to set therapy parameters (intensity, time). Device provides visual feedback on therapy type, remaining time, and parameters. Benefits patient through muscle stimulation; non-invasive approach to muscle conditioning.

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 series (cytotoxicity, irritation, sensitization).

Technological Characteristics

Electromagnetic field generator; pulse characteristics: 1-150 Hz repetition rate, 280 ± 20% µs duration, symmetrical biphasic sine wave. System includes console and applicators. Connectivity: standalone with 15.6" touch-screen interface. Power: 100-240 V AC, 50-60 Hz. Software: firmware-controlled. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, IEC 62304, ISO 14971, ISO 10993.

Indications for Use

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

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

• AM-100 (K163165)

Submission Summary (Full Text)

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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.

June 14, 2018 BTL Industries, Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752

Re: K180813

Trade/Device Name: BTL 799-2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: March 26, 2018 Received: March 29, 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. 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

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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,

# William J. Heetderks -S 2018.06.14 16:14:26 -04'00'

- Carlos L. Peña, PhD, MS for 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) K180813

Device Name BTL 799-2

Indications for Use (Describe)

BTL 799-2 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 and 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) |
|----------------------------------------------|---------------------------------------------|
| <div style="text-align: center;">X</div> | |

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Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected squares with the letters "BTL" inside each 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.

# 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: | June 14, 2018 |

#### Device Name

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

# Legally Marketed Predicate Devices

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

- . AM-100 (K163165)

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Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing the letters "BTL" in white. The squares are arranged in a row, with the first square slightly offset to the left and the third square slightly offset to the right. To the right of the squares is the text "BTL Industries" in gray.

#### Product Description

The BTL 799-2 is a non-invasive therapeutic device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the BTL 799-2 helps to strengthen, tone and firm the abdomen, buttocks and thighs. The device two outputs enable simultaneous treatment by two applicators.

The BTL 799-2 is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information quides the user stepby-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen and buttons on 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 799-2 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 and thighs.

## Non-clinical Testing

The BTL 799-2 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<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 |
| 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 |

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Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each nested inside the other, with the letters "BTL" stacked vertically inside the innermost square. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.

| 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 799-2 device has the same indications for use and similar technological characteristics and principles of operation as its predicate device. The BTL 799-2 device and its predicate 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 Essential technical characteristics of the BTL 799-2 and its predicate device, particularly the type of energy, pulse characteristics, type of operation and therapy time, are identical.

Compared to the predicate, the BTL 799-2 device is equipped with larger touch-screen control panel to increase user comfort. Technical characteristics of the applicator are comparable to its predicate. The subject device has two outputs to enable simultaneous treatment by two applicators.

The technological differences between the BTL 799-2 device and the predicate device do not raise any new types of safety or effectiveness questions.

| 510(k) number | Not Assigned | K163165 |
|--------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Device name | BTL 799-2 | AM-100 |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Product Code<br>and Regulation | Physical Medicine<br>21 CFR 890.5850<br>NGX – Stimulator, Muscle,<br>Powered, Muscle Conditioning | Physical Medicine<br>21 CFR 890.5850<br>NGX – Stimulator, Muscle, Powered,<br>Muscle Conditioning |

#### 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 interconnected blue squares with the letters "BTL" inside each square. To the right of the logo is the text "BTL Industries" in a dark gray sans-serif font.

| 510(k) number | Not Assigned | K163165 |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | BTL 799-2 | AM-100 |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Intended Use | BTL 799-2 is indicated to be used for:<br>• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.<br>• Strengthening, Toning and Firming of buttocks and thighs. | AM 100 is indicated to be used for:<br>• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.<br>• Strengthening, Toning and Firming of buttocks and thighs. |
| Primary Function | Muscle stimulation | Muscle stimulation |
| Principle of Action | Initiating action potential of nerves results in muscle contraction | Initiating action potential of nerves results in muscle contraction |
| Clinical Use | Prescription use | Prescription use |
| Electrical Protection | Class II, BF | Class II, BF |
| User Interface | Touch screen | Touch screen |
| Touch screen size | 15.6" (39.6 cm) | 8.4" (21.5 cm) |
| Firmware Controlled | Yes | Yes |
| Type of Energy | Magnetic field | Magnetic field |
| Number of outputs | 2 | 1 |
| Number of Magnetic<br>Coils<br>in the Applicator | 1 | 1 |
| Magnetic Field<br>Intensity | 299-6 applicator: 0.5–1.8 T | 299-1 applicator: 0.5–1.8 T<br>299-2 applicator: 0.7–2.5 T |
| 510(k) number | Not Assigned | K163165 |
| Device name | BTL 799-2 | AM-100 |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Type of Operation | Continuous | Continuous |
| Pulse Repetition Rate | 1 - 150 Hz | 1 - 150 Hz |
| Pulse Duration | 280 ± 20% µs | 280 ± 20% µs |
| Pulse Amplitude | 0 – 100% | 0 – 100% |
| Induced Current in<br>the Tissue | 28-30 mA | 28-30 mA |
| Selection of<br>parameters (Intensity,<br>Time) | Yes | Yes |
| Therapy Time | Up to 60 min | Up to 60 min |
| Shape of Stimulation<br>Pulse | Symmetrical Biphasic Sine Wave | Symmetrical Biphasic Sine Wave |
| Energy Source | 100 - 240 V AC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz |
| System Dimensions<br>(W×H×D) | 500×1380×580 mm | 500×970×580 mm |
| | (20×55×23 in) | (20×38×23 in) |
| Ambient Temperature | -10°C to +55°C | -10°C to +55°C |
| Environmental<br>Specifications | For indoor use only | For indoor use only |

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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, with the letters "BTL" inside the squares. 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.

# Substantial Equivalence

The BTL 799-2 device has the same intended use as its predicate devices. The technological characteristics of the predicate devices are similar to the BTL 799-2 device. Any differences between the predicate devices and BTL 799-2 device have no significant influence on safety or effectiveness of the BTL 799-2 device. Therefore, the BTL 799-2 device is substantially equivalent to the predicate devices.

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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" in white inside the innermost square. To the right of the square logo is the text "BTL Industries" in a dark gray sans-serif font.

# Conclusion

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