(149 days)
The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles:
(1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time.
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(2) Gravity Steam At 132°C for 15 minutes with a 30 minutes dry time.
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The tray is intended for sterilization of non-porous loads.
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Do not stack trays during sterilization.
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The tested Tray represents the worst case validated load of 667.52 grams.
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Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.
The Standard Sterilizable Tray is a reusable perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage. The tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses.
The Standard Sterilizable Tray is a container composed of three main components: a lid, a trav base and a variable inner trav, all made of polyphenylsulfone (Radel R5000). The inner tray has silicone rubber that is co-molded in the plastic of the inner tray as well as silicone grommets. In addition, accessory stainless-steel pan may be included in the tray.
The Standard Sterilizable Tray is available in one size with outer dimensions of 7.3 inch x 5.5 inch x 2.4 inch and offered in 2 inner tray configurations with varied instrument loads.
The provided document is a 510(k) Summary for a medical device called the "Standard Sterilizable Tray." It outlines the device's characteristics, indications for use, comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: The document describes non-clinical testing for a sterilization tray, which is a physical device, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study aspects for AI/ML device performance (like "human readers improve with AI," "standalone algorithm performance," "number of experts for ground truth," "adjudication method," and "training set details") are not applicable to this submission. The information provided focuses on the physical and functional performance of the sterilization tray.
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-5: Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | Observe the cytotoxicity potential of the device extract. | Morphological Grade 2 (mild) or better | Pass |
| ISO 17664: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices | Verify the continued performance of the device during its useful life. | No visual degradation, silicone retention performance | Pass |
| TIR30 & TIR 12: Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices; Designing, testing and labeling reusable medical devices for reprocessing in health care facilities | Verify the effectiveness of the recommended cleaning process. |
§ 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).