(267 days)
The Avinent Surgical Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for the following cycle: Prevaccum Steam - At 132° for 4 minutes with a 30 minute dry time. -The trays are intended for sterilization of non-porous loads. -The trays are recommended not to be stacked during sterilization. -The Biomimetic Coral Sterilization Cassette Guided Surgery represents the worst case validated load due to the number of components (32 instruments) and the weight of 599.6 grams. -Avinent Implant System SLU does not make any lumen claims for the Avinent Surgical Tray. -The tray will be marketed in the variations found in the following table.
The Avinent Surgical Tray is a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization. Each tray consists of three components – a base tray, a lid, and an internal individualized insert tray. All of the three components are perforated for steam penetration. The internal tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and torque wrench. The tray is available in one size, 207.5 x 157.5 x 71.7mm. The tray comes in two variations, Coral and Ocean. The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows them to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared wrap must be used for sterilization purposes to maintain the sterility of contents. The trays are reusable and the tray material allows repeated sterilization cycles. The lid, base, and insert are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC and is identical to the Radel used in predicate device cleared under K142519. Radel R 5000 CL 301 is used for the lid, Radel R-5100 BK # 937 is used for the base and Radel R-5100 GY #1037 is used for the insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain drills and the tool holder with cradle on the base tray are made of medical grade silicone material which has been manufactured to meet FDA 21 CFR 177.2600. These brackets and holders are used to secure the instruments during transport, sterilization, and storage. Although these trays are reusable they will not be serviced or repaired. The instruments to be sterilized in the proposed trays are all non-porous devices and included dental surgical drills and tools. The tools and drills are all class I exempt.
This document describes the non-clinical testing performed for the Avinent Surgical Tray (K191566) to demonstrate its safety and effectiveness. The information provided heavily focuses on the validation of the tray's ability to be cleaned and sterilized, along with its durability and biocompatibility, as opposed to an AI/ML device. Therefore, many of the requested criteria related to AI/ML device performance, such as MRMC studies, ground truth establishment for training sets, and expert qualifications for independent evaluation, are not applicable to this submission.
Here is the breakdown of the acceptance criteria and study results based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Testing | Purpose of Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Cleaning Validation | Validate the cleaning cycle in the instructions for use | No visible soil. | |
| Hemoglobin less than 2.2μg/cm². | |||
| Protein level ≤6.4 μg/cm². | |||
| MEM reactivity grade of 2 or less. | No visible soil. All acceptance criteria met. | ||
| Steam Sterilization Validation | Validate the half-cycle of the cycle in the instructions for use | No growth on half cycles. | |
| No moisture on full drying cycle. | |||
| Pass on Chemical Indicators half and full cycle. | Pass on chemical indicators half and full cycle. No moisture on full drying cycle. No growth on half cycle. | ||
| 100 cycles sterilization | Show the tray will last at least 100 sterilization cycles | Pass visual inspection and test of functionality. | At all cycle counts passed visual inspection and test of functionality. |
| Cytotoxicity | Sterilized instruments were tested to demonstrate there were no residuals on them which would change their biocompatibility. | Pass is a score of no greater than 2 (based on ISO 10993-5 and -12 for cytotoxicity). | Pass with score of 0. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact "sample sizes" in terms of number of devices tested for each validation (e.g., how many trays were subjected to cleaning validation, sterilization, or 100 cycles). It refers to "the tray" being tested.
- Data Provenance: The studies were conducted by AVINENT Implant System, S.L.U. or a contracted lab to validate the device's performance. The origin of the data is implied to be from laboratory testing related to the device itself. It is inherently prospective as these are validation tests conducted specifically for this 510(k) submission. No information on country of origin for the data is explicitly stated, but the company is located in Spain.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the testing described is related to physical and biological performance of a medical device (sterilization tray), not an AI/ML algorithm. Ground truth here is established through objective laboratory measurements and standardized biological and physical tests (e.g., visible soil, specific chemical limits, microbial growth, visual inspection criteria for durability, cytotoxicity scores). No human experts are described as contributing to "ground truth" in terms of interpretation or consensus for these specific tests.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. The results are based on objective measurements and established pass/fail criteria for cleaning effectiveness, sterility, durability, and biocompatibility.
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
Not applicable. This device is a surgical tray for sterilization, not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation 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/ML algorithm.
7. The Type of Ground Truth Used
The ground truth for these tests is based on:
- Objective Measurements: e.g., precise levels of hemoglobin and protein for cleaning validation, absence/presence of microbial growth for sterilization, visual inspection against pre-defined criteria, and quantitative scores for cytotoxicity.
- Standardized Criteria: Adherence to established scientific and regulatory standards (e.g., ISO 10993-5, and general sterility and cleaning validation principles).
- Pass/Fail Criteria: Predetermined thresholds for acceptable performance in each test.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.
§ 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).