(102 days)
These warming cabinets are designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use.
These devices are 120 or 220 V Ac powered warming cabinets designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use. The particular cabinet configuration can be deduced from its model number: SWC = Single Warming Cabinet. DWC = Dual Warming Cabinet. G = Glass Door The temperature ranges and capacities vary according to model but all have: Adjustable Temperature Range Digital Control Dual Display Push Button Operation Rapid Warm Time High Accuracy.
The provided document is a 510(k) summary for warming cabinets (SWC/DWC Various Models) and does not contain information about acceptance criteria for a device evaluated with a study (like an AI/ML device). Instead, it's a notification to the FDA to market a medical device, demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, as the document does not describe such a study or criteria for this type of medical device (warming cabinets).
The document focuses on:
- Device Name: SWC/DWC (Various Models) Warming Cabinets
- Regulation Number and Name: 21 CFR 890.5950, Powered Heating Unit
- Product Code: LHC
- Indications for Use: To store, warm, and maintain the recommended temperature of irrigation solutions prior to use.
- Predicate Device: K993797, Enthermics Medical Systems Fluid Warming Cabinet
- Conclusion: Based on bench and standards testing, the device is deemed as safe and effective as the predicate device, with few technological differences and no new indications for use, thus substantially equivalent.
There is no mention of an algorithm or AI component, nor any study involving a test set, ground truth, or expert review, as would be relevant for an AI/ML device. The "testing" referred to is "bench and standards testing," which typically involves engineering and performance validation against industry standards for warming cabinets, not a clinical or AI performance study.
§ 890.5950 Powered heating unit.
(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.