(106 days)
The Vivaer ARC Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the coagulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue, in the internal nasal valve area.
The Vivaer ARC Stylus is a handheld bipolar radiofrequency (RF) probe designed for use in otorhinolaryngology (ENT) surgery. The Stylus comprises a handle, shaft and treatment tip. The treatment tip consists of an array of bipolar electrodes and a temperature sensor that allows for monitoring of tissue temperature during RF energy delivery. The Stylus is designed for use with the Aerin Console. It includes features to allow compatibility with and authentication by the Aerin Console. The Stylus connects to the Aerin Console via a flexible cable.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Device Performance (Non-Clinical) | System responsiveness | Met all performance testing requirements. |
| Effectiveness for clinical use | Met all performance testing requirements. | |
| Adequate shaft strength (Force load testing) | Verified. | |
| Thermocouple accuracy and response time (water bath immersion) | Efficacy supported. | |
| Tissue heating time (using representative soft tissues of the nasal airway) | Efficacy supported. | |
| Comparable thermal lesion volumes to predicate device | Showed that the Vivaer ARC Stylus creates thermal lesion volumes comparable to the predicate device. | |
| Device Safety (Non-Clinical) | Biocompatibility (AAMI/ANSI/ISO 10993-1 (2009/(R) 2013)) | Demonstrated through testing. |
| Sterilization validation (ANSI/AAMI/ISO 11135:2014 and ISO 10993-7:2008) | Performed in accordance with standards. | |
| Electrical safety (IEC 60601-1:2005/A1:2012 and IEC 60601-2-2:2009) | Demonstrated through testing. | |
| Electromagnetic compatibility (IEC 60601-1-2:2007/AC:2010) | Performed according to standard. | |
| Packaging validation (Transit testing, visual inspection, accelerated aging, gross leak detection, seal strength testing in accordance with ASTM D4169-14, D4332-14, F1980-07(2011), F2096-11, F88/F88M-15) | Met all acceptance criteria. | |
| Long-term safety and healing in nasal tissue (in vivo canine study) | Treatment resulted in durable change of submucosal gland population, no significant fibrosis, tissue contraction, or cartilage degeneration after 6 months. Healing process complete or near-complete at 6 months. Supports long-term safety. | |
| Clinical Efficacy | Primary Efficacy Endpoint: Statistically significantly greater than 15-point improvement in mean NOSE score from baseline to 26 weeks post-procedure. | Met. Mean NOSE score decreased 55 points (SD 21) from baseline to 26 weeks (paired t-test, p |
§ 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.