(88 days)
The Kirwan Model 28 1500 Generator is a general purpose solid state monopolar generator with independent bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
An isolated output monopolar electrosurgery generator with independent bipolar electrosurgery generator. The monopolar generator has continuously adjustable 0-150 watts in three cut modes of cut, blend 1, blend 2 and two coagulation modes 0-75 watts. The bipolar generator is continuously adjustable 0-50. Outputs of both generators are independently controlled and RF isolated from each other. Each generator handswitch system is powered by independent low voltage (7 Vdc) isolated power supplies. Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) monopolar electrosurgerygenerators and bipolar coagulators.
The document provided is a 510(k) summary for the Kirwan Model 28 1500 Electrosurgery Generator. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study data with specific acceptance criteria and performance metrics described in your request.
Therefore, the provided text does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance. The submission primarily discusses technical specifications and adherence to safety guidelines (IEC 601-1-2 and ANSI HF-18) for leakage and monitoring, but not performance metrics relative to clinical acceptance criteria.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size and ground truth establishment for a training set.
The document states that the device is an "isolated output monopolar electrosurgery generator with independent bipolar electrosurgery generator" and specifies power outputs for different modes (cut, blend, coagulation). It also mentions that "Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines" and "RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines." These are safety and technical specifications, not clinical performance acceptance criteria or results of a study designed to demonstrate such.
The FDA's review concludes that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary criterion for 510(k) clearance. This determination is based on comparing the device's technical characteristics and intended use to those of existing devices, rather than on new clinical effectiveness studies with the specific details requested in your prompt.
§ 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.