(210 days)
The IOGYN System is intended to distend the uterus by filling it with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and provide fluid management through the closed loop recirculation of filtered distension fluid. It is also intended for cutting and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device.
The IOGYN System is comprised of the following: IOGYN Controller with Integrated Fluid Management, Footswitch, Fluid Management Accessories, IOGYN Resecting Device. The IOGYN 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 uterine pathology. Fluid infusion and aspiration of the uterine cavity are controlled by the IOGYN Controller's peristaltic pumps, in conjunction with the Fluid Management Accessories; these components form a closed loop recirculating system. These integrated peristaltic pumps are operated by a software pressure control algorithm that measures and controls intrauterine cavity pressure by varying saline infusion and aspiration rates in response to pressure changes during aspiration and tissue resection using the Resecting Device. The IOGYN Controller Graphical User Interface (GUI) has fluid control settings which allow the user to toggle infusion ON/OFF and to set the cavity pressure from 30-125mmHg. The IOGYN System uses a closed loop fluid management system with a single 3-liter saline bag that continuously recirculates filtered distension fluid throughout the procedure. The fluid absorption is limited by the volume within the 3-liter saline bag minus the dead volume within the system, which limits the deliverable volume to less than 2.5L. The 2.5L of recirculated fluid is passed through a tissue catch and then a molecular filter to generate optically clear, sterile, filtered distension fluid which is returned to the 3 liter saline bag and recirculated.
The request is about acceptance criteria and study information for a specific medical device, IOGYN System. However, the provided text describes the device, its regulatory information, warnings, precautions, and a summary of nonclinical/bench studies, and clinical information without explicitly stating detailed acceptance criteria for each test or a comprehensive study proving specific quantitative acceptance criteria.
The document outlines various performance tests and their results (all reported as "Pass"), but it often refers to "device specification" or "target specification" without detailing the specific numerical or qualitative targets that constitute acceptance. For example, in the "Performance Testing - Fluid Management" section, it says "Specification for flow rate was met" but doesn't state what that flow rate specification was. Similarly, for "Pressure Control," it states "Actual pressure should not exceed set pressure by (b)(4) Trade Secret/CCI for more than (b)(4) Trade Secret/CCI" but the numerical values are redacted.
Therefore, a table of acceptance criteria and reported performance with quantitative metrics for each test cannot be fully constructed from the provided text due to the lack of explicit, unredacted numerical acceptance criteria for most tests.
However, I can extract the available information regarding the studies and performance as much as possible.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, explicit numerical acceptance criteria are largely redacted or not provided in the document. The table below summarizes the tests performed and the reported results (all "Pass"), indicating that the device met its internal specifications, even if those specifications are not detailed in this public document.
| Test Category | Specific Test / Criterion | Acceptance Criteria (as implied/stated) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility (Hemolysis, complement activation, coagulation), Reproductive Toxicity, Pyrogen testing (Filter and Aspiration/Infusion tubing) | Compliance with ISO 10993-1-2009 for patient-contacting materials and filtrate. Filtrate not posing significant reproductive toxicity risk. Filtration for bacteria, endotoxins, viruses meeting applicable test standards. | All tests passed; sufficient information provided. |
| Shelf Life/Sterility | Sterility Assurance Level (SAL), Packaging Integrity (Visual, Dye Penetration, Seal Peel Strength), Device Performance (RF connector, vapor/bubble formation, oscillations of inner tube, pressure sensor, tissue resection/aspiration without clogging, discoloration). | SAL of 10^-6 (VDmax method). Met ASTM standards for packaging integrity. Met specific functional criteria for device components (e.g., vapor/bubble formation, target oscillations, specific pressure sensor reading). | All tests passed. 7-month labeled shelf-life supported. |
| EMC and Electrical Safety | Electrical Safety Testing | Compliance with IEC 60601-1, UL 60601-1, CSA C22.2 No 601.1, EN 60601-1. | Pass (in both active and standby modes) |
| System Electromagnetic Compatibility (Radiated/Conducted Emissions, Current Harmonics, Voltage Fluctuations, Electrostatic Discharge, Radiated/Conducted Immunity, Surge, Power Frequency Magnetic Immunity, Voltage Dips and Interrupts) | Compliance with IEC 60601-1-2 and IEC 60601-2-2, CISPR 11, IEC 61000 series. | Pass (in both active and standby modes) | |
| Software | Software development, verification, validation, hazard analysis | Compliance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) for 'MAJOR' LOC devices; adequate mitigation of key hazards (fluid overload, overpressurization, air/gas embolism); software performs as intended. | Documentation provided; adequate and acceptable. |
| Mechanical Testing | Resecting Device (RD) Shaft Compression/Tensile, RD Cutting Window Bend, RD Cable Tensile, FMA Tubing to Connectors Tensile | RD shaft resists buckling under specified force; tensile force for RD shaft and cable meets device specification; bending force for cutting window meets device specification; tensile force for FMA tubing meets device specification. | All met the acceptance criteria ("Pass"). |
| Performance Testing (FMA) | Temperature and Coagulation Testing | Maximum temperature and coagulation depth meet predefined target specifications (ex vivo testing). | Pass |
| Maximum Aspiration Flow Rate (Diagnostic Mode, Resection Mode) | Specification for flow rate met. | Pass | |
| Maximum Infusion Flow Rate | Specification for flow rate met. | Pass | |
| Maximum Vacuum | Specification for vacuum met. | Pass | |
| Pressure Control | Actual pressure should not exceed set pressure by (b)(4) for more than (b)(4) of the time. | Pass | |
| Over Pressure Relief Testing | Pressure relief activates within (b)(4) of overpressure condition. | Pass | |
| Relief Valve | Pressure maintained (b)(4) mmHg. | Pass | |
| Backflow Valve | Valve activates at (b)(4) pressure. | Pass | |
| Dead Volume | Volume less than 2.5L. | Pass | |
| Filtration Testing (Molecular Filter, Tissue Catch Container and Capacity) | Molecular filter capable of capturing minimum blood specified while maintaining target pressure. Tissue catch meets filtration ability and maximum tissue capacity specifications. | All specifications met ("Pass"). | |
| Durability Testing | No device issues or rust/corrosion after (b)(4) hours of operation and tissue resection. | Pass | |
| Simulated Use Testing | Tissue coagulation, cutting, aspiration, and visualization were evaluated and met requirements. | Pass | |
| Usability Verification | Users able to appropriately follow IFU to setup system and perform procedure under simulated use conditions. | Pass | |
| Clinical Performance (Primary Endpoint) | Ability to resect tissue with the IOGYN system (Percentage of Polyp/Myoma removed) | Myoma: 75-100% removal for the majority of cases. Polyp: 75-100% removal for all cases. (Implied acceptance based on positive presentation of results). | Myoma (n=19): 16 (75-100% removed), 3 (0-49% removed). Polyp (n=29): 29 (100% removed). |
| Clinical Safety | Fluid deficit, Serious adverse events, Unanticipated adverse device effects, Histopathology of removed tissue. | Fluid deficit not exceeding 2500 mL. No serious adverse events or unanticipated adverse device effects. Histopathology showing consistent zone of thermal damage and sufficient tissue viability. | Fluid deficit did not exceed 2500 mL in any case. No serious adverse events or unanticipated adverse device effects reported. Histopathology showed consistent zone of thermal damage and sufficient tissue viability. |
2. Sample Sizes and Data Provenance for Test Sets
- Nonclinical/Bench Studies:
- Shelf Life Testing: Resection device (n=30) and fluid management accessories (n=30) were tested at baseline and after 7 months of real-time aging. Packaging integrity (peel strength, dye penetration) involved n=10 samples each. Device functionality tests involved n=10 samples.
- Mechanical Testing: 10 samples following simulated use and corrosion exposure.
- Performance Testing (Fluid Management): 10 samples of FMA and RDs.
- Durability Testing: Devices operated for over (b)(4) Trade Secret/CCI (number redacted) hours.
- Simulated Use Testing: Used (b)(4) Trade Secret/CCI (description redacted).
- Data Provenance: Bench testing, ex-vivo testing (for Temperature and Coagulation Testing) in a lab setting.
- Clinical Testing:
- Sample Size: 36 subjects (age 25 to 65 years with endometrial polyps and/or submucosal myomas) enrolled. 34 subjects were treated.
- Data Provenance: Prospective (implied by "clinical studies were conducted...between October 2012 and May 2013" with follow-up), multi-country (Mexico, Hungary, Canada).
3. Number of Experts and Qualifications for Establishing Ground Truth (Clinical Test Set)
The provided text does not specify the number of experts used to establish ground truth for the clinical test set, nor their specific qualifications (e.g., radiologist with X years of experience). The clinical study focused on the "ability to resect tissue" and observed "histopathology examination of the removed tissue," which implies a pathologist would be involved in ground truth, but no details are given. The report states "The sponsor concluded that a large intramural myoma migrated into the visual field secondary to incision of the myoma capsule," suggesting clinical observation and potentially a surgeon's assessment.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical test set or any other test set. Clinical outcomes appear to be reported as observed within the study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as described in the provided text. The clinical study evaluated the device's performance directly, not human readers' improvement with or without AI assistance. The IOGYN System is a medical device for hysteroscopic procedures, not an AI diagnostic tool that assists human readers.
6. Standalone (Algorithm Only) Performance Study
As the IOGYN System is a closed-loop hysteroscopic insufflator with cutter-coagulator, it is a physical device that performs surgical functions and fluid management. It is not an "algorithm only" device in the sense of a diagnostic AI. Its "performance" is inherently linked to its physical operation, and thus, a "standalone algorithm only" study is not applicable in the typical AI context. However, the software components underwent standalone verification and validation testing as part of the overall software safety and performance assessment for a 'MAJOR' level of concern device.
7. Type of Ground Truth Used
- Nonclinical/Bench Studies: Ground truth was established by engineering specifications, physical measurements, and defined performance criteria (e.g., flow rates, pressure ranges, mechanical strength limits, bacterial/viral removal percentages, durability hours).
- Clinical Testing: Ground truth for the primary endpoint (tissue resection) was based on observed surgical outcomes (percentage of myoma/polyp resected) and histopathology results of the removed tissue. Safety ground truth included clinical observation of adverse events and fluid deficit measurements.
8. Sample Size for the Training Set
The document does not specify a "training set" in the context of an AI/machine learning algorithm, as the IOGYN System is a physical device with integrated software for control, not a learning algorithm that requires a traditional training set. The software itself underwent hazard analysis, verification, and validation, but this is distinct from training an AI model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no mention of a "training set" for an AI/machine learning algorithm in the provided document. The software's "ground truth" or correct functionality was established through software requirements specifications, design documents, and subsequent verification and validation testing against those specifications.
§ 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.