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510(k) Data Aggregation
(175 days)
SERVICE MANAGER SM40SE
The intended use for the SM40SE console is to position and manage devices such as medical gas, high and low voltage electrical, communication and accessories such as equipment shelves, drawers, IV poles and smoke evacuation units.
The smoke plume evacuator integrated into the SM40SE is intended for the evacuation and filtration of smoke plume and odor generated during laser or electrosurgery.
The SM40SE is a space management custom configured consoles into which a variety of medical devices are integrated including a surgical smoke evacuator.
These SM40SE consoles are suspended from articulated ceiling pendant in general operating rooms, minimally invasive surgery suites and post-anaesthesia care units.
This 510(k) summary (K053464) for the SM40SE Smoke Management System provides very limited information regarding acceptance criteria and performance studies. The document primarily focuses on establishing substantial equivalence to predicate devices and describes the intended use and general features of the device.
Here's an analysis based on the provided text, highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not contain any specific acceptance criteria or reported device performance metrics for the SM40SE. It generally discusses the function of its integrated smoke plume evacuator to evacuate and filter smoke and odor, but without quantifiable targets or results.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe any specific test set, its sample size, or the provenance of any data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention any ground truth establishment or the use of experts for performance evaluation.
4. Adjudication Method for the Test Set:
Since no test set or ground truth establishment is described, there is no information on adjudication methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. There is no mention of human readers, AI assistance, or an effect size for improvement with AI. This is a medical device, not an AI software.
6. Standalone (Algorithm Only) Performance Study:
The document does not describe a standalone performance study for an algorithm. This device is a physical system with an integrated smoke evacuator, not an AI algorithm.
7. Type of Ground Truth Used:
The document does not specify any type of ground truth used, as no performance studies are detailed.
8. Sample Size for the Training Set:
The document does not mention any training set or its sample size. This is not an AI/ML device that would typically have a training set.
9. How Ground Truth for the Training Set was Established:
As no training set is described, there is no information on how its ground truth would be established.
Summary of Device and Approval:
The K053464 submission is for the SM40SE, a space management console with an integrated smoke plume evacuator.
- Intended Use: The console positions and manages devices (medical gas, electrical, communication, accessories) and the smoke plume evacuator evacuates and filters smoke and odor generated during laser or electrosurgery.
- Substantial Equivalence: The device was found substantially equivalent to:
- Approval Date: June 6, 2006.
- Classification: Class II, Product Code FYD (Surgical Exhaust Apparatus).
Conclusion:
This 510(k) summary focuses on the formulation of product equivalence rather than presenting detailed performance data against specific acceptance criteria. For devices like the SM40SE, substantial equivalence is often established through detailed comparisons of design, materials, manufacturing processes, and intended use with legally marketed predicate devices, rather than extensive clinical studies or quantitative performance metrics typically seen with diagnostic or therapeutic devices that rely on novel technologies or algorithms. The approval indicates that the FDA deemed the device as safe and effective as the predicates based on the provided information, without requiring explicit tabular performance data or discussion of AI-related study components.
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