(34 days)
The Oratec Interventions™ Model ORA 40 Electrothermal Generator, in combination with Oratec thermal/coagulating probes, is designed for general surgical use, including orthopaedic and arthroscopic applications, in coagulating soft tissues. This device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Oratec Interventions™ Model ORA 40 Electrothermal Generator
This document is a 510(k) premarket notification approval letter from the FDA for a medical device called the "Oratec Interventions Model ORA 40 Electrothermal Generator". It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or the results of a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the input text. The document primarily focuses on regulatory approval and indications for use, not performance studies or acceptance criteria.
To answer your request, I would need a document that describes:
- Specific performance metrics for the device (e.g., accuracy, precision, impedance, temperature control).
- Quantitative acceptance criteria for those metrics.
- Details of a study (e.g., a clinical trial or performance validation study) that evaluates the device against these 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.