BTL-899A

K213344 · BTL Industries, Inc. · GEI · Jan 5, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K213344
• Device Name: BTL-899A
• Applicant: BTL Industries, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

BTL-899A is indicated to be used for: Non-invasive lipolysis (breakdown of fat) of the abdomen. Reduction in circumference of the abdomen. Non-invasive lipolysis (breakdown of fat) of the thighs. Reduction in circumference of the thighs. BTL-899A is intended for use with skin type I - VI. Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under.

Device Story

BTL-899A is a non-invasive therapeutic device for fat reduction; combines bipolar radiofrequency (RF) and electromagnetic stimulation. System consists of console with touch-screen interface and two applicators for hands-free simultaneous treatment. Operator sets therapy parameters via screen; device monitors time and parameters; includes emergency stop. Used in clinical settings by trained operators. RF energy (27.12 MHz) and electromagnetic pulses induce lipolysis; clinical evidence supports efficacy for upper arms via fat thickness reduction. Benefits include non-invasive fat breakdown and circumference reduction with high patient satisfaction and comfort.

Clinical Evidence

Single-arm, open-label clinical study (n=40) evaluated non-invasive lipolysis of upper arms. Primary endpoint: correct identification of pre-treatment vs. 3-month follow-up images by ≥2 of 3 blinded evaluators. Trial met primary endpoint (>75% success rate). Secondary endpoints: safety, patient satisfaction (94% at 1 month, 97% at 3 months), and comfort (all subjects found therapy comfortable).

Technological Characteristics

System console with bipolar RF (27.12 MHz, 60W max) and electromagnetic stimulation. Applicators (AP-C-1, AP-C-2, AP-C-4/5) feature magnetic coils. Biphasic, sinusoidal waveform; pulse rate 1-150 Hz. Class II, BF electrical protection. Touch-screen interface. Complies with IEC 60601-1, IEC 62304, ISO 14971, ISO 10993-1/5/10.

Indications for Use

Indicated for non-invasive lipolysis and circumference reduction of abdomen and thighs (skin types I-VI) and upper arms (skin types II-III, BMI ≤ 30).

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• BTL-899 FP (K211107)

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 5, 2022

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

Re: K213344

Trade/Device Name: BTL-899A Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 5, 2021 Received: November 9, 2021

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/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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K213344

Device Name BTL-899A

Indications for Use (Describe)

BTL-899A is indicated to be used for:

Non-invasive lipolysis (breakdown of fat) of the abdomen. Reduction in circumference of the abdomen. Non-invasive lipolysis (breakdown of fat) of the thighs. Reduction in circumference of the thighs. BTL-899A is intended for use with skin type I - VI. Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X 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 a geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three squares, each nested inside the other. The text "BTL Industries" is written in a sans-serif font.

# 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 | January 5th, 2022 |

#### Device Name

| Trade/Proprietary Name: | BTL-899A |
|------------------------------|-------------------------------------------------------------|
| Primary Classification Name: | Electrosurgical, Cutting & Coagulation Device & Accessories |
| Classification Regulation: | 878.4400, Class II |
| Classification Product Code: | GEI |

## Legally Marketed Predicate Device

The BTL-899A is a state-of-the-art high-frequency energy 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 numbers:

- . BTL-899 FP (K211107)

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Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of two parts: a geometric symbol on the left and the text "BTL Industries" on the right. The geometric symbol is made up of three nested squares, each rotated 45 degrees. The text "BTL Industries" is written in a sans-serif font and is gray in color.

## Product Description

The BTL-899A is a non-invasive therapeutic device.

BTL-899A consists of a main unit and applicators. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device is equipped with an emergency button to terminate the therapy. The two outputs (applicators) of the device enable hands-free simultaneous treatment.

#### Indications for Use

BTL-899A is indicated to be used for:

- Non-invasive lipolysis (breakdown of fat) of the abdomen. ●
- . Reduction in circumference of the abdomen.
- Non-invasive lipolysis (breakdown of fat) of the thighs.
- Reduction in circumference of the thighs. ●
- BTL-899A is intended for use with skin types I - VI.
- Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and ● BMI 30 or under.

#### Non-clinical Testing (Performance, Bench Testing)

The BTL-899A 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 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 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 |

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Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interlocking squares, with the letters "BTL" inside the leftmost square. To the right of the squares is the text "BTL Industries" in a simple, sans-serif font. The color of the logo and text is a dark gray or blue-gray.

## Clinical Testing

BTL Industries conducted a clinical investigation in order to study the effect of the device for non-invasive lipolysis on human arms.

The primary objective of the study was to gather clinical evidence that the BTL-899 device, equipped with applicator 899-AP-C-2, is capable of inducing non-invasive lipolysis on human upper arms. Correct identification of pre-treatment and 3-months follow-up images by at least two out of three independent blinded evaluators had to be reported.

The secondary objectives of the study were to evaluate the safety of the BTL-899 device for non-invasive lipolysis (breakdown of fat) of the upper arms as well as to assess the participants' satisfaction from the therapy and how comfortable it was. Statistically significant reduction of upper arms fat thickness had to be observed.

The clinical investigation used a single-arm, open-label, interventional design. Forty (40) participants received treatments with the study device and were examined at 1-month and 3-month follow-up intervals.

All three blinded evaluators correctly recognized the pre-/post treatment images with more than 75% success rate and thus the trial meets its primary efficacy endpoint.

The overall satisfaction with the study treatment was 94% and 97% of the participants satisfied with their result at 1-month and 3-months follow-ups, respectively. Furthermore, all the subjects found the therapy comfortable with seven reporting weak pain while 33 reporting no pain at all.

The treatment with the BTL-899 device has shown to be both effective and safe for non-invasive lipolysis and fat thickness reduction of upper arms.

#### Technological Characteristics

The BTL-899A device has the same intended use and identical technological characteristics and principles of operation to its predicate device. The BTL-899A device and its predicate are comprised of a system console and applicator(s). The system console consists of the generators, computer, and the touch-screen control panel.

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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric shape on the left and the text "BTL Industries" on the right. The geometric shape is made up of three squares that are nested inside each other. The text is in a dark gray sans-serif font.

The mechanism of action and technological similarities and differences between the BTL-899 FP 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.

## Comparison with the Predicate Device

| 510(k) number | Not assigned | K211107 | Significant |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Device name | BTL-899A | BTL-899 FP | Difference |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | |
| Product Code<br>and Regulation | General & Plastic Surgery<br>21 CFR 878.4400<br>GEI - Electrosurgical, Cutting &<br>Coagulation & Accessories | General & Plastic Surgery<br>21 CFR 878.4400<br>GEI - Electrosurgical, Cutting &<br>Coagulation & Accessories | None |
| Indications for Use | BTL-899A is indicated to be used<br>for:<br>• Non-invasive lipolysis<br>(breakdown of fat) of the<br>abdomen.<br>• Reduction in circumference of<br>the abdomen<br>• Non-invasive lipolysis<br>(breakdown of fat) of the<br>thighs.<br>• Reduction in circumference of<br>the thighs.<br>• BTL-899A is intended for use<br>with skin types I - VI.<br>• Non-invasive lipolysis of the<br>upper arms limited to skin<br>types II and III and BMI 30 or<br>under. | BTL-899 FP is indicated to be<br>used for:<br>• Non-invasive lipolysis<br>(breakdown of fat) of the<br>abdomen.<br>• Reduction in circumference of<br>the abdomen<br>• Non-invasive lipolysis<br>(breakdown of fat) of the<br>thighs.<br>• Reduction in circumference of<br>the thighs.<br>• BTL-899 FP is intended for<br>use with skin types I - VI. | Not<br>significantly<br>different |
| Basic Technology | The system combines bipolar<br>radiofrequency with<br>electromagnetic stimulation. | The system combines bipolar<br>radiofrequency with<br>electromagnetic stimulation. | None |
| Clinical Use | Prescription use | Prescription use | None |
| Electrical<br>Protection | Class II, BF | Class II, BF | None |
| User Interface | Touch screen | Touch screen | None |
| Firmware<br>Controlled | Yes | Yes | None |
| Number of output<br>channels | 2 | 2 | None |
| RF Type | bipolar | bipolar | None |
| Max. RF Power | 60 W (2x30 W) | 60 W (2x30 W) | None |
| RF Frequency | 27.12 Mhz | 27.12 Mhz | None |
| Number of<br>Magnetic coils in<br>the Applicators | 1 | 1 | None |
| Magnetic Field<br>Intensity (on the<br>coil surface) | AP-C-1 - 0.5 to 1.8 T<br>AP-C-2 - 0.7 to 2.0 T<br>AP-C-4/5 - 0.35 to 1.3 T | AP-C-1 - 0.5 to 1.8 T | Not significantly<br>different |
| Pulse Repetition<br>Rate - supported<br>by the device | 1 - 150 Hz | 1 – 150 Hz | None |
| Pulse Duration | AP-C-1 - 280 µs ± 20% µs<br>AP-C-2 - 190 µs ± 20% µs<br>AP-C-4/5 - 260 µs ± 20% µs | AP-C-1 - 280 µs ± 20% µs | Not significantly<br>different |
| Waveform | Biphasic | Biphasic | None |
| Shape | Sinusoidal | Sinusoidal | None |
| Temperature<br>Sensor | Yes | Yes | None |
| Selection of<br>parameters<br>(Intensity, Time) | Yes | Yes | None |
| Application | Hands-free, applicator fixed by<br>fixation belt | Hands-free, applicator fixed by<br>fixation belt | None |
| Therapy Time | Up to 30 min | Up to 30 min | None |
| Energy Source | 100 - 240 V AC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz | None |
| System<br>Dimensions<br>(W×H×D) | 23 x 39 x 29 in<br>(592 x 985 x 730 mm) | 23 x 39 x 29 in<br>(592 x 985 x 730 mm) | None |
| System Weight | 85 kg | 85 kg | None |
| Operating Ambient Temperature | +10°C to +30°C | +10°C to +30°C | None |
| Operating Relative Humidity | 30% to 75% | 30% to 75% | None |
| Environmental Specifications | For indoor use only | For indoor use only | None |

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Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected squares, with the letters "BTL" inside the leftmost square. To the right of the square logo is the text "BTL Industries" in a simple, sans-serif font. The logo and text are in a dark gray color.

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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, each nested inside the other, with the letters "BTL" in white inside the innermost 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.

## Substantial Equivalence

The BTL-899A device has expanded indications for use to include lipolysis of the arms, which is based on positive results from clinical testing.

The BTL-899A device has a new applicator, AP-C-4 and AP-C-5, which is technologically equivalent to the previously approved AP-C-1 but with an improved shape to cover a larger area of the abdomen.

The predicate device BTL-899FP (K211107) and the proposed device are with identical mechanisms of action and technoloqy.

The safety of the device has been evaluated and no new risks have been identified.

Therefore these differences do not raise any new questions of safety or effectiveness.

## Conclusion

Based upon the intended use and the known technical and clinical data provided in this pre-market notification, the BTL-899A device has been shown to be substantially equivalent to the currently marketed predicate device.