(59 days)
Not Found
No
The description focuses on electrostimulation and electromagnetic fields, with no mention of AI or ML capabilities. The control unit facilitates user interaction and parameter setting, not autonomous decision-making or learning.
No.
The intended use explicitly states "aesthetic use" and "facial and neck stimulation or body skin stimulation," rather than treating or preventing a disease or condition. While the device description mentions "therapy" and "therapeutic parameters," the indication for use specifies an aesthetic purpose, which is not a therapeutic use in the medical sense.
No
The device is indicated for aesthetic use and neuro-muscle stimulation through an electromagnetic field, not for identifying or diagnosing a medical condition.
No
The device description clearly outlines physical hardware components such as a handpiece, electrodes, holding arm, connection cables, and a discomfort button, indicating it is a physical medical device with software control, not a software-only device.
Based on the provided information, the BTL-785BNF Handpiece device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The stated intended use is for "aesthetic use including facial and neck stimulation or body skin stimulation." This describes a therapeutic or aesthetic application directly on the human body, not the examination of specimens derived from the human body.
- Device Description: The description details an electrostimulation device that applies an electromagnetic field to interact with tissues for neuro-muscle stimulation and provides a low degree of warming. This is a physical therapy or aesthetic treatment device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device interacts directly with the patient's body.
IVD devices are specifically designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The BTL-785BNF Handpiece does not fit this definition.
N/A
Intended Use / Indications for Use
The BTL-785BNF Handpiece 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 Handpiece is a state-of-the-art electrostimulation device that enables the application of therapy by an electromagnetic field.
The subjected device is intended to be used together with a main control unit that is equipped with a large color touch screen that significantly 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 easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The BTL-785BNF Handpiece is a specially developed device that can be used with the applicators and the main control unit. The generated electromagnetic field is interact with the tissues of the human body in order to achieve neuro-muscle stimulation. The radiofrequency is providing a low degree of warming to enhance the patient's comfort during the treatment.
The BTL-785BNF Handpiece consists of the following main components:
- BTL-785BNF 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
A clinical study was not conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The seal features a stylized depiction of a human figure, while the text is in a clear, sans-serif font, with "FDA" in a blue square.
September 18, 2023
BTL Industries Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K232172
Trade/Device Name: BTL-785BNF Handpiece Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NFO Dated: July 3, 2023 Received: July 21, 2023
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.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tushar Bansal -S
for 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 Ouality Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K232172
Device Name BTL-785BNF Handpiece
Indications for Use (Describe)
The BTL-785BNF Handpiece device has the following indications for use:
The device is indicated for aesthetic use including facial and neck stimulation 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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3
510(k) Summary
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: | June 23, 2023 |
Device
| Trade/Proprietary Name: | BTL-785BNF Handpiece |
|---|---|
| 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 Handpiece is a state-of-the-art device with accessories intended for electrostimulation therapy, and is substantially equivalent to the following products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers:
- Avazzia OTC TENS for Aesthetics, model BEST-AV1: EZZI-LIFT Device ( K191951) ●
Product Description
The BTL-785BNF Handpiece is a state-of-the-art electrostimulation device that enables the application of therapy by an electromagnetic field.
The subjected device is intended to be used together with a main control unit that is equipped with a large color touch screen that significantly 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 easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The BTL-785BNF Handpiece is a specially developed device that can be used with the applicators and the main control unit. The generated electromagnetic field is interact with the tissues of the human body in order to achieve neuro-muscle stimulation. The radiofrequency is providing a low degree of warming to enhance the patient's comfort during the treatment.
The BTL-785BNF Handpiece consists of the following main components:
- BTL-785BNF Handpiece
- · Single-use application electrodes
- Holding arm
- · Connection cables
- Therapy discomfort button
Indications for Use
The BTL-785BNF Handpiece 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 Handpiece device has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards:
5
| 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.
Comparison with the Predicate Device
| 510(k) number | K232172 | K191951 |
|---|---|---|
| Device name | ||
| Company name | BTL-785BNF Handpiece | |
| BTL Industries, Inc. | Avazzia OTC TENS for Aesthetics, | |
| model BEST-AV1: EZZI-LIFT | ||
| Device Avazzia, 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 |
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| Indications for Use | The device is indicated for aesthetic use including facial and neck or body skin stimulation. | Device is indicated for over-the counter aesthetic use including facial and neck stimulation or body skin stimulation. |
|---|---|---|
| Anatomic Sites | Face, neck, and body | Face, neck, and body |
| Number of Output Modes | 1 | 4 |
| Low Battery Indicator | N/A | Yes |
| Automatic shut off | N/A | 60 min |
| 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 | ||
| Compliance with 21 CFR 898 | Yes | Yes |
| Weight | 2500 g | 150 g |
| Dimensions [W x H x D] inches | 38.98" x 53.94" x 34.65" | 2.6" X 4.7" X 1.35" |
| Housing Materials and Construction | PCBs and leads inside plastic, or foam case housing | PCBs inside plastic case housing |
| User Interface Display | Yes on the main controll unit. | LEDs and switches |
| Energy type | Electric stimulation | Electric stimulation |
| Additional energy | RF warming | N/A |
| Number, Size, and Type of Batteries | Mains power | |
| 100-240V, 50-60 Hz | Two 1.5 V AA batteries | |
| Waveform Shape | Biphasic rectangular pulse modulated by trapezoidal | positive square wave followed by a damped sinusoidal waveform of variable duration depending on damping and body loading |
| Max output voltage [V] (+/-20%) |
- at 500 Ω
- at 2,000 Ω
- at 10,000 Ω | BTL-785-2, -8, -9
Max. 48,5V @ 10 - 373 Ω
48,5V @ 500 Ω
48,5V @ 2000 Ω
0 @ 10 000 Ω | -42 @ 500 Ω
-122 @ 2000 Ω
-348 @ 10 000 Ω |
| | BTL-785-1, -7
Max. 48,5V @ 10 - 757 Ω
48,5V @ 500 Ω
48,5V @ 2000 Ω
0 @ 10 000 Ω | |
| | BTL-785-2, -8, -9
Max. 130 mA @ 10 - 373 Ohm | |
| | Max output current
(+/-20%)
- at 500 Ω
- at 2,000 Ω
- at 10,000 Ω | 97 mA @ 500 Ω
24 mA @ 2000 Ω
0 mA @ 10000 Ω |
| | | BTL-785-1, -7
Max. 64 mA @ 10 - 757 Ω
64 mA @ 500 Ω
24 mA @ 2000 Ω
0 mA @ 10000 Ω |
| | | |
| Max current density at
500 Ω [μA/mm²] | BTL-785-2 - 243 μA/mm²
BTL-785-8 - 335 μA/mm²
BTL-785-9 - 277 μA/mm²
BTL-785-1 - 168 μA/mm²
BTL-785-7 - 337 μA/mm² | Built-in, Y,
Brush: 800 μA/mm²
Pencil: 19,000 μA/mm² |
| | | |
| Max average power
density at 500 Ω
[μW/mm²] | BTL-785-2 - 0,047 W/cm²
BTL-785-8 - 0,065 W/cm²
BTL-785-9 - 0,054 W/cm²
BTL-785-1 - 0,033 W/cm²
BTL-785-7 - 0,065 W/cm² | Built-in, Y,
Brush: 500 μW/mm²
Pencil: 3,500 μW/mm² |
| | | |
| Net Charge per pulse | Zero (pulse is biphasic symmetrical) | 4 μC |
| Max phase charge per
pulse at 500 Ω [μC] | BTL-785-2, -8, -9
15 μC
BTL-785-1, -7
10 μC | 10 μC |
| | 10 μC | |
| Duration of primary
[μs]
(depolarizing phase) | 80 μs | 500 μs |
| Pulse Duration [μs] | 160 μs | 1 100 μs |
| Frequency [Hz] | 250 | 15 to 121 |
| Electrodes
(a) materials | Conductive ink (Silver) | Stainless steel 316 |
| | | |
| (b) electroconductive
media | Conductive hydrogel | n/a |
| | | |
| (c) electrode-to-skin
impedance range | 10-5000 Ohm | less than 15 |
| | | |
| (d) max duration of
use (same as device
shut off) | 20 min | 60 min |
| (e) conductive
surface area | BTL-785-1 - 3.8 cm²
BTL-785-2 - 4 cm²
BTL-785-7 - 1.9 cm²
BTL-785-8 - 2.9 cm²
BTL-785-9 - 3.5 cm² | built in rectangular - 1.94 cm²
spherical - 5.60 cm²
brush/comb - 0.56 cm²
small circular,
pencil-like - 0.023 cm² |
7
8
Substantial Equivalence
The BTL-785BNF Handpiece device has equivalent technological characteristics and similar intended use compared to the predicate device.
The predicate device utilizes electric stimulation in order to achieve therapeutic effect. The subjected device BTL-785BNF Handpiece also utilizes electromagnetic stimulation for its main therapeutic effect; however, the device is also equipped with a monopolar radiofrequency generator. The RF warms the patient at the application site to increase patient convenience during therapy.
Any differences between the predicate devices and BTL-785BNF Handpiece have no significant influence on safety or effectiveness of the BTL-785BNF Handpiece.
Therefore, the BTL-785BNF Handpiece 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 Handpiece device has been shown to be substantially equivalent to the currently cleared predicate device and secondary predicate device for requested intended use.