(89 days)
The Candidate Devices are intended for irrigation, evacuation of body fluids, and electrosurgical cutting/coagulation during general laparoscopic surgical procedures, (e.q. laparoscopic cholecystectorny, appendectomy and herniorrhaphy). They are not intended for use in hysteroscopy or for contraceptive coagulation of the Fallopian tube.
The Candidate Devices are indicated for use in patients eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures.
When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, suction source, electrosurgical generator and suction/irrigation trumpet valve, the Candidate Devices provide irrigation, suction and electrosurgical cutting and coagulation capabilities to the operative site during general laparoscopic surgical procedures.
Provides electrosurgical cutting and coagulation to the surgical site during general laparoscopic surgical procedures by communicating the high-frequency electric current generated by a legally-marketed electrosurgical generator to the operative site.
The Candidate Devices consist of a stainless steel cannula and connector used to communicate electrosurgical, suction, and irrigation capabilities to the operative site during laparoscopic surgical procedures.
I am sorry, but the provided text focuses on the regulatory submission (510(k) summary) of the Modulap® Disposable Unipolar Electrosurgical Probes and Inserts. This type of document is about demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving performance against specific acceptance criteria.
Therefore, the information you requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text. The document confirms that the device provides "electrosurgical cutting and coagulation capabilities", but it does not detail how this performance was measured or how acceptance criteria were met through a specific study.
The FDA's 510(k) review process primarily focuses on comparing a new device to an existing, legally marketed predicate device to ensure it is as safe and effective, rather than requiring a full-scale clinical trial to establish de novo performance criteria for every new submission, especially for accessories like these.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.