(189 days)
The Proposed HydroFlex Hysteroscopic Distention System is intended to provide distention and irrigation of the uterus with low viscosity fluids for diagnostic and/or operative hysteroscopy.
The modified 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 better visualization during hysteroscopic procedures and flushes blood and tissue debris from the operative site. The modified 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 provided text describes modifications to the Davol HydroFlex™ HD System, a hysteroscopic distention and irrigation system. The 510(k) submission aims to demonstrate substantial equivalence to previous versions and predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Parameter | Acceptance Criteria (based on predicate or guidance) | Reported Device Performance (Modified HydroFlex HD) | Equivalence Demonstrated? |
|---|---|---|---|
| Maximum Static Intrauterine Pressure | Below 150 mmHg (based on "Draft Submission Guidance for a 510(k), Hysteroscopic and Laparoscopic Insufflators" dated Aug 1, 1995) | Below 150 mmHg (same as original HydroFlex HD, also stated as "approximately 100mmHg or 2.0 psig" by the main controller in the description) | Yes |
| Irrigation Flow Rate | At least 600 ml/minute (based on Hamou Endomat predicate) | Up to 600 ml/min or 630 ml/minute (higher than original HydroFlex HD, substantially equivalent to Hamou Endomat) | Yes |
| Pressure Relief Valve (PRV) Functionality | To relieve static pressures to below 150 mmHg (same as original HydroFlex HD PRV) | Relieves pressures to an acceptable level for hysteroscopic distention procedures, equivalent to the original HydroFlex HD PRV | Yes |
| Biocompatibility of Materials in Fluid Path | Materials suitable for externally communicating devices with limited duration tissue contact (Guidance: FDA General Program Memorandum #G9S-1) | Materials shown to be suitable | Yes |
| Electrical Safety Standards | Conformance to UL 2601-1 and ANSI/AAMI ES1-1993: Safe Current Limits for Electromechanical Apparatus (same as original HydroFlex HD Controller) | Conforms (no changes to controller, so original test results apply) | Yes |
| Electromagnetic Compatibility Standards | Conformance to IEC 601-1-2 (same as original HydroFlex HD Controller) | Conforms (no changes to controller, so original test results apply) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of devices or test runs) used for the performance testing. It refers to "testing was performed to evaluate the effect of the modifications on performance."
The data provenance is for a medical device manufactured by Davol Inc. in Cranston, RI, USA. The testing appears to be prospective testing conducted specifically for this 510(k) submission to demonstrate the performance of the modified device in comparison to its predicates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a fluid management system, and its performance is evaluated through engineering and functional testing against specified parameters (e.g., pressure, flow rate). There is no "ground truth" derived from expert interpretation of medical images or patient outcomes in the context of this device's performance claims.
4. Adjudication Method for the Test Set
This is not applicable as there is no human interpretation or subjective assessment involved that would require adjudication. Performance is measured objectively.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of medical images or data. The HydroFlex HD System is an accessory device that provides mechanical functions (distention and irrigation).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The HydroFlex HD System is a physical device, not an algorithm. Its performance is inherent to its design and functionality, which is what the testing evaluated.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing in this submission is established through objective engineering measurements (e.g., pressure gauges, flow meters) against pre-defined specifications and regulatory guidance. For biocompatibility, the ground truth is adherence to established standards and guidelines (e.g., FDA General Program Memorandum #G9S-1).
8. The Sample Size for the Training Set
This is not applicable. The device is an electro-mechanical system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this device.
§ 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.