(115 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on mechanical and fluid control systems.
No.
A therapeutic device is one that treats a disease or condition. This device is primarily for fluid management and tissue removal during hysteroscopic procedures, which are diagnostic and operative, but the device itself does not provide a therapeutic effect in terms of treating the underlying condition. It facilitates the procedure.
No
The device is primarily intended for fluid management during hysteroscopy and for operating hysteroscopic morcellators, not for making a diagnosis. While it monitors fluid volume differential, this is a functional parameter, not a diagnostic one.
No
The device description explicitly states the system consists of a console and single-use procedure kit, including hardware components like motors, pressure sensors, tube sets, and a waste bag. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Fluent Pro Fluid Management System Function: The description clearly states the device's purpose is to manage fluid during hysteroscopic procedures (examining and operating within the uterus). It provides fluid distension, monitors fluid volume, and assists with tissue removal.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient to provide diagnostic information. It is a surgical and fluid management tool used during a procedure.
Therefore, based on the provided information, the Fluent Pro Fluid Management System falls under the category of a surgical or procedural device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HIG, HIH
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.
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)
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, "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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below that.
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
1
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
2
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
3
Indications for Use
510(k) Number (if known) K240886
Device Name Fluent Pro Fluid Management System
Indications for Use (Describe)
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.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 Drive | |
| Marlborough, MA 01752 USA | |
| Establishment Registration #: | 1222780 |
| Contact Person: | Meghan Wakeford |
| Principal Regulatory Affairs Specialist | |
| P: 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 and |
| accessories) | |
| 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 and |
| accessories) | |
| 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:
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.
5
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:
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.
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.
6
Substantial Equivalence:
| | Fluent Pro Fluid Management System
Hologic, Inc.
Proposed Device | Fluent Fluid Management System
(K180825)
Hologic, Inc.
Predicate Device |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | 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. | 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. |
| Prescription
or OTC | Prescription Use | Prescription Use |
| Product Code | HIG, HIH | HIG, HIH |
| Regulation
Number | 21 CFR 884.1700 | 21 CFR 884.1700 |
| Method of
Use | Uterine distention to enable
hysteroscopic surgical removal of
intrauterine tissue | Uterine distention to enable
hysteroscopic surgical removal of
intrauterine tissue |
| Mechanism
of Action | Fluid flow with a single peristaltic pump
for irrigation and single peristaltic pump
for vacuum | Fluid flow with a single peristaltic pump
for irrigation and single peristaltic pump
for vacuum |
| 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 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. | 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. |
| Inflow Pump
Design &
Mechanism | Electro-mechanical peristaltic pump | Electro-mechanical peristaltic pump |
| Pressure
Control
Range | 40-150 mmHg | 40-120 mmHg |
| Maximum
Intrauterine
Pressure | 150 mmHg | 120 mmHg |
| Maximum
Inflow Rate | 1000 mL/min | 650 mL/min |
| | Fluent Pro Fluid Management System
Hologic, Inc.
Proposed Device | Fluent Fluid Management System
(K180825)
Hologic, Inc.
Predicate Device |
| Adjustable
Suction
Settings | Low, Medium, and High | Non-adjustable |
| Intrauterine
Pressure
Display | Pressure setting and actual pressure level
displayed on the procedure screen | Pressure setting displayed on the
procedure screen |
| Deficit Limit
Range | 100-2500 mL in increments of 50 mL at
start of procedure
Deficit can be increased beyond 2500
mL after procedure has started based on
physician discretion | 100-2500 mL in increments of 50 mL at
start of procedure
Deficit can be increased beyond 2500
mL after procedure has started based on
physician discretion |
| Fluid Deficit
Tracking | Displays Deficit, Deficit Limit, and Total
Fluid In | Displays Deficit and Deficit Limit |
| Deficit
Accuracy | $\pm$ 50 mL under normal use | $\pm$ 50 mL under normal use |
| Drive
Control
Motor speed | 2200 $\pm$ 270 RPM | 2200 $\pm$ 270 RPM |
| MyoSure
Operating
Modes | System allows operation of TRD control
functions with or without operation of
the inflow and outflow pumps. | System allows operation of TRD control
functions during operation of the inflow
and outflow pumps. |
| Electrical
Safety &
EMC Testing | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 |
| Disposable
Procedure
Kit
Sterilization
Method | Ethylene Oxide | Ethylene Oxide |
| Biocompatibility
Testing
per ISO
10993-1 | Yes | Yes |
7
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,
8
"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).