(90 days)
The Somnoplasty™ System is intended for the reduction of the incidence of airway obstructions in patients suffering from UARS or OSAS.
The Somnoplasty " System is intended for the reduction of the incidence of airway obstructions in patients suffering from UARS or OSAS.
The Somnoplasty®" System is intended for the reduction of the incidence of airway obstructions in patients suffering from UARS (Upper Airway Resistance Syndrome) or OSAS (Obstructive Sleep Apnea Syndrome).
The Somnoplasty™ System is comprised of an Electrosurgical (RF) Generator and Tissue Coagulating Electrodes. The RF Generator has controls for target temperature, target energy, power delivered and time of energy delivery. The unit has readouts for total energy delivered, impedance, number of active channels and temperature for up to 3 thermocouples per channel. Connectors on the front panel include connectors for coagulating and dispersive electrodes and a footpedal. The electrodes are provided with various handpiece configurations to facilitate the placement of the needles in the tissue to be ablated.
Accessories included with the generator include a line power cable and single pedal footpedal.
The provided document does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested. The document is a 510(k) summary and related FDA correspondence, primarily focusing on the device's intended use, comparison to predicate devices, and FDA clearance.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about a test set, its sample size, or data provenance.
- Information on the number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance data.
- The type of ground truth used (e.g., pathology, outcomes data).
- The sample size for the training set.
- How ground truth for the training set was established.
The document mentions that "Performance validation testing, including a clinical study, has been done to validate the performance of the device," but it does not provide any specifics or results from that study. It also states the device "is safe and effective in its intended use" based on comparisons and validation results, but no metrics or criteria are elaborated upon.
§ 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.