(120 days)
The Hysteroscopy Pump HM6 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 Hysteroscopy Pump HM6 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 cart. The irrigation pump unit is a single roller pump that functions according to the peristaltic system and includes a manmachine interface (MMI) and a touch-screen display. The Hysteroscopy Pump HM6 is to be used with specially designed single use irrigation and outflow tube sets that are supplied sterile. The fluid monitoring unit of the Hysteroscopy Pump HM6 is a microprocessor controlled device, which monitors the amount of delivered irrigation solution and compares it with the volume of the secretions returned to the container. The monitoring enables the surgeon to observe the quantity of fluids left in the patient. The irrigation pump unit of the proposed device indicates any fluid deficit that exceeds the fluid deficit level pre-set by the surgeon. The Hysteroscopy Pump HM6 determines both the inflow and outflow volume by means of two separate scales.
This document describes a 510(k) premarket notification for the Hysteroscopy Pump HM6. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical studies with acceptance criteria. Therefore, the information provided is primarily focused on demonstrating the similarity of the new device to existing devices on the market, relying on bench testing for performance.
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical trial proving a specific efficacy or accuracy metric. Instead, the "performance testing" section refers to bench tests and compliance with standards. The key "acceptance criterion" for this 510(k) submission is showing that the device is substantially equivalent to predicate devices and that the modifications do not raise new questions of safety and effectiveness.
The document highlights the following performance aspects and their comparison to the predicate Aquilex System:
| Acceptance Criterion (Implied) | Reported Device Performance (Hysteroscopy Pump HM6) |
|---|---|
| Accuracy of fluid deficit measurement | Improved to = 0% compared to = 10% for the predicate device (Aquilex System) due to a separate scale for inflow volume. |
| Maximum selectable pressure | Identical to the Aquilex System (150 mmHg). |
| Safety features (e.g., active pressure reduction, overpressure warnings, fluid deficit warnings) | Same or similar to predicate devices. |
| Software validation | Performed in accordance with FDA Guidance document "General Principles of Software Validation", with the software considered "Major Level of Concern". |
| Electrical Safety and EMC | Performed in accordance with IEC 60601-1 by an accredited test institute. |
| Design modifications (mechanics, hardware, software) | Results from internal design control process, including risk analysis. Validation and verification testing of system specifications performed as bench tests. |
| Tubing design and material | Identical to the Aquilex System, with minor length changes and addition of a clamp for the outflow tube set. |
| Fluid bag detection feature | New safety feature informs user if fluid in bag is |
§ 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.