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510(k) Data Aggregation
(261 days)
ST-Z5 surgical trays are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. ST-Z5 surgical trays are intended to allow sterilization of the enclosed medical devices.
ST-Z5 surgical trays require the use of an FDA cleared wrap to maintain the sterility of the enclosed devices.
The trays are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle:
Pre-vacuum steam: 132 ℃ (270 ℃) for 4 minutes with 20 minutes drying time.
ST-Z5 surgical trays are intended for sterilization of non-porous loads. ST-Z5 surgical trays are recommended not to be stacked during sterilization.
The subject device trays are reusable rigid containers, comprising a base (bottom), a removable inner tray, and a lid (cover). The subject device trays are to be used to organize and protect the instruments that are sterilized in the trays 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 contents 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 polyphenylsulfone (PPSU), and holders of various geometries to position instruments in the trays are manufactured from silicone. The subject device includes two instrument trays that have the same size (same lid, base, and enclosed volume) and two inner tray configurations.
This document describes the validation of the ST-Z5 surgical trays for sterilization.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Automated Cleaning Validation (FDA Guidance: Reprocess Medical Devices in Healthcare Settings: Validation Methods and Labeling) | Validate cleaning instructions, ensure sterilization cycle effectiveness. | Protein assay: < 6.4 µg/cm² (Quantitation limits: 2.0 µg/mL)Hemoglobin assay: < 2.2 µg/cm² (Quantitation limits: 10.0 µg/mL) | Pass |
| Sterilization Validation (including sterilant penetration and dry time validation) (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2) | Validate sterilization instructions, ensure appropriate sterilization of tray and contents. | Sterilization: 3 consecutive half-cycles for each of two tray sizes to demonstrate complete inactivation of all biological indicators; Minimum SAL of 10⁻⁶ achieved. | Pass |
| Dry Time | Validate drying instructions for wrapped tray storage. | Weight gain after drying not to exceed ±3% (using pre-cycle and post-cycle weights). | Pass |
| Life Cycle / Simulated Use Life Validation (FDA Guidance: Reprocessing Medical Devices in Healthcare Settings: Validation Methods and Labeling) | Validate service life of trays. | Visual inspection, component dimensional fit verification, functional closure/latch verification for 101 use cycles. | Pass |
| Biocompatibility of Subject Device (by cytotoxicity testing) (ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12) | Evaluate cytotoxicity potential using in vitro cell culture assay. | Non-cytotoxic if ≤ 30% reduction of L-929 cell viability after exposure to device extract. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical data, as it explicitly states, "No clinical data were included in this submission."
For the non-clinical tests:
- Sterilization Validation: "3 consecutive half-cycles performed for each of the two sizes of trays". This implies a sample size of at least 6 sterilization cycles (3 for each size) for this part of the testing.
- Life Cycle Validation: The device was tested for "101 use cycles".
- For other tests (Automated Cleaning, Dry Time, Biocompatibility), specific sample sizes are not detailed beyond the statement that "the nonclinical testing provided for these devices met the acceptance criteria".
Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer (Z-Systems AG) or a contracted testing facility. No country of origin for the data is specified, but the manufacturer is based in Switzerland. The studies are prospective in the sense that they are designed and executed to validate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission is for a medical device (sterilization trays) and relies on non-clinical performance data and established standards (e.g., ISO, AAMI, FDA guidance) rather than expert-derived ground truth from human observations or interpretations.
4. Adjudication Method for the Test Set
Not applicable. The tests are based on objective measurements against predefined acceptance criteria from established standards, not on human interpretation or adjudication processes like 2+1 or 3+1. For visual inspections in the life cycle test, the assessment would be against predefined criteria by the testing personnel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document explicitly states, "No clinical data were included in this submission." An MRMC study involves human readers interpreting cases, which is not relevant for this device's validation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable, as this device is a physical medical device (sterilization trays) and not an AI algorithm.
7. Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is defined by:
- Quantitative measurements against established thresholds (e.g., µg/cm² for protein/hemoglobin assays, percentage weight gain for dry time, cell viability reduction for cytotoxicity).
- Qualitative assessments against predefined criteria (e.g., complete inactivation of biological indicators, visual inspection for integrity, component fit, functional closure for life cycle testing).
- These are based on recognized international and national standards (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12) and FDA guidance documents.
8. Sample Size for the Training Set
Not applicable, as this is a physical medical device validation, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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