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The BTL-199 is intended to stimulate peripheral nerves for relief of chronic intractable pain, post-traumatic pain, post-surgical pain and/or for relief of chronic painful diabetic peripheral neuropathy in the lower extremities. The BTL-199 is for use on patients 18 and older.

The BTL-199 is an electromagnetic stimulator that delivers brief, focused electromagnetic pulses to non-invasively stimulate peripheral nerves, providing pain relief.

The device consists of a main unit and specialized applicators, designed to deliver precise and effective therapy. The main unit is equipped with an intuitive color touch screen that provides step-by-step guidance for the operator throughout the therapy process. The device features a preset treatment protocol for ease of use, while also allowing operators to customize parameters to meet specific therapeutic needs. Adjustable parameters include frequency (up to 150 Hz), therapy time (up to 30 minutes), and intensity (0-100%). The interface displays detailed information about the therapy settings and session progress (i.e., treatment duration). The device uses a temperature sensor to monitor the temperature of the coil to ensure that the maximum permissible temperature of the applicator's contact areas (i.e., 43°C) are not exceeded. It also has an intensity predictor function that limits the maximum adjustable intensity of the device based on the therapy parameters set, so as not to overheat and damage the device.

The device is equipped with three sets of applicators: AP-C-1, AP-C-2, and AP-C-4/5. Each applicator is intended for a different body area depending on the size and shape of the treated body part.

• Applicator AP-C-1 is intended for treatment of larger body areas, such as back, waist, thighs, etc.
• Applicator AP-C-2 is intended for treatment of smaller body areas, such as hands, arms, legs, etc.
• Applicators AP-C-4/5 (AP-C-4 and AP-C-5 - for each side of the body respectively) is primarily intended for treatment of waist and lower back.

The provided FDA 510(k) clearance letter and summary for the BTL-199 device does not include any clinical study data or describe acceptance criteria related to device performance in a clinical setting.

The submission is based on the device being "substantially equivalent" to predicate devices, which generally means that it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. For devices like the BTL-199, classified as Class II, substantial equivalence can often be demonstrated through non-clinical testing (bench testing, electrical safety, biocompatibility, etc.) and a comparison of technological characteristics with predicate devices that have already been cleared.

The "Clinical Testing" section explicitly states "Not applicable," which confirms that a clinical study proving device performance against specific acceptance criteria (like accuracy, sensitivity, or improvement in patient outcomes) was not required or submitted for this 510(k) clearance.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them based on the provided text, as such information is not present. The document focuses on demonstrating substantial equivalence for regulatory clearance, not on presenting performance data from a clinical trial.

If this were a device requiring clinical performance data (e.g., an AI-powered diagnostic device), the 510(k) summary would typically include a section detailing the clinical study, its methodology, and the results compared against pre-defined acceptance criteria. This is not the case for the BTL-199.

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