(219 days)
The InterActive Complete 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 sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles:
- (1) Prevaccum Steam At 132℃ for 4 minutes with a 20 minutes dry time.
- (2) Gravity Steam At 132% for 15 minutes with a 30 minutes dry time.
- The trays are intended for sterilization of non-porous loads.
- The trays are recommended not to be stacked during sterilization.
- The Complete Surgical Tray represents the worst case validated load due to the number of components) and the weight of 608.05 grams.
- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Interactive Complete Surgical Tray.
- The tray will be marketed in following variations.
| Device Model Name | Max no. of Instruments | Weight of each tray
with instruments (gms.) |
|-------------------|------------------------|------------------------------------------------|
| CST | 45 | 608.05 |
| ICST | 34 | 467.26 |
| IBST | 18 | 453.59 |
| IST | 0 | 404.37 |
The InterActive Complete 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 insert tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and ratchet. The tray is available in only one size of approximately 7.2 inches X 5.6 inches X 2.4 inches and will be marketed in four different variations – (1) InterActive Complete Surgical Tray (ICST) containing 34 instruments, (2) InterActive Basic Surgical Tray (IBST) containing almost half the number of instruments as ICST, (3) InterActive Surgical Tray (IST), empty tray containing no instruments, and (4) Complete Surgical Tray (CST), containing 45 instruments.
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 it 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 sterilization wrap must be used for sterilization purposes to maintain the sterility of the 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 K052992 and K012105. Radel R 5000 CL 301 is used for the lid, and Radel R 5100 NT15 is used for base and insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain the 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 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 tray are all non-porous devices and include dental surgical drills and tools. The tools are class I exempt and the drills have Class II pre-market notification clearance.
The provided text describes the performance testing for the InterActive Complete Surgical Tray, a device designed to hold dental surgical drills and tools for steam sterilization and transport. The relevant sections for acceptance criteria and the study proving it meets these criteria are primarily found under "7. Non-Clinical Performance Testing" and "TABLE 2: Substantial Equivalence: Comparison with Predicates on Performance Testing".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" with numerical targets in a dedicated table format. Instead, it refers to compliance with specific standards and successful conduct of tests. The reported device performance is indicated by "Yes" for meeting the test requirements.
| Acceptance Criteria (Inferred from Standards) | Reported Device Performance (as stated in document) |
|---|---|
| Sterilant Penetration: Validated as per AAMI/ANSI/ISO 17665; AAMI TIR 12 | Yes (Steam Sterilization Validations conducted as per AAMI/ANSI/ISO 17665; AAMI TIR 12) |
| Toxicological Properties (Biocompatibility): Tests as per ISO 10993-5; ISO 10993-12 | Yes (Cytotoxicity Tests conducted as per ISO 10993-5; ISO 10993-12) |
| Transportation Studies (Packaging Integrity): Tests as per ASTM D4169 | Yes (Distribution Studies conducted as per ASTM D4169) |
| Cleaning Instructions for Reusable Devices: Validations as per AAMI TIR 30; AAMI TIR 12 | Yes (Cleaning Validations conducted as per AAMI TIR 30; AAMI TIR 12) |
| Material Compatibility (Repeat Sterilization): Demonstrated for Radel | Yes (Radel Technical Data Sheet confirms material compatibility) |
| Drying Time: Validated in steam sterilization report AAMI/ANSI/ISO 17665; AAMI TIR 12 | Yes (Validated in Steam Sterilization report AAMI/ANSI/ISO 17665; AAMI TIR 12) |
| Vent/Volume Ratio: (Implicitly acceptable if sterilization is achieved) | All proposed trays are 0.184 in²/in³. The Complete Surgical Tray (CST) represents the worst-case vent to volume ratio and achieved sterilization successfully. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample size used for each specific non-clinical performance test. It only confirms that the tests were conducted.
The data provenance is retrospective, as these are non-clinical (laboratory/engineering) tests conducted on the device to demonstrate its performance against established standards. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying compliance with U.S. and international standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to this type of non-clinical device testing. "Ground truth" established by experts is typically relevant for studies involving human interpretation (e.g., diagnostic imaging studies). For this device, compliance is measured against engineering and sterilization standards.
4. Adjudication Method for the Test Set:
This information is not applicable to this type of non-clinical device testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies or studies involving multiple human interpreters to resolve disagreements in expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a device or AI on human reader performance, usually in a diagnostic context. The document describes non-clinical performance testing for a sterilization tray and does not involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, standalone performance testing was done. The entire "Non-Clinical Performance Testing" section describes the performance of the device itself (the sterilization tray) under various conditions (steam sterilization, cleaning, transport, biocompatibility) without human intervention in its primary function.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical performance tests is defined by the acceptance criteria within the cited national and international engineering and sterilization standards. For example:
- Sterilant Penetration: Successfully killing biological indicators or defined sterility assurance levels (SALs) as per AAMI/ANSI/ISO 17665.
- Toxicological Properties: No cytotoxic effects observed as per ISO 10993-5.
- Cleaning: Reduction of bioburden/soil to acceptable levels as per AAMI TIR 30.
- Packaging Integrity: Maintenance of package integrity after transport simulations as per ASTM D4169.
8. The Sample Size for the Training Set:
This information is not applicable. The device described is a physical medical device (sterilization tray), not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this 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).