(58 days)
The AtriCure Dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.
The AtriCure Dissector™ is a hand held, single use, surgical articulated dissector with intearal light source intended to for use by qualified surgeons only. The surgeon is able to articulate the distal member of the device by means of hand actuated rotation knob. The surgeon directly controls the amount of articulation and tissue dissection. A small light source is attached to the distal tip of the articulation member, which remains illuminated for a minimum of four (4) hours. Multiple models of the Dissector™ are available with varving shaft lengths to accommodate surgeon preference and differing patient habitus.
The provided text is a 510(k) Summary for a medical device called the AtriCure Dissector™. It describes the device, its intended use, and claims substantial equivalence to a previously cleared device. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample size, ground truth, or expert involvement in such a study.
The document does mention:
- "Appropriate product testing was conducted according to the Design Control requirements as defined in 21 CFR 820.30 to evaluate conformance to product specification and substantial equivalence to the legally marketed device."
- "These activities included Risk Analysis, Process Verification, and Biocompatibility Testing."
- **"Biocompatibility testing was conducted according to ISO 10993-1 to confirm that the modified Dissector™ is safe for limited use (
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.