(161 days)
The SteriTite® container system is designed for use in hospitals and health care facilities to contain medical devices for sterilization, storage, transportation, and aseptic presentation of contents. It is intended to be used to sterilize medical devices including surfaces and lumens in steam, gas (EO) and gas plasma (STERRAD Sterilization). The SteriTite container is designed to maintain sterility of the contents until it is used.
The SteriTite container system and MediTray product is intended to be used to contain medical devices for sterilization, storage, transportation and aseptic presentation of contents in health care facilization of surfaces and lumented dev in EO. Metal lumens 2.2mm diameter or larger and length up to 45.7 cm and porous (silicone) lumened devices 3 mm diameter or larger and length up to 40 cm were validated. The SterTite container is designed to maintain sterility of the contents until it is used
The SteriTite container system consists of a family of rigid reusable scaled containers that provide an effective sterilization packaging method for medical devices. Cases and lids are interchangeable. A part number and lot number identify each component of the container, including lid, base, retaincr/valve plate and insert basket or tray. The SteriTite system is designed for sterilant penetration through vents/perforations in the lid and in perforated bottom models in the base of SteriTite sealed containers as well. MedifFray case trays, baskets and insert boxes may be placed within sealed containers or wrapped.
The provided text is a 510(k) summary for the SteriTite® rigid reusable sterilization container system. It describes the device and explicitly states its substantial equivalence to a predicate device, the Genesis™ container (K012931), based on a comparison of properties, specifications, and performance.
However, the document does not describe the outcome of a study proving the device meets acceptance criteria. Instead, it presents a comparison table showing that the SteriTite® container has similar characteristics and has undergone similar validation testing as its predicate device. This is a common approach in 510(k) submissions to demonstrate substantial equivalence, rather than providing the detailed results of a specific study against predefined acceptance criteria.
Therefore, many of the requested fields cannot be directly extracted from the provided text because it focuses on a comparative assessment rather than a detailed study report.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria as pass/fail thresholds with specific numerical or qualitative targets. Instead, it compares the SteriTite® device's properties and validation testing to those of the predicate device. The "performance" is implicitly deemed acceptable if it matches or exceeds the predicate's performance.
| Property/Specification | Acceptance Criteria (Implicit: Similar to Predicate) | SteriTite® Performance (Reported) | Predicate (Genesis™) Performance (for comparison) |
|---|---|---|---|
| Indicated for containing instruments for EO and transport | YES | YES | YES |
| Intended to be reused | YES | YES | YES |
| Closed System | YES | YES | YES |
| Sealed | YES | YES | YES |
| Incorporates a filter system to permit entry of sterilant agent | YES | YES | YES |
| Incorporates a filter system to prevent microbial migration during transport | YES | YES | YES |
| Conformance to AAMI ST33 Standard testing requirements | YES | YES | YES |
| Pre-vacuum steam validation testing | YES | YES | YES |
| Gravity Displacement steam validation testing | YES | YES | YES |
| EO Sterilization validation testing | YES (perforated bottom containers) | YES (solid and perforated bottom containers) | YES (perforated bottom containers) |
| STERRAD Sterilization validation testing | YES | YES | YES |
| Load capacity | Up to 11 Lbs. | STU load up to 22 lbs. | Up to 11 Lbs. |
| Sterility Maintenance - Barrier properties | Event Related Sterility Maintenance: 180-day (30-day) real time | Event Related Sterility Maintenance: 90-day real time w/weekly handling events. 30-day real time with daily handling events | Event Related Sterility Maintenance: 180-day (30-day) real time |
| Aeration Time | 24 Hours | 12 Hours | 24 Hours |
| Test organism/inoculated product | Inoculated spore carriers with 1 x 10^6^ Bacillus Subtilis var. niger | YES | YES |
| Inoculated Blades | YES | YES | YES |
| Inoculated Lumens | YES (3mm diameter metal) | YES (2.2mm diameter metal) | YES (3mm diameter metal) |
| Inoculated Nylon | N/A (for predicate) | YES | N/A |
| Inoculated Silicone | N/A (for predicate) | YES | N/A |
| Inoculated Radel | N/A (for predicate) | YES | N/A |
2. Sample size used for the test set and the data provenance
The document mentions "validation testing" but does not specify the sample sizes used for these tests for either the SteriTite® device or the predicate. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The implication is that these are laboratory validation tests.
3. 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 validation testing described appears to be laboratory-based performance testing rather than expert-based adjudication of results.
4. Adjudication method
This information is not provided. Given the nature of the validation tests (e.g., sterilization effectiveness, sterility maintenance), it's likely they involve objective measurements rather than expert adjudication.
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
Not applicable. This document describes a medical device for sterilization, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes a physical medical device. It is not an algorithm or software.
7. The type of ground truth used
For the validation testing mentioned (e.g., EO sterilization, sterility maintenance), the "ground truth" would likely be based on microbiological assays/indicators to confirm sterility and physical integrity testing for sterility maintenance. For load capacity, it's weight measurement. The document implies objective, measurable outcomes.
8. The sample size for the training set
Not applicable. This section refers to data used to train algorithms, which is not relevant for a physical medical device like a sterilization container.
9. How the ground truth for the training set was established
Not applicable. As above, this pertains to algorithm training, which is not relevant here.
§ 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).