(87 days)
The Nucleotomy Catheter is intended to be used for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.
The Nucleotomy Catheter is a minimally invasive thermoelectric device. When used in The Nucleolonity Cuthers is a missanerator the Nucleotomy Catheter delivers thermal energy to targeted locations inside the disc. The distal portion of the tip is flexible such that the device can targeted locations instice the answ The flexible tip contains a resistive metal coil, which produces heat when current flows through it. The device contains a thermocouple for monitoring and controlling the temperature of the treated tissue.
This 510(k) summary does not contain any performance data or acceptance criteria. It is a clearance document that states the device, a "Nucleotomy Catheter," is substantially equivalent to a predicate device (SpineCATH Intradiscal Catheter K993967).
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This document only states that "Safety and biocompatibility testing were conducted to support this claim of substantial equivalence," without providing any specific criteria or results.
- Sample size used for the test set and the data provenance: No test set information is present.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable as no test set data is provided.
- Adjudication method for the test set: Not applicable as no test set data is provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No indication of such a study.
- If a standalone performance study was done: No standalone performance data is mentioned.
- The type of ground truth used: Not applicable as no ground truth data is provided.
- The sample size for the training set: No training set information is present.
- How the ground truth for the training set was established: Not applicable as no training set data is provided.
The document focuses on:
- Device Name: Nucleotomy Catheter
- Device Description: Minimally invasive thermoelectric device for delivering thermal energy to disc material. Contains a flexible tip with a resistive metal coil and a thermocouple for temperature control.
- Indications for Use: Coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.
- Predicate Device: SpineCATH Intradiscal Catheter K993967
- Conclusion: The device is substantially equivalent to the predicate device based on technological characteristics, similar intended use, and safety/biocompatibility testing (details of which are not provided in this summary).
§ 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.