(113 days)
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.
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.
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.
§ 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.