(102 days)
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.
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.
The provided text describes the TR-100 device and its substantial equivalence to a predicate device (Exilis XP) for market clearance. The key study mentioned is a clinical performance testing to prove the device's ability to reach and maintain an effective treatment temperature.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document defines the "Effective Treatment Temperature" as 40 - 45 °C (104 - 113 °F) for both the TR-100 and the predicate device, Exilis XP. The clinical testing aims to prove that the TR-100 reaches this temperature and maintains it for the required time.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effective Treatment Temperature is reached and maintained for the required time | The clinical performance testing was conducted "to prove that the device reaches the effective treatment temperature and maintain it for required time." The effective treatment temperature is specified as 40 - 45 °C (104 - 113 °F). While the document states the aim of the test was to prove this, it does not explicitly provide the specific quantitative results (e.g., average temperature achieved, duration maintained) from this testing within the provided text. It merely states that the study was performed to demonstrate this capability. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size used for the clinical performance testing.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the clinical performance test. Given the nature of a thermal device where the "ground truth" is likely direct temperature measurement, it may not have relied on expert interpretation in the same way an image-based diagnostic device would.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The clinical testing described is focused on the device's ability to achieve and maintain temperature, not on the improvement of human readers with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable in the context of this device. The TR-100 is a physical device that delivers radiofrequency energy and massage, not an algorithm for image analysis or diagnosis. The "performance" being evaluated is its physical delivery of heat, not an algorithmic output.
7. The Type of Ground Truth Used
The ground truth implicitly used for the clinical performance testing would be direct temperature measurements of the tissue being treated. The acceptance criteria themselves define the target temperature range (40-45 °C).
8. The Sample Size for the Training Set
The document does not mention a training set. This is a physical therapy device with heating capabilities, not an AI/ML device that requires a training set in the typical sense. The "training" would be the engineering and developmental phases to tune the device's output to achieve the desired therapeutic temperature.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (in the AI/ML sense) is mentioned or relevant for this type of device.
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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
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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
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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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5 - 510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.47 Loring DriveFramingham, MA 01702Tel: +1-866-285-1656Fax: +1-888-499-2502 |
|---|---|
| Applicant: | BTL Industries, Inc.47 Loring DriveFramingham, MA 01702Tel: +1-866-285-1656Fax: +1-888-499-2502 |
| Contact Person: | Jan Zarsky |
|---|---|
| BTL Industries, Inc. | |
| Executive VP | |
| zarsky@btlnet.com |
| 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).
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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
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- 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 Surgery21 CFR 878.4400Electrosurgical cutting and coagulationand accessories | General & Plastic Surgery21 CFR 878.4400Electrosurgical cutting and coagulation andaccessories |
| Product Code | PBX | PBX |
| Indications forUse | The TR-100 device is intended toprovide heating for the purpose ofelevating tissue temperature for selectedmedical conditions such as temporaryrelief of pain, muscle spasms, andincrease in local circulation. The TR-100massage device is intended to provide atemporary reduction in the appearanceof cellulite. | The Exilis XP device is intended to provideheating for the purpose of elevating tissuetemperature for selected medical conditionssuch as temporary relief of pain, musclespasms, and increase in local circulation.The Exilis XP massage device is intended toprovide a temporary reduction in theappearance of cellulite. |
| DeviceTechnologies | Application of the heat to the tissue viaRF energy. Massaging of body partswith massage tip. | Application of the heat to the tissue via RFenergy. Massaging of body parts withmassage attachment. |
| ElectricalProtection | Class II, BF | Class II, BF |
| Color TouchScreen | 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 incontact with skin | 3.14 cm² | 1.13 - 2.54 cm² |
| Maximum OutputPower(Density) | Up to 300 W(95.5 W/cm2) | Up to 120 W(47.2 - 106.2 W/cm²) |
| EffectiveTreatmentTemperature | 40 - 45 °C (104 - 113 °F) | 40 - 45 °C (104 - 113 °F) |
| Skin TemperatureMonitoring | Based on Patient's Feedback.Integrated IR thermometer. | Based on Patient's Feedback.Separate IR thermometer. |
| Heating EnergyType | Radiofrequency | Radiofrequency |
| Modes ofOperation | Monopolar | Monopolar |
| Output Frequency | 0.5 MHz ± 50 kHz | 3.25 MHz ± 50 kHz |
| Waveform | Sinusoid | Sinusoid |
| Massage TipMaterial | Metal | Grey Plastic material |
| Massageapplication | Manual Circular,Automatic Vertical | Manual Circular |
| Material of theGenerator Case | Aluminium, Plastic, Stainless Steel | Aluminium, Plastic, Stainless Steel |
| Handpiece HolderAvailability | 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 theGenerator Case | Aluminum, Plastic, Stainless Steel | Aluminum, Plastic, Stainless Steel |
| RF EnergyEmission Indicator | YES | YES |
| Dimensions(W x H x D) | 600 × 1000 × 600 mm(24" × 39" × 24") | 406 × 270 × 302 mm(15.98" × 10.63" × 11.87") |
| Weight | 50.7 lb (23 kg) | 16 lb (7.3 kg) |
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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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.