(84 days)
TR-100 (K161551)
Not Found
No
The description focuses on standard therapeutic device components and functions, with no mention of AI or ML capabilities. The "microprocessor-driven control unit" is a common component in modern medical devices and does not inherently indicate AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the 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" and "to provide a temporary reduction in the appearance of cellulite," which are therapeutic applications. Additionally, the "Device Description" directly refers to it as a "non-invasive therapeutic device."
No
The device description indicates it is a "non-invasive therapeutic device" for applying therapy, and the intended use specifies it provides "heating for the purpose of elevating tissue temperature" for relief of pain, muscle spasms, and increased circulation, as well as temporary reduction in cellulite. These are all therapeutic actions, not diagnostic ones.
No
The device description explicitly lists hardware components such as a control unit, energy generators, a touch screen, and a handpiece, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing heating for therapeutic purposes (pain relief, muscle spasms, circulation) and temporary reduction of cellulite. These are all direct treatments applied to the patient's body.
- Device Description: The description details a non-invasive therapeutic device that applies a high-frequency field and massage. It describes the components involved in delivering this therapy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to analyze samples taken from the body to provide diagnostic or other health-related information. This device is designed to directly treat the body.
N/A
Intended Use / Indications for Use
The BTL-084 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 BTL-084 massage device is intended to provide a temporary reduction in the appearance of cellulite.
Product codes
PBX
Device Description
The BTL-084 is a non-invasive therapeutic device enables the application of therapy by a 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 BTL-084 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
The substantial equivalence determination for the BTL-084 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
Not Found
Predicate Device(s)
TR-100 (K161551)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in blue, with "FDA" in a larger font size than the rest of the text.
March 29, 2019
BTL Industries, Inc. Mr. David Chmel VP of Operation 362 Elm Street Marlborough, Massachusetts 01752
Re: K190023
Trade/Device Name: Btl-084 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: December 28, 2018 Received: January 4, 2019
Dear Mr. 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 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
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/7 description: The image shows the text "Long H. Chen -S" in a large, sans-serif font. The text is arranged in two lines, with "Long H." on the first line and "Chen -S" on the second line. The letters are black, and the background is white. There is a light blue design element in the background.
Digitally signed by Long H. Chen -S Date: 2019.03.29 07:33:49 -04'00'
for
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190023
Device Name BTL-084
Indications for Use (Describe)
The BTL-084 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 BTL-084 massage device is intended to provide a temporary reduction in the appearance of cellulite.
Type of Use (Select one or both, as applicable) | |
---|---|
X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three nested squares, with the letters "BTL" inside the innermost square.
510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | David Chmel
BTL Industries, Inc.
chmel@btlnet.com |
| Summary Preparation Date: | March 28, 2019 |
Device Name
Trade/Proprietary Name: | BTL-084 |
---|---|
Primary Classification Name: | Electrosurgical cutting and coagulation device and |
accessories | |
Classification Regulation: | 21 CFR 878.4400, Class II |
Classification Product Code: | PBX |
Legally Marketed Predicate Devices
The BTL-084 is a state-of-the-art radiofrequency device with integrated massager and 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 number:
- TR-100 (K161551)
4
Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing the letters "B", "T", and "L" respectively. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font.
Product Description
The BTL-084 is a non-invasive therapeutic device enables the application of therapy by a 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 BTL-084 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
Intended Use
The BTL-084 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 BTL-084 massage device is intended to provide a temporary reduction in the appearance of cellulite.
Non-clinical Testing
The BTL BTL-084 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 and essential performance |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance - Collateral standard:
Electromagnetic disturbances – 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 |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements for
basic safety and 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 |
5
Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three overlapping blue squares with the letters "BTL" inside. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.
ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation and testing within 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 sensitization |
Clinical testing
The substantial equivalence determination for the BTL-084 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.
Technological Characteristics
The BTL-084 device has the same indications for use and similar technological characteristics and principles of operation as its predicate device. The BTL-084 device and its predicate are comprised of a system console and RF applicator with integrated massager. The system console consists of the radiofrequency generator, computer, and the touchscreen control panel. The Essential technical characteristics of the BTL-084 and its predicate device, particularly the type of energy, mode of operation, effective treatment temperature and the safety elements (e.g. skin temperature monitoring) are identical.
Compared to the predicate, the BTL-084 device has lower maximum output power and output frequency, sufficient to reach the effective treatment temperature. The subject device has slightly smaller massage tip and larger RF tip surface to enable treatment of larger area at the same time.
The technological differences between the BTL-084 device and the predicate device do not raise any new types of safety or effectiveness questions.
Substantial Equivalence
The BTL-084 device has the same intended use as its predicate devices. The technological characteristics of the predicate devices are similar to the BTL-084 device. Any differences between the predicate devices and BTL-084 device have no significant influence on safety or effectiveness of the BTL-084 device. Therefore, the BTL-084 device is substantially equivalent to the predicate devices.
Conclusion
Based upon the intended use and known technical information provided in this pre-market notification, the BTL-084 device has been shown to be substantially equivalent to currently marketed predicate device.