(109 days)
Not Found
No
The summary describes a standard electrostimulation device with a user interface for setting parameters. There is no mention of AI, ML, or any features that suggest adaptive learning or data-driven decision making beyond user input. The performance studies focus on electrical safety and standards compliance, not algorithmic performance.
No.
The device is indicated for aesthetic use, specifically for skin stimulation, and the description explicitly refers to the application of "therapy by electrical stimulation". Therefore, it is a therapeutic device.
No
The device is described as an "electrostimulation device" for "aesthetic use including facial and neck or body skin stimulation." Its purpose is to deliver therapy, not to diagnose a condition.
No
The device description explicitly lists hardware components such as a main control unit, handpiece, electrodes, holding arm, connection cables, and a therapy discomfort button. This indicates it is a physical device with software control, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aesthetic use including facial and neck or body skin stimulation." This describes a therapeutic or aesthetic application directly on the body, not the examination of specimens taken from the body.
- Device Description: The description details an "electrostimulation device" that applies electrical stimulation to the patient's skin. This is a physical interaction with the body, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
In vitro diagnostics are tests performed on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is entirely external and therapeutic/aesthetic.
N/A
Intended Use / 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.
Product codes
NFO
Device 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial and neck or body skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 essential performance
- IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances – Requirements and tests
- IEC 60601-2-10 Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety 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 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 sensitization
Clinical performance data: A clinical study was not conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary K242532
General Information
| Sponsor: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | David Chmel
BTL Industries, Inc.
chmel@btlnet.com |
| Summary Preparation
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 |
5
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
6
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
essential performance |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic disturbances
– Requirements and tests |
| IEC 60601-2-10 | Medical electrical equipment – Part 2-10: Particular requirements for the basic
safety and essential performance of nerve and muscle stimulators |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements for basic safety
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
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
sensitization |
Clinical performance data
A clinical study was not conducted.
7
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 | ||
| and Regulation | Neurology | |
| 21 CFR 882.5890 | ||
| NFO - Stimulator, Transcutaneous | ||
| Electrical, Aesthetic Purposes | Neurology | |
| 21 CFR 882.5890 | ||
| NFO - Stimulator, Transcutaneous | ||
| Electrical, Aesthetic Purposes | ||
| Clinical use | Rx Only | Rx Only |
| Indications for | ||
| Use | The device is indicated for aesthetic use | |
| including facial and neck or body skin | ||
| stimulation. | The device is indicated for aesthetic use | |
| including facial and neck or body skin | ||
| stimulation. | ||
| Anatomic Sites | Face, neck, and body | Face, neck, and body |
| Compliance with | ||
| Voluntary | ||
| Standards | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-2-10 | ||
| ISO 14971 | ||
| IEC 62366 | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-2-10 | ||
| ISO 14971 | ||
| IEC 62366 | ||
| Handpiece Weight | 2500 g | 2500 g |
| Handpiece | ||
| Dimensions | ||
| [W x H x D] | 38.98" x 53.94" x 34.65" | 38.98" x 53.94" x 34.65" |
| Housing Materials | ||
| and Construction | PCBs and leads inside plastic, or foam | |
| case housing | PCBs and leads inside plastic, or foam | |
| case housing | ||
| User Interface | ||
| Display | Yes on the main controll unit. | Yes on the main controll unit. |
| Energy type | Electric stimulation | Electric stimulation |
| Power source | Mains power | |
| 100-240V, 50-60 Hz | Mains power | |
| 100-240V, 50-60 Hz | ||
| Waveform Shape | Biphasic rectangular pulse modulated by | |
| trapezoidal | Biphasic rectangular pulse modulated by | |
| trapezoidal |
8
| 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 | ||
| voltage [V] | ||
| (+/-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 | ||
| current | ||
| (+/-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 |
9
| Max current
density at 500 Ω
| [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 | ||
| power | ||
| density at 500 Ω | ||
| [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 | ||
| pulse | Zero (pulse is biphasic symmetrical) | Zero (pulse is biphasic symmetrical) |
| Max phase charge | ||
| per pulse at 500 Ω | ||
| [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 | ||
| 5 µC | ||
| Duration of | ||
| primary [µs] | ||
| (depolarizing | ||
| phase) | 80 µs | 80 µs |
| Pulse Duration | ||
| [µs] | 160 µs | 160 µs |
10
| (a) Electrodes
| materials | Conductive ink (Silver) | Conductive ink (Silver) |
|---|---|---|
| (b) | ||
| electroconductive | ||
| media | Conductive hydrogel | Conductive hydrogel |
| (c) electrode-to- | ||
| skin impedance | ||
| range | 10-5000 Ohm | 10-5000 Ohm |
| (d) max duration | ||
| of use | 20 min | 20 min |
| (e) conductive | ||
| surface area | BTL-785-7-1 - 3.8 cm² | |
| BTL-785-7-2 - 4 cm² | ||
| BTL-785-7-7 - 1.9 cm² | ||
| BTL-785-7-8 - 2.9 cm² | ||
| BTL-785-7-9 - 3.5 cm² | ||
| BTL-785-7-11 - 1.8 cm² | BTL-785-7-1 - 3.8 cm² | |
| BTL-785-7-2 - 4 cm² | ||
| BTL-785-7-7 - 1.9 cm² | ||
| BTL-785-7-8 - 2.9 cm² | ||
| 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.