K Number

Device Name

Fluent Fluid Management System

Manufacturer

Hologic, Inc.

Date Cleared

2018-08-03

(126 days)

Product Code

HIG HIH

Regulation Number

884.1700

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K112642, K172566

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and fluid control systems, pressure sensing, and a graphical user interface. There is no mention of AI, ML, image processing, or data-driven decision-making beyond basic alerts and control mechanisms.

Therapeutic

No
A therapeutic device is one that treats or alleviates a disease or condition. This device is used during diagnostic and operative hysteroscopy for fluid management and morcellator control, which are supportive functions for the procedure rather than direct therapeutic actions themselves.

Diagnostic

No
The device is intended to provide liquid distension of the uterus, monitor fluid volume differential, provide drive/control/suction for morcellators, and manage fluid (inflow/outflow). While it "monitors" fluid, this monitoring is for management purposes (e.g., fluid deficit tracking, overpressure protection) during diagnostic and operative hysteroscopy, rather than to make a diagnosis itself. Its primary functions are fluid management and morcellator control.

SaMD (Software as a Medical Device)

The device description explicitly states that the system consists of a console with motors, sensors, and a touchscreen, as well as single-use procedure kits with tubing and a waste bag. These are physical hardware components, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Fluent Fluid Management System is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for providing liquid distension of the uterus, monitoring fluid volume differential, and providing drive, control, and suction for hysteroscopic morcellators. These are all procedures performed in vivo (within the living body) during a surgical or diagnostic procedure.
Device Description: The description details a system for managing fluid flow and controlling a surgical tool (morcellator) within the uterus. This aligns with an in vivo medical device.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) in vitro (outside the living body) to provide information for diagnosis, monitoring, or treatment.

IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. The Fluent Fluid Management System's function is to facilitate a surgical/diagnostic procedure within the body itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

HIG, HIH

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

uterus

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Testing included:

Sterility and Shelf Life: EtO sterilization per ISO 11135:2014 and EtO and ECH residual testing in accordance with ISO 10993-7:2008 were conducted. Package integrity testing per ASTM F1980-16 and transport validation and accelerated aging testing with functional testing were performed for the sterile components to confirm a three-year shelf life.
Biocompatibility: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO10993-10:2010), Irritation (ISO10993-10:2010), and Acute System Toxicity (ISO 10993-11:2006) tests were conducted.
Software: System design control verification and validation testing, including 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; IEC 60601-1-2:2007; IEC 60601-1-6:2010 (Third Edition) + A1:2013.
Performance Testing (Non-clinical): 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.
Key Results: The performance data demonstrate that the Fluent Fluid Management System is substantially equivalent to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K112642, K172566

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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.

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

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.

5.4. Device Description:

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

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).

Table 5-1: Device Comparison of Technological Characteristics
Device and
Predicate
Devices	Aquilex Fluid
Control System
K112642
Predicate 1	MyoSure
Tissue
Removal
System
K172566
Predicate 2	Fluent Fluid
Management
System
Subject Device	Comparison to
Predicates
General Device Characteristics
Method of
Use	Uterine
distention	Drive, control, and
suction for
hysteroscopic
morcellators and
hysteroscopic
resection and
removal of tissue via
tissue removal
devices	Uterine distension
(fluid management)
and drive, control,
and suction for
hysteroscopic
morcellators	Similar
Mechanism of
Action	Fluid flow with a
single roller
peristaltic pump
for irrigation
and a
diaphragm
pump for
vacuum.	The console
provides
mechanical
control, drive, and
suction for the
hysteroscopic
morcellator.	Fluid flow with a
single peristaltic
pump for irrigation
and single peristaltic
pump for vacuum.	Similar
Mode of
Operation	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	Vacuum is used to
pull tissue into
the side- facing
cutting window
where it is cut and
aspirated through
the cutter and
deposited into a
collection
canister.	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.
Vacuum is created
to pull tissue into
the side-facing
cutting window
where it is cut and
aspirated through
the cutter and
deposited into a
collection canister.	Similar
Fluid Management System
Pressure
Control
Range	40-150mmHg	N/A	40-120mmHg	Different
Maximum
Intrauterine
Pressure	150mmHg	N/A	120mmHg	Different
Flow rate
(maximum)	800mL/min	N/A	650mL/min	Different
Overpressure
Protection	Yes	N/A	Yes	Same
Fluid Deficit
Tracking	Yes	N/A	Yes	Same
Drive Control Console for Hysteroscopic Morcellators
Morcellator
drive
Rotation
Speed	N/A	8075±1000 RPM	8075±1000 RPM	Same

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:

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.