(655 days)
The device is intended to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.
MILLENNIUM series are sophisticated equipments but of very friendly use, adaptable to the different demands thanks to the wide possibilities of configuration and choice of the cycles.
The equipments are able to treat in fast way every type of load through various patented systems and hi-tech solutions.
MILLENNIUM series sterilizers are equipped with a 5.5, 17 or 21 lites sterilization chamber and are characterized by an advanced fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by an effective final vacuum drying phase able to eliminate any trace of condensation from the load.
An exclusive steam generation system, combined with the advanced control system, guarantees an high process speed and high stability of the thermodynamic parameters during the whole sterilization process and consequently full safety and perfect result.
The equipment offers sterilization programmes optimized for an effective, fast sterilization of different tools and materials used in medical environment, particularly the dental one.
The sterilization program of a MILLENNIUM series sterilizer can properly be described by a sequence of phases, each with a well defined activity.
Acceptance Criteria and Study for Mocom Millennium Series Steam Sterilizers
This submission describes the Mocom Millennium series of steam sterilizers (models B, B+, B2, Bµ) and their equivalence to predicate devices (W&H Lisa and Midmark M9 UltraClave). The acceptance criteria are implicitly defined by the parameters and performance characteristics of the various sterilization programs offered by the devices, and the study demonstrates that these devices meet those criteria by being substantially equivalent to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by the operational parameters and load capacities of the predicate devices and the Millennium series sterilizers themselves. The reported device performance is presented as the various sterilization programs with their specific parameters.
The following table summarizes the typical performance characteristics, which serve as the acceptance criteria and the device's reported performance for various programs across the Millennium series. Since the document states "The new device is safe and effective as the predicate devices" and "MILLENNIUM series sterilizers are substantially equivalent to the W&H Lisa Steam Sterilizer and Midmark M9 UltraClave Steam Sterilizer," the acceptance criteria for the Millennium series are effectively the performance characteristics of these predicate devices as well as the demonstrated performance of the Millennium series devices as detailed in the "Table of the Available Programs" for each model.
| Criterion Type | Acceptance Criteria (e.g., from Predicate Devices & specified programs) | Reported Device Performance (Millennium Series) |
|---|---|---|
| Sterilization Programs | Equivalent to predicate devices, providing cycles for various loads (porous, hollow, wrapped, solid, emergency, and test cycles like Bowie & Dick, Vacuum). | All Millennium models (B, B+, B2, Bµ) offer 134°C Porous, 121°C Porous, 134°C Hollow, 121°C Hollow, 134°C Wrapped, 121°C Wrapped, 134°C Solid, 121°C Solid, 134°C Emergency, 134°C/121°C Custom, Bowie & Dick Test, and Vacuum Test cycles with specific parameters. |
| Temperature | Typically 134°C or 121°C. Bowie & Dick test at 273°F (134°C). | Met: All programs specify 134°C or 121°C (except Bowie & Dick at 273°F). |
| Pressure (relative) | Typically 2.10 bar (for 134°C) or 1.10 bar (for 121°C). | Met: Programs specify 2.10 bar (for 134°C) or 1.10 bar (for 121°C). Vacuum test at -0.80 bar. |
| Holding Time | Program-specific, e.g., 4 min (134°C) or 20 min (121°C). | Met: Ranges from 3 min (Emergency) to 20 min (121°C programs). Custom programs allow >4 min or >20 min. |
| Pre-vacuum | Fractional (for porous/hollow) or Single (for solid). | Met: "F" (Fractionated) for porous/hollow, "S" (Single) for solid. (Fractionated = 3 vacuum + 3 pressure pulses; Single = 1 vacuum + 1 pressure pulse). |
| Drying Cycle | Long (for packaged/porous) or Short (for unpackaged solids). | Met: "L" (Long) for porous/packaged, "S" (Short) for unpackaged solid/hollow. Validated Long drying times: 16.5 min (B, B2), 12.5 min (B+), 6 min (Bµ). Validated Short drying times: 7 min (B), 6 min (B+), 8 min (B2), 4 min (Bµ). |
| Total Cycle Time | Program specific, comparable to predicate devices. | Met: Indicative times provided for each program (e.g., Millennium B porous 134°C: 41 min; Millennium Bµ emergency 134°C: 9 min). Calculated with half-load. |
| Water Consumption | Comparable to predicate devices and acceptable for medical use. | Met: Average H2O consumption per cycle provided (e.g., Millennium B porous 134°C: 525 ml; Millennium Bµ solid 134°C: 125 ml). |
| Energy Consumption | Comparable to predicate devices and acceptable for medical use. | Met: Average energy consumption per cycle provided (e.g., Millennium B porous 134°C: 0.8 kWh; Millennium Bµ emergency 134°C: 0.4 kWh). |
| Load Capacity | Max total mass, max mass per tray, max mass per article. | Met: Specific maximum mass limits for different load types are provided for each model (e.g., Millennium B: Max total mass for unpackaged solid material is 6.00 kg; Millennium Bµ: Max total mass for porous material is 0.30 kg). |
Note: The document explicitly states that the "EXTRA and INTELLIGENT options" for drying and the "FAST option" for drying have not been validated. Also, the "134°C / 121°C CUSTOM program has not been validated." This indicates that these specific features, while present, are not part of the validated acceptance criteria for "safe and effective" claim and would require further validation if used as primary sterilization programs.
2. Sample Size Used for the Test Set and the Data Provenance
The document is a 510(k) premarket notification for substantial equivalence, not a clinical trial report. As such, it does not describe a "test set" in the context of an AI/ML device evaluating data. Instead, the "study" for this device involved engineering and performance testing to demonstrate that the sterilizers meet the specified operational parameters and effectively sterilize various loads.
- Sample Size for Testing: The document does not specify a quantitative "sample size" in terms of number of sterilization cycles or tests performed. It refers to various "programs" and their associated parameters (temperature, pressure, holding time, drying time, load types, and maximum masses). These parameters derive from general standards for steam sterilization and performance testing typical for such devices.
- Data Provenance: The data provenance is from engineering and performance testing conducted by the manufacturer (M.O.COM. s.r.l.) in Italy. This would be considered prospective testing to characterize the device's technical performance. The results are presented in the form of tables detailing the various sterilization cycles and their validated/specified parameters. While not explicitly stated, such testing would typically involve:
- Physical Monitoring: Temperature and pressure sensors placed within the chamber and load.
- Biological Indicators: Used to confirm sterility within various load configurations.
- Chemical Indicators: Used to confirm exposure to sterilization conditions.
- Bowie-Dick Test: Specifically mentioned in the tables to confirm air removal and steam penetration for porous loads.
- Vacuum Test: Specifically mentioned to evaluate vacuum integrity.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
In the context of a steam sterilizer, "ground truth" for a test set would pertain to the successful sterilization of items and the accurate measurement of physical parameters during a cycle.
- Number of Experts: The document does not specify a number of experts. The data presented (e.g., total cycle time, water/energy consumption, max load mass) would be derived from standard engineering and microbiological validation protocols.
- Qualifications of Experts: The "experts" involved in verifying the sterilizer's performance would primarily be:
- Engineers: Responsible for designing, building, and testing the device to meet specified physical parameters (temperature accuracy, pressure control, vacuum levels, timing).
- Microbiologists/Sterilization Scientists: Responsible for validating the sterilization efficacy using biological indicators and ensuring the device achieves a sterility assurance level (SAL) appropriate for medical devices.
- Regulatory Affairs Personnel: To ensure compliance with relevant standards and regulations (e.g., ISO, AAMI, FDA).
These are implied roles based on the nature of the device and regulatory submission, rather than explicitly stated individuals in this document.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving expert consensus on subjective evaluations (e.g., medical image interpretation). For a device like a steam sterilizer, "adjudication" is not directly applicable in this sense.
Instead, the "adjudication" for the performance of a steam sterilizer involves:
- Conformance to Standards: Ensuring the device operates within the parameters set by recognized national and international standards for steam sterilization (e.g., EN 13060 for small steam sterilizers).
- Successful Sterilization Endpoints: Confirming the inactivation of biological indicators, meeting specific physical parameter thresholds (temperature, pressure, time), and passing routine tests like the Bowie & Dick test and Vacuum test.
- Engineering Validation: Verification and validation activities by the manufacturer's R&D, Quality Assurance, and Engineering teams to ensure the device performs as designed and meets its specifications.
The document implies that these standard industry practices for validation were followed, leading to the reported performance characteristics for each program.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic or AI-assisted interpretation devices where multiple human readers evaluate multiple cases, often with and without AI assistance, to measure changes in diagnostic performance.
This document is a 510(k) submission for a medical device (steam sterilizer), which is an entirely different class of device and does not involve human interpretation of cases or AI assistance in that sense. The comparison provided in the submission is purely based on the technological characteristics and intended use of the sterilizer against predicate devices, establishing "substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this question is not applicable to a steam sterilizer. The Millennium series of sterilizers are electromechanical devices that perform a physical process of sterilization. They do not involve algorithms in the sense of AI/ML interpretation where a "standalone" or "human-in-the-loop" performance would be evaluated. The sterilizer operates autonomously based on its programmed cycles, with human interaction limited to loading/unloading and program selection.
7. The Type of Ground Truth Used
The "ground truth" for a steam sterilizer is:
- Physical Parameters: Accurate measurements of temperature, pressure, and time achieved within the sterilization chamber and the load.
- Sterility Assurance: The confirmed inactivation of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) as demonstrated by biological indicators (BIs) placed within test loads, achieving a specified sterility assurance level (SAL).
- Process Indicators: Successful change in color/state of chemical indicators (CIs) to confirm exposure to sterilization conditions.
- Test Pack Results: Successful passing of Bowie-Dick tests (for air removal and steam penetration) and Vacuum tests (for chamber integrity).
These are established through rigorous engineering and microbiological validation during the development and testing phases of the sterilizer. The tables in the document reflect the parameters of cycles that have demonstrated these ground truths.
8. The Sample Size for the Training Set
This question is not applicable. Training sets are relevant for AI/ML algorithms. The Mocom Millennium series sterilizers are not described as incorporating AI/ML, and therefore, there is no "training set." The device's operation is based on pre-programmed, validated sterilization cycles and control systems.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for an AI/ML algorithm. The "ground truth" for the device's efficacy is established through the validation of its physical and biological performance against accepted sterilization standards, as explained in point 7.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).