(147 days)
The Aquilex Fluid Control System H112 is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.
The Aquilex Fluid Control System H112 is a microprocessor controlled device that consists of the following two main components: (1) an irrigation pump unit and (2) and fluid monitoring unit that are to be placed on a special roller stand. The irrigation pump unit is a single roller pump that functions according to the peristaltic system. It is to be used with specially designed single use irrigation and outflow tube sets that are supplied sterile. The irrigation pump unit of the proposed device is only operational in conjunction with the fluid monitoring unit. Strict fluid intake and output surveillance is therefore ensured during the entire procedure.
The Aquilex Fluid Control System H112 is a medical device intended to provide liquid distension of the uterus during hysteroscopy and monitor fluid differential. The provided document details the 510(k) premarket notification for this device, comparing it to predicate devices to demonstrate substantial equivalence rather than presenting an exhaustive de novo clinical study with specific acceptance criteria that one would find for an AI/ML device.
However, based on the performance testing section, we can infer the acceptance criteria and reported device performance from the bench testing conducted.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Inferred from study description) | Reported Device Performance |
|---|---|---|
| Pump Display Pressure Accuracy | Pump display and model pressure measurements must be equal within the accuracy capability of the pressure display (5 mmHg increments) throughout the entire pressure range of the irrigation pump. | "The test results show that the pump display and model pressure measurements are equal within the accuracy capability of the pressure display (5 mmHg increments) throughout the entire pressure range of the irrigation pump." |
| Pressure Compensation for Morcellator Activation | Prevent uterine collapse due to pressure losses, effectively compensate initial short-term pressure losses, and recover to stable pressures within a few seconds after morcellator deactivation. | "The test results demonstrate the ability of the Aquilex System to effectively compensate for pressure changes resulting from aspiration when the MyoSure morcellator is activated across the full range of possible system settings... pressure losses that occurred after activation of the morcellator never fell to a critical point... initial short-term pressure losses were compensated effectively... recovery to stable pressures was reached within a few seconds after the morcellator was deactivated." |
| Fluid Deficit Determination Accuracy | Deficit accuracy must be within a range substantially equivalent to the accuracy of predicate devices and other cleared hysteroscopic fluid monitoring systems. | "The test results show that the deficit accuracy in each test run was within a range that is substantially equivalent to the accuracy of the predicate devices and other cleared hysteroscopic fluid monitoring systems." |
| Electrical Safety | Compliance with IEC 60601-1 (General Requirements for Medical Electrical Equipment - Part 1: General Requirements for Safety). | "The Aquilex Fluid Control System H112 has been tested and complies with the international standard IEC 60601-1..." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests). | "...and IEC60601-1-2..." |
| Sterility Validation | Compliance with ISO 11135-1 (Sterilization of health care products - Ethylene Oxide - Part 1) and ISO 10993-7 (Biological Evaluation of Medical Devices - Part 7); EO |
§ 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.