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510(k) Data Aggregation
(300 days)
Instrument tray, for semi-rigid ureteroscope
The instrument tray is intended to be used to enclose and protect one Olympus semi-rigid ureteroscope, models WA2UR11A, WA2UR12A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR22A, WA2UR23A WA2UR31A, and WA2UR32A (K200369), and accessories during sterilization in a prevacuum steam 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. |
| Unwrapped non-porous instruments | 3 min. |
-
Exposure time at a temperature of 135 °C (275 °F:) Wrapped instruments .......................................................................................................................................................... Unwrapped non-porous instruments ................ 3 min.
-
Drying time.........................................................................................................................30 min.
After steam sterilization, let the instrument tray cool down at room temperature. - Cool-down time...............................................................................................................................30 min.
The instrument tray is also intended for the enclosure of Olympus semi-rigid ureteroscopes and accessories during transport and storage within the reprocessing cycle. The instrument tray is not compatible with flexible ureteroscopes.
The instrument tray is to be used in conjunction with a FDA cleared sterilization wrap. Maintenance of sterility depends on the sterilization wrap.
Worst case load:
The instrument tray containing a ureteroscope, attachments, light-guide cable adapters, sealing caps and stopcocks must not exceed a weight of 3300 grams (7.27 lb) altogether.
The instrument tray, for semi-rigid ureteroscope is specifically designed for enclosure of Olympus ureteroscopes and accessories during sterilization and storage of Olympus ureteroscopes and accessories after sterilization, as well as enclosure during transport within the reprocessing cycle. A loaded instrument tray cannot be used for automated cleaning of the contained devices.
The Olympus instrument tray 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.
The provided text describes the acceptance criteria and study results for the "Instrument tray, for semi-rigid ureteroscope" (K203492).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ISO 10993-5:2009 (Biocompatibility) | Demonstration of biocompatibility for materials that contact the loaded devices | Non-cytotoxic under the conditions of the study | Pass |
| ISO 10993-12:2012 (Chemical analysis, sample preparation) | Not explicitly stated as a separate purpose in the table, but related to biocompatibility evaluation. | Non-cytotoxic under the conditions of the study | Pass |
| Cleaning validation | Demonstration of the efficacy of the cleaning procedure | Visibly clean | |
| Residual protein content less than 3 microgram/cm² | |||
| Residual TOC less than 12 microgram/cm² | Pass | ||
| Half-cycle sterilization validation | Demonstration of 6 log reduction of stearothermophilus Geobacillus under half cycle conditions | No viable growth | Pass |
| Verification of tray durability after repeated sterilization cycles | Demonstration of tray durability over 400 sterilization cycles | No visible degradation | |
| No corrosion | |||
| Legibility of markings | Pass | ||
| Evaluation of residual moisture | Demonstrate adequate drying time | No visible condensation or pooling on the wrap and contents free of visible condensation | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test within the "Summary of Non-clinical Testing" section. It refers to "the study" or "400 sterilization cycles" for the durability test.
- Sample Size: Not explicitly stated for most tests, except for "400 sterilization cycles" for the durability test.
- Data Provenance: The studies were conducted in support of a 510(k) premarket notification for a medical device. This indicates the data is likely prospective and generated specifically for regulatory submission, rather than retrospective analysis of existing data. The manufacturer is Olympus Winter & Ibe GmbH, located in Hamburg, Germany, so the origin of the data would be associated with their testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are primarily engineering and microbiology validation tests (e.g., biocompatibility, cleaning efficacy, sterilization efficacy, durability, moisture evaluation). These types of tests typically rely on standardized protocols and objective measurements rather than expert consensus on subjective interpretations.
4. Adjudication method for the test set
This information is not applicable/not provided as the tests are objective performance evaluations with defined criteria, not requiring adjudication in the context of expert review or consensus building.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any discussion of AI assistance. This device is an instrument tray for sterilization, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a physical instrument tray, not an algorithm, and does not involve AI or software performance.
7. The type of ground truth used
The ground truth for these performance tests is based on:
- Objective measurement against pre-defined thresholds: For cleaning validation (residual protein/TOC), sterilization validation (6 log reduction, no viable growth), and residual moisture (no visible condensation).
- Visual inspection and observation against criteria: For cleaning validation (visibly clean), durability (no visible degradation, no corrosion, legibility of markings).
- Standardized biological assays: For biocompatibility (non-cytotoxic).
These are all empirical and objective measures, not pathology, outcomes data, or expert consensus in the typical sense of diagnostic accuracy.
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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