(83 days)
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 are intended for use in hospital and health care facilities and are intended to be used in an identical manner as the Belimed Steam Sterilizers Series 4-8.
Modifications made from the predicate device include:
- Additional Gravity cycles
- Increase of recommended load capacity.
- New version of Programmable Logic control (PLC) and new operating panel (MMI)
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are available as a single door prevacuum/gravity or double door prevacuum/gravity version.
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are designed to be used for the terminal sterilization of porous and non-porous, heat and moisture stabile materials in the healthcare facilities.
Depending of the chosen cycle materials as different as textiles, unwrapped or wrapped instrument trays with single or multiple instruments may be sterilized.
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are factory equipped with cycles which have been tested in accordance with ANSI/AAMI ST8:2008 under defined load conditions. The predicate devices with a chamber volume of 305 l, 440 l, and 595 l have been validated previously.
The provided text describes a 510(k) summary for a steam sterilizer, not an AI/ML-enabled medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/ML device performance (e.g., sensitivity, specificity, AUC) are not applicable here.
Instead, the acceptance criteria for this sterilizer are based on its ability to effectively sterilize various loads and meet established safety and performance standards. The "study that proves the device meets the acceptance criteria" refers to a series of nonclinical verification studies based on recognized standards.
Here's how to interpret the information provided in the context of a steam sterilizer:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ANSI/AAMI ST8:2008 and other standards) | Reported Device Performance (Effectiveness, based on verification studies) |
|---|---|
| Sterility Assurance Level (SAL) of at least 10-6 reduction: Demonstrated through complete kill of biological indicators and achieving sufficient time-at-temperature (Fo of at least 12 minutes by half cycle). | Achieved for all cycles: Prevac, Prevac Flash, and Gravity cycles demonstrated a sterility assurance level of at least 10-6 through achievement of a time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle. |
| Empty chamber testing (Section 5.4.2.5 of ANSI/AMMI ST8:2008): Capability to provide steady state thermal conditions within the chamber corresponding with predicted SAL in the load. Meets requirements of Section 4.4.2.2 and 4.4.2.5 of ANSI/AAMI ST8. | Performed and met criteria: Demonstrated the sterilizer's capability to provide steady state thermal conditions within the chamber that are corresponding with the predicted sterility assurance level (SAL) in the load. |
| Prevac cycles verification using fabric test pack (Section 5.5.2 ANSI/AAMI ST8:2008): Moisture retention less than 3% increase in pre-sterilization test pack weight, no wet spots. | Qualified and met criteria: Moisture retention of less than 3% increase in pre-sterilization test pack weight, and exhibited no wet spots. |
| Prevac and Gravity cycles verification using full load instruments trays (Section 5.5.4 of ANSI/AAMI ST8:2008): Moisture retention less than 20% increase in pre-sterilization weight of the towel, no wet spots on outer wrapper. | Qualified and met criteria: Moisture retention of less than 20% increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper. |
| Bowie-Dick Test cycle verification (Section 5.6 of ANSI/AAMI ST8): Uniform color change throughout the test sheet, load temperature devices attained exposure temperature within 10 seconds of progressing into the exposure phase. | Verified and qualified: Demonstrated a uniform color change throughout the test sheet and the load temperature devices attained the exposure temperature within 10 seconds of progressing into the exposure phase. |
| Software validation: Performed according to FDA's moderate level of concern recommendations ("Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (May 2005)"). | Performed and met criteria: "The software validation for the cycle operation was performed according to FDA's moderate level of concern recommendations..." |
| Compliance with Safety Standards: ANSI/AAMI ST8:2008, ANSI/AAMI ST79:2006+A1:2008, IEC EN 62304:2006, EN ISO 14971:2007, ISO 13485:2007, IEC EN 60601-1-2:2007, UL 61010-1:2004, IEC EN 61010-2-040:2005, ASME Section VIII, Division 1 for unfired pressure vessels Ed. 2007+Addenda 2008. | Complies with listed standards: "Belimed Steam Sterilizer MST-V complies with the following safety standards." (Lists all standards). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document doesn't specify a precise numerical "sample size" in terms of cases or images, as would be typical for an AI/ML study. Instead, it refers to performing tests on various "test packs," "instrument trays," and "empty chambers" for different cycles (PreVac, Gravity, Flash, Bowie-Dick, Leak Test, Warm-up). The number of times each test was performed is not explicitly stated, but the implication is that sufficient repetitions were done to demonstrate consistent performance as per the standards.
- Data Provenance: The tests were conducted by Belimed Sauter AG. The standards referenced (ANSI/AAMI ST8:2008, etc.) are international/US standards. The document doesn't state specific countries of origin for the data or if it was retrospective/prospective in the clinical sense, as these are non-clinical performance tests on a manufactured device. It seems to be a prospective set of tests performed for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the AI/ML sense. Ground truth here is established by the physical performance of the sterilizer validated against established scientific principles and industry standards (e.g., complete kill of biological indicators, Fo values, temperature and pressure measurements, moisture retention, color change in Bowie-Dick tests).
- The "experts" would be the engineers and technicians at Belimed Sauter AG trained to conduct these specific validation tests according to the standards. No medical experts (like radiologists) are involved in establishing this type of physical ground truth.
4. Adjudication Method for the Test Set:
- Not applicable in the AI/ML sense. The "adjudication" is inherent in successfully meeting the quantitative and qualitative criteria defined by the relevant standards (e.g., reaching a certain Fo value, achieving uniform color change, staying below a certain moisture retention percentage). There's no human "adjudication" of results in the traditional sense; rather, the device either passes or fails the objective performance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- Not applicable. This is a standalone medical device (a sterilizer), not an AI/ML diagnostic or assistive tool. There are no "human readers" to compare performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable in the AI/ML sense. The device itself is "standalone" in that it performs its function of sterilization automatically based on programmed cycles. The performance metrics listed are of the device itself (e.g., its ability to maintain specific temperatures, pressures, and times), not of an algorithm generating an output that a human then interprets.
7. The Type of Ground Truth Used:
- Established scientific and engineering principles, and validated industry standards:
- Biological efficacy: Complete kill of biological indicators, achieving a sterility assurance level (SAL) of 10-6 reduction.
- Physical parameters: Precise temperature and pressure control, specific exposure times, moisture retention levels, uniform heat distribution (Bowie-Dick test).
- Compliance with published standards: ANSI/AAMI ST8:2008, ANSI/AAMI ST79:2006+A1:2008, various IEC, EN, ISO, UL, and ASME standards.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a "training set." The device is designed, manufactured, and then validated against pre-defined performance standards.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set for an algorithm. The "ground truth" for the device's design and factory programming is based on extensive engineering knowledge, scientific principles of sterilization, and compliance with the aforementioned industry standards for sterilizer performance.
§ 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).