(272 days)
The intended use of the Quantum 2000 System is for in-office electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include:
- Cervical Conization.
- Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
- External Anogenital Lesions.
- Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.
WALLACH QUNATUM 2000 ELECTROSURGICAL SYSTEM
This document is a 510(k) premarket notification decision letter from the FDA to Wallach Surgical Devices, Inc. regarding their Quantum 2000 Electrosurgical System. It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
The provided text does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory clearance document, not a clinical study report. It indicates that the device is substantially equivalent to devices marketed prior to May 28, 1976, which is the basis for its clearance, not performance against specific acceptance criteria.
Therefore, I cannot answer the questions regarding acceptance criteria and a study that proves the device meets the acceptance criteria from the provided text.
§ 884.4120 Gynecologic electrocautery and accessories.
(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).