(147 days)
Not Found
No
The description mentions a "microprocessor controlled device" and a "flow and pressure regulation algorithm," but there is no mention of AI, ML, or related terms like neural networks or deep learning. The functionality described appears to be based on traditional control systems and algorithms.
No.
The device is used for distension and monitoring during hysteroscopy, which is a diagnostic and operative procedure, but the device itself does not directly treat a disease or condition.
Yes
The device is intended to monitor the volume differential of irrigation fluid during diagnostic hysteroscopy, which is a diagnostic procedure. Its function in monitoring fluid volume supports the diagnostic process by providing essential data.
No
The device description explicitly states it consists of two main hardware components: an irrigation pump unit and a fluid monitoring unit, which are placed on a roller stand. It also mentions single-use irrigation and outflow tube sets. This is not a software-only device.
Based on the provided information, the Aquilex Fluid Control System H112 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide liquid distension of the uterus and monitor fluid volume during hysteroscopy. This is a procedure performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The device is a pump and monitoring system for managing fluid flow during a surgical procedure. It does not analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, urine, or any other biological sample. The device's function is purely mechanical (pumping and monitoring fluid).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Aquilex Fluid Control System H112 does not fit this definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HIG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
§ 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.
0
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:
1
Image /page/1/Picture/0 description: The image shows a logo with the words "WORLD OF MEDICINE" written below it. The logo itself is a circle with a design inside that looks like a combination of a loop and a triangle. There is a small circle with a dot inside it in the upper right part of the larger circle.
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.
2
Image /page/2/Picture/0 description: The image shows a logo with the text "WORLD OF MEDICINE" underneath it. The logo consists of a circle with a design inside that resembles a stylized figure or symbol. The text is in a bold, sans-serif font and is centered below the logo.
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
3
Image /page/3/Picture/0 description: The image shows a logo with the text "WORLD OF MEDICINE" underneath it. The logo consists of a circle with a design inside that resembles a stylized figure or symbol. There is a small circle with a dot inside it in the upper right portion of the larger circle. The text is in all capital letters and appears to be a sans-serif font.
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.
4
Image /page/4/Picture/0 description: The image shows a logo with the text "WORLD OF MEDICINE" underneath it. The logo consists of a circle with a symbol inside. The symbol appears to be a stylized representation of a medical symbol, possibly incorporating elements of a caduceus or similar emblem. The text is in all caps and appears to be a simple sans-serif font.
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