BTL-899F

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 21, 2023 BTL Industries Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752 Re: K230467 Trade/Device Name: BTL-899F Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: August 17, 2023 Received: August 23, 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. 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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 {1}------------------------------------------------ 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 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). Sincerely, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.09.21 13:17:11 -04'00' Mark Trumbore, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230467 Device Name BTL-899F Indications for Use (Describe) BTL-899F 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-899F is intended for use with skin types I VI. - · Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I IV. - · 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) | | | | |-------------------------------------------------|------------------------------------------------------------------|--|--| | | and the control control control of the control of the control of | | | > Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The text "K230467" is located in the upper left corner of the image. # 510(k) Summary #### General Information | Sponsor: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: +1-866-285-1656<br>Fax: +1-888-499-2502 | |-----------------------------|-----------------------------------------------------------------------------------------------------------------| | Applicant: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: +1-866-285-1656<br>Fax: +1-888-499-2502 | | Contact Person: | David Chmel<br>BTL Industries, Inc.<br>chmel@btlnet.com | | Summary Preparation<br>Date | September 20, 2023 | #### Device Name | Trade/Proprietary Name: | BTL-899F | |------------------------------|-------------------------------------------------------------| | Primary Classification Name: | Electrosurgical, Cutting & Coagulation Device & Accessories | | Classification Regulation: | 878.4400, Class II | | Classification Product Code: | GEI | #### Legally Marketed Predicate Device The BTL-899F 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-899A (K213344) . {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of three blue squares that are nested inside of each other. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font. ## Product Description The BTL-899F is a non-invasive therapeutic device. BTL-899F 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-899F 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-899F is intended for use with skin types I - VI. - Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I - IV. - Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and ● BMI 30 and under. ## Non-clinical Testing (Performance, Bench Testing) The BTL-899F 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 | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of three blue squares that are nested inside each other. The letters "BTL" are written inside the innermost square. To the right of the squares, the words "BTL Industries" are written in gray. # Clinical Testing A clinical investigation has been conducted in order to study the effect of the device for non-invasive lipolysis on human flanks. The primary objective of the study was to gather clinical evidence that the BTL-899 device, equipped with applicators 899-AP-C-4 & 899-AP-C-5, is capable of inducing non-invasive lipolysis on human flanks. A mean population reduction of flanks' fat thickness pre- vs 3-months post-treatment had to be observed. 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 flanks as well as to assess the participants' satisfaction and level of comfort. A minimum 75% of the subjects' pre-treatment and 3-month follow-up post-treatment images had to be correctly identified by at least two of three independent blinded evaluators. The clinical investigation used a single-arm, open-label, interventional design. Fifty-five (55) subjects were enrolled to the study. Fifty-one (51) participants attended the final 3-month follow-up. A mean population reduction of flanks' fat thickness pre- vs 3 months post-treatment was observed and the results showed 5 mm reduction in the mean fat thickness. The primary endpoint was met. - The average fat thickness reduction measured by the ultrasound was 5 mm The secondary endpoints were met. - The procedure with the device for non-invasive lipolysis of flanks was considered as safe. Only one anticipated side effect of the procedure was observed in one patient: A participant reported mild erythema lasting 1 hour after the second procedure that resolved itself without medical intervention. Erythema is an expected and declared side effect in the operator's manual due to the nature of the technology used for the procedure. - All three independent blinded evaluators identified pre-treatment and 3-month follow-up images ● with more than 75% accuracy. The rate of successful recognition of the subject's pre-/post treatment photographs was 88.2%. - . The procedure was found comfortable and virtually painless. All the participants in the trial agreed or strongly agreed with the procedures being comfortable. All the participants were satisfied or very satisfied with the procedure at the 3-month follow-up. All the participants reported improved, much improved, or very much improved appearance of the flanks area at the 3-month follow-up. {6}------------------------------------------------ Image /page/6/Picture/1 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 logo is the text "BTL Industries" in a gray, sans-serif font. ## Technological Characteristics The BTL-899F device has the same intended use and identical technological characteristics and principles of operation to its predicate device. The BTL-899F 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. The mechanism of action and technological similarities and differences between the BTL-899F 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 | | Predicate device | Subject device | |-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number<br>Device name | K213344<br>BTL-899A | K230467<br>BTL-899F | | 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 | | 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<br>(breakdown of fat) of the upper<br>arms limited to skin types II<br>and III and BMI 30 and under | BTL-899F is indicated to be<br>used for:<br>• Non-invasive lipolysis<br>(breakdown of fat) of the<br>abdomen.<br>• Reduction in<br>circumference of the<br>abdomen.<br>• Non-invasive lipolysis<br>(breakdown of fat) of the<br>thighs.<br>• Reduction in<br>circumference of the<br>thighs.<br>• BTL-899F is intended for<br>use with skin types I – VI.<br>• Non-invasive lipolysis<br>(breakdown of fat) of the<br>flanks limited to skin types<br>I - IV.<br>• Non-invasive lipolysis<br>(breakdown of fat) of the<br>upper arms limited to skin | | | | types II and III and BMI 30<br>and under | | Basic Technology | The system combines bipolar<br>radiofrequency with<br>electromagnetic stimulation. | The system combines bipolar<br>radiofrequency with<br>electromagnetic stimulation. | | Clinical Use | Prescription use | Prescription use | | Electrical<br>Protection | Class II, BF | Class II, BF | | User Interface | Touch screen | Touch screen | | Firmware<br>Controlled | Yes | Yes | | Number of output<br>channels | 2 | 2 | | RF Type | bipolar | bipolar | | Max. RF Power | 60 W (2x30 W) | 60 W (2x30 W) | | RF Frequency | 27.12 Mhz | 27.12 Mhz | | Number of<br>Magnetic coils in<br>the Applicators | 1 | 1 | | 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<br>AP-C-2 - 0.7 to 2.0 T<br>AP-C-4/5 - 0.35 to 1.3 T | | Pulse Repetition<br>Rate - supported<br>by the device | 1 – 150 Hz | 1 – 150 Hz | | 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<br>AP-C-2 - 190 μs ± 20% μs<br>AP-C-4/5 - 260 μs ± 20% μs | | Waveform | Biphasic | Biphasic | | Shape | Sinusoidal | Sinusoidal | | | | | | Temperature<br>Sensor | Yes | Yes | | Selection of<br>parameters<br>(Intensity, Time) | Yes | Yes | | Application | Hands-free, applicator fixed by<br>fixation belt | Hands-free, applicator fixed by<br>fixation belt | | Therapy Time | Up to 30 min | Up to 30 min | | Energy Source | 100 - 240 V AC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz | | 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) | | System Weight | 85 kg | 85 kg | | Operating Ambient<br>Temperature | +10°C to +30°C | +10°C to +30°C | | Operating Relative<br>Humidity | 30% to 75% | 30% to 75% | | Environmental<br>Specifications | For indoor use only | For indoor use only | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric design on the left and the text "BTL Industries" on the right. The geometric design appears to be three interlocking squares with the letters "BTL" inside. {8}------------------------------------------------ trics #### Substantial Equivalence The BTL-899F device has expanded indications for use based on positive results from clinical testing. The predicate device BTL-899A (K213344) and the proposed device have identical mechanisms of action and technology. The safety of the device has been evaluated and no new risks have been identified. Therefore these differences do not raise any 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-899F device has been shown to be substantially equivalent to the currently marketed predicate device.