(58 days)
The Symphion Operative Hysteroscopy System and accessories are intended for resection and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device by distending the uterus with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and providing fluid management through either the closed loop recirculation of filtered distension fluid or non-filtered distension fluid.
The Symphion Operative Hysteroscopy System is comprised of the following:
- Controller with IV Pole and Footswitch
- Resecting Device
- Fluid Management Accessories (INFINITY FMA and EXPRESS FMA)
- Fluid Deficit Readout Optional Accessory
The Symphion Operative Hysteroscopy System provides an integrated control system with bipolar radiofrequency outputs (cut and coagulation) and fluid management through the use of two integrated peristaltic pumps. The Resecting Device is a bipolar radiofrequency device configured for the resection and aspiration of the uterine pathology. Fluid infusion and aspiration of the uterine cavity are controlled by the Controller's peristaltic pumps, in conjunction with the Fluid Management Accessories. The Symphion Controller, with software version 3.0.0 or higher, is designed to be used in either a recirculating (closed-loop) or non-recirculating system configuration. The Fluid Manaqement Accessories are disposable tubing sets and are available in two models, INFINITY FMA and EXPRESS FMA. The FMAs are designed to assist with the delivery, monitoring, and control of the amount of distention media delivered to the uterine cavity when used with the Symphion controller. When the controller is used with the INFINITY FMA, the system components form a closed-loop recirculating system configuration. Alternatively, when the controller is used with EXPRESS FMA, the system components form an open, nonrecirculating, system configuration. The INFINITY FMA is designed to be used in all types of intrauterine pathology whereas the EXPRESS FMA, lower cost alternative, may be more suitable for softer type tissues or in procedures that require a shorter resection time such as polypectomy, visual D&C and similar.
The integrated peristaltic pumps are operated by a software pressure control algorithm, specific to use with either INFINITY FMA or EXPRESS FMA configurations, that measures and controls intra-uterine cavity pressure by varying saline infusion and aspiration rates in response to pressure changes during aspiration and tissue resection when using the Resection Device. The Symphion Controller Graphical User Interface has two options for initial set up depending on which FMA configuration is being used during the procedure. There are fluid control settings which allow the user to toggle infusion ON/OFF and to set the target cavity pressure from 45-125mmHg. Subsequent to the initial setup GUI, all procedure and control settings are identical regardless of which FMA configuration is being used. The system includes an optional Fluid Deficit Readout accessory device which is an independent saline bag measurement scale to present the user with a digital real-time fluid loss/fluid deficit reading during the Symphion procedure.
The provided document is a 510(k) premarket notification decision letter from the FDA regarding the Minerva Surgical Symphion Operative Hysteroscopy System. It details the device, its intended use, comparison to predicate devices, and a summary of non-clinical testing. However, it does not contain the specific acceptance criteria, reported device performance data, sample sizes, expert qualifications, or adjudication methods typically found in a clinical study report. It states that "Clinical Testing was not required."
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, or MRMC studies, as this information is not present in the provided text.
The document only summarizes that:
- A range of non-clinical performance tests were conducted.
- These tests were performed at the system, component, and subassembly levels.
- The system met its performance specifications and performs as intended.
- "All results have been deemed acceptable" for various tests (Biocompatibility, Software Verification, Electrical Equipment Safety, Sterilization, Shelf Life Testing, Packaging and Transit Testing).
- For Performance Testing (Special Controls), which covers aspects like mechanical testing, pressure testing, fluid delivery, flow rate, simulated use, filtration, blood filtration capacity, tissue collection capacity, and filtrate characterization, "All results have been deemed acceptable."
Since clinical testing was not required for this 510(k) submission, there isn't a "study that proves the device meets the acceptance criteria" in the sense of a clinical trial with human subjects and associated statistical analyses as would be typically implied by your request. The provided text only confirms that non-clinical performance and design verification tests were completed and deemed acceptable.
§ 884.1710 Closed loop hysteroscopic insufflator with cutter-coagulator.
(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 10
−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.