(109 days)
The sterilization mats are intended to be used in conjunction with the V-PRO™ Sterilization Trays (K070769) to cushion and stabilize instruments during sterilization in the Amsco V-PRO Low Temperature Sterilization Systems.
The sterilization mats have been validated for use in the three pre-programmed V-PRO sterilization cycles [Lumen Cycle (the only cycle of the V-PRO 1 Sterilizer), Non Lumen Cycle, and Flexible Cycle].
The sterilization mats are used to cushion and stabilize devices placed into the V-PRO Sterilization Trays (K070769). The mats are available in sizes to fit the four V-PRO Sterilization Trays. The mats are a diamond grid design with fingers that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the V-PRO Trays.
The mats are designed to allow sterilization of cleaned and dried medical devices during the V-PRO Lumen (K062297), Non Lumen (K083097) and Flexible (K102330) Cycles in the V-PRO Sterilizers.
This document describes the acceptance criteria and study proving the STERIS Sterilization Mats meet these criteria for use in V-PRO Sterilizers.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| Demonstration of Effective Sterilant Penetration | Worst case test article for each of the three V-PRO Sterilization Cycles (Lumen, Non Lumen, Flexible) must be reproducibly sterilized under worst case ½ cycle conditions. | PASS |
| Demonstration of Biocompatibility | Silicone shall be non cytotoxic after exposure to worst case V-PRO Cycle conditions. Residual hydrogen peroxide levels must be below acceptable levels after exposure to worst case V-PRO Cycle conditions. | PASS |
| Demonstration of Sterilant and Cleaning Agent Compatibility | After processing through multiple cleaning and worst case sterilization cycles, the mats must not display any incompatibilities with VAPROX HC sterilant and typical cleaning agents. | PASS |
| Cleaning Evaluation | The mats must be easy to clean using either a manual or an automated process. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for each test category. However, it does provide details about the validation loads used in the sterilization efficacy tests for the various V-PRO cycles:
- Lumen Cycle: Validation load consisted of two instrument trays (containing two mats and 20 instrument organizers) and two pouches for a total weight of 19.65 lbs. This testing used a maximum of twenty (20) lumens per load.
- Non Lumen Cycle: Validation load consisted of two instrument trays containing two mats, and 20 instrument organizers and two pouches for a total weight of 19.65 lbs.
- Flexible Cycle (Configuration 1 - Two endoscopes): Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. Each endoscope was packaged into a tray with a silicone mat, 20 instrument organizers, and a light cord.
- Flexible Cycle (Configuration 2 - One endoscope + non-lumened instruments): One flexible endoscope in a tray with a silicone mat, 20 instrument organizers, and a light cord. Also included was an additional instrument tray (containing a mat and 20 instrument organizers) and one pouch for a total load weight of 24.0 lbs.
The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be prospective performance tests conducted by the manufacturer, STERIS Corporation, to demonstrate the device's efficacy and safety.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission (510(k) for sterilization accessories) typically relies on standardized test methods and quantitative measurements (e.g., microbial lethality assays, chemical analysis for residuals, visual inspection for material compatibility). Therefore, the "ground truth" is established through objective scientific measurements and established protocols, rather than expert consensus on diagnostic images or clinical outcomes. The document does not mention the involvement of external experts to establish ground truth for the test set.
4. Adjudication Method for the Test Set
Given the nature of the tests (sterilization efficacy, biocompatibility, material compatibility, cleaning evaluation), an adjudication method like 2+1 or 3+1 typically used for subjective diagnostic assessments is not applicable. The results are based on direct measurements and qualitative observations against predefined scientific criteria. A "PASS" or "FAIL" determination is likely made based on whether the measured outcomes meet the quantitative or qualitative acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) with and without AI assistance. The STERIS Sterilization Mats are a sterilization accessory, and their performance is assessed through objective physical and biological tests, not through human interpretation of diagnostic output.
6. Standalone Performance Study
Yes, the studies described are standalone performance studies (i.e., algorithm only without human-in-the-loop performance). The tests evaluate the performance of the sterilization mats themselves within the context of the V-PRO sterilization cycles, independent of human operators assisting an AI algorithm.
7. Type of Ground Truth Used
The ground truth used for these studies is based on:
- Sterilization Efficacy: Demonstrated by reproducible sterilization of worst-case test articles under worst-case ½ cycle conditions. This implies the use of biological indicators or similar methods to confirm microbial kill, which is an objective outcome measure.
- Biocompatibility: Measured by assessing cytotoxicity and residual hydrogen peroxide levels. These are objective laboratory tests.
- Material Compatibility: Assessed by observing the absence of incompatibilities (e.g., degradation, discoloration) after exposure to multiple cleaning and sterilization cycles. This is based on qualitative visual assessment against established standards for material integrity.
- Cleaning Evaluation: Assessed by the ease of cleaning, likely through standardized cleaning protocols and visual inspection for cleanliness.
In summary, the ground truth is primarily based on objective scientific measurements, established chemical and biological testing protocols, and qualitative assessments of physical and material integrity.
8. Sample Size for the Training Set
The document does not mention a training set or any machine learning components. This device is a physical accessory evaluated through traditional engineering and biological performance testing, not an AI-powered device. Therefore, the concept of a "training set" is not applicable here.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set or AI component, the ground truth for a training set was not applicable and therefore not established.
§ 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).