The Fluent Fluid Management System 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 while providing drive, control and suction for hysteroscopic morcellators.

Device Description

The Fluent Fluid Management System is a hysteroscopic fluid management system and drive console for hysteroscopic morcellators. The Fluent Fluid Management System consists of a console and single-use procedure kit. The single use procedure kit consists of a sterile Inflow Tube Set (In-FloPak) and Outflow Tube Set (Out-FloPak) with a nonsterile Waste Bag. The two FloPaks and Waste Bag connect to the Console for performing hysteroscopic procedures. The console includes motors that control inflow and outflow of fluid for hysteroscopic insufflation, as well as a pressure sensor monitoring system and graphical user interface touchscreen. In addition, the console includes a connection for MyoSure Tissue Removal Devices and a pneumatic foot pedal to perform tissue removal procedures. The Fluent Fluid Management System is compatible with currently marketed MyoSure Tissue Removal Devices. The primary functions of the subject device are fluid distension, fluid deficit tracking, and morcellator drive control. The subject device includes a deficit alert feature as well as an overpressure protection mechanism.

AI/ML Overview

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive clinical study report with detailed acceptance criteria and performance data in a structured format. Therefore, I will extract relevant information where available, and note when specific details (like numerical acceptance criteria or clinical study specifics) are not explicitly stated.

Acceptance Criteria and Device Performance

The 510(k) summary does not explicitly present a table of acceptance criteria with corresponding reported device performance values in a quantifiable manner that is typical for a clinical study. Instead, it relies on demonstrating that the new device's performance is "substantially equivalent" to the predicate devices. The performance testing section describes categories of tests conducted, implying that the device successfully met internal specifications and standards relevant to those tests.

However, based on the "Comparison of Technological Characteristics" Table 5-1 and the "Performance Testing" section, we can infer some operational parameters and functional aspects that would have associated acceptance criteria internally.

Performance Characteristic (Inferred Acceptance Criteria)	Reported Device Performance (Fluent Fluid Management System)	Notes / Implicit Acceptance
Fluid Management System
Pressure Control Range	40-120 mmHg	Different from Predicate 1 (40-150 mmHg), but within safe and effective range. No specific acceptance threshold for this range is given.
Maximum Intrauterine Pressure	120 mmHg	Different from Predicate 1 (150 mmHg), but within safe limits.
Flow rate (maximum)	650 mL/min	Different from Predicate 1 (800 mL/min), but deemed acceptable for use.
Overpressure Protection	Yes	Same as Predicate 1. Implied: Must function reliably.
Fluid Deficit Tracking	Yes	Same as Predicate 1. Implied: Must accurately track fluid deficit.
Drive Control Console for Hysteroscopic Morcellators
Morcellator Drive Rotation Speed	8075 ± 1000 RPM	Same as Predicate 2. Implied: Must maintain this speed within tolerance.
Sterility and Shelf Life
EtO Sterilization	Per ISO 11135:2014 & ISO 10993-7:2008	Successful completion implies acceptance.
Package Integrity	Per ASTM F1980-16	Successful completion implies acceptance.
Shelf Life (Sterile Components)	Three-year shelf life confirmed	Confirmed by accelerated aging and functional testing.
Biocompatibility
Cytotoxicity	ISO 10993-5:2009 compliant	Successful completion implies acceptance.
Sensitization	ISO 10993-10:2010 compliant	Successful completion implies acceptance.
Irritation	ISO 10993-10:2010 compliant	Successful completion implies acceptance.
Acute System Toxicity	ISO 10993-11:2006 compliant	Successful completion implies acceptance.
Software
System Design Control Verification & Validation	Successfully performed, Major Level of Concern	In accordance with FDA Guidance (May 2005). Successful completion implies acceptance.
Electrical Safety and EMC
Medical Electrical Equipment Standards	IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-6:2010	Successful completion implies acceptance.
Performance Testing (Functional)
Inflow/Outflow Tubing Sets	Design verification (mechanical testing)	Successful completion implies acceptance.
Inflow Rate, Outflow Rate, TRD Suction	Fluid management validation testing to assess	Successful completion implies acceptance.
Intrauterine Pressure Control	Testing conducted	Successful completion implies acceptance.
System cutting performance	For the drive control system	Successful completion implies acceptance.

Study Details:

Sample size used for the test set and the data provenance:
- The document describes non-clinical performance testing (design verification, fluid management validation, intrauterine pressure control, system performance, system cutting performance).
- It does not specify sample sizes for these tests (e.g., how many units were tested, how many trials were conducted for each metric).
- The data provenance is internal to Hologic, Inc. (the manufacturer), as these are manufacturing and engineering validation tests. There's no mention of external data or specific countries of origin beyond the company's location in Marlborough, MA, USA.
- These tests are inherently prospective in nature, as they involve testing the manufactured device against pre-defined specifications.
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):
- This question is not applicable in the context of the provided 510(k) summary. The summary describes engineering and performance validation tests for a medical device (hysteroscopic insufflator/morcellator drive), not a diagnostic algorithm or a clinical study requiring expert assessment of medical images or patient outcomes to establish ground truth. The "ground truth" for these tests would be the established engineering specifications and regulatory standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as the tests described are technical performance validations, not clinical assessments requiring adjudication by multiple experts. The results of the engineering tests would be pass/fail against predetermined specifications.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices, where the AI assists human readers (e.g., radiologists). The Fluent Fluid Management System is a surgical assist device, not a diagnostic imaging device with an AI component for human reader assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is a hardware system with integrated software for fluid management and morcellator control. Its "performance" is inherently standalone in the sense that the system itself performs its functions (e.g., maintaining pressure, tracking deficit, driving the morcellator) without direct human-in-the-loop influence on those specific operations. However, the device is used by a human surgeon. There is no "algorithm only" performance study in the typical AI sense. The performance tests (fluid management, cutting performance) were done on the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance testing, the "ground truth" refers to the engineering specifications, design requirements, and applicable industry standards (e.g., ISO, ASTM, IEC standards for sterilization, biocompatibility, electrical safety, and performance metrics as defined by the manufacturer). There is no "expert consensus," "pathology," or "outcomes data" ground truth discussed for these particular non-clinical studies.
The sample size for the training set:
- This question is not applicable as this is not an AI/machine learning device that requires a "training set" in the conventional sense. The device's software is built on established algorithms for control, not on learning from a large dataset.
How the ground truth for the training set was established:
- This question is not applicable for the same reasons as point 7.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

August 3, 2018

Hologic, Inc. Christine M. Cameron Manager, Regulatory Affairs 250 Campus Drive Marlborough, MA 01752

Re: K180825

Trade/Device Name: Fluent Fluid Management System Regulation Number: 21 CFR& 884.1700 Regulation Name: Hysteroscopic Insufflator Regulatory Class: II Product Code: HIG, HIH Dated: July 3, 2018 Received: July 5, 2018

Dear Christine M. Cameron:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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.

Michael T. Bailey -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)

K180825

Device Name Fluent Fluid Management System

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)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Date: July 31. 2018

5.1. 510(k) Submitter:

Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Telephone: 508.263.8654 Establishment Registration Number: 1222780

Contact: Christine Cameron, Regulatory Affairs Manager Email: Christine.Cameron@hologic.com Phone: 508-263-8654

5.2. Device:

Trade Name: Fluent Fluid Management System Common/Usual Name: Hysteroscopic Insufflator Regulation Number: 21.CFR.Reg 884.1700 Regulation Name: Hysteroscopic insufflator Product Code: HIG (insufflator, hysteroscopic), HIH (hysteroscope (and accessories)) Device Class: Class II

5.3. Predicate Devices:

Predicate 1 Tradename: Aquilex Fluid Control System H112 Submitter / 510(k) Holder: W.O.M. World of Medicine AG 510(k) #'s: K112642

Predicate 2

Tradename: MyoSure Tissue Removal Device System and MyoSure Tissue Removal Devices Submitter / 510(k) Holder: Hologic, Inc. 510(k) #'s: K172566

The predicate devices have not been subject to a design related recall.

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5.4. Device Description:

The Fluent Fluid Management System is a hysteroscopic fluid management system and drive console for hysteroscopic morcellators.

The Fluent Fluid Management System consists of a console and single-use procedure kit. The single use procedure kit consists of a sterile Inflow Tube Set (In-FloPak) and Outflow Tube Set (Out-FloPak) with a nonsterile Waste Bag. The two FloPaks and Waste Bag connect to the Console for performing hysteroscopic procedures. The console includes motors that control inflow and outflow of fluid for hysteroscopic insufflation, as well as a pressure sensor monitoring system and graphical user interface touchscreen.

In addition, the console includes a connection for MyoSure Tissue Removal Devices and a pneumatic foot pedal to perform tissue removal procedures. The Fluent Fluid Management System is compatible with currently marketed MyoSure Tissue Removal Devices.

The primary functions of the subject device are fluid distension, fluid deficit tracking, and morcellator drive control. The subject device includes a deficit alert feature as well as an overpressure protection mechanism.

5.5. Indications for Use:

The subject device has the same general intended use as the primary and secondary predicate devices, respectively: (1) to provide liquid distension of the uterus while monitoring irrigation fluid and (2) to provide drive control for morcellators during hysteroscopic procedures. The subject device indications include reference to both the fluid management function of the primary predicate and the "drive, control, and suction for hysteroscopic morcellators" function of the secondary predicate to reflect the combination of these two device functions into the subject device. These features do not interfere with each other and do not change the overall intended use relative to the predicate devices.

5.6. Comparison of Characteristics:

The method of use, mechanism of action, mode of operation and functional performance of the Fluent Fluid Management System are substantially equivalent to the Aquilex Fluid Control System H112 (K112642) for fluid management utilized for uterine distention as well as the MyoSure Tissue Removal Device System, specifically the console for providing drive, control and suction for the MyoSure Tissue Removal Devices for tissue removal (K172566).

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Table 5-1: Device Comparison of Technological Characteristics
Device andPredicateDevices	Aquilex FluidControl SystemK112642Predicate 1	MyoSureTissueRemovalSystemK172566Predicate 2	Fluent FluidManagementSystemSubject Device	Comparison toPredicates
General Device Characteristics
Method ofUse	Uterinedistention	Drive, control, andsuction forhysteroscopicmorcellators andhysteroscopicresection andremoval of tissue viatissue removaldevices	Uterine distension(fluid management)and drive, control,and suction forhysteroscopicmorcellators	Similar
Mechanism ofAction	Fluid flow with asingle rollerperistaltic pumpfor irrigationand adiaphragmpump forvacuum.	The consoleprovidesmechanicalcontrol, drive, andsuction for thehysteroscopicmorcellator.	Fluid flow with asingle peristalticpump for irrigationand single peristalticpump for vacuum.	Similar
Mode ofOperation	Provide liquiddistension ofthe uterusduringdiagnostic andoperativehysteroscopy,and to monitorthe volumedifferentialbetween theirrigation fluidflowing intoand out of theuterus	Vacuum is used topull tissue intothe side- facingcutting windowwhere it is cut andaspirated throughthe cutter anddeposited into acollectioncanister.	Provide liquiddistension of theuterus duringdiagnostic andoperativehysteroscopy, andto monitor thevolume differentialbetween theirrigation fluidflowing into and outof the uterus.Vacuum is createdto pull tissue intothe side-facingcutting windowwhere it is cut andaspirated throughthe cutter anddeposited into acollection canister.	Similar
Fluid Management System
PressureControlRange	40-150mmHg	N/A	40-120mmHg	Different
MaximumIntrauterinePressure	150mmHg	N/A	120mmHg	Different
Flow rate(maximum)	800mL/min	N/A	650mL/min	Different
OverpressureProtection	Yes	N/A	Yes	Same
Fluid DeficitTracking	Yes	N/A	Yes	Same
Drive Control Console for Hysteroscopic Morcellators
MorcellatordriveRotationSpeed	N/A	8075±1000 RPM	8075±1000 RPM	Same

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The descriptive characteristics of the Fluent Fluid Management System and the predicate devices are shown in the table above. K112642 is the primary predicate used to compare the technological characteristics of the fluid management function (hysteroscopic insufflator) of the subject device, while K172566 is used only to compare the morcellator drive-control console function of the subject device. The combination of these features does not change the intended use or risk profile relative to the independent predicate devices.

The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness.

5.7. Performance Testing:

Sterility and Shelf Life

For the sterile Inflow/Outflow tubing, EtO sterilization per ISO 11135:2014 and EtO and ECH residual testing in accordance with ISO 10993-7:2008 were conducted. In addition, package integrity testing per ASTM F1980-16 and transport validation and accelerated aging testing with functional testing were performed for the sterile components in order to confirm the three-year shelf life.

Biocompatibility:

Cytotoxicity - ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
Sensitization - ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Irritation ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests ● for irritation and skin sensitization
Acute System Toxicity - ISO 10993-11:2006 - Part 11: Tests for systemic toxicity

Software

The Fluent Fluid Management System successfully performed system design control verification and validation testing, which included software documentation for a Major Level of Concern in accordance with FDA's Guidance for the Content of premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005).

Electrical Safety and EMC:

IEC 60601-1:2005 + A1:2012, C1:2009 + A2:2010 Medical Electrical Equipment - Part 1 General requirements for safety and essential performance.
IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-1-6:2010 (Third Edition) + A1:2013 Medical electrical equipment - Part 1-6: Particular requirements for the basic safety and essential performance: Usability

Performance Testing

Non-clinical performance testing was conducted to verify the functional performance of the subject device. The performance testing included the following:

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Design verification (mechanical testing) of the inflow/outflow tubing sets
. Fluid management validation testing to assess inflow rate, outflow rate, and TRD suction
Intrauterine pressure control testing ●
System performance testing ●
System cutting performance for the drive control system

5.8. Conclusion:

The performance data demonstrate that the Fluent Fluid Management System is substantially equivalent to the predicate devices.

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.