The DOLPHIN® 3 Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.

Device Description

The DOLPHIN® 3 will be used during Hysteroscopic procedures where physicians need to monitor fluid pressure and fluid loss. The system will provide delivery of low viscosity distension fluid through a disposable tubing set that includes an integrated pressure transducer. The system will calculate and display fluid pressure and fluid deficit while providing distension of the uterus for visualization and flow. The DOLPHIN® 3 provides both audible and visual alarms if pressure levels are too high or if the user-set fluid deficit alarm levels are exceeded. The DOLPHIN® 3 incorporates a two-bag distension fluid system that utilizes a bladder bag to provide steady pressure on (each) the fluid bags. The two bladder bags are essentially pneumatic "bag squeezers" set within a rigid housing that contains the fluid bags. The DOLPHIN® 3 fluid pump adjusts the pressure applied to the distension fluid bags by inflating or deflating the pneumatic bladder. The infusion pressure can be set by the user between 40-140 mm Hg (40 mmHg is the factory default setting at power up) The system can accommodate 1, 2 or 3 liter fluid bags, The sterile/disposable tubing set with integrated pressure transducer is used to deliver fluid from the DOLPHIN® 3 to the inflow port on the hysteroscope. The device weighs the fluid in order to calculate the deficit. Any fluid dispensed but not returned to the collection canisters is considered part of the deficit.

AI/ML Overview

The provided text describes a 510(k) summary for the DOLPHIN® 3 Fluid Management System. It outlines the device's intended use, product description, and a summary of nonclinical/bench testing performed to verify its performance. However, it does not include specific acceptance criteria for performance metrics in a tabular format, nor does it detail a study that directly proves the device meets such criteria with numerical results. The document primarily focuses on verifying functionality and safety rather than quantifying performance against pre-defined acceptance thresholds in a clinical or comparative study with human readers.

Therefore, much of the requested information cannot be extracted from the provided text. I will provide what is available and note what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary lists multiple performance/functional tests conducted but does not specify numerical acceptance criteria for these tests or quantitatively report the device's performance against such criteria. The document generally states that tests were conducted "to verify that the subject device met specified requirements" or "to determine the ability" or "to verify functionality," without providing the actual values or thresholds.

Acceptance Criteria (Not Explicitly Stated as Quantitative)	Reported Device Performance (General Statements)
Pressure Accuracy vs Flow Rate: (Implicit: maintain accuracy across various output pressures and flow rates for different hysteroscopes)	"Illustrated the intrauterine pressure developed by the DOLPHIN®3 at various output pressures and flow rates." "Comparative testing included three different make/models of hysteroscopes. The intrauterine pressure versus flow data for the predicate and subject devices were plotted for each scope." (No specific accuracy numbers or comparison results provided).
Simulated Procedure: (Implicit: maintain fluid management data accuracy and alarm functions during a simulated procedure)	"Verify that fluid management data accuracy and alarm functions are maintained throughout a simulated procedure." (No specific accuracy or alarm performance metrics provided).
Load Cell Overstrain Test: (Implicit: functionality of mechanical load cell protection)	"Verify functionality of the mechanical Load Cell protection incorporated in the design... by applying an overstraining force on the load cells." (No specific force limits or post-test functionality results provided).
Fluid Bag and Canister Compatibility Test: (Implicit: compatibility and function with recommended fluid bags and collection canisters)	"The purpose of the test was to verify the equipment is compatible and functions with the recommended manufacturer's fluid bags of various sizes and recommended collection canisters." (No specific compatibility results provided).
Calibration Protocol: (Implicit: functionality of calibration module and accuracy across working range)	"Verified functionality of the Calibration module and Calibration Verification module. Checked accuracy through the working range of all the load cells in the machine and verified the functionality of the software trigger for Passing/Failing the calibration check." (No specific accuracy range or pass/fail rates provided).
External Transducer Check Test: (Implicit: ability to identify faulty external pressure transducers)	"Determine the ability of the subject device to identify faulty external pressure transducers (part of the Tubing Set) due to open wiring connections." (No specific detection rates or methods described).
Internal Pressure Transducer Check Procedure: (Implicit: software and hardware pressure cutout limits meet specifications)	"Verify the software and hardware pressure cutout limits meet performance specifications." (No specific limits or verification results provided).
Acoustic Level Test: (Implicit: alarms are discernible and audible)	"In all cases alarms were measurably discernible from the pump background noise and audible to the operator." (No specific decibel levels or audibility criteria provided).
Bladder Bag Inflate/Deflate Test: (Implicit: meet PPS for inflate/deflate times and flow rates)	"Verify PPS requirements for Bladder Bag inflate/deflate times and flow rates." (No specific times or flow rates provided).
Operational Tilt Test: (Implicit: operate and maintain fluid deficit accuracy under incline/tilt)	"Determined the subject device's ability to operate and maintain fluid deficit accuracy, when subjected to an incline and tilt deviation from a normal operational position on a level floor." (No specific operational limits, tilt angles, or accuracy deviation reported).
Dolphin 3 Splash Test: (Implicit: function after splash and after drying)	"This test verified that the DOLPHIN®3 Hysteroscopic Fluid Management System will function within the Product Performance Specifications immediately after being subjected to an in-process splash of conductive solution and also function after allowing a 24 hour drying period to occur." (No specific functionality checks or performance degradation metrics reported).
Pneumatic Test Protocol: (Implicit: verify pump and pneumatic circuit performance requirements)	"The purpose of the test was to verify pump and pneumatic circuit performance requirements." (No specific performance metrics provided).
Operational Environment Test: (Implicit: operate in intended environment and after shock/vibration; pass LCD, LED, Alarms, Calibration, and Fluid tests, inspected for damage)	"Verify (1) the subject device operates within its intended operating environment as specified in product performance specifications and (2) that the device continues to operate after exposure to vibration/shock likely to be experienced during use." "Proper Dolphin operation was verified by completing the following functional tests: LCD and LED Initialization Tests, Alarms Initialization Test, Calibration Functional Test, Fluid Test, Inspection for Visible Damage." (No specific environmental parameters, shock/vibration levels, or test results provided).
Pressure vs. Bag Volume: (Implicit: ability to maintain pressure as irrigation bag drains)	"This test characterizes the ability of DOLPHIN 3 to maintain pressure as the irrigation bag drains." (No specific pressure maintenance parameters or results provided).

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the document. The tests described are bench/nonclinical tests, not human subject studies or data-driven clinical trials. There is no mention of a "test set" in the context of clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable and not provided in the document. As this is a bench/nonclinical study for a hardware system, there is no "ground truth" derived from expert review or clinical data. The tests focus on the device's physical and functional performance.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document for the reasons stated above.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided in the document. The DOLPHIN® 3 is a fluid management system, not an AI-powered diagnostic device, and the studies described are bench tests, not MRMC studies involving human readers.

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

This information is not applicable and not provided in the document. The device is a physical system with sensors and controls, not a standalone algorithm. The tests described assess the device's physical and functional performance, not algorithm-only performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

This information is not applicable and not provided. The "ground truth" for the nonclinical tests would be the established engineering specifications and physical principles against which the device's performance is measured. For example, for "Pressure Accuracy vs Flow Rate," the ground truth would be accepted physics and engineering standards for pressure and flow.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. As this is not an AI/machine learning device, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided in the document for the reasons stated above.

Summary

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DOLPHIN® 3 Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772 Traditional 510(k) 510/k) Summar Mar 25, 2011

510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. DOLPHIN® 3 Fluid Management System

JUL 19 2011

)

General Information

Manufacturer/Submitter:

Gyrus ACMI, Inc 136 Turnpike Rd. Southborough, MA 01772-2104

Establishment Registration Number:

3003790304

March 25, 2011

Contact Person:

Graham A. L. Baillie MS Associate Manager, Regulatory Affairs

Date Prepared:

Device Description

Classification Name:

Hysteroscopic Insufflator Class 2 21 CFR 884.1700 85 HIG

Project Name:

Trade Name(s):

Generic/Common Name:

DOLPHIN® 3

DOLPHIN® 3 Fluid Management System

Hysteroscopic Insufflator

Predicate Devices

Gyrus ACMI DOLPHIN® II Fluid Management System

Intended Use

The DOLPHIN® 3 Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.

Product Description

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DOLPHIN® 3 Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

K110852
Page 2 of 4
Traditional 510(k) Notification
510(k) Summary
Mar 25, 2011

DOLPHIN® 3 provides both audible and visual alarms if pressure levels are too high or if the user-set fluid deficit alarm levels are exceeded.

The DOLPHIN® 3 incorporates a two-bag distension fluid system that utilizes a bladder bag to provide steady pressure on (each) the fluid bags. The two bladder bags are essentially pneumatic "bag squeezers" set within a rigid housing that contains the fluid bags. The DOLPHIN® 3 fluid pump adjusts the pressure applied to the distension fluid bags by inflating or deflating the pneumatic bladder. The infusion pressure can be set by the user between 40-140 mm Hg (40 mmHg is the factory default setting at power up) The system can accommodate 1, 2 or 3 liter fluid bags, The sterile/disposable tubing set with integrated pressure transducer is used to deliver fluid from the DOLPHIN® 3 to the inflow port on the hysteroscope. The device weighs the fluid in order to calculate the deficit. Any fluid dispensed but not returned to the collection canisters is considered part of the deficit.

Summary Listing of Nonclinical/Bench Testing

The following performance/functional tests were conducted to verify that the subject device met specified requirements.

Pressure Accuracy vs Flow Rate: Illustrated the intrauterine pressure developed by the DOLPHIN®3 at various output pressures and flow rates. Comparitive testing included three different make/models of hysteroscopes. The intrauterine pressure versus flow data for the predicate and subject devices were plotted for each scope. 2) Simulated Procedure: Verify that fluid management data accuracy and alarm functions are maintained throughout a simulated procedure.
Load Cell Overstrain Test: Verify functionality of the mechanical Load Cell protection incorporated in the design of the DOLPHIN®3 Load cell sub assemblies (upper and lower) by applying an overstraining force on the load cells.
Fluid Bag and Canister Compatibility Test: The purpose of the test was to verify the equipment is compatible and functions with the recommended manufacturer's fluid bags of various sizes and recommended collection canisters.
Calibration Protocol: Verified functionality of the Calibration module and Calibration Verification module. Checked accuracy through the working range of all the load cells in the machine and verified the functionality of the software trigger for Passing/Failing the calibration check.
External Transducer Check Test. The purpose of the test was to determine the ability of the subject device to identify faulty external pressure transducers (part of the Tubing Set) due to open wiring connections.
Internal Pressure Transducer Check Procedure: Verify the software and hardware pressure cutout limits meet performance specifications.
Acoustic Level Test: In all cases alarms were measurably discernible from the pump background noise and audible to the operator.
Bladder Bag Inflate/Deflate Test: The purpose of the test was to verify PPS requirements for Bladder Bag inflate/deflate times and flow rates.
Operational Tilt Test: Determined the subject device's ability to operate and maintain fluid deficit accuracy, when subjected to an incline and tilt deviation from a normal operational position on a level floor.

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DOLPHIN® 3 Gyrus ACMI. Inc. 136 Turnpike Road Southborough, MA 01772

K110852
Page 3 of 4
Traditional 510(k) Notification
510(k) Summary
Mar 25, 2011

i 1) Dolphin 3 Splash Test: This test verified that the DOLPHIN®3 Hysteroscopic Fluid Management System will function within the Product Performance Specifications immediately after being subjected to an in-process splash of conductive solution and also function after allowing a 24 hour drying period to occur

Pneumatic Test Protocol: The purpose of the test was to verify pump and pneumatic circuit performance requirements.
Operational Environment Test: Verify (1) the subject device operates within its intended operating environment as specified in product performance specifications and (2) that the device continues to operate after exposure to vibration/shock likely to be experienced during use. Proper Dolphin operation was verified by completing the following functional tests:

LCD and LED Initialization Tests .
Alarms Initialization Test .
Calibration Functional Test .
Fluid Test .
Inspection for Visible Damage .

Pressure vs. Bag Volume: This test characterizes the ability of DOLPHIN 3 to maintain pressure as the irrigation bag drains.

The following standards were referenced in electrical safety, EMC, biocompatibility and sterilization testing:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11. Amendment 2, 1995
EC 60601-1-2, Medical electrical equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests Edition 2.1(Edition 2:2001 consolidated with Amendment 1:2004)
AAMI / ANSI / ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing (2003)
AAMI / ANSI / ISO 10993-5, Biological evaluation of medical devices – Part 5 : Tests for In Vitro Cytoxicity (1999)
AAMI / ANSI / ISO 10993-7, Biological evaluation of medical devices - Part 7: Ehylene Oxide Sterilization Residuals. (2001)
AAMI / ANSI / ISO 10993-10, Biological evaluation of medical devices – Part 10: Tests for Irritation and Delaved-type (2002)
AAMI /ANSI / ISO 11135-1. Sterilization of health care products - Ethylene oxide - Part1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
AAMI /ANSI / ISO 11607-1, Packaging for terminally sterilized medical devices -Part1: Requirements for materials, sterile barriersystems and packaging systems, 3ed (2006)
AAMI /ANSI / ISO 11607-2, Packaging for terminally sterilized medical devices -Part 2: Validation requirements for forming, sealing and assembly process, 1ed (2006)

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Traditional 510(k) N 510(k) Summar Mar 25, 2011

DOLPHIN® 3 Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

Technological Characteristics and Substantial Equivalence

The DOLPHIN® 3 Hysteroscopic Insufflator is an upgrade to the predicate DOLPHIN® II device currently marketed by Gyrus ACMI, Inc. The DOLPHIN® 3 will be marketed with updated software, hardware, and an additional fluid distension bag. The DOLPHIN® 3 will have the identical indications as the predicate DOLPHIN® II, K011876. The software, mechanical design and tubing set have been updated to accommodate the additional fluid bag. The same bladder bag and self contained pump design, used in the DOLPHIN® II to regulate fluid pressure, is incorporated in the DOLPHIN® 3. The tubing set and integrated transducer remains a single use accessory sterilized by EtO.

In summary, the DOLPHIN® 3 is substantially equivalent to the predicate DOLPHIN® II device and presents no new questions of safety or efficacy.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines that curve and flow downwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Graham Baillie Associate Manager, Regulatory Affairs Gyrus ACMI, Inc. 136 Turnpike Road SOUTHBOROUGH MA 01772

JUL 1 9 2011

Re: K110852

Trade Name: DOLPHIN®3 Fluid Management System Regulation Number: 21 CFR $884.1700 Regulation Name: Hysteroscopic insufflator Regulatory Class: II Product Code: HIG Dated: June 23, 2011 Received: June 24, 2011

Dear Mr. Baillie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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

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Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Hubert Lenoir MD

erbert P. Lerner, M.D., Director (Acting) 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): . K110852

Device Name: _ _ DOLPHIN® 3 Fluid Management System

Indications For Use:

The DOLPHIN® 3 Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Afald Kenn

oductive. Gastro-F nal, and

Page 1 of ___1

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.