|
(a) Identification. A closed loop hysteroscopic insufflator with cutter-coagulator is a prescription device configured for hysteroscopic insufflation, resection, and coagulation. It is used to perform diagnostic and surgical procedures (i.e., resection and coagulation). This device type contains a closed-loop recirculating fluid management system for the controlled delivery of filtered distension fluid. This device type also contains a bipolar radiofrequency device used in conjunction with a hysteroscope for resection and coagulation of intrauterine tissues.
(b) Classification. Class II (special controls). The special control(s) for this device are:
(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Software validation, verification, and hazard analysis must be provided.
(3) Electrical equipment safety, including appropriate thermal and mechanical safety and electromagnetic compatibility (EMC) testing must be performed.
(4) Device components that are labeled sterile must be validated to a sterility assurance level of 10â??6.
(5) Shelf-life testing that demonstrates the device packaging maintains sterility and the functionality of the device is maintained following simulated shipping and handling must be provided to support the proposed shelf life.
(6) Non-clinical testing data must demonstrate the performance characteristics of the device. Detailed protocols and the test reports must be provided for each test.
(i) The following tests must be performed for the resection portion of the device:
(A) Mechanical testing to assess critical joint strength.
(B) Device electrode temperature testing.
(C) Coagulation depth testing.
(D) Simulated use testing.
(E) Device durability testing.
(ii) The following tests must be performed for the fluid management portion of the device:
(A) Mechanical testing to assess tensile strength of connections.
(B) Pressure testing that demonstrates the following parameters, including accuracy of the pressure displayed; appropriate detection and response to overpressure conditions; activation of a secondary overpressure relief valve at the maximum safe level; and all accessories within the fluid path meet the pressure requirements.
(C) Fluid delivery volume testing that demonstrates that the maximum fluid volume delivered is below a predefined level.
(D) Flow rate testing.
(E) Simulated use testing.
(F) Filtration testing.
(G) Blood filtration capacity testing.
(H) Tissue collection capacity testing.
(I) Filtrate characterization and testing that demonstrates that the continuous reintroduction of filtrate into the uterus does not pose a safety risk.
(7) Clinician labeling must include:
(i) Specific instructions and the clinical training needed for the safe use of the device.
(ii) Appropriate warnings, precautions, and information related to overpressurization.
(iii) Appropriate EMC information.
(iv) An expiration date/shelf life.
[82 FR 35073, July 28, 2017]
| 
