(51 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 O
- Fluid Management Accessories o
- 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 intra-uterine 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 3liter 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 two levels of filtration - the first level of filtration removes resected tissue and bulk particles; the second level of filtration removes cellular materials, hemoglobin, plasma proteins, cytokines, coagulation factors, bacteria and viruses. These two levels of filtration generate optically clear, sterile, filtered distension fluid which is returned to the 3 liter saline bag and recirculated.
The provided text is a 510(k) summary for a medical device called the IOGYN System. It focuses on demonstrating substantial equivalence to a predicate device after minor material changes and does not provide detailed information about acceptance criteria and comprehensive study results in the format requested.
Therefore, much of the requested information cannot be extracted from this document.
However, I can extract what is available:
1. A table of acceptance criteria and the reported device performance
The document mentions "Performance Testing" which includes:
- Simulated Use
- Durability Testing
- Hi Pot Testing
- Tensile Strength
- Flow Rate
- Pressure Testing
- System undeliverable volume (dead volume)
It states "All device bench test results were acceptable. Data demonstrate that the Resecting Device and the Fluid Management Accessories meet design specifications and are suitable for the intended use and labeled shelf-life."
Without the specific design specifications or quantitative acceptance criteria, a table cannot be fully constructed. The document only provides a qualitative statement that results were "acceptable" and met "design specifications."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Acceptable |
| Not specified | Meets design specifications |
| Not specified | Suitable for intended use |
| Not specified | Suitable for labeled shelf-life |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for any of the performance tests. There is no information regarding the provenance of the data (e.g., country of origin) or whether it was retrospective or prospective. The testing described appears to be bench/laboratory testing rather than clinical study data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This entire section is not applicable. The document describes bench testing for material changes in a medical device (IOGYN System), not a study involving human subjects or image interpretation that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study assessing diagnostic performance or requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth as typically defined in diagnostic studies is not relevant here. The "ground truth" for the performance tests would be the established engineering specifications and validated test methods for mechanical, electrical, and fluid dynamics properties.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.