(102 days)
Not Found
No
The description focuses on standard medical device components and functions (radiofrequency, massager, microprocessor-driven control unit, user interface) and does not mention any AI or ML capabilities. The performance study also focuses on temperature control, not algorithmic performance.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation" and "temporary reduction in the appearance of cellulite," which are all therapeutic purposes.
No
Explanation: The device's intended use is to provide heating and massage for therapeutic purposes (pain relief, circulation, cellulite reduction), not to diagnose medical conditions.
No
The device description explicitly details hardware components such as a control unit, high-frequency electromagnetic energy generator, massage generator, touch screen, and handpiece.
Based on the provided information, the TR-100 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing heating and massage for therapeutic purposes (pain relief, muscle spasms, circulation, cellulite reduction). This involves direct application to the body for treatment, not the examination of specimens from the body.
- Device Description: The description details a radiofrequency device with a massager, control unit, and handpiece. This aligns with a physical therapy or aesthetic device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is to apply energy and massage to the body.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The TR-100's function falls outside of this definition.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PBX
Device 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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
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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) |
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:
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"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."
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Section 5 - 510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702
Tel: +1-866-285-1656
Fax: +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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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
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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 | |
| 21 CFR 878.4400 | ||
| Electrosurgical cutting and coagulation | ||
| and accessories | General & Plastic Surgery | |
| 21 CFR 878.4400 | ||
| Electrosurgical cutting and coagulation and | ||
| accessories | ||
| Product Code | PBX | PBX |
| Indications for | ||
| Use | 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 Exilis XP 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 Exilis XP massage device is intended to | ||
| provide a temporary reduction in the | ||
| appearance of cellulite. | ||
| Device | ||
| Technologies | Application of the heat to the tissue via | |
| RF energy. Massaging of body parts | ||
| with massage tip. | Application of the heat to the tissue via RF | |
| energy. Massaging of body parts with | ||
| massage attachment. | ||
| Electrical | ||
| Protection | Class II, BF | Class II, BF |
| Color Touch | ||
| 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 | ||
| contact with skin | 3.14 cm² | 1.13 - 2.54 cm² |
| Maximum Output | ||
| Power | ||
| (Density) | Up to 300 W | |
| (95.5 W/cm2) | Up to 120 W | |
| (47.2 - 106.2 W/cm²) | ||
| Effective | ||
| Treatment | ||
| Temperature | 40 - 45 °C (104 - 113 °F) | 40 - 45 °C (104 - 113 °F) |
| Skin Temperature | ||
| Monitoring | Based on Patient's Feedback. | |
| Integrated IR thermometer. | Based on Patient's Feedback. | |
| Separate IR thermometer. | ||
| Heating Energy | ||
| Type | Radiofrequency | Radiofrequency |
| Modes of | ||
| Operation | Monopolar | Monopolar |
| Output Frequency | 0.5 MHz ± 50 kHz | 3.25 MHz ± 50 kHz |
| Waveform | Sinusoid | Sinusoid |
| Massage Tip | ||
| Material | Metal | Grey Plastic material |
| Massage | ||
| application | Manual Circular, | |
| Automatic Vertical | Manual Circular | |
| Material of the | ||
| Generator Case | Aluminium, Plastic, Stainless Steel | Aluminium, Plastic, Stainless Steel |
| Handpiece Holder | ||
| 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 | ||
| Generator Case | Aluminum, Plastic, Stainless Steel | Aluminum, Plastic, Stainless Steel |
| RF Energy | ||
| Emission 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.