(184 days)
The Irrigation/Aspiration/Coagulation Electrodes, ICE-311 and ICE-511, are indicated for electrosurgical fulguration (coagulation) of the uterine cervix as part of the procedure called Loop Excision of the Transformation Zone (LETZ®), or other loop electrosurgery procedures where simultaneous electrosurgical fulguration and small-volume fluid irrigation and/or aspiration is needed.
The device consists of a stainless steel spherical ball electrode attached to an ULTEM® irrigation and aspiration head that has PVC irrigation and aspiration tubes. The posterior end of the electrode shaft fits snugly into a standard electrosurgical pen which is connected to an electrosurgical generator that has been cleared for marketing by the FDA. The irrigation tube has a PVC female Luer fitting for connection to a fluid source and the aspiration tube has an ABS suction adapter for connection to a standard vacuum suction system.
The provided document is a 510(k) summary for a medical device called the "TBD Irrigation Aspiration Coagulation Electrode" (ICE). This summary describes the device and its substantial equivalence to previously cleared devices. However, it does not include a detailed study proving the device meets specific acceptance criteria in the format requested.
The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and functional comparisons with predicate devices, rather than presenting a performance study with defined acceptance criteria.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and what is missing:
Information that can be extracted/inferred:
- Device Performance Reported: The document reports that:
- "Laboratory tests of the UMP ICE and the MMP #0055 have demonstrated that the irrigation fluid flow differs by less than 4% and that the aspiration capability differs by less than 8%."
- "The coagulation capabilities of the UMP ICE and the UMP ACE are equivalent since they are based on the same UMP DBL electrodes."
Information that is missing or not explicitly detailed in the provided text:
- A table of acceptance criteria: Specific, quantifiable acceptance criteria are not explicitly defined in the document as "acceptance criteria." Instead, the performance metrics mentioned above (e.g.,
§ 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).