(84 days)
The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.
The HeatWave™ Electrode is a sterile, single-use, monopolar electrode designed to be used in conjunction with an electrosurgical generator via an electrosurgical pencil and a dispersive pad. The HeatWave Electrode will be sold individually and/or in a kit containing an electrode, electrosurgical pencil and an electrosurgical dispersive pad.
The provided document describes a 510(k) submission for the HeatWave™ Electrode. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission relies on demonstrating substantial equivalence, rather than conducting new clinical studies with defined acceptance criteria and performance outcomes.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or specific performance metrics from a comparative effectiveness or standalone study.
Instead, the submission focuses on:
- Device Description: A sterile, single-use, monopolar electrode for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures.
- Intended Use: As stated above.
- Substantial Equivalence: Claimed to be substantially equivalent in design, function, and intended use to the TAC™ Probes (ORATEC Interventions, Inc.) and ArthoWand CAPS (ArthroCare Corporation).
- Testing for Safety and Effectiveness: The document briefly states, "Testing has been done to prove safety and effectiveness of the devices," but it does not provide details of this testing, including acceptance criteria or results. It is typical for 510(k) submissions to rely on non-clinical bench testing, biocompatibility testing, and electrical safety testing, but specific results are not included in this summary.
- Comparison to Predicate Devices: A table highlights similarities and dissimilarities in materials, dimensions, and sterilization methods between the HeatWave Electrode and its predicate devices.
In summary, none of the specific details about acceptance criteria, study design, statistical analysis, or expert involvement for proving device performance are present in this 510(k) summary. The FDA's clearance (K991830) is based on a finding of "substantial equivalence" to existing, legally marketed devices, not on a new clinical study demonstrating specific performance against predefined acceptance criteria.
§ 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.