(59 days)
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.
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.
This document, primarily a 510(k) summary for the BTL-785BNF Handpiece, does not contain information about acceptance criteria for a device's performance in a clinical study, nor does it describe a study that explicitly proves the device meets specific acceptance criteria. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance metrics against pre-defined acceptance criteria from a clinical trial.
However, it does provide information about non-clinical testing performed to establish safety and compliance with relevant standards, which can be thought of as a form of "acceptance criteria" for safety.
Here's a breakdown of the requested information based on the provided text, noting where information is explicitly stated or absent:
-
A table of acceptance criteria and the reported device performance
- Not explicitly provided in the context of clinical performance. The document states, "A clinical study was not conducted."
- The document does list compliance with voluntary standards as a form of performance or acceptance criteria for safety. The reported device performance is that it "has been found to comply with applicable medical device safety standards."
Acceptance Criteria (Safety Standards) Reported Device Performance (Compliance) IEC 60601-1 (Basic safety & essential performance) Complies IEC 60601-1-2 (EMC) Complies IEC 60601-2-10 (Nerve & muscle stimulators) Complies IEC 60601-1-6 (Usability) Complies IEC 62304 (Software life cycle) Complies ISO 14971 (Risk management) Complies ISO 10993-1 (Biological evaluation) Complies ISO 10993-5 (In vitro cytotoxicity) Complies ISO 10993-10 (Irritation & sensitization) Complies -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document explicitly states, "A clinical study was not conducted." Therefore, there is no test set in the traditional sense of a clinical trial. The "test set" for substantiating safety and performance was the device itself subjected to non-clinical laboratory testing against international standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical study was conducted. The "ground truth" for the non-clinical tests would be the specifications and requirements of the referenced international safety standards. These do not involve human experts establishing ground truth in the context of interpreting clinical outcomes.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical study was conducted. Adjudication methods are typically relevant in clinical trials for resolving disagreements among readers or evaluators of clinical data.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This document is for a physical medical device (Transcutaneous Electrical Nerve Stimulator) and not an AI-assisted diagnostic or predictive device. Therefore, an MRMC study and AI assistance are not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm; it is a physical electrostimulation device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical safety and performance aspects, the "ground truth" would be the requirements and specifications outlined in the international consensus standards (e.g., IEC 60601-series, ISO 14971, ISO 10993-series). The device was tested to demonstrate compliance with these standards.
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The sample size for the training set
- Not applicable. No clinical study was conducted, and this is not an AI/algorithm-based device that would typically involve a "training set."
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How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/algorithm was used or established.
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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
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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
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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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510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +1-888-499-2502 |
|---|---|
| Applicant: | BTL Industries, Inc.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +1-888-499-2502 |
| Contact Person: | David ChmelBTL Industries, Inc.chmel@btlnet.com |
| Summary PreparationDate: | 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:
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| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety andessential performance |
|---|---|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safetyand essential performance - Collateral standard: Electromagnetic disturbances- Requirements and tests |
| IEC 60601-2-10 | Medical electrical equipment – Part 2-10: Particular requirements for the basicsafety and essential performance of nerve and muscle stimulators |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safetyand 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 withina 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 skinsensitization |
Clinical performance data
A clinical study was not conducted.
Comparison with the Predicate Device
| 510(k) number | K232172 | K191951 |
|---|---|---|
| Device nameCompany name | BTL-785BNF HandpieceBTL Industries, Inc. | Avazzia OTC TENS for Aesthetics,model BEST-AV1: EZZI-LIFTDevice Avazzia, Inc |
| Type | Subject device | Predicate device |
| Product Codeand Regulation | Neurology21 CFR 882.5890NFO– Stimulator, TranscutaneousElectrical, Aesthetic Purposes | Neurology21 CFR 882.5890NFO– Stimulator, TranscutaneousElectrical, 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 60601-1IEC 60601-1-2IEC 60601-2-10ISO 14971IEC 62366 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10ISO 14971IEC 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 power100-240V, 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, -9Max. 48,5V @ 10 - 373 Ω48,5V @ 500 Ω48,5V @ 2000 Ω0 @ 10 000 Ω | -42 @ 500 Ω-122 @ 2000 Ω-348 @ 10 000 Ω |
| BTL-785-1, -7Max. 48,5V @ 10 - 757 Ω48,5V @ 500 Ω48,5V @ 2000 Ω0 @ 10 000 Ω | ||
| BTL-785-2, -8, -9Max. 130 mA @ 10 - 373 Ohm | ||
| Max output current(+/-20%)- at 500 Ω- at 2,000 Ω- at 10,000 Ω | 97 mA @ 500 Ω24 mA @ 2000 Ω0 mA @ 10000 Ω | |
| BTL-785-1, -7Max. 64 mA @ 10 - 757 Ω64 mA @ 500 Ω24 mA @ 2000 Ω0 mA @ 10000 Ω | ||
| Max current density at500 Ω [μA/mm²] | BTL-785-2 - 243 μA/mm²BTL-785-8 - 335 μA/mm²BTL-785-9 - 277 μA/mm²BTL-785-1 - 168 μA/mm²BTL-785-7 - 337 μA/mm² | Built-in, Y,Brush: 800 μA/mm²Pencil: 19,000 μA/mm² |
| Max average powerdensity at 500 Ω[μW/mm²] | BTL-785-2 - 0,047 W/cm²BTL-785-8 - 0,065 W/cm²BTL-785-9 - 0,054 W/cm²BTL-785-1 - 0,033 W/cm²BTL-785-7 - 0,065 W/cm² | Built-in, Y,Brush: 500 μW/mm²Pencil: 3,500 μW/mm² |
| Net Charge per pulse | Zero (pulse is biphasic symmetrical) | 4 μC |
| Max phase charge perpulse at 500 Ω [μC] | BTL-785-2, -8, -915 μCBTL-785-1, -710 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) electroconductivemedia | Conductive hydrogel | n/a |
| (c) electrode-to-skinimpedance range | 10-5000 Ohm | less than 15 |
| (d) max duration ofuse (same as deviceshut off) | 20 min | 60 min |
| (e) conductivesurface area | BTL-785-1 - 3.8 cm²BTL-785-2 - 4 cm²BTL-785-7 - 1.9 cm²BTL-785-8 - 2.9 cm²BTL-785-9 - 3.5 cm² | built in rectangular - 1.94 cm²spherical - 5.60 cm²brush/comb - 0.56 cm²small circular,pencil-like - 0.023 cm² |
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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.
§ 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).