The Fluent Pro 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 liquid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators.

Device Description

The Fluent Pro Fluid Management System is a hysteroscopic fluid management system and drive console for hysteroscopic morcellators. The Fluent Pro Fluid Management System consists of a console and single-use procedure kit. The single-use procedure kit consists of sterile inflow (In-FloPak) and outflow (Out-FloPak) tube sets, and a non-sterile waste bag. The FloPaks and waste bag connect for use in hysteroscopic procedures. The console includes motors that control fluid inflow and outflow for hysteroscopic insufflation, as well as a pressure sensor monitoring system and graphical user interface. In addition, the console includes a connection for MyoSure Tissue Removal Devices and a pneumatic foot pedal to perform tissue removal procedures. The Fluent Pro Fluid Management System is compatible with currently marketed MyoSure Tissue Removal Devices.

AI/ML Overview

This FDA 510(k) summary describes a medical device, the Fluent Pro Fluid Management System, for which substantial equivalence is claimed against a predicate device. The document focuses on regulatory compliance and device characteristics rather than a clinical study evaluating diagnostic or treatment efficacy.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance cannot be fully extracted or accurately described from the provided text. These types of details are typically found in clinical study reports, which are not included here.

However, based on the provided text, I can infer and extract some information related to performance testing and acceptance criteria as described in the context of device safety and functional equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are functional and safety performance, demonstrated through various engineering and bench tests, rather than clinical efficacy metrics.

Performance Metric	Acceptance Criteria (Implied/Directly Stated)	Reported Device Performance (Summary)
Biocompatibility	Compliance with ISO 10993-1, 5, 10, 11, 23 (cytotoxicity, sensitization, systemic toxicity, irritation)	Patient contacting materials are biocompatible and comply with ISO 10993-1:2018 requirements.
Sterilization	Compliance with ISO 11135:2014	Sterilization validation conducted in accordance with ISO 11135:2014.
Shelf-Life	Compliance with ASTM F1980 (36 months shelf life)	Passed shelf-life testing per ASTM F1980, achieving a 36-month shelf life.
Electrical Safety & EMC	Compliance with IEC 60601-1 and IEC 60601-1-2	Underwent electrical safety and EMC testing in accordance with IEC 60601-1 and IEC 60601-1-2.
Intrauterine Pressure Control & Fluid Deficit Accuracy	Deficit Accuracy: $\pm$ 50 mL under normal use (specified for predicate and proposed device)	Passed Intrauterine Pressure Control and Fluid Deficit Bench Testing. (Implied: met $\pm$ 50 mL accuracy)
System Mechanical, Hardware, Electrical	Not explicitly stated but implied to meet design specifications	Passed System Mechanical, Hardware, and Electrical Bench Testing.
Software	Not explicitly stated but implied to meet design specifications	Passed Software Unit, Integration, and System Testing.
Disposables (Pull Force, Flow Rate, Duty Cycle)	Not explicitly stated but implied to meet design specifications	Passed Disposables Pull Force, Flow Rate, and Duty Cycle Bench Testing.
Usability	Compliance with IEC 62366-1:2015 + A1:2020 and FDA Guidance	Passed simulated use testing in accordance with IEC 62366-1 and FDA Guidance.

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

The document does not specify exact sample sizes for the various performance tests (e.g., number of units tested for electrical safety, number of sterility tests etc.). The provenance of the "data" is from internal company testing and validation activities as part of the 510(k) submission process. These are all prospective tests conducted on the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in the context of this 510(k) submission. The "ground truth" for these engineering and performance tests is defined by adherence to international standards and design specifications, not expert consensus on medical images or patient outcomes.

4. Adjudication method

Not applicable. Testing involves engineering verification and validation against objective standards and specifications, not subjective expert adjudication.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images) with and without AI assistance to assess improved accuracy or efficiency. The Fluent Pro Fluid Management System is a hysteroscopic insufflator and morcellator control system; its functions are mechanical and fluidic control, not diagnostic interpretation.

6. Standalone (i.e. algorithm only without human-in-the loop performance) was done

This refers to an AI algorithm's performance without human interaction. This is not applicable to the Fluent Pro Fluid Management System, as it is a physical medical device with software components that control mechanical actions, not an AI-driven image analysis or diagnostic algorithm. Its "performance" is its functional operation in conjunction with a human operator during a hysteroscopic procedure.

7. The type of ground truth used

For the performance testing mentioned, the "ground truth" is defined by:

International Standards: e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, IEC 60601-1/1-2 for electrical safety/EMC, IEC 62366-1 for usability.
Device Design Specifications: For metrics like Intrauterine Pressure Control, Fluid Deficit Accuracy ($\pm$ 50 mL), Maximum Inflow Rate, etc. These are objective engineering parameters.

8. The sample size for the training set

Not applicable. The Fluent Pro Fluid Management System is not an AI/ML device that requires a "training set" in the conventional sense for learning and model development. The software within the device undergoes testing (unit, integration, system testing) to ensure it performs according to its predefined logical and control functions, not to train a learning algorithm.

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

Not applicable, as there is no "training set" for an AI/ML algorithm.

Summary

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July 25, 2024

Hologic, Inc. Meghan Wakeford Principal Regulatory Affairs Specialist 250 Campus Drive Marlborough, Massachusetts 01752

Re: K240886

Trade/Device Name: Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S): Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210): Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) Regulation Number: 21 CFR 884.1700 Regulation Name: Hysteroscopic Insufflator Regulatory Class: II Product Code: HIG, HIH Received: June 27, 2024

Dear Meghan Wakeford:

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 (the 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 available 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

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K240886 - Meghan Wakeford

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jason Roberts -S

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K240886

Device Name Fluent Pro 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)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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Traditional 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92

Date Prepared:	March 29, 2024
Manufacturer:	Hologic, Inc.250 Campus DriveMarlborough, MA 01752 USA
Establishment Registration #:	1222780
Contact Person:	Meghan WakefordPrincipal Regulatory Affairs SpecialistP: 508.263.6172
Identification of the Device:
Proprietary/Trade Name:	Fluent® Pro Fluid Management System
Classification Name:	Hysteroscopic Insufflator
Regulatory Number:	21 CFR 884.1700
Product Codes:	HIG (Hysteroscopic Insufflator), HIH (Hysteroscope andaccessories)
Device Class:	Class II
Review Panel:	Obstetrics/Gynecology
Identification of the Legally Marketed Predicate Device:
Trade Name:	Fluent® Fluid Management System
Classification Name:	Hysteroscopic Insufflator
Regulatory Number:	21 CFR 884.1700
Product Codes:	HIG (Hysteroscopic Insufflator), HIH (Hysteroscope andaccessories)
Device Class:	Class II
Review Panel:	Obstetrics/Gynecology
Submitter/510(k) Holder:	Hologic, Inc.
Clearance:	K180825 (August 3, 2018)

The legally marketed predicate device, the Fluid Management System (K180825) has not been subject to design-related recalls.

Device Description:

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

Indications for Use:

Standards:

ISO 14971:2019 Medical Devices Application of Risk Management to Medical Devices ●
ISO 10993-1:2018 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing . within a Risk Management Process
IEC 60601-1:2005 + A1:2012 + A2:2020 – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-2:2014 + A1:2020 - Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 62304:2006 + A1:2015 - Medical Device Software - Software Life Cycle Processes
. IEC 62366-1:2015 + A1:2020 - Medical Devices - Part 1: Application of Usability Engineering to Medical Devices

FDA Guidance Documents:

"Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k)," issued July ● 31, 1995
"Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: . Evaluation and Testing within a Risk Management Process"" issued September 8, 2023
. "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," issued January 8, 2024
"Content of Premarket Submissions for Device Software Functions," issued June 14, 2023
"Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," issued September 27, 2023.
"Electromagnetic Compatibility (EMC) of Medical Devices," issued June 6, 2022
"Applying Human Factors and Usability Engineering to Medical Devices," issued February 3, ● 2016

Comparison with Predicate Device:

The Hologic Fluent Pro Fluid Management System has the same intended use, method of operation, and key functional elements as the predicate device, the Hologic Fluent Fluid Management System (K180825). The proposed device presents similar technological characteristics as the predicate device in order to provide fluid distention of the uterus during diagnostic and operative hysteroscopy procedures and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus, while providing drive, control, and suction for the MyoSure tissue removal devices.

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Substantial Equivalence:

	Fluent Pro Fluid Management SystemHologic, Inc.Proposed Device	Fluent Fluid Management System(K180825)Hologic, Inc.Predicate Device
Indicationsfor Use	The Fluent Pro Fluid ManagementSystem is intended to provide liquiddistension of the uterus during diagnosticand operative hysteroscopy, and tomonitor the volume differential betweenthe irrigation liquid flowing into and outof the uterus while providing drive,control and suction for hysteroscopicmorcellators.	The Fluent Fluid Management System isintended to provide liquid distension ofthe uterus during diagnostic andoperative hysteroscopy, and to monitorthe volume differential between theirrigation fluid flowing into and out ofthe uterus while providing drive, controland suction for hysteroscopicmorcellators.
Prescriptionor OTC	Prescription Use	Prescription Use
Product Code	HIG, HIH	HIG, HIH
RegulationNumber	21 CFR 884.1700	21 CFR 884.1700
Method ofUse	Uterine distention to enablehysteroscopic surgical removal ofintrauterine tissue	Uterine distention to enablehysteroscopic surgical removal ofintrauterine tissue
Mechanismof Action	Fluid flow with a single peristaltic pumpfor irrigation and single peristaltic pumpfor vacuum	Fluid flow with a single peristaltic pumpfor irrigation and single peristaltic pumpfor vacuum
Mode ofOperation	Provide liquid distension of the uterusduring diagnostic and operativehysteroscopy, and to monitor the volumedifferential between the irrigation fluidflowing into and out of the uterus.Vacuum is created to pull tissue into theside-facing cutting window where it iscut and aspirated through the cutter anddeposited into a collection canister.	Provide liquid distension of the uterusduring diagnostic and operativehysteroscopy, and to monitor the volumedifferential between the irrigation fluidflowing into and out of the uterus.Vacuum is created to pull tissue into theside-facing cutting window where it iscut and aspirated through the cutter anddeposited into a collection canister.
Inflow PumpDesign &Mechanism	Electro-mechanical peristaltic pump	Electro-mechanical peristaltic pump
PressureControlRange	40-150 mmHg	40-120 mmHg
MaximumIntrauterinePressure	150 mmHg	120 mmHg
MaximumInflow Rate	1000 mL/min	650 mL/min
	Fluent Pro Fluid Management SystemHologic, Inc.Proposed Device	Fluent Fluid Management System(K180825)Hologic, Inc.Predicate Device
AdjustableSuctionSettings	Low, Medium, and High	Non-adjustable
IntrauterinePressureDisplay	Pressure setting and actual pressure leveldisplayed on the procedure screen	Pressure setting displayed on theprocedure screen
Deficit LimitRange	100-2500 mL in increments of 50 mL atstart of procedureDeficit can be increased beyond 2500mL after procedure has started based onphysician discretion	100-2500 mL in increments of 50 mL atstart of procedureDeficit can be increased beyond 2500mL after procedure has started based onphysician discretion
Fluid DeficitTracking	Displays Deficit, Deficit Limit, and TotalFluid In	Displays Deficit and Deficit Limit
DeficitAccuracy	$\pm$ 50 mL under normal use	$\pm$ 50 mL under normal use
DriveControlMotor speed	2200 $\pm$ 270 RPM	2200 $\pm$ 270 RPM
MyoSureOperatingModes	System allows operation of TRD controlfunctions with or without operation ofthe inflow and outflow pumps.	System allows operation of TRD controlfunctions during operation of the inflowand outflow pumps.
ElectricalSafety &EMC Testing	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-2
DisposableProcedureKitSterilizationMethod	Ethylene Oxide	Ethylene Oxide
BiocompatibilityTestingper ISO10993-1	Yes	Yes

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Summary of Testing:

The Fluent Pro Fluid Management System has successfully passed the following performance and simulated-use testing to demonstrate the device is substantially equivalent to the predicate devices and meets design specifications.

Biocompatibility Testing

Biocompatibility testing was performed on the patient contacting materials of the Fluent Pro Fluid Management System in accordance with FDA Guidance Use of International Standard ISO-10993,

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"Biological evaluation of medical devices – Part 1: Evaluation and Testing within a Risk Management Process," issued on September 8, 2023. The material analysis and testing demonstrate the patient contacting materials are biocompatible and comply with the requirements of ISO 10993-1: 2018 Biological evaluation of medical devices – Part 1: Evaluation and Testing within a Risk Management Process for externally communicating, limited exposure, tissue contacting devices:

. ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicitv
ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin ● sensitization
ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic ● toxicity
. ISO 10993-23:2021 - Biological evaluation of medical devices – Part 11: Tests for irritation

Sterilization and Shelf-Life Testing

The Fluent Pro Fluid Management System Procedure Kit is provided as a sterile, single-use device, Sterilization validation was conducted in accordance with ISO 11135:2014. The shelf-life of the disposable product and its packaging integrity were tested in accordance with ASTM F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, and has a shelf life of 36 months.

Electrical Safety and Electromagnetic Compatibility Testing

The Compass Revolution Colpotomy Device underwent electrical safety and electromagnetic compatibility testing in accordance with the following standards:

IEC 60601-1:2005 + A1:2012 + A2:2020 Medical Electrical Equipment Part 1: General ● Requirements for Basic Safety and Essential Performance
IEC 60601-1-2:2014 + A1:2020 - Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests

Performance Testing

The following performance testing was conducted to support the substantial equivalence of the Fluent Pro Fluid Management System to the predicate:

Intrauterine Pressure Control and Fluid Deficit Bench Testing ●
System Mechanical, Hardware, and Electrical Bench Testing ●
Software Unit, Integration, and System Testing
Disposables Pull Force. Flow Rate, and Duty Cycle Bench Testing .

Usability Testing

Simulated use testing was performed in accordance with IEC 62366-1:2015 + A1:2020 - Medical Devices - Part 1: Application of Usability Engineering to Medical Devices and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices," issued February 3, 2016.

Conclusion:

Based on the information submitted in this premarket notification, including the intended use, technological characteristics, and operational use, the Hologic Fluent Pro Fluid Management System has been shown to be substantially equivalent to the predicate device, Fluent Fluid Management System (K180825).

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.