(147 days)
BTL-703 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.
The BTL-703 is comprised of a device unit and applicator that deliver radiofrequency energy to the targeted tissue. The device is designed to enable hands-free treatment. Easyto-use color touch screen allows for maximum operator comfort. The main unit is placed in a specially designed cart, the shape of which provides maximum operator comfort and easy movement of the device in the office. The BTL-703 consists of the following main components: microprocessor-driven control unit, high-frequency energy generator, user interface with 15,6" HD touch screen, four-point applicator.
The acceptance criteria and study information for the BTL-703 device, based on the provided FDA 510(k) summary, are described below.
Please note: This document focuses on the regulatory submission information. For medical devices like the BTL-703 (Shortwave Diathermy), the "performance" in the context of a 510(k) submission primarily refers to meeting safety and fundamental operational requirements and demonstrating substantial equivalence to a predicate device. It typically does not involve the same kind of clinical trial efficacy metrics (sensitivity, specificity, etc.) as AI/software devices. The "acceptance criteria" here are therefore related to safety standards and the ability to achieve a therapeutic temperature range.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety and Essential Performance Standards | Compliance with recognized medical device safety standards. Specifically: | - IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (Complied) |
- IEC 60601-1-2: Collateral standard: Electromagnetic Disturbance – Requirements and tests (Complied)
- IEC 62304: Medical device software – Software life cycle processes (Complied)
- ISO 14971: Medical devices - Application of risk management to medical devices (Complied)
- ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (Complied)
- ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity (Complied)
- ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization (Complied) |
| Ablity to achieve therapeutic temperature | The device should be able to maintain a therapeutic temperature range in vivo (in relevant body tissues). Specific target: approximately 40-45°C. | The study confirmed the ability of the BTL-703 device to maintain the temperature in the range of approx. 40-45°C in vivo. |
| Substantial Equivalence | Demonstration that the technological characteristics and indications for use are substantially equivalent to a legally marketed predicate device (K120093, BTL Elite), raising no new safety or effectiveness questions. | Comparison table provided showing similar indications for use, principle of action, clinical use, electrical protection, user interface, firmware control, type of energy, working frequency (27.12 MHz), therapy time (1-30 min), hands-free application, stop remote control, and applicator contact monitor. Differences (e.g., no pulsed mode, negative pressure applicator fixation, thermal stabilization system) were determined not to raise new safety or effectiveness questions. |
2. Sample size used for the test set and the data provenance
- Test Set (Animal Study): The document only mentions a "study in porcine model" for demonstrating temperature maintenance. It does not provide the specific sample size (number of animals or test points) used in this model.
- Data Provenance: The animal study was conducted in a porcine model. The country of origin for the data is not specified. This was a prospective study designed to specifically evaluate the device's ability to maintain temperature in vivo.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for the animal study was objective temperature measurement, not a subjective assessment by human experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The animal study involved direct physical measurements (temperature), not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The BTL-703 is a physical therapy device that applies heat, not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance improvements are not relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The BTL-703 is a physical medical device, not a software algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the animal study: The ground truth was based on objective temperature measurements within the porcine model.
- For demonstrating substantial equivalence: The ground truth was based on adherence to established medical device safety standards (e.g., IEC, ISO) and comparison of technical specifications and indications for use with the predicate device.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that sense. The non-clinical testing involved rigorous testing against established standards.
9. How the ground truth for the training set was established
Not applicable (as it's not an AI/ML device with a training set). The "ground truth" for the non-clinical testing was established by internationally recognized and harmonized medical device safety and performance standards.
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.