(152 days)
The Neptune 3 Waste Management System is intended to be used in the operating room, pathology, surgical centers and doctor's offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautery or laser devices.
The Neptune 3 Waste Management System provides fluid waste management, fluid volume measurement and surgical smoke evacuation capabilities and is also equipped with a motorized IV pole. The Stryker Neptune 3 Rover (Model Number 0703-001-000) is a mobile device used to suction and collect waste fluids and evacuate smoke during surgical procedures. The Stryker Neptune 3 Rover collects surgical waste fluid within a closed suction system and is paired with a compatible Stryker Neptune 2 Docking Station (0702-014-000) to facilitate disposal.
The provided document is a 510(k) premarket notification for the Neptune 3 Waste Management System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or significant improvements through complex clinical trials typically associated with AI/ML devices or new drug applications.
Therefore, the document does not contain information about:
- A table of acceptance criteria and reported device performance for an AI/ML or diagnostic accuracy study.
- Sample sizes used for test sets specifically for diagnostic performance.
- Data provenance (country of origin, retrospective/prospective) for a clinical test set.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication methods for ground truth.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes of human reader improvement with AI assistance.
- Standalone algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcome data) for a diagnostic output.
- Sample size for training sets.
- How ground truth for training data was established.
Instead, the document details non-clinical performance data to support substantial equivalence. The acceptance criteria described are for engineering and functional performance tests of the device, not diagnostic accuracy.
Here's an overview of the acceptance criteria and study types relevant to this document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering Focus):
The document states that the Neptune 3 Waste Management System met all identified acceptance criteria for each test, demonstrating passing results. The specific numerical acceptance criteria are not detailed in this public summary, but the type of performance evaluated is listed.
| Performance Test | Acceptance Criteria (Implied) | Reported Performance |
|---|---|---|
| Electrical Safety & EMC | Compliance with IEC 60601-1 and IEC 60601-1-2 standards | Device complies with IEC 60601-1 and IEC 60601-1-2 (including RF wireless). |
| Software V&V | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Major level of concern) | Software verification and validation testing was conducted and documentation provided as recommended. |
| Suction Performance | Ability to quickly aspirate fluids, worst-case simulated use | Met all identified acceptance criteria, demonstrating passing results. |
| ISO 10079-1 (Suction Safety) | Compliance with minimum safety and performance for medical/surgical suction equipment | Met all identified acceptance criteria, demonstrating passing results. |
| Smoke Blower Performance | Predetermined acceptance criteria for minimum/maximum flow rates | Met all identified acceptance criteria, demonstrating passing results. |
| IV Pole Performance | Predetermined acceptance criteria for extension/retraction times | Met all identified acceptance criteria, demonstrating passing results. |
| Docking Performance | Compatibility with Neptune 2 Docking Station, waste off-load after worst-case use | Met all identified acceptance criteria, demonstrating passing results. |
| ULPA Filtration | Compliance with IEST-RP-CC007 under worst-case flow/vacuum | Met identified acceptance criteria, demonstrating passing results. |
| Human Factors Evaluation | Compliance with FDA's "Applying Human Factors and Usability Engineering..." and IEC 62366-1 | Human factors analysis and usability testing was performed in support of SE. |
2. Sample Size for Test Set and Data Provenance:
This information is not applicable in the context of the provided document. The tests conducted are functional and engineering performance tests on the device itself, not clinical studies involving patient data or diagnostic output. The "test set" here refers to the specific test conditions or units used in engineering verification.
3. Number of Experts and Qualifications for Ground Truth:
This information is not applicable. Ground truth for these engineering tests would be established by validated test methods and instrumentation, not by expert human interpretation of medical images or conditions.
4. Adjudication Method for Test Set:
This information is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. An MRMC study was not conducted. This type of study is relevant for evaluating the impact of AI systems on human diagnostic performance, which is not the purpose of this 510(k) submission for a fluid waste management system.
6. Standalone Algorithm Performance:
No. This device does not feature a diagnostic algorithm; thus, standalone algorithm performance is not applicable.
7. Type of Ground Truth Used:
The "ground truth" for the performance claims in this document is based on engineering standards, predetermined functional specifications, and validated test methodologies. For example:
- Electrical safety is proven against IEC standards.
- Suction performance is measured against specified flow rates and vacuum levels.
- Filtration is evaluated against established particle penetration standards (IEST-RP-CC007).
8. Sample Size for Training Set:
This information is not applicable. This device is not an AI/ML device that requires a training set of data. The "training" of this device involves its manufacturing and calibration according to specifications, not data-driven machine learning.
9. How Ground Truth for Training Set was Established:
This information is not applicable.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.