(93 days)
S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized 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 cycles, 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 4 instrument trays. The subject device trays are reusable rigid containers, comprising a base (bottom), one or more removable inner travs, 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 3 sizes (same lid, base, and enclosed volume), and a total of 4 tray configurations.
The document provides information on the nonclinical testing performed for the S.I.N. Instrument Kits to demonstrate they meet acceptance criteria.
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Acceptance Criteria | Results |
|---|---|---|
| Manual Cleaning Validation | Protein assay Acceptance criterion: No color change = absence of protein residue. Sensitivity = 1 µg protein residue. | |
| Total organic carbon assay Acceptance criterion: results )** | Endotoxin results ≤ 20 EU/device. | Pass |
| Sterilization Validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2) | 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 | Using pre-cycle and post-cycle weights, the weight gain after drying will be ≤ 3%. | Pass |
| Life Cycle / Simulated Use Life Validation | Visual inspection, component dimensional fit verification, functional closure/latch verification for 250 use cycles. | Pass |
| Biocompatibility of Subject Device (Cytotoxicity testing - ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12) | Non-cytotoxic if ≤ 50% of L-929 cells exposed to extract of device show rounding and lysis. | Pass |
2. Sample sizes used for the test set and the data provenance
- Sterilization Validation: 3 consecutive half-cycles were performed for each of the 3 sizes of trays. This indicates a sample size of at least 9 sterilization cycles in total (3 sizes * 3 half-cycles).
- Other tests: The exact sample sizes for Manual Cleaning Validation, Bacterial Endotoxin Testing, Dry Time, Life Cycle / Simulated Use Life Validation, and Biocompatibility are not explicitly stated by number, but the results indicate that sufficient samples were tested to meet the acceptance criteria.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that the manufacturer is S.I.N. - Sistema de Implante Nacional S.A. from Brazil, it is likely the testing was conducted in Brazil or at an international testing facility. The nature of the tests (laboratory testing of medical devices) implies a prospective test setup.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The tests performed are laboratory-based performances of a medical device (instrument kits for sterilization) against established regulatory standards and guidance, not diagnostic evaluations requiring expert consensus on "ground truth."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable for this type of nonclinical, laboratory-based device performance testing. Ground truth is established by the predefined acceptance criteria of the test methodologies.
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
No. This type of study is not applicable as the device is a medical instrument kit for sterilization, not an AI-based diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This concept is not applicable as the device is a physical medical instrument kit.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on established scientific and regulatory standards and methods for medical device sterilization, cleaning, biocompatibility, and durability. These include:
- Predefined acceptance criteria based on standard test methods (e.g., absence of protein residue, endotoxin levels, sterility assurance level (SAL), weight gain after drying, visual inspection for integrity, cytotoxicity).
- Compliance with recognized standards such as USP , ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 10993-5, and ANSI/AAMI/ISO 10993-12.
- FDA Guidance documents (e.g., "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling").
8. The sample size for the training set
This section is not applicable as the device is a physical medical instrument kit, not an AI/machine learning model that requires training data.
9. How the ground truth for the training set was established
This section is not applicable as the device is a physical medical instrument kit and does not involve a training set or AI model.
§ 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).