(90 days)
For use in cutting, vaporizing and coagulating soft tissue for clinical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open & endoscopic general surger y
Accu-Pulse is a DC excited gas-slab pulsed CO2 laser which produces 1-15 watts average power (see below for additional Surgical specifications).
The document provided is a 510(k) summary for the Accu-Pulse CO2 Surgical Laser System. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove device performance is not available in the provided text.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of acceptance criteria with corresponding device performance metrics from a study. Instead, it provides a "Table of Substantial Equivalence" which compares the Accu-Pulse to two predicate devices on various features. This table implicitly defines the acceptable range of performance as being comparable to the predicate devices.
| Feature | Predicate Device (Tissue Technologies Tru-Pulse) | Accu-Pulse (Reported Performance) |
|---|---|---|
| Power | 1-10 Watts | 1-15 Watts |
| Wavelength | 10.6 microns | 10.6 microns |
| Energy Density at Tissue | 5 J/cm² | 5 J/cm² |
| Indications for Use | Coagulation, vaporization, ablation of or cutting of soft tissue in dermatology, plastic surgery, podiatry and otorhinolaryngology | Coagulation, vaporization, ablation of or cutting of soft tissue in dermatology, plastic surgery, podiatry and otorhinolaryngology |
| Laser Type | DC slab excited | DC slab excited |
| Spot Size | 1, 3, 5mm | 3mm, 5mm & 7mm |
| Average Power | 1-10 Watts | 1-15 Watts |
| Mode | Multi-mode | Multi-mode |
| Exposure Duration |
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.