(130 days)
BTL 799-2L is indicated to be used for:
- · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, Toning and Firming of buttocks, thighs and calves.
- · Improvement of muscle tone and firmness, for strengthening muscles in arms.
The BTL 799-2L is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The device has two outputs that enable simultaneous treatment by two applicators.
The BTL 799-2L is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user stepby-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
This is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than conducting a de novo study to establish new performance criteria. Therefore, the information typically found in a study proving a device meets acceptance criteria, such as a table of acceptance criteria and reported device performance metrics like sensitivity, specificity, or AUC, a specific sample size for a test set, expert qualifications, or adjudication methods, is not present here.
Instead, the submission focuses on non-clinical testing to ensure safety and essential performance, and a comparison of technological characteristics to predicate devices to argue for substantial equivalence.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics in the typical sense (e.g., sensitivity, specificity). The acceptance criteria implicitly are compliance with various medical device safety and performance standards (listed below) and having technological characteristics and intended use similar enough to predicate devices to not raise new safety or effectiveness concerns.
- Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity) are reported as this is a comparison to a predicate device, not a de novo performance study. The device's "performance" is demonstrated by its adherence to safety standards and its functional similarity to legally marketed devices.
2. Sample size used for the test set and the data provenance
- This information is not provided as this submission relies on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, not through a clinical performance study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as there is no mention of a test set with expert-established ground truth.
4. Adjudication method for the test set
- This information is not provided as there is no mention of a test set or 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
- This information is not provided as this device is a physical muscle stimulator, not an AI-assisted diagnostic or imaging device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable/provided as this device is a physical muscle stimulator, not an algorithm.
7. The type of ground truth used
- Not applicable as no clinical study with a ground truth is described. The "ground truth" for this submission revolves around compliance with recognized medical device safety standards and the established safety and effectiveness of the predicate devices it is compared against.
8. The sample size for the training set
- This information is not provided as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- This information is not provided as this is not an AI/machine learning device requiring a training set.
Non-clinical Testing Summary:
The BTL 799-2L device underwent thorough evaluation for electrical safety and compliance 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 60601-1-6: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-10: Medical Electrical Equipment – Part 2-10: Particular Requirements for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators
- IEC 62304: Medical device software - Software life cycle processes
- ISO 14971: Medical devices – Application of risk management to medical devices
- 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
The comparison table provided details the technological characteristics of the BTL 799-2L compared to its primary predicate BTL 799-2T (K182106) and secondary predicate HPM-6000 (K160992). The key argument is that any differences do not raise new types of safety or effectiveness questions, thus demonstrating substantial equivalence.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).