(57 days)
The SteriCUBE Multiple Tray Sterilization System) is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit must be used with the SteriCUBE System Transfer Cart, SteriCUBE System Filters and SteriCUBE System Integrity Locks.
The SteriCUBE System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray.
The SteriCUBE System was tested and validated with rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Do not use with instruments containing lumens with an inner diameter smaller than 0.7mm and an overall length longer than 500mm or lumens with an inner diameter smaller than 1.0mm and an overall length longer than 850mm.
Use only uncovered, perforated or wire mesh general delivery trays within the SteriCUBE System.
The SteriCUBE® Multiple Tray Sterilization Systems are also referred to as the “SteriCUBE Systems” and include the SteriCUBE MTS225 System and the SteriCUBE MTS300 System. The SteriCUBE System is comprised of the stainless steel sterilization cabinet and adjustable transfer cart. An optional reusable ceramic drain filter and single use filters and integrity locks with sterilization indicator dots are used with the system for each sterilization cycle. The optional ceramic drain filter should be replaced every 6 months or after 160 uses, whichever comes first. An optional STEAMPlus™ tray record card with STEAMPlus sterilization integrator (SPS Medical) may be utilized by the healthcare provider. Adjustable shelves within the cabinet can hold up to three trays (uncovered, perforated or wire mesh) of devices and/or surgical instruments intended for a single patient surgery. No more than 25 pounds can be loaded per tray for a maximum of 75 pounds per shelf. The MTS300 Cabinet (with four shelves) can hold up to 300 pounds per load and the MTS225 Cabinet (with three shelves) can hold up to 225 pounds per load. The loaded cabinet is deployed from the adjustable transfer cart and processed in pre-vacuum steam sterilizers. Processing includes the standard conditioning phase of the autoclave followed by a sterilization cycle time of 4 minutes and a dry cycle of a minimum of 5 minutes. Sterility is maintained for up to 30 days.
The provided text describes the SteriCUBE® Multiple Tray Sterilization Systems and its equivalency to a predicate device. It indicates that performance data was generated but does not contain a detailed study report that includes specific acceptance criteria and outcome metrics in the format requested.
However, based on the information provided, we can infer some aspects related to acceptance criteria and the study's scope:
1. A table of acceptance criteria and the reported device performance
The document mentions validation of the SteriCUBE System. Based on the "Indications for Use" and "Comparison of Technological Characteristics," the following can be inferred as performance criteria and statements:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Sterilization Efficacy: Achieve a 10⁻⁶ Sterility Assurance Level (SAL) | Achieved a 10⁻⁶ SAL when sterilizing rigid instruments containing lumens with an inner diameter of 0.7mm and overall length of 500mm, as well as lumens with an inner diameter of 1.0mm and overall length of 850mm. |
| Minimum Drying Time | Met the shorter minimum dry time of 5 minutes. |
| Sterility Maintenance Duration | Maintained sterility for 30 days. |
| Compatibility with specific lumen sizes | Tested and validated with rigid instruments containing lumens with an inner diameter of 0.7mm and 500mm length, and 1.0mm and 850mm length. |
| Incompatibility with smaller/longer lumens | Not for use with instruments containing lumens with an inner diameter smaller than 0.7mm and overall length longer than 500mm, or lumens with an inner diameter smaller than 1.0mm and overall length longer than 850mm. |
| Use with prevacuum steam sterilizers | Intended for use in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. |
| Load capacity per tray | No more than 3 trays per shelf or 25 lbs. per tray. |
| Volume-to-Vent Ratio | MTS300: 129.131; MTS225: 94.725 (Identical to predicate) |
| Cabinet Material | 16 gauge stainless steel (Identical to predicate) |
| Filter Material | Heavy duty sterilization wrap by SPS Medical (Identical to predicate, with optional ceramic drain filter and paper filter separators also used effectively) |
2. Sample size used for the test set and the data provenance
The document states, "Nonclinical data was generated to ensure the SteriCUBE System continues to meet the intended use. Sterilization efficacy verification studies were performed in accordance with the appropriate requirements of ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization."
- Sample size: Not specified in the provided text.
- Data provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). It is "nonclinical data."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a sterilization system and the performance data concerns sterilization efficacy and material properties, not diagnostic interpretation by human experts. The ground truth would be established through laboratory testing and physical measurements (e.g., sterility testing, temperature/pressure monitoring, material strength tests).
4. Adjudication method for the test set
This section is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic studies, not for the technical validation of a sterilization device.
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
This section is not applicable. The device is a sterilization system, not an AI-powered diagnostic tool engaging human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a sterilization system and does not involve algorithms or human-in-the-loop performance in the context of an AI device. The "standalone" performance here refers to the device's ability to achieve sterilization and maintain sterility on its own, which is what the "Nonclinical data" and "Sterilization efficacy verification studies" would assess.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for a sterilization system would be established through:
- Biological Indicator (BI) testing: Using bacterial spores (e.g., Geobacillus stearothermophilus) to confirm a 10⁻⁶ SAL (Sterility Assurance Level) after the sterilization process.
- Physical and Chemical Indicators: Monitoring temperature, pressure, and sterilant penetration within the system during the cycle.
- Material Testing: Durability, integrity, and performance of the system's components (filters, cabinet, etc.) over time and repeated use.
- Microbial Challenge Testing: Introducing known levels of microorganisms to device lumens to ensure effective sterilization.
The text explicitly mentions "Sterilization efficacy verification studies were performed in accordance with the appropriate requirements of ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization," which outlines methods for establishing such ground truth.
8. The sample size for the training set
This section is not applicable. The device is a physical sterilization system, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
§ 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).