(69 days)
The Temperature Sensor Probe, used with Varian ablation systems, is intended for monitoring tissue temperature near the ablation site.
Temperature Sensor Probe is an optional accessory designed for use with compatible Varian ablation systems. Principal components of the temperature sensor probe include:
- Needle
- Handle
- Lead cable and connector
The provided text describes the regulatory clearance of a Temperature Sensor Probe (ABL-18TP20) for use with Varian ablation systems for monitoring tissue temperature. The submission focuses on demonstrating substantial equivalence to a predicate device, the Emprint™ Ablation System with Thermosphere Technology: K200796, specifically the Ablation Remote Temperature Probe (RTP20).
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Feature/Characteristic | Acceptance Criteria (Predicate Device K200796, RTP20) | Reported Device Performance (Subject Device: Temperature Sensor Probe) |
|---|---|---|
| Intended Use/Indications for Use | Monitoring tissue temperature at or near the ablation site. | Monitoring tissue temperature near the ablation site. |
| Operating Principle | Measures tissue temperature in real time via a thermocouple within the tip of the probe. | Measures tissue temperature in real time via a thermocouple within the tip of the probe. |
| Product code, FDA regulation, class | NEY, 21 CFR 878.4400, Class II | NEY, 21 CFR 878.4400, Class II |
| Prescription (Rx only) | Yes | Yes |
| Optional Accessory | Yes | Yes |
| Measuring Site | At or near ablation site | Tissue near ablation site |
| Temperature Range (Accuracy) | 37°C - 60°C (±1.5°C) | 10°C - 60°C (±2°C) |
| Thermocouple-based sensor at tip | Yes | Yes |
| Signal Processing & Display | Real-time, continuous display of tissue temperature. | Real-time, continuous display of tissue temperature. |
| Tissue Contact per ISO 10993-1 | External communicating device, in contact with tissue/bone/dentin and limited contact duration (A) ( |
§ 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.