(126 days)
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.
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.
Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:
Disclaimer: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive clinical study report with detailed acceptance criteria and performance data in a structured format. Therefore, I will extract relevant information where available, and note when specific details (like numerical acceptance criteria or clinical study specifics) are not explicitly stated.
Acceptance Criteria and Device Performance
The 510(k) summary does not explicitly present a table of acceptance criteria with corresponding reported device performance values in a quantifiable manner that is typical for a clinical study. Instead, it relies on demonstrating that the new device's performance is "substantially equivalent" to the predicate devices. The performance testing section describes categories of tests conducted, implying that the device successfully met internal specifications and standards relevant to those tests.
However, based on the "Comparison of Technological Characteristics" Table 5-1 and the "Performance Testing" section, we can infer some operational parameters and functional aspects that would have associated acceptance criteria internally.
| Performance Characteristic (Inferred Acceptance Criteria) | Reported Device Performance (Fluent Fluid Management System) | Notes / Implicit Acceptance |
|---|---|---|
| Fluid Management System | ||
| Pressure Control Range | 40-120 mmHg | Different from Predicate 1 (40-150 mmHg), but within safe and effective range. No specific acceptance threshold for this range is given. |
| Maximum Intrauterine Pressure | 120 mmHg | Different from Predicate 1 (150 mmHg), but within safe limits. |
| Flow rate (maximum) | 650 mL/min | Different from Predicate 1 (800 mL/min), but deemed acceptable for use. |
| Overpressure Protection | Yes | Same as Predicate 1. Implied: Must function reliably. |
| Fluid Deficit Tracking | Yes | Same as Predicate 1. Implied: Must accurately track fluid deficit. |
| Drive Control Console for Hysteroscopic Morcellators | ||
| Morcellator Drive Rotation Speed | 8075 ± 1000 RPM | Same as Predicate 2. Implied: Must maintain this speed within tolerance. |
| Sterility and Shelf Life | ||
| EtO Sterilization | Per ISO 11135:2014 & ISO 10993-7:2008 | Successful completion implies acceptance. |
| Package Integrity | Per ASTM F1980-16 | Successful completion implies acceptance. |
| Shelf Life (Sterile Components) | Three-year shelf life confirmed | Confirmed by accelerated aging and functional testing. |
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5:2009 compliant | Successful completion implies acceptance. |
| Sensitization | ISO 10993-10:2010 compliant | Successful completion implies acceptance. |
| Irritation | ISO 10993-10:2010 compliant | Successful completion implies acceptance. |
| Acute System Toxicity | ISO 10993-11:2006 compliant | Successful completion implies acceptance. |
| Software | ||
| System Design Control Verification & Validation | Successfully performed, Major Level of Concern | In accordance with FDA Guidance (May 2005). Successful completion implies acceptance. |
| Electrical Safety and EMC | ||
| Medical Electrical Equipment Standards | IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-6:2010 | Successful completion implies acceptance. |
| Performance Testing (Functional) | ||
| Inflow/Outflow Tubing Sets | Design verification (mechanical testing) | Successful completion implies acceptance. |
| Inflow Rate, Outflow Rate, TRD Suction | Fluid management validation testing to assess | Successful completion implies acceptance. |
| Intrauterine Pressure Control | Testing conducted | Successful completion implies acceptance. |
| System cutting performance | For the drive control system | Successful completion implies acceptance. |
Study Details:
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Sample size used for the test set and the data provenance:
- The document describes non-clinical performance testing (design verification, fluid management validation, intrauterine pressure control, system performance, system cutting performance).
- It does not specify sample sizes for these tests (e.g., how many units were tested, how many trials were conducted for each metric).
- The data provenance is internal to Hologic, Inc. (the manufacturer), as these are manufacturing and engineering validation tests. There's no mention of external data or specific countries of origin beyond the company's location in Marlborough, MA, USA.
- These tests are inherently prospective in nature, as they involve testing the manufactured device against pre-defined specifications.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This question is not applicable in the context of the provided 510(k) summary. The summary describes engineering and performance validation tests for a medical device (hysteroscopic insufflator/morcellator drive), not a diagnostic algorithm or a clinical study requiring expert assessment of medical images or patient outcomes to establish ground truth. The "ground truth" for these tests would be the established engineering specifications and regulatory standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as the tests described are technical performance validations, not clinical assessments requiring adjudication by multiple experts. The results of the engineering tests would be pass/fail against predetermined specifications.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices, where the AI assists human readers (e.g., radiologists). The Fluent Fluid Management System is a surgical assist device, not a diagnostic imaging device with an AI component for human reader assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is a hardware system with integrated software for fluid management and morcellator control. Its "performance" is inherently standalone in the sense that the system itself performs its functions (e.g., maintaining pressure, tracking deficit, driving the morcellator) without direct human-in-the-loop influence on those specific operations. However, the device is used by a human surgeon. There is no "algorithm only" performance study in the typical AI sense. The performance tests (fluid management, cutting performance) were done on the device itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance testing, the "ground truth" refers to the engineering specifications, design requirements, and applicable industry standards (e.g., ISO, ASTM, IEC standards for sterilization, biocompatibility, electrical safety, and performance metrics as defined by the manufacturer). There is no "expert consensus," "pathology," or "outcomes data" ground truth discussed for these particular non-clinical studies.
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The sample size for the training set:
- This question is not applicable as this is not an AI/machine learning device that requires a "training set" in the conventional sense. The device's software is built on established algorithms for control, not on learning from a large dataset.
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How the ground truth for the training set was established:
- This question is not applicable for the same reasons as point 7.
§ 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.