THERMACOOL TC SYSTEM

• K Number: K030142
• Device Name: THERMACOOL TC SYSTEM
• Manufacturer: THERMAGE, INC.
• Date Cleared: 2003-02-03 ( 19 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Special
• Panel: SU
• Reference & Predicate Devices: K013639 , K021402

Intended Use

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.

Device Description

The device as described in the above referenced Premarket Notifications has been modified to include a reformulated Coupling Fluid.

AI/ML Overview

This 510(k) premarket notification for the ThermaCool TC System primarily concerns a modification to an existing device, specifically a reformulated Coupling Fluid. The submission explicitly states that "There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories."

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document focuses on establishing substantial equivalence to previously cleared devices (K013639 and K021402) for the modified system (specifically the new coupling fluid), rather than demonstrating a new performance for the entire ThermaCool TC System. Substantial equivalence for this type of modification often relies on comparing material properties and safety, rather than extensive clinical performance studies with specific statistical metrics.

Here's why the prompt's requested information is not available in the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not present. The document does not define specific performance metrics or acceptance criteria for the device or its new coupling fluid.
• 2. Sample size used for the test set and the data provenance: Not present. There is no mention of a test set, sample size, or data provenance.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. Ground truth is not discussed as there is no performance study.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not present.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This is not an AI-assisted device.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not present. This is not an AI algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not present.
• 8. The sample size for the training set: Not present.
• 9. How the ground truth for the training set was established: Not present.

The key takeaway is that this 510(k) is for a minor modification (coupling fluid reformulation) to an already cleared device, and thus, the submission primarily addresses the substantial equivalence of this modification, not a comprehensive performance study of the entire system as if it were a novel device.

Regulation Number and Section

§ 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.