(210 days)
The Benesta™ Sterilization Tray is intended to enclose and protect the Caldera Medical Rod Lens Hysteroscope and accessories during sterilization and storage.
The Benesta™Sterilization Tray must be used in conjunction wrap that is cleared by the FDA for the indicated sterilization cycles.
STEAM STERILIZATION
| Pre-Vacuum | Gravity | |
|---|---|---|
| Temperature | 132 °C | 132°C |
| Exposure Time | 4 minutes | 15 minutes |
| Dry Time | 45 minutes | 45 minutes |
| Device Storage Conditions | Do not double stack, store in a cool dry location after | |
| sterilization | ||
| Sterility using FDA validated wrap | Sterility is maintained until wrap is opened or | |
| otherwise compromised | ||
| Validated Device Contents | ≤20 lbs. (1) Caldera Medical Rod Lens Hysteroscope | |
| (1) Caldera Medical Removable Outflow Channel (2) | ||
| Light post adapters, (1) | ||
| Valve Cap (2) Valve Insert End Cap |
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This document is a marketing clearance letter from the FDA for a medical device called the "Benesta Medical Sterilization Tray" (K193603). It is not a study or regulatory approval for an AI/ML medical device. Therefore, it does not contain the information required to answer your prompt regarding acceptance criteria and a study proving device performance for an AI/ML device.
The document states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act. It outlines the intended use and steam sterilization parameters for the tray when used with specific Caldera Medical instruments.
To answer your questions, I would need a document that describes the clinical performance or validation study of an AI/ML medical device. This document is related to a physical sterilization tray, not a software algorithm.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).