(281 days)
The SteriTite universal container system with MediTray products is a reusable sterilization container system intended to be used to enclose other medical devices (blades and lumens), which are to be sterilized, transported and stored by a health care provider.
The SteriTite container system is intended for use in STERRAD 200. STERRAD NX and Ozone 125L sterilizers, as well as the sealed containers are intended for pre-vacuum steam flash sterilization (270°F for 4 minutes).
The SteriTite perforated bottom container with disposable polypropylene filters (Polypro) must be used for STERRAD Sterilization. The paper filter is recommended for prevacuum steam flash sterilization. For ozone sterilization, either disposable naper or polypropylene filters can be used.
The SteriTite universal container system with MediTray products is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The SteriTite container system is intended for use in STERRAD 200, STERRAD NX and Ozone 125L sterilizers, as well as the sealed containers are intended for prevacuum steam flash sterilization (270°F for 4 minutes). The container may be used for sterilization of medical devices including full instrument sets and mixed loads.
SteriTite Sealed Container system is recommended for surface and lumens:
-In STERRAD® 200 Sterilization, process only stainless steel lumened instruments of 3mm diameter or larger and a length up to 400 mm.
-In STERRAD NX standard cycle, process stainless steel lumened instruments of 2mm diameter or larger and up to 400 mm in length.
-In STERRAD NX advanced cycle, process stainless steel lumened instruments of 1mm diameter or larger and up to 500 mm in length and porous lumens (flexible endoscope) of 1mm diameter or larger and up to 850 mm in length.
-In Pre-vacuum Steam Flash Sterilization, process stainless steel lumened instruments of 2mm diameter or larger and a length of up to 400 mm as well as porous lumens of 3mm diameter or larger and a length up to 400 mm.
-In Ozone 125L Sterilization, process stainless steel lumened instruments of 3mm diameter or larger and a length up to 470 mm.
The attached tables identify which products with disposable filter may be sterilized in the respective sterilization cycles.
The SteriTite universal container system consists of a family of rigid reusable containers and inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite® container has both solid and perforated base containers. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. A stainless steel latching mechanism with handles on both ends secures the lid to the base and provide a method to incorporate tamper proof disposable locks. Each filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts provide instrument protection and secure devices for sterilization within the container. The lids and bases as well as retention plates of the same model and size are compatible and interchangeable throughout its useful life. Vent holes are offset to prevent strike through. All components may be easily disassembled for cleaning.
The provided text is a 510(k) summary for the Case Medical SteriTite Universal Container System, a reusable sterilization container. The document describes the device's intended use and performance data, but it does not describe an AI/ML device or a study involving human readers or expert ground truth in the typical sense of evaluating diagnostic accuracy.
Therefore, many of the requested categories (acceptance criteria derived from diagnostic performance, sample sizes for test/training sets for AI, expert qualifications, MRMC studies, standalone algorithm performance, specific ground truth types for AI, adjudication methods) are not applicable to this submission.
The "acceptance criteria" for this device relate to its ability to achieve sterility, and the "study" is the microbial challenge testing.
Here's an interpretation based on the information provided, tailored to the context of a medical device sterilization container, rather than a diagnostic AI:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Sterility Assurance | Elimination of a biological challenge ("overkill method" of sterility assurance). Demonstrated compatibility with specified sterilization methods (STERRAD 200, STERRAD NX, Ozone 125L, Pre-Vacuum Steam Flash). Ability to sterilize various instrument types and lumens within specified dimensions for each sterilization method. | Successful elimination of biological challenges. Demonstrated effective sterilization for: |
- STERRAD 200: Stainless steel lumens of 3mm diameter or larger and a length up to 400 mm.
- STERRAD NX Standard Cycle: Stainless steel lumens of 2mm diameter or larger and up to 400 mm in length.
- STERRAD NX Advanced Cycle: Stainless steel lumens of 1mm diameter or larger and up to 500 mm in length, and porous lumens (flexible endoscopes) of 1mm diameter or larger and up to 850 mm in length.
- Pre-Vacuum Steam Flash: Stainless steel lumens of 2mm diameter or larger and a length of up to 400 mm, and porous lumens of 3mm diameter or larger and a length up to 400 mm.
- Ozone 125L: Stainless steel lumens of 3mm diameter or larger and a length up to 470 mm.
Compatibility tables provided for specific container models and MediTray products across all specified sterilization methods. |
| Worst-Case Loading | Successful sterilization of maximum specified load weights for each sterilization method. | Validated for: - STERRAD NX & STERRAD 200: Maximum load of 22 lbs (10 kg) including the container.
- Pre-Vacuum Steam & Ozone 125L: Maximum load of 35 lbs (15.8 kg) total weight. |
| Device Configuration | Ability to maintain sterility and proper function in various configurations (e.g., specific container models, use of inner baskets/trays, specific filter types for each sterilizer). Sufficient vent holes to prevent "strike-through." | Testing performed with inner baskets/trays representative of MediTray product line. Specific container models (e.g., perforated base "G" models for STERRAD) and filter types (Polypro for STERRAD, paper/polypropylene for Ozone, paper for Pre-vacuum Steam) specified for different sterilization methods. Validation testing considered worst-case scenarios based on the number of vents per container volume. Internal stacking and component utilization validated under fractional and half cycle conditions. Vent holes are offset to prevent strike-through. |
| Biocompatibility/Material| The container is made of anodized aluminum with passivated stainless steel hardware and silicone gaskets, indicating material safety for its intended use. | Materials chosen are common for these types of devices. While not an explicit "acceptance criterion" in a numerical sense, the description implies material suitability. |
The following points address the remaining questions, with notes on their applicability to this non-AI medical device submission:
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Size: The document does not specify a numerical sample size in terms of "N" cycles or containers tested. It refers to "microbial challenge testing" using "replicate cycles." It also mentions "sample containers were validated" in worst-case scenarios.
- Data Provenance: The testing was conducted in "independent laboratories." The country of origin of the data is not specified, but the submission is to the U.S. FDA. The testing appears to be prospective performance testing specifically designed to validate the device's sterilization capabilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This concept is not applicable to this type of device submission. The "ground truth" for sterilization devices is the inactivation of biological indicators, which is a measurable, objective scientific outcome, not an expert-derived consensus or interpretation.
4. Adjudication Method for the Test Set
- Not applicable. Sterilization efficacy testing involves objective measures (e.g., absence of bacterial growth from biological indicators), not subjective interpretations requiring 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 device is a physical sterilization container, not an AI or imaging diagnostic tool. There are no human "readers" or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical sterilization container.
7. The Type of Ground Truth Used
- For this device, the ground truth for performance is established through microbial challenge testing, specifically the "elimination of a biological challenge" (sterility assurance). This involves using biological indicators with known microbial populations to objective demonstrate inactivation. This is an objective, laboratory-based measurement of efficacy against microorganisms.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve machine learning or AI, and therefore no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI/ML algorithm.
§ 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).