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510(k) Data Aggregation
(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 < 5 mg/10 days, ECH < 5 mg/10 days, SAL ≤ 10^-6. | "ETO sterility validation of the tube sets was performed in accordance with ISO 11135-1... and ISO 10993-7... Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO < 5 mg / 10 days and ECH < 5 mg / 10 days that remain on the tube set will not be exceeded. A sterility assurance level (SAL) of ≤ 10^-6 is achieved." |
| Package and Product Integrity | Compliance with ISO11607-1 (Packaging for Terminally Sterilized Medical Devices) and ASTM-F-1980-02 (Standard for Accelerated Aging of Sterile Medical Device Packages). | "Package and product integrity of the tube sets were tested in accordance with ISO11607-1... and ASTM-F-1980-02..." |
2. Sample size used for the test set and the data provenance
The document describes bench testing, meaning the "test set" consisted of physical bench setups and equipment rather than patient data. Specific sample sizes (e.g., number of test runs, number of cycles) for each test are not explicitly quantified in the summary, but the wording implies that a sufficient number of tests were performed to demonstrate compliance and consistency.
- Pump Display Pressure Accuracy: Implied multiple pressure points across the entire range with a uterine model.
- Pressure Compensation for Morcellator Activation: Implied multiple tests across the full range of possible system settings with the MyoSure morcellator and high vacuum pump.
- Fluid Deficit Determination Accuracy: "each test run" implies multiple runs were conducted.
- Sterility Validation & Package/Product Integrity: These are standard laboratory tests often conducted on a sample of manufactured devices/packages.
Data Provenance: The tests were conducted in a laboratory/bench setting by the manufacturer (W.O.M. WORLD OF MEDICINE AG). This is typically considered prospective testing for device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to the described performance testing. The ground truth for this device (e.g., actual pressure, actual fluid volume, sterility) is established by physical measurement standards, calibrated equipment, and internationally recognized testing protocols (e.g., IEC, ISO, ASTM standards), not by human expert consensus or clinical judgment.
4. Adjudication method for the test set
This is not applicable. The performance tests are quantitative measurements against predefined physical or regulatory standards using instruments, not subjective interpretations 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
None. This document describes a 510(k) premarket notification for a hardware medical device (fluid control system), not an AI/ML diagnostic or assistive software. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is entirely irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence. The performance testing described (pump accuracy, pressure compensation, fluid deficit accuracy, electrical safety, sterility, packaging) assesses the device's functionality and adherence to specifications without human intervention in the loop of the measurement itself. The device is designed to operate autonomously in performing its functions (pumping, monitoring, regulating).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the performance testing is based on:
- Physical measurement standards: Calibrated pressure gauges, flow sensors, weighing scales for fluid volume, and electrical measurement equipment.
- Engineering specifications and algorithms: For the pump's pressure regulation and fluid deficit calculation.
- International standards: For electrical safety (IEC 60601-1, IEC 60601-1-2), sterility (ISO 11135-1, ISO 10993-7), and packaging (ISO11607-1, ASTM-F-1980-02).
- Equivalence to predicate devices: For fluid deficit accuracy, the ground truth for "acceptable range" is implicitly established by the performance of legally marketed predicate devices.
8. The sample size for the training set
Not Applicable. This is a hardware device submission, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's "training" or development involves engineering design, prototyping, and iterative testing, not the statistical training of a machine learning model on a dataset.
9. How the ground truth for the training set was established
Not Applicable. As there is no "training set" for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The device's operational parameters and design were developed through traditional engineering principles validated by physical testing.
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