(77 days)
The SubNovii is intended for the removal and destruction of skin lesions and coaqulation of tissue.
The SubNovii Advanced Plasma Technology is a handheld battery powered device that, when activated and placed in close proximity to the skin, generates an ionized electrical arc through the tip of an electrode (Tip) to the skin without the device or the electrode touching the skin. The SubNovii Advanced Plasma Technology consists of the SubNovii handpiece, single use disposable tips and a battery charger.
The provided FDA 510(k) summary for the SubNovii Advanced Plasma Technology references acceptance criteria and studies primarily focused on establishing substantial equivalence to a predicate device, rather than defining novel performance criteria for a diagnostic AI device.
Here's a breakdown of the requested information based on the provided text, with clarifications where direct answers are not available due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate equivalence) | Reported Device Performance (SubNovii) |
|---|---|
| Electrical Safety | Pass (Compliance with EN 60601-1) |
| Electromagnetic Compatibility (EMC) | Pass (Compliance with EN 60601-1-2) |
| Tissue Damage (Superficiality) | Equivalent to predicate device (tissue damages |
§ 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.