(97 days)
The BTL-899M device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The BTL-899M device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Indications for Use for Muscle Stimulators:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
The BTL-899M is a non-invasive therapeutic device. The device is comprised of a main unit and an applicator that deliver electromagnetic energy to the targeted tissue. The device's output enables handsfree treatment.
The application of electromagnetic energy to the patient's feeling of magnetic stimulation of underlying muscles, joints and connective tissue accompanied by a pleasant feeling of warming sensation in the application area, which may contribute to increased local blood circulation and help the patient to relax and make the treatment more comfortable.
The BTL-899M is equipped with a large color touch-screen that significantly facilitates the use of the device. The on-screen information guides 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.
This document (K232937) is a 510(k) premarket notification for a medical device called BTL-899M, a Powered Muscle Stimulator. The key takeaway from this document is that the FDA has determined the BTL-899M device is substantially equivalent to a legally marketed predicate device (HPM-6000, K160992).
Therefore, the primary method of proving the device meets acceptance criteria is through demonstrating substantial equivalence to a predicate device by satisfying safety and performance standards for the device type, rather than conducting a separate clinical study with specific acceptance criteria as one might for a novel AI device with new claims.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a traditional medical device (Powered Muscle Stimulator) and not an AI/ML diagnostic tool, the "acceptance criteria" are primarily related to safety, electrical performance, and functional equivalence to the predicate device, demonstrated through non-clinical testing and comparison. There are no specific "performance metrics" in the sense of accuracy, sensitivity, or specificity as there would be for an AI-driven diagnostic.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Intended Use | Identical to predicate device | Yes, BTL-899M has identical Indications for Use as HPM-6000. |
| Technological Characteristics | Similar to predicate device; differences do not raise new safety/effectiveness questions. | See detailed comparison table (pages 8-9). Key features like basic operation, energy type (electromagnetic), pulse repetition rate, magnetic field intensity, pulse duration, and pulse shape are same or comparable. Minor differences (screen size, number of applicators, therapy time) are deemed not to raise new safety/effectiveness questions. |
| Electrical Safety | Compliance with relevant IEC standards | Complies with IEC 60601-1, IEC 60601-1-2 (EMC), IEC 60601-1-6 (Usability). |
| Software Safety | Compliance with software lifecycle processes | Complies with IEC 62304. |
| Risk Management | Application of risk management principles | Complies with ISO 14971. |
| Biocompatibility | Evaluation for biological safety | Complies with ISO 10993-1, ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization). |
| Performance (Functional) | Delivers expected magnetic and RF energy outputs within acceptable ranges. | Magnetic field intensity, pulse duration, pulse amplitude, and shape of stimulation pulse are within the range and type demonstrated by the predicate device. Addition of RF energy for warming sensation is confirmed to be subtherapeutic and monitored by a temperature sensor, and does not "raise any unacceptable risks or questions related to safety or effectiveness." |
| Therapy Time | Functionality for prescribed therapy duration | Adjustable up to 30 minutes (predicate up to 60 min). Justified that repeated use can achieve similar dosage and it does not raise safety/efficacy concerns. |
| Applicators | Delivers intended therapy output and is safe. | Single applicator (AP-C-1) with similar max output parameters to predicate's 299-1 applicator. Deemed not to raise safety/efficacy concerns. |
| Environmental | Operates within specified environmental conditions. | Meets operating ambient temperature and relative humidity criteria. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states "Clinical Testing: Not applicable" (page 7). This means there was no clinical test set or associated data provenance (e.g., country, retrospective/prospective) in the traditional sense for evaluating device performance against a diagnostic or therapeutic outcome. The testing was primarily non-clinical (bench testing) to ensure safety and functional equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since there was no clinical testing or a "test set" in the context of diagnostic performance, there were no experts used to establish ground truth in this manner. The ground truth, in a regulatory context, for this type of device, is established by its compliance with recognized safety and performance standards and its comparison to an already cleared device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was performed.
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. This device is a powered muscle stimulator, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is compliance with recognized standards for electrical safety, software safety, risk management, biocompatibility, and functional equivalence to the legally marketed predicate device. There is no "ground truth" related to disease diagnosis or treatment outcomes in the way one would describe it for an AI/diagnostic device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).