The Aquilex® Fluid Control System AQL-100S is intended to provide fluid 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 Description

The Aquilex® Fluid Control System AQL-100S is a modified version of the primary predicate device, Aquilex Fluid Control System H112 (K112642). The proposed device is a microprocessor-controlled device that consists of the following two main components: (1) an irrigation pump unit including suction pumps (AQL-110P) and (2) and fluid monitoring unit (AQL-100CBS) that are to be placed on a roller stand. The irrigation pump unit (AQL-110P) of the Aquilex® Fluid Control System AQL-100S is a microprocessor-controlled device that functions according to the peristaltic principle and consists of the following components: (1) a casing. (2) a power switch, (3) a power supply, (4) mains cable, (5) a roller wheel, (6) a pump head, (7) suction pumps, (8) various setting keys and (9) display elements. The irrigation pump unit (AQL-110P) is to be used with specially designed single use irrigation and outflow tube sets that are delivered sterile (AQL-110 and AQL-111). In addition, the suction pumps of the irrigation pump unit are to be used with specially designed non-sterile vacuum tube sets (AQL-114). The fluid monitoring unit (AQL-100CBS) consists of the following main components: (1) two scale units, (2), a bag holder, (4) a bag deflector, (5) a container holder, and (6) a roller wheel base. The irrigation pump unit of the proposed device is only operational in conjunction with the fluid monitoring unit.

AI/ML Overview

The provided document in the prompt relates to a 510(k) premarket notification for a medical device called the "Aquilex® Fluid Control System AQL-100S." This document describes the device, its intended use, comparison to predicate devices, and a summary of performance data collected to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria tables nor detailed results from a clinical study proving the device meets those criteria. Instead, it provides a summary of various bench tests and compliance with standards (electrical safety, EMC, software, biocompatibility, sterilization, shelf life) to support its substantial equivalence claim, rather than a clinical study with acceptance criteria for device performance in a real-world or simulated clinical setting.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document in the manner typically associated with studies demonstrating performance against specific clinical or diagnostic metrics.

Based on the available information, here's what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document mentions "Bench testing was performed to demonstrate that the fluid deficit determination...is substantially equivalent...in terms of accuracy." However, it does not provide a specific table of acceptance criteria for this accuracy or the reported numerical performance values (e.g., mean accuracy, standard deviation, or specific thresholds).

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified for any of the performance tests. The bench testing refers to "fluid deficit determination" but doesn't quantify the number of measurements or conditions.
Data Provenance: The tests (electrical safety, EMC, software verification/validation, biocompatibility, sterilization, shelf life, bench testing) are described as performed by "independent laboratories" or internally. No information on country of origin of data or whether it was retrospective or prospective is given, as these are typically laboratory/bench tests, not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. The performance tests described are laboratory-based and do not involve human interpretation or subjective assessment that would require "experts to establish ground truth" in the clinical sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. There's no human adjudication involved in the described bench and standard compliance tests.

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:

Not applicable. This device is a fluid control system, not an AI or imaging diagnostic device that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The performance tests are essentially standalone for the device, as they assess its functional capabilities (e.g., electrical safety, fluid deficit accuracy) without human intervention in the primary measurement. However, this is not an "algorithm only" study in the context of AI, but rather a functional characterization of hardware and software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the bench testing related to "fluid deficit determination," the ground truth would likely be established by highly accurate reference measurement systems (e.g., precise scales or flow meters) that are calibrated and traceable to known standards. This is inherent in laboratory bench testing. The document doesn't explicitly state the specifics of this ground truth.

8. The sample size for the training set:

Not applicable. This is not an AI-driven device requiring a training set in the typical machine learning sense. The software development and testing, while mentioned (IEC 62304), refers to traditional software verification and validation, not machine learning model training.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for an AI model.

Summary of available information:

Criterion	Details from Document
Acceptance Criteria & Reported Performance	Acceptance Criteria: Unspecified. The document states bench testing was performed to demonstrate "fluid deficit determination...is substantially equivalent...in terms of accuracy" to the predicate device (Hysteroscopy Pump HM6). No numerical acceptance thresholds or target accuracy values are provided. Reported Performance: No specific numerical performance values (e.g., accuracy percentages, error ranges) are reported for the fluid deficit determination. The conclusion is that the device "is substantially equivalent" to the predicate for this function.
Test Set Sample Size	Not specified for any of the performance tests.
Data Provenance	Tests performed by "independent laboratories" or internally. No details on country of origin or retrospective/prospective nature.
Number & Qualifications of Experts for Ground Truth	Not applicable; tests are laboratory-based, not reliant on expert clinical interpretation for ground truth.
Adjudication Method for Test Set	Not applicable; no human adjudication involved in these functional tests.
MRMC Comparative Effectiveness Study	No. This is a fluid control system, not an imaging/AI diagnostic device.
Standalone Performance Study	Yes, the various bench, electrical safety, EMC, software, biocompatibility, sterilization, and shelf-life tests assess the device's performance in a standalone context against relevant standards and predicate device functions.
Type of Ground Truth Used	For "fluid deficit determination," ground truth would be established by precise, calibrated reference measurement systems in a laboratory setting. Not explicitly detailed in the document.
Training Set Sample Size	Not applicable; this device does not use machine learning that requires a training set. Software verification and validation followed IEC 62304.
How Training Set Ground Truth was Established	Not applicable; no training set for AI.

The document primarily relies on demonstrating compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993 series, ISO 11135, ISO 14937, ISO 11607-1, ASTM-F1980) and bench testing indicating functional equivalence to a predicate device for its 510(k) clearance, rather than reporting detailed clinical study results with explicit acceptance criteria often found for diagnostic or treatment efficacy devices.

Summary

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February 5, 2018

W.O.M. World of Medicine GmbH % Susanne Raab Regulatory Consultant Susanne Raab Guenthersburgallee 75 60389 Frankfurt GERMANY

K172040 Re:

Trade/Device Name: Aquilex® Fluid Control System AOL-100S Regulation Number: 21 CFR 884.1700 Regulation Name: Hysteroscopic insufflator Regulatory Class: Class II Product Code: HIG Dated: January 3, 2018 Received: January 10, 2018

Dear Susanne 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 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Joyce M. Whang -S

for

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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Indications for Use

510(k) Number (if known) K172040

Device Name Aquilex® Fluid Control System AQL-100S

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	□

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

General Information:

Submitter:	W.O.M. WORLD OF MEDICINE GmbHSalzufer 810587 BerlinGermanyPhone: +49 30 39981 594Fax: +49 30 39981 593
Registration Number:	3001556604
Contact Person:	Susanne RaabRegulatory ConsultantGuenthersburgallee 7560389 FrankfurtPhone: 0049 69 28606161e-mail: sbraab@comcast.net
Date Prepared:	January 30, 2018
Proposed Device:
Trade Name:	Aquilex® Fluid Control System AQL-100S
Common Name:	Hysteroscopic Insufflator, Fluid MonitoringSystem and Tube Sets
Classification Name:	Hysteroscopic Insufflator and Accessories
Regulation Number:	21 CFR 884.1700
Regulation Name:	Hysteroscopic Insufflator
Regulatory Class:	II
Product Code:	HIG
Predicate Devices:
Primary Predicate Device:
Trade Name:	Aquilex Fluid Control System H112
510(k) Number:	K112642
Applicant:	W.O.M. WORLD OF MEDICINE GmbH
Regulation Number:	21 CFR 884.1700
Regulatory Class:	II
Product Code:	HIG

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Secondary Predicate Device:

Trade Name:	Hysteroscopy Pump HM6
510(k) Number:	K123732
Applicant:	W.O.M. WORLD OF MEDICINE GmbH
Regulation Number:	21 CFR 884.1700
Regulatory Class:	II
Product Code:	HIG

The predicate devices were not subject to a design-related recall.

Device Description:

Intended Use / Indication for Use:

The Aquilex® Fluid Control System AOL-100S is intended to provide fluid 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.

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Substantial Equivalence and Comparison of Technological Characteristics:

The proposed device, Aquilex® Fluid Control System AQL-100S, is substantially equivalent to the predicate devices, Aquilex Fluid Control System H112 (K112642) and Hysteroscopy Pump HM6 (K123732). As stated above the proposed device, Aquilex® Fluid Control System AQL-100S, is a modified version of the primary predicate device, Aquilex Fluid Control System H112.

The proposed device, Aquilex® Fluid Control System AQL-100S, and the predicate devices, Aquilex Fluid Control System H112 and Hysteroscopy Pump HM6, are all intended to provide fluid 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 proposed device and the predicate devices have the same intended use.

Furthermore, tThe proposed device, Aquilex® Fluid Control System AQL-100S, and the predicate device, Aquilex Fluid Control System H112 and Hysteroscopy Pump HM6, use the same basic operating principles and incorporate the same basic design. All three devices incorporate the following main components: (1) irrigation pump, (2) fluid monitoring unit, (3) irrigation and outflow tube sets.

The modification to the Aquilex® Fluid Control System AQL-100S in comparison to the primary predicate device, Aquilex Fluid Control System H112, do not raise different questions of safety and effectiveness. The differences between both devices are the following:

Incorporation of a separate bag scale into the fluid monitoring unit of the . Aquilex® Fluid Control System AQL-100S to calculate the inflow volume, whereas the Aquilex Fluid Control System H112 determines the inflow volume based on the number of rotation of the roller wheel.
. Change in design of the cart to allow for a mounting of the bag scale and addition of bag deflector.
. Incorporation of a fluid bag and container change detection feature into the Aquilex® Fluid Control System AQL-100S.
. Increase in the suction pressure of the low suction pump from 125 to 225 mmHg.
. The inflow tubing AQL-110 of the primary predicate device has been slightly modified.

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· The filter of the reusable vacuum tubing is manufactured by a different supplier.
With regards to the incorporation of an additional bag scale, the proposed device, Aquilex® Fluid Control System AQL-100S, is substantially equivalent to the secondary predicate device, Hystersocopy Pump HM6, that also utilizes a separate scale for determination of the inflow volume.

With regards to the incorporation of a separate bag scale into the fluid monitoring unit to determine the inflow volume and change in design of the cart to allow for a mounting of the bag scale, the proposed device, Aquilex® Fluid Control System AQL-100S, is substantial equivalent to the secondary predicate device, Hysteroscopy Pump HM6. Like the proposed device, Aquilex® Fluid Control System AQL-100S, the secondary predicate device, Hysteroscopy Pump HM6, incorporates a separate scale to determine the inflow volume for calculation of the fluid deficit.

With regards to the fluid bag change detection feature is substantially equivalent to the secondary predicate device, Hysteroscopy Pump HM6, that incorporates the same feature. The bag deflector was added to the fluid monitoring unit of the proposed device. Aquilex® Fluid Control System AOL-100S. to protect the bag scale from fluid.

The increase in the suction pressure of the suction pump from 125 to 225 mmHg, that was implemented due to end user demand to ensure fluid suction even if the tubing is draped over the patient's leg.

The modifications that were made on the inflow tubing AQL-110 are minor and have not changed the material, suppliers and manufacturing method.

Performance Data:

Electrical Safety and Electromagnetic Compatibility Testing:

Electrical safety and electromagnetic compatibility testing was performed by independent laboratories and the test results demonstrate that the proposed device conforms to the below standards:

IEC 60601-1 2005/(R)2012 and A1: 2012, C1:2009/(R)2012 andA2: ● 2010/(R)2012 (consolidated text); and
IEC 60601-1-2 Fourth Edition: 2014.

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Software:

The software was considered as major level of concern in accordance with the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Software verification and validation testing of the Aquilex® Fluid Control System AQL-100S demonstrates that the device performs as intended. It was developed, tested and verified in accordance with the above FDA guidance document and in accordance with the following standard:

IEC 62304 First Edition 2006-05. .

Biocompatibility:

Biocompatibility testing was performed in accordance with:

AAMI/ANSI/ISO 10993-1 Fourth Edition 2009-10-15 Biological . evaluation of medical devices- Evaluation and testing within a risk management system;
. ISO 10993-5: 2009 (R) 2014 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
. ISO 10993-10 Third Edition 2010-08-01 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization; and
. ISO 10993-11 Second Edition 2006-08-15- Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
. ISO 10993-12:2007 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials.

Sterilization and Shelf Life:

Sterilization validation was performed in accordance with:

. ISO 10993-7 Second Edition 2008-10-15- Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals;
. AAMI TIR 28 2009/(R)2013. Product adoption and process equivalency for ethylene oxide sterilization;

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ISO 11135-1:2007 Sterilization of health care products Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices;
. ISO 14937 Second Edition 2009-10-15- Sterilization of health care products - General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.

Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO < 4 mg and ECH < 5 mg after 4 days of aeration (gas release) that remain on the tube set will not be exceeded. As a result of the sterilization validation, a sterility assurance level (SAL) ≤ 106 in accordance with ANSI/AAMI/ISO 11135-1 was achieved. Package and product integrity of the tube sets were tested in accordance with ISO11607-1 - Packaging for terminally sterilized medical devices and ASTM-F1980:2002 - Standard for accelerated aging of sterile medical device packages.

Bench Testing:

Bench testing was performed to demonstrate that the fluid deficit determination of the proposed device, Aquilex® Fluid Control System AQL-100S, using a bag and container scale, is substantially equivalent to that of the secondary predicate device, Hysteroscopy Pump HM6, in terms of accuracy.

Conclusion:

The Aquilex® Fluid Control System AQL-100S is substantially equivalent to the predicate devices: Aquilex Fluid Control System H112 and Hysteroscopy Pump HM6.

Regulation Number and Section

§ 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.