BTL-785BNF-E

K242532 · BTL Industries, Inc. · NFO · Dec 13, 2024 · Neurology

Device Facts

• Record ID: K242532
• Device Name: BTL-785BNF-E
• Applicant: BTL Industries, Inc.
• Product Code: NFO · Neurology
• Decision Date: Dec 13, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is indicated for aesthetic use including facial and neck or body skin stimulation.

Device Story

BTL-785BNF-E is an electrostimulation device for aesthetic skin stimulation on face, neck, and body. System comprises main control unit with color touch screen, handpiece, single-use application electrodes, holding arm, connection cables, and therapy discomfort button. User interface guides therapy procedure; parameters set via touch screen. Device delivers biphasic rectangular electrical pulses modulated by trapezoidal waveform to skin tissues. Used in clinical settings by trained operators. Output provides electrical stimulation to achieve skin stimulation; therapy duration typically 20 minutes. Benefits include non-invasive aesthetic skin stimulation. New BTL-785-7-11 applicator introduced for improved fit on upper cheek and periocular region.

Clinical Evidence

No clinical data. Bench testing only. Device evaluated for electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10), usability (IEC 60601-1-6), software lifecycle (IEC 62304), risk management (ISO 14971), and biocompatibility (ISO 10993-1, -5, -10).

Technological Characteristics

Electrostimulation device; mains powered (100-240V). Biphasic symmetrical rectangular pulse waveform. Electrodes use conductive silver ink with hydrogel. Electrode-to-skin impedance range 10-5000 Ohm. Compliance with IEC 60601-1, 60601-1-2, 60601-2-10, 60601-1-6, ISO 14971, ISO 10993. Software lifecycle per IEC 62304.

Indications for Use

Indicated for aesthetic use including facial, neck, or body skin stimulation in patients seeking cosmetic treatment.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• BTL-785BNF Handpiece (K233604)

Submission Summary (Full Text)

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December 13, 2024

BTL Industries, Inc. David Chmel CEO North America 362 Elm Street Marlborough, Massachusetts 01752

Re: K242532

Trade/Device Name: BTL-785BNF-E Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: November 20, 2024 Received: November 20, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Heather L. Dean -S

Heather Dean, PhD

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

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#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242532

Device Name

BTL-785BNF-E

Indications for Use (Describe)

The BTL-785BNF-E device has the following indications for use: The device is indicated for aesthetic use including facial and neck or body skin stimulation. 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 K242532

# 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: | November 20, 2024 |

## Device

| Trade/Proprietary Name: | BTL-785BNF-E |
|------------------------------|------------------------------------------------------------|
| Primary Classification Name: | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Classification Regulation: | 21 CFR 882.5890, Class II |
| Classification Product Code: | NFO |

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#### Legally Marketed Predicate Device

The BTL-785BNF-E is a state-of-the-art device with accessories intended for electrostimulation therapy and RF warming, and is substantially equivalent to the following product that is already cleared for distribution in the USA under the following 510(k) Premarket Notification number:

- BTL-785BNF Handpiece (K233604) ●
#### Product Description

The BTL-785BNF-E is a state-of-the-art electrostimulation device that enables the application of therapy by electrical stimulation to patient's skin for aesthetic use.

The main control unit is equipped with a large color touch screen that 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 set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, the remaining therapy time and the main therapy parameters on the screen.

The generated electrical stimulation is intenact with the tissues of the human body in order to achieve skin stimulation in the face.

The device consists of the following main components:

- · BTL-785 main unit
- BTL-785-7 Handpiece
- Single-use application electrodes
- Holding arm
- · Connection cables
- Therapy discomfort button

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#### Indications for Use

The BTL-785BNF-E device has the following indications for use:

The device is indicated for aesthetic use including facial and neck or body skin stimulation.

#### Non-clinical Testing (Performance Data)

The BTL-785BNF-E device has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards:

| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for basic safety and<br>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 60601-2-10 | Medical electrical equipment – Part 2-10: Particular requirements for the basic<br>safety and essential performance of nerve and muscle stimulators |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements for basic safety<br>and essential performance - Collateral standard: Usability |
| 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 |

#### Clinical performance data

A clinical study was not conducted.

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## Comparison with the Predicate Device

| 510(k) number | Not assigned | K232172 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Device name | BTL-785BNF-E | BTL-785BNF Handpiece |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Type | Subject device | Predicate device |
| Product Code<br>and Regulation | Neurology<br>21 CFR 882.5890<br>NFO - Stimulator, Transcutaneous<br>Electrical, Aesthetic Purposes | Neurology<br>21 CFR 882.5890<br>NFO - Stimulator, Transcutaneous<br>Electrical, Aesthetic Purposes |
| Clinical use | Rx Only | Rx Only |
| Indications for<br>Use | The device is indicated for aesthetic use<br>including facial and neck or body skin<br>stimulation. | The device is indicated for aesthetic use<br>including facial and neck or body skin<br>stimulation. |
| Anatomic Sites | Face, neck, and body | Face, neck, and body |
| Compliance with<br>Voluntary<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>ISO 14971<br>IEC 62366 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>ISO 14971<br>IEC 62366 |
| Handpiece Weight | 2500 g | 2500 g |
| Handpiece<br>Dimensions<br>[W x H x D] | 38.98" x 53.94" x 34.65" | 38.98" x 53.94" x 34.65" |
| Housing Materials<br>and Construction | PCBs and leads inside plastic, or foam<br>case housing | PCBs and leads inside plastic, or foam<br>case housing |
| User Interface<br>Display | Yes on the main controll unit. | Yes on the main controll unit. |
| Energy type | Electric stimulation | Electric stimulation |
| Power source | Mains power<br>100-240V, 50-60 Hz | Mains power<br>100-240V, 50-60 Hz |
| Waveform Shape | Biphasic rectangular pulse modulated by<br>trapezoidal | Biphasic rectangular pulse modulated by<br>trapezoidal |

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| | BTL-785-7-2, -8, -9 | BTL-785-7-2, -8, -9 |
|---------------------------------------|----------------------------|----------------------------|
| | 48,5V @ 500 Ω | 48,5V @ 500 Ω |
| | 48,5V @ 2000 Ω | 48,5V @ 2000 Ω |
| | 0 @ 10 000 Ω | 0 @ 10 000 Ω |
| Max output<br>voltage [V]<br>(+/-20%) | | |
| - at 500 Ω | BTL-785-7-1, -7 | BTL-785-7-1, -7 |
| - at 2,000 Ω | 48,5V @ 500 Ω | 48,5V @ 500 Ω |
| - at 10,000 Ω | 48,5V @ 2000 Ω | 48,5V @ 2000 Ω |
| | 0 @ 10 000 Ω | 0 @ 10 000 Ω |
| | BTL-785-7-11 | |
| | 48,5V @ 500 Ω | |
| | 48,5V @ 2000 Ω | |
| | 0 @ 10 000 Ω | |
| | | |
| | BTL-785-7-2, -8, -9 | BTL-785-7-2, -8, -9 |
| | Max. 130 mA @ 10 - 373 Ohm | Max. 130 mA @ 10 - 373 Ohm |
| | 97 mA @ 500 Ω | 97 mA @ 500 Ω |
| | 24 mA @ 2000 Ω | 24 mA @ 2000 Ω |
| Max output<br>current<br>(+/-20%) | 0 mA @ 10000 Ω | 0 mA @ 10000 Ω |
| - at 500 Ω | BTL-785-7-1, -7 | BTL-785-7-1, -7 |
| | Max. 64 mA @ 10 - 757 Ω | Max. 64 mA @ 10 - 757 Ω |
| - at 2,000 Ω | 64 mA @ 500 Ω | 64 mA @ 500 Ω |
| | 24 mA @ 2000 Ω | 24 mA @ 2000 Ω |
| - at 10,000 Ω | 0 mA @ 10000 Ω | 0 mA @ 10000 Ω |
| | BTL-785-7-11 | |
| | Max. 30 mA @ 10 - 1900 Ω | |
| | 30 mA @ 500 Ω | |
| | 26 mA @ 2000 Ω | |
| | 0 mA @ 10000 Ω | |

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| Max current<br>density at 500 Ω<br>[µA/mm²] | BTL-785-7-2 – 243 µA/mm² | BTL-785-7-2 – 243 µA/mm² |
|--------------------------------------------------------|--------------------------------------|--------------------------------------|
| | BTL-785-7-8 – 335 µA/mm² | BTL-785-7-8 – 335 µA/mm² |
| | BTL-785-7-9 – 277 µA/mm² | BTL-785-7-9 – 277 µA/mm² |
| | BTL-785-7-1 – 168 µA/mm² | BTL-785-7-1 – 168 µA/mm² |
| | BTL-785-7-7 – 337 µA/mm² | BTL-785-7-7 – 337 µA/mm² |
| | BTL-785-7-11 – 164 µA/mm² | |
| Max average<br>power<br>density at 500 Ω<br>[W/cm²] | BTL-785-7-2 – 0,047 W/cm² | BTL-785-7-2 – 0,047 W/cm² |
| | BTL-785-7-8 – 0,065 W/cm² | BTL-785-7-8 – 0,065 W/cm² |
| | BTL-785-7-9 – 0,054 W/cm² | BTL-785-7-9 – 0,054 W/cm² |
| | BTL-785-7-1 – 0,033 W/cm² | BTL-785-7-1 – 0,033 W/cm² |
| | BTL-785-7-7 – 0,065 W/cm² | BTL-785-7-7 – 0,065 W/cm² |
| | BTL-785-7-11 – 0,032 W/cm² | |
| Net Charge per<br>pulse | Zero (pulse is biphasic symmetrical) | Zero (pulse is biphasic symmetrical) |
| Max phase charge<br>per pulse at 500 Ω<br>[µC] | BTL-785-7-2, -8, -9 | BTL-785-7-2, -8, -9 |
| | 15 µC | 15 µC |
| | BTL-785-7-1, -7 | BTL-785-7-1, -7 |
| | 10 µC | 10 µC |
| | BTL-785-7-11<br>5 µC | |
| Duration of<br>primary [µs]<br>(depolarizing<br>phase) | 80 µs | 80 µs |
| Pulse Duration<br>[µs] | 160 µs | 160 µs |

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| (a) Electrodes<br>materials | Conductive ink (Silver) | Conductive ink (Silver) |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| (b)<br>electroconductive<br>media | Conductive hydrogel | Conductive hydrogel |
| (c) electrode-to-<br>skin impedance<br>range | 10-5000 Ohm | 10-5000 Ohm |
| (d) max duration<br>of use | 20 min | 20 min |
| (e) conductive<br>surface area | BTL-785-7-1 - 3.8 cm²<br>BTL-785-7-2 - 4 cm²<br>BTL-785-7-7 - 1.9 cm²<br>BTL-785-7-8 - 2.9 cm²<br>BTL-785-7-9 - 3.5 cm²<br>BTL-785-7-11 - 1.8 cm² | BTL-785-7-1 - 3.8 cm²<br>BTL-785-7-2 - 4 cm²<br>BTL-785-7-7 - 1.9 cm²<br>BTL-785-7-8 - 2.9 cm²<br>BTL-785-7-9 - 3.5 cm² |

#### Substantial Equivalence

The difference between the subject device and the predicate device (K232172) is the introduction of a new disposable applicator, the BTL-785-7-11. This applicator features a shape specifically designed to better fit the treatment area - the upper cheek and the periocular region outside the orbital rim. Otherwise, it remains substantially equivalent to the applicators previously cleared for the predicate device (K232172) in terms of materials used, manufacturing processes, technology used, method of use, and intended purpose.

The BTL-785BNF-E device has the same technological characteristics and intended use compared to the predicate device. Differences between the predicate device and the BTL-785BNF-E have no significant influence on safety or effectiveness of the BTL-785BNF-E device.

Therefore, the BTL-785BNF-E device is substantially equivalent to the predicate device.

#### Conclusion

Based upon the intended use, comparison of technical characteristics and performance testing provided in this premarket notification, the BTL-785BNF-E device has been shown to be substantially equivalent to the currently cleared predicate device for requested intended use.