(84 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 three (3) 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 instruments in the kits are manufactured from silicone. The subject device includes two (2) sizes (lid, base, and enclosed volume), and a total of three (3) tray configurations.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the S.I.N. Instrument Kits.
Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Manual Cleaning Validation (FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling) | Validate cleaning instructions and ensure sterilization cycle effectiveness. | Protein assay: No color change = absence of protein residue (Sensitivity = 1 µg protein residue). Total organic carbon assay: Results ) | Validate cleaning instructions and ensure BET level meets FDA expectation (≤ 20 EU/device). |
| Sterilization Validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2) | Validate sterilization instructions and ensure appropriate sterilization of 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 (Referenced from K201688) | Validate that sterilization instructions 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) | 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 (Cytotoxicity testing - ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12) | 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 |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document mentions "3 consecutive half-cycles performed for each of 3 sizes of trays" for Sterilization Validation. For Biocompatibility, it states "L-929 cells exposed to extract of device." The exact number of units or iterations per test beyond what is explicitly stated (e.g., how many trays were tested for cleaning, how many units for biocompatibility extract) is not explicitly detailed in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only lists the standards followed (e.g., FDA Guidance, USP, ANSI/AAMI/ISO).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The tests performed are laboratory-based and follow established standards, implying no human expert consensus was required to establish ground truth for these specific performance criteria.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable as the tests are non-clinical, objective validations against predetermined criteria, not assessments requiring expert adjudication of subjective findings.
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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 MRMC comparative effectiveness study was done. This device (S.I.N. Instrument Kits, which are instrument sterilization trays) is a physical medical device, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI assistance" is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone (algorithm-only) performance study was done. As mentioned above, this is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for these non-clinical tests is based on objective measurements and adherence to established regulatory standards and protocols (e.g., protein residue levels, endotoxin levels, sterility assurance level (SAL), weight change, visual inspection, dimensional verification, cell viability).
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The sample size for the training set:
- There is no training set as this is a physical medical device validation, not a machine learning model.
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How the ground truth for the training set was established:
- This question is not applicable as there is no training set.
§ 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).