(121 days)
S.I.N. Instrument Kits are intended to enclose other medical devices that are to be sterlized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle: Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time. S.I.N. Instrument Kits are intended for sterilization of non-porous loads. S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The subject device includes a total of 14 instrument trays. The subject device trays are reusable rigid containers, comprising a base (bottom), one or more removable inner trays, and a lid (cover). The subject device trays are to be used to organize and protect the instruments that are sterilized by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior components during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone (PSU), and holders of various geometries to position instrument in the kits are manufactured from silicone. The subject device includes a total of 5 sizes (same lid, base, and enclosed volume), and a total of 14 tray configurations.
The provided text describes the acceptance criteria and a non-clinical study to prove that the S.I.N. Instrument Kits meet these criteria for their intended use as sterilization wraps/containers.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Manual Cleaning Validation (FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, March 2015) | To validate that the cleaning instructions provided in the Instructions for Use appropriately clean the tray, and to ensure the sterilization cycle will be effective. | Protein assay: No color change = absence of protein residue (Sensitivity = 1 µg protein residue) | |
| Total organic carbon assay: results ) | To validate that the cleaning instructions provided in the Instructions for Use appropriately clean the tray, and to ensure the BET level meets FDA expectation (≤ 20 EU/device). | Endotoxin results ≤ 20 EU/device | Pass |
| Sterilization Validation (including sterilant penetration and dry time validation) (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2) | To validate that the sterilization instructions listed in the Instructions for Use appropriately sterilize the tray and contents. | 3 consecutive half-cycles performed for each of 3 sizes of trays demonstrate complete inactivation of all biologic indicators; A minimum SAL of 10^-6 is achieved if the Instructions for Use are followed. | Pass |
| Dry time (part of Sterilization Validation) | To validate that the sterilization instructions listed in the Instructions for Use appropriately dry the wrapped tray for storage. | Using pre-cycle and post-cycle weights, the weight gain after drying will be ≤ 3%. | Pass |
| Life Cycle / Simulated Use Life Validation (FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, March 2015) | To validate the service life of the trays as stated in the Instructions for Use. | Visual inspection, component dimensional fit verification, functional closure/latch verification for 250 use cycles. | Pass |
| Biocompatibility of Subject Device (by cytotoxicity testing) (ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12) | To evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay. | Non-cytotoxic if ≤ 50% of L-929 cells exposed to extract of device show rounding and lysis. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set:
- For Sterilization Validation, the test set involved "3 sizes of trays". The document lists 5 overall tray dimensions and 14 configurations, suggesting that not all configurations were tested for sterilization, but rather representative sizes.
- For Life Cycle / Simulated Use Life Validation, the testing involved simulating 250 use cycles.
- Specific quantities for other tests (Manual Cleaning, Bacterial Endotoxin, Biocompatibility) are not explicitly stated, but the "Pass" results imply adequate testing was performed.
- Data Provenance: The document states the manufacturer is S.I.N. - Sistema de Implante Nacional S.A. based in São Paulo, Brazil. The testing described is non-clinical, implying laboratory-based studies rather than patient data. The document does not specify if the testing was performed retrospectively or prospectively, but standard validation studies like these are typically conducted prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable to this study. The study involves non-clinical performance testing of a medical device (sterilization instrument kits), not an AI algorithm or diagnostic device that requires human expert review to establish ground truth from patient data. The "ground truth" here is based on objective, quantifiable measures against established industry standards for sterility, cleanliness, and material properties.
4. Adjudication Method for the Test Set:
This information is not applicable as the study involves objective, non-clinical laboratory testing, not subjective human-in-the-loop performance evaluation that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices (especially AI-assisted models) where human readers (e.g., radiologists) interpret images or data, and their performance is compared with and without AI assistance. This submission describes the non-clinical performance of a sterilization instrument kit, which does not involve human interpretation in the same way. The document explicitly states: "No clinical data were included in this submission."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical instrument kit for sterilization, not an AI algorithm or software. The testing performed is to validate the physical and functional aspects of the kit itself.
7. The Type of Ground Truth Used:
The ground truth used for this device is based on objective, quantifiable measurements and adherence to established industry standards for medical device reprocessing and biocompatibility. Specifically:
- Sterility: Sterility Assurance Level (SAL) of 10^-6, complete inactivation of all biologic indicators.
- Cleanliness: Absence of protein residue (no color change in protein assay), Total Organic Carbon (TOC) assay results below limit of quantification.
- Endotoxin Levels: Endotoxin results ≤ 20 EU/device.
- Dryness: Weight gain after drying ≤ 3%.
- Physical integrity and functionality: Visual inspection, component dimensional fit verification, and functional closure/latch verification after simulated use cycles.
- Biocompatibility: Non-cytotoxic according to L-929 cell exposure.
These are not "expert consensus", "pathology", or "outcomes data" in the typical sense applied to diagnostic AI models.
8. The Sample Size for the Training Set:
This information is not applicable. This is a physical medical device, not an AI model 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 AI model or training set involved.
§ 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).