(199 days)
The loop electrodes are designed for the LEEP or LLETZ procedure, which is performed to remove a lesion of abnormal cells from the cervix. The loop electrode is attached to an electrosurgical generator that mits an electrical current used to cut away the affected tiscues following the removal of the cells in the affected area the ball electrode is used to seal the area and stop any bleeding that may have occurred.
Some indications for use are:
- a. Cervical conizations
- b. Large Loop Excision of the Transformation Zone (LLETZ) in the Diagnosis and Treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
- c. External Anogenital Lesions
- d. Large Vaginal Intraepithelial Neoplasic (VAIN) Lesions.
Disposable Ball and Loop Electrodes
The provided text is a 510(k) clearance letter from the FDA for a medical device: "Disposable Ball and Loop Electrodes". This type of document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting detailed studies with acceptance criteria and performance data like those you'd find for novel high-risk devices or software as a medical device (SaMD).
Therefore, the input document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or MRMC studies.
The clearance letter indicates that the device is "substantially equivalent" to legally marketed predicate devices, meaning that the FDA determined it is as safe and effective as a device already on the market. This often relies on comparing the new device's design, materials, and intended use to a predicate device, rather than requiring extensive clinical trials with specific performance metrics against pre-defined acceptance criteria.
In summary, the provided document does not contain the study details, acceptance criteria, or performance data that you've asked for due to the nature of a 510(k) substantial equivalence determination.
§ 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).