(299 days)
The instrument basket is intended to be used to enclose and protect one Olympus video telescope for sterilization in a prevacuum steam sterilizer or STERRAD® sterilizer using the following parameters or cycles:
• Prevacuum steam sterilization
| - Exposure time at a temperature of 132 °C (269.6 °F:) | |
|---|---|
| Wrapped instruments | 4 min. |
| Immediate-use non-porous instruments | 3 min. |
| - Exposure time at a temperature of 135 °C (275 °F:) | |
|---|---|
| Wrapped instruments | 3 min. |
| Immediate-use non-porous instruments | 3 min. |
| - Drying time | 30 min. |
|---|---|
| --------------- | --------- |
After steam sterilization, let the instrument basket cool down at room temperature.
| - Cool-down time | 30 min. |
|---|---|
| ------------------ | --------- |
• STERRAD® sterilization
-
STERRAD® 100S cycle
-
STERRAD® 100NX™: standard cycle and express cycle
The instrument basket is not intended to maintain sterility. It is intended to be used in conjunction with a 510K cleared sterilization wrap to maintain sterility of the enclosed Olympus video telescope and accessories.
Validated worst-case load
The instrument basket which is double-wrapped in a sterilization wrap with one enclosed Olympus video telescope and accessories must not exceed 8.708 lb (3950 g).
The instrument basket, for ENDOEYE is specifically designed for enclosure of Olympus video telescopes and accessories during sterilization and storage of Olympus video telescopes and accessories after sterilization as well as enclosure during transport within the reprocessing cycle.
The Olympus instrument basket is autoclavable and delivered in non-sterile condition to the customer. It is reusable and has to be reprocessed before first and each subsequent use according to defined reprocessing methods in the Instructions for Use.
Rigid containment device consisting of a base with lid which can be fastened by a latching mechanism. The device is perforated in order to enable reprocessing of enclosed medical devices held in place by silicone retainers.
The provided text describes a medical device, an instrument basket, for which K171692 is a 510(k) premarket notification. The document outlines the device's indications for use, comparison to a predicate device, and performance data from various tests. However, it does not contain information on "acceptance criteria" for a diagnostic or AI device, nor does it present a study proving a device meets acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).
The device in question, an "Instrument basket, for ENDOEYE," is classified as a "Sterilization wrap" (21 CFR 880.6850, Product Code: KCT). It's a container designed to hold surgical instruments during sterilization processes. The performance data presented relates to the physical and material properties of the basket itself, ensuring it can withstand sterilization and is biocompatible, not to diagnostic performance or AI effectiveness.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and the reported device performance: The document does not define such criteria for diagnostic performance. The "performance data" section focuses on biocompatibility and physical integrity during sterilization.
- Sample size used for the test set and the data provenance: Not applicable, as no diagnostic test set is described.
- Number of experts used to establish the ground truth and their qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI or diagnostic device.
- Standalone (algorithm only without human-in-the-loop performance): Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The "Performance Data" section (page 8) explicitly states that "Performance tests were carried out to ensure that the system functions as intended and meets design specifications." The listed tests are:
- Biocompatibility testing: Conducted according to ISO 10993 standards (Biological Safety toxicology, Cytotoxicity, Chemical Analysis).
- Performance Bench Testing: Focused on mechanical protection, enabling automated cleaning/disinfection, enabling use with sterilization wrap, and enabling sterilization of loaded video telescopes. These were conducted as required by AAMI / ANSI ST77:2013 (containment devices for reusable medical device sterilization).
These tests ensure the safety and functionality of the sterilization basket, not the diagnostic performance or AI capabilities of a medical image analysis tool.
§ 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).