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510(k) Data Aggregation
(115 days)
Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure
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 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.
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: ± 50 mL under normal use (specified for predicate and proposed device) | Passed Intrauterine Pressure Control and Fluid Deficit Bench Testing. (Implied: met ± 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 (± 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.
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