TR-100

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 13, 2016 BTL Industries, Inc. Mr. Jan Zarsky Director 47 Loring Drive Framingham, Massachusetts 01702 Re: K161551 Trade/Device Name: TR-100 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Dated: August 31, 2016 Received: September 1, 2016 Dear Mr. Zarsky: 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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth {1}------------------------------------------------ in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Christopher J. Ronk -S Fox Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) n/a K161551 Device Name TR-100 Indications for Use (Describe) The TR-100 device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The TR-100 massage device is intended to provide a temporary reduction in the appearance of cellulite. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | 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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo with three interconnected blue diamonds. The letters "B", "T", and "L" are placed inside each of the diamonds, respectively. The logo has a clean and modern design. # Section 5 - 510(k) Summary ## General Information | Sponsor: | BTL Industries, Inc.<br>47 Loring Drive<br>Framingham, MA 01702<br>Tel: +1-866-285-1656<br>Fax: +1-888-499-2502 | |------------|-----------------------------------------------------------------------------------------------------------------| | Applicant: | BTL Industries, Inc.<br>47 Loring Drive<br>Framingham, MA 01702<br>Tel: +1-866-285-1656<br>Fax: +1-888-499-2502 | | Contact Person: | Jan Zarsky | |-----------------|--------------------------------------------------------------------| | | BTL Industries, Inc. | | | Executive VP | | | <span style="text-decoration: underline;">zarsky@btlnet.com</span> | | Summary Preparation | | |---------------------|-------------| | Date: | 09 May 2016 | ### Device Names | Trade/Proprietary Name: | TR-100 | |------------------------------|---------------------------------------------------------| | Primary Classification Name: | Electrosurgical cutting and coagulation and accessories | | Common Name: | Combined high frequency and pulsed massager | | Classification Regulation: | 878.4400 | | Product Code: | PBX | ## Legally Marketed Predicate Devices The TR-100 is substantially equivalent to the current product that is already cleared for USA distribution under the following 510(k) Premarket Notification number: - . Exilis XP (K143040). {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with three interconnected blue diamonds. The letters "B", "T", and "L" are placed inside each of the diamonds, respectively. The logo has a clean and modern design. ## Product Description The TR-100 is a state-of-the-art radiofrequency device with integrated massager, that enables the application of therapy by a non-invasive, high-frequency field. The control unit of the system is fitted with a color touch screen, to facilitate use of the device. The on-screen information guides the operator through the entire therapy. For easier control, the handpiece is equipped with buttons, enabling operation of the device during therapy. The energy flow is indicated by the illuminated treatment tip. The TR-100 consists of the following main components: - . microprocessor-driven control unit - high-frequency electromagnetic energy generator - . massage generator - . user interface with 8.4" color touch screen - handpiece #### Indications for Use The TR-100 RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain. muscle spasms, and increase in local circulation. The TR-100 massage device is intended to provide a temporary reduction in the appearance of cellulite. ### Non-clinical Testing The TR-100 device has been thoroughly evaluated for electrical safety. The TR-100 has been found to conform to applicable medical device safety standards. The device complies with the following standards: - ISO 14971 Medical devices – Application of risk management to medical devices - IEC 62304 Medical Device Software - Software Life Cycle Processes - IEC 60601-1 General requirements for safety - IEC 60601-1-2 Electromagnetic compatibility-Requirements and Tests - IEC 60601-2-2 Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories - ISO 10993-1 Evaluation and testing within a risk management process - ISO 10993-5 Biological Evaluation of Medical Devices-Tests for In Vitro toxicity {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with the letters BTL in a stylized font. The letters are arranged within three interconnected diamond shapes. The logo is a solid blue color and is set against a white background. - ISO 10993-10 Biological Evaluation of Medical Devices—Test for Irritation and Skin Sensitization ## Clinical testing The substantial equivalence determination for the TR-100 is based on clinical performance testing. The aim of the performance test was to prove that the device reaches the effective treatment temperature and maintain it for required time. ### Comparison with the Predicate Device | Device Name | TR-100 | Exilis XP | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | BTL Industries, Inc. | BTL Industries, Inc. | | 510(k) Number | n/a | K143040 | | Regulation | General & Plastic Surgery<br>21 CFR 878.4400<br>Electrosurgical cutting and coagulation<br>and accessories | General & Plastic Surgery<br>21 CFR 878.4400<br>Electrosurgical cutting and coagulation and<br>accessories | | Product Code | PBX | PBX | | Indications for<br>Use | The TR-100 device is intended to<br>provide heating for the purpose of<br>elevating tissue temperature for selected<br>medical conditions such as temporary<br>relief of pain, muscle spasms, and<br>increase in local circulation. The TR-100<br>massage device is intended to provide a<br>temporary reduction in the appearance<br>of cellulite. | The Exilis XP device is intended to provide<br>heating for the purpose of elevating tissue<br>temperature for selected medical conditions<br>such as temporary relief of pain, muscle<br>spasms, and increase in local circulation.<br>The Exilis XP massage device is intended to<br>provide a temporary reduction in the<br>appearance of cellulite. | | Device<br>Technologies | Application of the heat to the tissue via<br>RF energy. Massaging of body parts<br>with massage tip. | Application of the heat to the tissue via RF<br>energy. Massaging of body parts with<br>massage attachment. | | Electrical<br>Protection | Class II, BF | Class II, BF | | Color Touch<br>Screen | 8.4" (215mm) / 640x480 pixel | 8.4" (215mm) / 640x480 pixel | | | | | | Device Name | TR-100 | Exilis XP | | Manufacturer | BTL Industries, Inc. | BTL Industries, Inc. | | 510(k) Number | n/a | K143040 | | RF Tip Surface in<br>contact with skin | 3.14 cm² | 1.13 - 2.54 cm² | | Maximum Output<br>Power<br>(Density) | Up to 300 W<br>(95.5 W/cm2) | Up to 120 W<br>(47.2 - 106.2 W/cm²) | | Effective<br>Treatment<br>Temperature | 40 - 45 °C (104 - 113 °F) | 40 - 45 °C (104 - 113 °F) | | Skin Temperature<br>Monitoring | Based on Patient's Feedback.<br>Integrated IR thermometer. | Based on Patient's Feedback.<br>Separate IR thermometer. | | Heating Energy<br>Type | Radiofrequency | Radiofrequency | | Modes of<br>Operation | Monopolar | Monopolar | | Output Frequency | 0.5 MHz ± 50 kHz | 3.25 MHz ± 50 kHz | | Waveform | Sinusoid | Sinusoid | | Massage Tip<br>Material | Metal | Grey Plastic material | | Massage<br>application | Manual Circular,<br>Automatic Vertical | Manual Circular | | Material of the<br>Generator Case | Aluminium, Plastic, Stainless Steel | Aluminium, Plastic, Stainless Steel | | Handpiece Holder<br>Availability | YES | YES | | Patch Electrode | YES | YES | | Energy Source | 100 - 240 VAC, max 7A, 50-60 Hz | 110 - 240 V, max 4A, 50-60 Hz | | Device Name | TR-100 | Exilis XP | | Manufacturer | BTL Industries, Inc. | BTL Industries, Inc. | | 510(k) Number | n/a | K143040 | | Material of the<br>Generator Case | Aluminum, Plastic, Stainless Steel | Aluminum, Plastic, Stainless Steel | | RF Energy<br>Emission Indicator | YES | YES | | Dimensions<br>(W x H x D) | 600 × 1000 × 600 mm<br>(24" × 39" × 24") | 406 × 270 × 302 mm<br>(15.98" × 10.63" × 11.87") | | Weight | 50.7 lb (23 kg) | 16 lb (7.3 kg) | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a blue logo with the letters B, T, and L. The letters are inside of three diamond shapes that are connected to each other. The diamond shapes are also blue. The logo is simple and modern. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo with the letters B, T, and L. The letters are in blue and are inside of three diamond shapes. The diamond shapes are connected to each other. The logo is simple and modern. ### Substantial Equivalence Based upon the intended use and technical information provided in this pre-market notification, the TR-100 device has been shown to be substantially equivalent to currently marketed predicate device. ## Conclusion Based on the aforementioned information, the TR-100 is safe and effective and substantially equivalent to the identified predicate device.