(275 days)
The BTL-785F device has the following indications for use:
The BTL-785F with BTL-785-1 applicator 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-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite.
The BTL-785F with BTL-785-2 applicator is indicated 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-785F with BTL-785-3 applicator 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 Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-1, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.
The BTL-785F is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field.
The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information quides the user step by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy. The energy flow's quality is indicated by the illuminated treatment tip. The BTL-785F device comes with four different types of applicators.
The BTL-785F device consists of the following main components:
- microprocessor-driven control unit
- radiofrequency generator
- user interface with 15.6" color touch screen
- applicators for an application of radiofrequency
- exchangeable applicator tips
Here's a breakdown of the acceptance criteria and study information for the BTL-785F device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Study Type/Method |
|---|---|---|---|
| Electrical Safety | IEC 60601-1 | Complies with standard | Bench testing |
| IEC 60601-1-2 | Complies with standard | Bench testing | |
| IEC 60601-2-2 | Complies with standard | Bench testing | |
| IEC 60601-2-5 | Complies with standard | Bench testing | |
| IEC 60601-1-6 | Complies with standard | Bench testing | |
| Software Life Cycle | IEC 62304 | Complies with standard | Documentation Review |
| Risk Management | ISO 14971 | Complies with standard | Documentation Review |
| Biocompatibility | ISO 10993-1 | Complies with standard | Bench testing |
| ISO 10993-5 | Complies with standard | Bench testing | |
| ISO 10993-7 | Complies with standard | Bench testing | |
| ISO 10993-10 | Complies with standard | Bench testing | |
| ISO 10993-11 | Complies with standard | Bench testing | |
| Sterilization | ISO 11135 | Complies with standard | Documentation Review |
| Packaging | ISO 11607-1 | Complies with standard | Documentation Review |
| ISO 11607-2 | Complies with standard | Documentation Review | |
| Therapeutic Efficacy | Achieve and maintain therapeutic temperature on different treated areas for at least 10min | Device demonstrated ability to achieve and maintain therapeutic temperature for at least 10 minutes | Bench testing |
| Power Output & Geometry | Power output of generator and geometry of 785-4 applicator identical to predicate | Demonstrated to be identical to predicate | Bench testing |
Study Details
Based on the provided document, the BTL-785F device primarily relies on bench testing and compliance with recognized international standards to demonstrate substantial equivalence and meet acceptance criteria. The document does not describe a clinical study with human subjects in the traditional sense of a comparative effectiveness study.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient data or samples from a clinical trial. The testing described is primarily bench testing for engineering and safety compliance. Therefore, there is no information on a sample size for a "test set" in a clinical context, nor is there information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes bench testing against engineering standards, not a diagnostic or prognostic device requiring expert-established ground truth on human data.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes bench testing against engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication of an MRMC comparative effectiveness study being performed for the BTL-785F device. The submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with safety and performance standards.
6. Standalone (Algorithm Only) Performance
The BTL-785F is an electrosurgical cutting and coagulation device and a massager, not an AI/algorithm-based diagnostic or prognostic device. Therefore, a "standalone algorithm performance" study is not applicable. The device's performance is inherently tied to its physical operation and interaction with tissue.
7. Type of Ground Truth Used
The "ground truth" for the performance claims in this submission is established by:
- International Standards: Compliance with detailed specifications outlined in standards like IEC 60601 series, ISO 14971, and ISO 10993 series.
- Engineering Specifications: The ability to achieve and maintain specific therapeutic temperatures and to match the power output and geometry of predicate devices.
8. Sample Size for the Training Set
This information is not applicable as the BTL-785F device is not an AI/machine learning product and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the BTL-785F device is not an AI/machine learning product and therefore does not have a "training set."
§ 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.