(85 days)
The proposed kit is indicated for suprapubic bladder drainage and percutancous access for the placement of theminsensor probes in patients undergoing ultrasound-guided urological cryosurgery procedures in accordance with the indications of legally marketed cryosurgery systems.
The kit is comprised of guidewire(s), access needles(s), dilator(s), divinage catheter with connecting tube, scalpel and syringe.
This document is a 510(k) Premarket Notification for a medical device (Percutaneous Introducer System) from 1996. It does not contain the type of detailed study information, acceptance criteria, or performance data that would be relevant to evaluating an AI/ML powered device. The document predates the widespread use of AI/ML in medical devices by decades.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to this 1996 device submission.
The document primarily focuses on establishing "substantial equivalence" of the device and its components to already legally marketed devices.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.