(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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WORLD OF MEDICINE
FEB - 6 2012
Aquilex Fluid Control System H112 Special 510(k) Premarket Notification
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
Submitter:
W.O.M. WORLD OF MEDICINE AG Alte Poststrasse 11 96337 Ludwigsstadt Germany
Phone: +49 9263 877 131 Fax: +49 9263 877 137
Contact Person:
Susanne Raab Regulatory Consultant 1480 Cambridge Street Cambridge, MA 02139
Phone: (617) 547-0628 (617) 520-2401 Fax: e-mail: sbraab@comcast.net
Date Prepared:
Aquilex Fluid Control System H112 Trade Name:
January 28, 2012
Common Name: Hysteroscopic Insufflator, Fluid Monitoring System and Tube Sets
Hystersoscopic Insufflator and Accessories under Classification Name:
21 C.F.R. 884.1700
Regulatory Class: II
HIG Product Code:
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Predicate Devices: IUR Fluid Management System, W.O.M. WORLD OF MEDICINE AG, K031616
FLOSIMPLE Arthroscopy Pump A120, W.O.M. WORLD OF MEDICINE AG, K062380
Flo-Stat Fluid Monitoring System, Gynecare Innovation Center, K083211
Karl Storz Hamou Endomat, Karl Storz Endoscopy-America, K936231
Device Description:
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.
Intended Use:
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.
Summary of Similarities and Differences in Technological Characteristics:
The Aquilex Fluid Control System H112 ("the Aquilex System") and the predicate devices use the same or similar basic operating principles and incorporate the same or similar basic design including materials. Specifically, the Aquilex System and the predicate devices IUR Fluid Managment System ("the IUR System") and Flo-Stat Fluid Monitoring System ("the Flo-Stat System") incorporate the following main components: (i) an irrigation pump, (ii) a fluid monitoring unit, and (iii) an irrigation tube set. Furthermore, like the predicate irrigation pump Karl Storz Hamou Endomat, the Aquilex System is designed with a vacuum function that is to be used with specially designed vacuum tube sets.
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The irrigation pumps of the Aquilex System and the predicate devices are all electro-mechanical and microprocessor controlled devices that function according to the peristaltic principle. Both the Aquilex System and the predicate devices utilize pressure sensors to monitor the intrauterine pressure. To achieve the desired pressure within the cavity, the pressure sensor of both the Aquilex System and the predicate devices are connected to a processor that controls the speed of the roller wheel and thus the volume of fluid that is delivered into the cavity. Specifically, the Aquilex System and the predicate devices Karl Storz Hamou Endomat and FLOSIMPLE Arthroscopy Pump A120 incorporate one pressure sensor that is located at the pump head. The maximum selectable pressure of the Aquilex System (150 mmHg) is similar to the maximum pressure settings of the predicate devices: Karl Storz Hamou Endomat (200 mmHg), IUR System (120 mmHg) and Flo-Stat System (100 mmHg). The irrigation tube set of the Aquilex System is identical in design to the irrigation tube set of the IUR System except for minor design changes to the pressure chamber, the incorporation of a clip socket and tubing connector as new components and the shortening of the overall length of the inflow tubing. In addition, the irrigation tube set is similar in design to the irrigation tube set of the FLOSIMPLE Arthroscopy Pump A120 (e.g. incorporation of clip socket and tubing connector, design of pressure chamber with one membrane).
The fluid monitoring units of the Aquilex System and the predicate devices IUR System and Flo-Stat System are electro-mechanical, microprocessor controlled devices that monitor the amount of delivered irrigation solution and compare it with the volume of the secretions returned to the container by means of a mass/volume differential measurement. To determine the fluid deficit during hysteroscopic procedures the Aquilex System measures the inflow volume using the rotation of the roller wheel and the outflow volume by means of a weighing scale, whereas the predicate devices IUR System and Flo-Stat System utilize a scale to measure both the inflow and outflow volume.
Finally, both the Aquilex System and the predicate devices are designed with the same or similar setting keys, display elements and safety features (e.g. active pressure reduction, overpressure warnings and fluid deficit warnings).
Substantial Equivalence:
The Aquilex Fluid Control System H112 is substantially equivalent to the IUR Fluid Management System (K031616), the Flo-Stat Fluid Monitoring System (K083211) the Karl Storz Hamou Endomat (K936231) and FLOSIMPLE Arthrsocopy Pump A120 (K062380). Specifically, the Aquilex Fluid Control System H112 and the predicate devices are intended to provide liquid distension of the uterus during
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diagnostic and operative hysteroscopy (Karl Storz Hamou Endomat), and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus (IUR Fluid Management System and Flo-Stat Fluid Monitoring System).
In addition, the Aquilex Fluid Control System H112 and the predicate devices use the same or similar basic operating principles and incorporate the same or similar basic design features including materials. The differences between the Aquilex Fluid Control System H112 and the predicate devices do not raise new questions of safety and effectiveness. The use of a single pressure sensor for pressure monitoring and regulation of the irrigation pump is substantially equivalent to the Karl Storz Hamou Endomat and FLOSIMPLE Arthroscopy Pump A120. The maximum pressure of the Aquilex System has been shown to be substantially equivalent to the predicate device IUR Fluid Management System, Karl Storz Hamou Endomat and other cleared hysteroscopic pumps. The incorporation of a vacuum function into the irrigation pump of the Aquilex Fluid Control System H112 is substantially similar to the vacuum function of the predicate device Karl Storz Hamou Endomat. Furthermore, the determination of the inflow volume using the rotation of the roller wheel has been demonstrated to be substantially equivalent to the fluid deficit determination of the predicate devices IUR Fluid Management System and Flo-Stat Fluid Management System and other cleared hysteroscopic fluid management systems. The irrigation tube set of the Aquilex Fluid Control System H112 is substantially similar to the irrigation tube set of the predicate devices IUR Fluid Management System, FLOSIMPLE Arthroscopy Pump A120 and other cleared tube sets manufactured by W.O.M. Finally, bench, sterility, and packaging test results demonstrate that the differences between the Aquilex Fluid Control System H112 and the predicate devices do not raise new questions of safety and effectiveness.
Performance Testing:
Testing was performed with the irrigation pump of the Aquilex Fluid Control System H112 to demonstrate the alignment of the uterine model pressure and pump display pressure under steady state conditions. 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.
In addition, bench testing has been conducted to demonstrate that the flow and pressure regulation algorithm of the Aquilex Fluid Control System H112 is designed to compensate for the intra-cavity pressure changes that result from activation and deactivation of the MyoSure morcellator when used with the high vacuum pump.
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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. In detail, the test results show that pressure losses that occurred after activation of the morcellator never fell to a critical point, thus preventing the collapse of the uterus, and that the initial short-term pressure losses were compensated effectively. Moreover, the test results show that a recovery to stable pressures was reached within a few seconds after the morcellator was deactivated.
Finally, bench testing was performed with the Aquilex Fluid Control System H112 and the inflow tube sets to measure the accuracy of the fluid deficit determination. 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.
The Aquilex Fluid Control System H112 has been tested and complies with the international standard IEC 60601-1, General Requirements for Medical Electrical Equipment - Part 1: General Requirements for Safety and IEC60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
ETO sterility validation of the tube sets was performed in accordance with ISO 11135-1, Sterilization of health care products -Ethylene Oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices; and ISO 10993-7, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. 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 ≤ 10t is achieved.
Package and product integrity of the tube sets were tested in accordance with ISO11607-1, Packaging for Terminally Sterilized Medical Devices and ASTM-F-1980-02, Standard for Accelerated Aging of Sterile Medical Device Packages.
Conclusion:
The Aquilex Fluid Control System H112 is substantially equivalent to the IUR Fluid Management System (K031616), the Flo-Stat Fluid Monitoring System (K083211), the Karl Storz Hamou Endomat (K936231) and the FLOSIMPLE Arthrsocopy Pump A120 (K062380). Specifically, the proposed device has the same intended use as the predicate devices. In addition, the Aquilex Fluid Control System H112 and the predicate devices use the same or similar basic operating principles and
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incorporate the same or similar basic design features including materials. The differences between the Aquilex Fluid Control System H112 and the predicate devices do not raise new questions of safety and effectiveness. Finally, bench, sterility and packaging testing demonstrate that the differences between the Aquilex Fluid Control System H112 and the predicate devices do not raise new questions of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
W.O.M. WORLD OF MEDICINE AG % Ms. Susanne Raab Regulatory Consultant 1480 Cambridge Street CAMBRIDGE MA 02139
FEB - 6 2012
Re: K112642
Trade/Device Name: Aquilex Fluid Control System H112 Regulation Number: 21 CFR§ 884.1700 Regulation Name: Hysteroscopic insufflator Regulatory Class: II Product Code: HIG Dated: January 31, 2012 Received: February 1, 2012
Dear Ms. Raab:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Act. The Act. The A general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin R. Fisher
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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WORLD OF MEDICINE. Fluid Control System H112 Special 510(k) Premarket Notification
INDICATIONS FOR USE STATMENT
510(k) Number (if known): 上川2642
Device Name: Aquilex Fluid Control System H112
Indications for Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| 510(k) Number | K112642 |
| Page 1 of 1 |
§ 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.