(336 days)
The HydroFlex HD Hysteroscopic Distention System is intended to provide distention and irrigation of the uterus with low viscosity fluids during diagnostic or operative hysteroscopy.
The HydroFlex HD system is designed to provide distention and irrigation of the uterus with low viscosity fluids during diagnostic or operative hysteroscopy. The system distends the uterus for for better visualization during hysteroscopic procedures and flushes blood and tissue debris from the operative site.
The HydroFlex HD hysteroscopic distention tubing set is intended for use with the HydroFlex Irrigation Pump Controller. Pressure in the pumping chamber is determined by the setting on the main controller which is calibrated to account for 16 inches of bag height above the outflow. Maximum static pressure (all outflow closed and no fluid flow) applied to the intrauterine space is limited to approximately 100mmHg or 2.0 psig, by the main controller. Rate of flow is dependent upon the pumping chamber pressure.
Fluid will stop flowing when the back pressure in the system equals the pressure setting on the controller. Under static pressure conditions with no outflow this will equal the intrauterine pressure. The impeller continues to spin even with flow stopped and, in this way, the selected pressure is maintained. Flow will automatically resume when system back pressure falls below the selected pressure.
The HydroFlex HD system is driven by an impeller pump which is powered by an electronic Controller. The input pressure is determined by the user selected setting on the electronic Controller. The Controller determines the speed of the impeller pump which drives the flow of irrigant and determines the resultant static pressure. Both the HydroFlex HD and the Zimmer CDIS system contain a pressure relief valve which limits the maximum intrauterine static pressure by releasing fluid through the valve and drain tube. The HydroFlex HD system pressure relief valve relieves static pressures if the pressure reaches 150mmHg.
The provided document is a 510(k) summary for the Davol Hydro-Flex HD System. It details the device's substantial equivalence to predicate devices based on laboratory bench testing. However, it does not contain the level of detail required for a comprehensive description of acceptance criteria and the study proving it meets those criteria, particularly concerning human reader performance, ground truth establishment for a training set, or specific sample sizes beyond the general mention of "laboratory bench testing."
Here's an attempt to extract the requested information, noting where the document is insufficient:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Static Intra-Uterine Pressure | Adequate for hysteroscopic distention and irrigation (equivalent to predicate devices, specifically Zimmer CDIS 85mmHg max, HydroFlex HD up to 100mmHg). | HydroFlex HD provides adequate static intra-uterine pressures; PRV relieves pressure to an acceptable level. |
| Irrigation Flow Rate | Adequate for hysteroscopic distention and irrigation (equivalent to predicate devices). | HydroFlex HD provides adequate irrigation flow rates. |
| Pressure Relief Valve (PRV) Function | Relieve excessive fluid pressure to an acceptable level (HydroFlex HD relieves at 150mmHg; Zimmer CDIS at 100-110mmHg). | PRV testing demonstrated the ability to relieve pressures to an acceptable level for hysteroscopic distention. |
| Biocompatibility | Materials in fluid path suitable for externally communicating devices with limited duration tissue contact. | Biocompatibility testing showed materials are suitable. |
| Electrical Safety | Conformance to UL 2601-1 and ANSI/AAMI ES1-1993. | HydroFlex HD system will conform to applicable electrical safety standards. |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 601-1-2. | HydroFlex HD system will conform to applicable electromagnetic compatibility standards. |
| Misuse Prevention | Minimize chance of incorrect disposable use with Controller. | Design features (labeling, recognition switches, LED display, confirmation button) implemented to minimize misuse. |
Note on Acceptance Criteria: The document primarily establishes "substantial equivalence" to predicate devices. The acceptance criteria are largely implicit in demonstrating that the HydroFlex HD system performs "adequately" and "similarly" to the predicate, or that differences do not raise new safety/effectiveness questions. Specific numerical acceptance criteria are not explicitly stated in most cases, beyond the pressure relief valve target.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "Laboratory bench testing" on "three different hysteroscopes" at "low, mid-range and maximum input pressures." This suggests some experimental design, but specific N-values (e.g., number of test runs, replicates) are not provided.
- Data Provenance: The testing was "Laboratory bench testing" conducted by Davol Inc. (the manufacturer). This is a prospective test, as it was performed during the development and regulatory submission process for the new device. Country of origin for the data is implicitly the USA, where Davol Inc. is based.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This study is a bench test comparing device performance against predetermined physical parameters and predicate device performance. It does not involve human interpretation or diagnostic decision-making that would require expert-established ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. As this was a laboratory bench test, there was no need for adjudication involving human readers or expert consensus. The measurements obtained would be objective (e.g., pressure readings, flow rates).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not conducted as this is a physical device (hysteroscopic distention and irrigation system), not an AI or imaging diagnostic tool that relies on human interpretation. Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes (Implicit). The "Laboratory bench testing" described assessed the device's performance (flow rates, pressures, PRV function) independently of a human operator's skill or intervention beyond setting initial parameters. It's an "algorithm only" equivalent in the sense that the device's mechanical and electronic functions were tested in isolation to determine its inherent performance characteristics.
7. Type of Ground Truth Used
- The ground truth used for this study was based on:
- Physical Measurements: Objective measurements of static pressure and flow rates.
- Engineering Specifications: The design parameters for the HydroFlex HD (e.g., max static pressure of 100mmHg, PRV relief at 150mmHg).
- Predicate Device Performance: The established performance characteristics of the Zimmer CDIS System and Linvatec Apex Universal Irrigation System served as benchmarks for demonstrating "substantial equivalence."
- Regulatory Standards: Conformance to electrical safety (UL 2601-1, ANSI/AAMI ES1-1993) and EMC (IEC 601-1-2) standards.
- Biocompatibility Standards: Conformance to FDA General Program Memorandum #G95-1.
8. Sample Size for the Training Set
- Not Applicable. This device is a mechanical and electronic system, not an AI or machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. No training set was used.
§ 884.1700 Hysteroscopic insufflator.
(a)
Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.