(25 days)
The ThermaCool TC System is indicated for use in
- Non-invasive treatment of periorbital rhytids and wrinkles
- Dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The device as described in the above referenced Premarket Notifications has been modified to include a modified Skin Marking Paper.
The provided document is a 510(k) premarket notification for the ThermaCool TC System. It describes a modification to an existing device, specifically a modified "Skin Marking Paper." This document focuses on establishing substantial equivalence to previously cleared devices (K013639 and K021402), rather than presenting a new study with acceptance criteria and device performance evaluation in the format requested.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in this document.
The document states:
- "There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories."
- It refers to "in-house Standard Operating Procedures and QSR based vendor qualification procedures" for manufacturing, but these do not constitute device performance acceptance criteria or a study proving those criteria are met for the device itself in terms of clinical or technical effectiveness.
- The FDA letter confirms that a substantial equivalence determination was made based on the indications for use provided.
§ 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.