AQUILEX FLUID CONTROL SYSTEM H112

K112642 · W.O.M. World of Medicine AG · HIG · Feb 6, 2012 · Obstetrics/Gynecology

Device Facts

Record IDK112642
Device NameAQUILEX FLUID CONTROL SYSTEM H112
ApplicantW.O.M. World of Medicine AG
Product CodeHIG · Obstetrics/Gynecology
Decision DateFeb 6, 2012
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 884.1700
Device ClassClass 2

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.

Device Story

Aquilex Fluid Control System H112 is a microprocessor-controlled device for hysteroscopic procedures; comprises irrigation pump unit and fluid monitoring unit on a roller stand. Inputs: irrigation fluid volume (via roller wheel rotation) and outflow volume (via weighing scale). Operation: peristaltic pump delivers fluid to uterus; pressure sensors at pump head monitor intrauterine pressure; processor adjusts roller wheel speed to maintain target pressure (max 150 mmHg). Output: fluid deficit calculation displayed to clinician. Used in clinical settings by physicians. System includes vacuum function for use with morcellators; compensates for pressure changes during morcellation to prevent uterine collapse. Benefits: maintains stable uterine distension and provides real-time fluid deficit monitoring to enhance patient safety during hysteroscopy.

Clinical Evidence

Bench testing only. Evaluated pressure regulation accuracy (within 5 mmHg) and fluid deficit determination accuracy against predicates. Validated pressure compensation performance during MyoSure morcellator activation/deactivation, demonstrating stable pressure maintenance and recovery. Complies with IEC 60601-1 and IEC 60601-1-2. Sterility and packaging validated per ISO 11135-1, ISO 10993-7, ISO 11607-1, and ASTM F-1980-02.

Technological Characteristics

Electro-mechanical, microprocessor-controlled peristaltic pump. Features: pressure sensors, weighing scale for outflow, vacuum function. Materials: single-use irrigation/outflow tube sets. Connectivity: standalone system. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 11135-1 (sterilization), ISO 10993-7 (EO residuals), ISO 11607-1 (packaging), ASTM F-1980-02 (aging).

Indications for Use

Indicated for patients undergoing diagnostic or operative hysteroscopy requiring uterine distension and fluid volume monitoring.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K112642 ### 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 < 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for "WORLD OF MEDICINE". The logo consists of a circle with a design inside, resembling a stylized eye or a symbol combining a loop and a triangle. The text "WORLD OF MEDICINE" is written in capital letters below the logo. The image is in black and white. 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. {6}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of one. #### 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 {7}------------------------------------------------ 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 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a symbol that appears to be a stylized representation of an eye or a stylized letter. The symbol consists of a large, incomplete circle with a smaller, rounded shape inside it. Below the rounded shape, there is a triangular shape. There is also a small circle or dot located outside and to the upper right of the larger circle. 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 |
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