(90 days)
The Aveta System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception.
The Aveta System is an integrated system which allows for visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and operative hysteroscopic procedures. The system includes a Controller with integrated fluid management which incorporates a dual peristaltic pump design to control the continuous inflow and outflow of saline to provide fluid distention of the uterine cavity. The Controller provides continuous monitoring of the intrauterine pressure to the set pressure, as well as monitoring of the volume differential between saline inflow from the uterus. The Controller connects to a sterile, single use Disposable Hysteroscope via a Reusable Hysteroscope Handset that allows visualization of the cervical canal and the uterine cavity and displays the images obtained from the hysteroscope on a standard monitor. For operative procedures, the Aveta System includes a sterile, mechanical Disposable Resecting Device powered by a motorized, Reusable Resecting Handset which is inserted through the sterile hysteroscope working channel to resect and remove endometrial polyps, submucous myomas and retained products of conception under suction.
The provided text describes the 510(k) premarket notification for the Aveta System but does not contain specific acceptance criteria or detailed study results with performance metrics that would typically be found in a clinical study report. The document focuses on demonstrating substantial equivalence to a predicate device.
However, it does list various performance data types that were provided in support of the substantial equivalence determination. Based on these, we can infer the types of acceptance criteria that would have been used, even if the specific numerical thresholds are not explicitly stated.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
As the document is a 510(k) summary, specific numerical acceptance criteria and detailed performance results are not provided. However, the "Performance Data" section (Page 10) lists the types of tests performed, which inherently implies associated acceptance criteria for each. Without the actual study reports, the exact performance values are unknown.
| Test Category | Inferred Acceptance Criteria Type | Reported Device Performance (as per document) |
|---|---|---|
| Software Verification & Validation | Adherence to IEC 62304:2006, functionality, and safety requirements (e.g., no critical software bugs found). | "Software Verification and Validation Testing performed per IEC 62304:2006 and documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" (Implies successful completion and compliance) |
| System Integrity | Withstanding specified operating pressures without failure. | "System withstands operating pressures" (Implies successful completion) |
| Functional Testing (Cut, Coagulation, Aspiration, Irrigation, Pressure Control) | Device operates as intended for each function, meeting specified performance parameters (e.g., flow rates, pressure accuracy, tissue resection capability). | "Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control" (Implies successful completion, device functions as intended) |
| Dimensional Inspection & Testing | Adherence to specified dimensions and tolerances. | "Dimensional Inspection and Testing" (Implies successful completion) |
| Functional Testing for all components | Each component functions reliably and as designed. | "Functional Testing for all components of the system" (Implies successful completion) |
| Maximum LED Tip Temperature | Temperature within safe limits to prevent tissue damage. | "Maximum LED Tip Temperature" (Implies successful completion, temperature within safe limits) |
| Fluid Deficit Limit Verification | Accurate measurement and control of fluid deficit within specified safety margins. | "Fluid Deficit Limit Verification testing" (Implies successful verification) |
| Simulated Use (Tissue Resection, Cavity Pressure, Imaging) | Effective tissue resection, stable cavity pressure, clear imaging for diagnostic and operative procedures. | "Simulated Use: Tissue resection, regulation of cavity pressure, imaging" (Implies successful performance in simulated scenarios) |
| Comparative Testing to Predicate (Pressure Control, Fluid Deficit, Fluid Control, Durability) | Performance of the Aveta System is comparable or superior to the predicate device in these aspects. | "Comparative testing to predicate for pressure control, fluid deficit, fluid control and durability." (Implies the Aveta System performs comparably or is substantially equivalent to the predicate in these aspects, justifying the 510(k) clearance) |
| Biocompatibility Testing | Compliance with ISO 10993-1:2009/(R)2013, indicating no adverse biological reactions. | "Biocompatibility Testing per ISO 10993-1:2009/(R)2013." (Implies successful compliance) |
| Sterilization Validation | Compliance with ISO 11135:2014 and ISO 11137-1/-2/-3:2013, ensuring sterility assurance level. | "Sterilization Validation per ISO 11135:2014 and ISO 11137-1/-2/-3:2013." (Implies successful validation, ensuring sterility) |
| Packaging Validation | Compliance with ASTM D4169:2016, ensuring product integrity during shipping and storage. | "Packaging Validation per ASTM D4169:2016." (Implies successful validation) |
| Accelerated Aging | Compliance with ASTM F1980:2016, demonstrating shelf life stability. | "Accelerated Aging per ASTM F1980:2016." (Implies successful demonstration of shelf life) |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-18 standards. | "Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-2:2014 and IEC 60601-2-18:2009." (Implies successful compliance with these standards) |
| Usability Testing | Compliance with FDA guidance and IEC 62366:2015, ensuring safe and effective human-device interaction. | "Usability Testing per FDA guidance and IEC 62366:2015" (Implies successful completion, ensuring usability and safety as per standards) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The listed tests are primarily engineering and bench testing, as well as simulated use. No information is given regarding human subject test sets or the number of cases.
- Data Provenance: The tests are indicated as performance data provided in support of substantial equivalence, which typically means the testing was conducted by Meditrina, Inc. (the manufacturer) or a contracted lab. The country of origin for the data is not specified, but the context implies it was generated to meet US FDA requirements. The data is prospective in the sense that Meditrina, Inc. generated it specifically for this premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The tests performed are primarily related to device function, safety, and performance against engineering specifications, rather than clinical diagnostic accuracy requiring ground truth established by experts. "Simulated Use" might involve experts, but the details are not given.
4. Adjudication Method for the Test Set
- This information is not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic decisions. The tests listed are not typically subject to such adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The document states "Comparative testing to predicate for pressure control, fluid deficit, fluid control and durability." This refers to technical performance comparisons between the devices, not a clinical study assessing human reader performance with and without AI assistance. The Aveta System appears to be a medical device for hysteroscopy procedures with integrated fluid management and resection capabilities, not primarily an AI-driven diagnostic imaging interpretation device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- The Aveta System is a medical device for hysteroscopy, not an AI algorithm. Therefore, a standalone algorithm-only performance assessment, as it pertains to AI/machine learning, is not applicable and was not performed. The "Software Verification and Validation Testing" addresses the software component of the device, but this is distinct from AI-specific standalone performance.
7. The Type of Ground Truth Used
- For the engineering and functional tests, the "ground truth" would be the engineering specifications, regulatory standards (e.g., ISO, IEC, ASTM), and the expected physical or electrical outcomes of the device's operation.
- For "Simulated Use" tests, the ground truth might come from established clinical protocols or expert assessment of the simulation's success.
- For "Comparative testing to predicate," the predicate device's established performance would serve as a benchmark or "ground truth" for comparison.
- Pathology or outcomes data are not explicitly mentioned as ground truth sources for the performance data presented here, although tissue resection is mentioned, implying that the resected tissue would eventually be sent for pathology in actual clinical use.
8. The Sample Size for the Training Set
- This information is not applicable or not provided as the Aveta System is a hardware/software medical device, not an AI/machine learning system that requires a distinct "training set" for model development in the traditional sense. Software verification and validation are performed, but this is testing against specifications, not training a model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no mention of a "training set" in the context of AI/machine learning for this device.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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.