(304 days)
The Olympus sterilization trays are intended to be used to enclose Olympus medical devices including hand instruments, trocars, camera heads, adapter, and endoscopes to be sterilized by a health care provider. It is intended to allow steam sterilization of the enclosed medical device.
The qualification for sterilizing endoscopic instruments were validated with a process challenge device (PCD) by a GLP approved laboratory. The PCD has a diameter of 2 mm and a length of 1500 mm.
The Olympus sterilization trays are to be sterilized in the following cycle:
Prevacuum Steam: 132°C - 134°C - 5 minutes minimum.
Drying Time: 10 – 20 minutes as needed.
The Sterilization trays, which are the subject of this premarket notification, are as follows:
| Item no. | Outer dimensions WxHxD[mm] | Detailed product description |
|---|---|---|
| A5938* | 595 x 61 x 295 | Instrument tray, with lid, for video telescope |
| A5951* | 478 x 41 x 224 | Insert tray, for 2.7 and 4.0 mm TruView arthroscopes |
| A5952* | 478 x 41 x 224 | Insert tray, for Diver-Line hand instruments |
| A5961* | 665 x 52 x 204 | Insert tray, for ureteroscopes, with lid |
| A5975* | 532 x 63 x 128 | Instrument tray, small, with lid |
| A5976* | 478 x 68 x 224 | Insert tray, for urology |
| A5977* | 478 x 68 x 224 | Insert tray, for 4 TroQ trocars |
| A5984* | Set: A5994 and WA05974 | Instrument tray, for camera head and adapter |
| A5992* | 478 x 54 x 224 | Instrument tray, for A3336A, A2027A and A5226A |
| A5994* | 478 x 68 x 224 | Insert tray, for camera head and adapter |
| A05951A* | 478 x 41 x 224 | Insert tray, for TrueView II and mini TrueView telescopes |
| A05952A* | 665 x 65 x 204 | Instrument tray, for SonoSurg instruments, with lid |
| A05961A* | 405 x 95 x 200 | Instrument tray, for compact cystoscope and compact hysteroscope, with lid |
| WA05970A | 537 x 139 x 268 | Instrument tray, with lid and silicone mat |
| WA05971A | 482 x 60 x 224 | Insert tray, for the upper part of WA05970A, with silicone mat |
| WA05972A | 480 x 47 x 224 | Insert tray, for 5 HiQ shafts and jaw inserts |
| WA05973A | 460 x 39 x 207 | Insert tray, for the bottom of WA05970A, with silicone mat |
| WA05974A | 488 x 31 x 235 | Lid, for insert trays |
| WA05980A | 438 x 176 | Spare mat, nubbly, silicone, for WA05970A and WA05971A |
| WA05981A | 400 x 175 | Spare mat, nubbly, silicone, for WA05973A |
| WA05990A | 446 x 88 x 49 | Instrument tray, for two telescopes, with lid |
| WA05994A* | 478 x 68 x 224 | Insert tray, for camera head and adapter |
| WA05995A* | 478 x 68 x 224 | Insert tray, pediatric urology |
| WA05980A* | 595 x 61 x 295 | Instrument tray, for video telescope |
The Olympus sterilization trays consist of perforated bottoms with or without perforated lids. The material of the bottom is thermoplastic, the material of the lid is thermoplastic with handles and locking tabs made from medical grade stainless steel. The silicone mats for fixture of the instruments are perforated for aeration.
The stripes are designed for minimal contact area with instruments and secure fixing.
Olympus sterilization trays will be sold non-sterile and can be reused after proper cleaning and sterilization.
The provided 510(k) summary for the Olympus Sterilization Trays (K033222) does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in the way a diagnostic AI device would. This document is a premarket notification for a medical device (sterilization trays), not an AI algorithm. Therefore, many of the requested categories are not applicable.
However, I can extract the relevant performance data and address the applicable points based on the information provided.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative sense for performance metrics like sensitivity or specificity, as it's a physical medical device. Instead, performance is demonstrated through validation of its intended function.
| Feature/Criterion | Reported Device Performance |
|---|---|
| Intended Use | Enclose medical devices for steam sterilization. |
| Reusability | Yes |
| Material Composition | Thermoplastic RADEL® |
| Design | Base with lid, attachable by locking tab. |
| Compatibility with Mats | Usable with silicone mats or special silicone holders. |
| Sterilant Penetration | Validated for Steam with Prevacuum. |
| Microbial Barrier Properties | To be used with approved sterilization wrap. |
| Material Compatibility | Compatible with Steam Sterilization at 134°C. |
| Toxicological Properties | Material biocompatible. |
| Drying time | 10 - 20 minutes (as needed for the specified cycle). |
| Sterilization Cycle (Prevacuum Steam) | 132°C - 134°C - 5 minutes minimum. |
No Acceptance Criteria for AI Performance are Present as This is Not an AI Device.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the device is a physical sterilization tray, not an AI model requiring a test set of data. The validation mentioned refers to the physical product's ability to withstand and facilitate sterilization.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The "ground truth" here is the physical and functional performance of the device, assessed through engineering and sterilization validation studies, not expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable for a physical medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
Not applicable. This is not an AI device, and therefore, no MRMC study looking at human reader improvement with AI assistance was performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
For the Olympus Sterilization Trays, the "ground truth" largely relies on:
- Engineering specifications and material science: Verification that the materials (thermoplastic RADEL®, stainless steel, silicone) meet performance requirements for temperature, mechanical stress, and biocompatibility.
- Sterilization efficacy validation: Demonstrated that the trays allow for proper steam penetration and drying during the specified sterilization cycle. The document explicitly states: "The qualification for sterilizing endoscopic instruments were validated with a process challenge device (PCD) by a GLP approved laboratory." This PCD likely simulates the most challenging conditions for sterilization within the tray.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical device, not an AI model. The validation for the device's performance was established through testing by a "GLP approved laboratory" using (at least) a Process Challenge Device (PCD) to ensure effective sterilization. Environmental testing and material compatibility assessments would also form part of this "ground truth" for a physical device.
§ 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).