(84 days)
The Belimed Steam Sterilizer TOP 5000, series 4-8, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000 Series 4 - 8 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).
The Belimed Steam Sterilizer TOP 5000 Series 4 – 8 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer TOP 5000 Series 9 - 18. The smaller Chamber size incorporates additional flexibility, in comparison to Series 9 -- 18, and allows to operate the sterilizer in an economical way. Motorized vertical door movement leads to an optimal compact design, and allows the operation of the sterilizer, where space is limited.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the Belimed Steam Sterilizer TOP 5000 Series 4-8.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterility Assurance Level (SAL) | At least 10^-6 (reduction factor of 10^6) | Achieved: All PREVAC, FLASH, and LIQUID cycles demonstrated an SAL of at least 10^-6 through achievement of a time-at-temperature sufficient to produce an F0 of at least 12 by ½ cycle. |
| Moisture Retention (PREVAC - Fabric Test Pack) | Less than 3% increase in pre-sterilization test pack weight and no wet spots. | Met: PREVAC cycles using the fabric test pack (Section 5.5.2 AAMI/ANSI-ST8:2001) demonstrated moisture retention of less than 3% increase in pre-sterilization test pack weight and exhibited no wet spots. |
| Moisture Retention (PREVAC - Full Load Instrument Trays) | Less than 20% increase in pre-sterilization weight of the towel and no wet spots on the outer wrapper. | Met: PREVAC cycles using full load instrument trays (Section 5.5.4 of ANSI/AAMI-ST8:2001) demonstrated moisture retention of less than 20% increase in pre-sterilization weight of the towel and exhibited no wet spots on the outer wrapper. |
| Wet Spots (FLASH cycles) | No wet spots. | Met: FLASH cycles using the unwrapped instrument tray (Section 5.5.5.1 AAMI/ANSI-ST8:2001 and ANSI/AAMI ST37:1996 section 7.7.3) exhibited no wet spots. |
| LIQUID cycles performance | Achieve and maintain 121°C in the center of the liquid for at least 12 minutes, water loss not exceeding 50 ml, and automatic sealing of the flask closure. | Met: LIQUID cycles using three 1'000 ml flasks (Section 5.5.3 of AAMI/ANSI-ST8:2001) demonstrated achieving and maintaining 121°C in the center of the liquid for at least 12 minutes, water loss not exceeding 50 ml, and automatic sealing of the flask closure. |
| Bowie-Dick (BD) Test Pack | Uniform color change throughout the test sheet. | Met: The BD cycle (Section 5.6 of AAMI/ANSI-ST8) demonstrated a uniform color change throughout the test sheet. |
| Software Validation | Per FDA's moderate level of concern recommendations in "Guidance for the Content for Pre-market Submissions for Software Contained in Medical Devices (5/29/98)". | Met: Software validation for cycle operation was performed according to the specified FDA guidance. |
| Electrical Safety | Compliance with UL 61010A-1:2002 and UL 61010A-2-041:2002. | Complies: The device complies with Underwriter Laboratory (UL) Code UL 61010A-1:2002 and UL 61010A-2-041:2002. |
| Electrical Safety (Canadian) | Compliance with CSA C22.2 No. 1010-1 (IEC61010-1:2001). | Complies: The device complies with Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 (IEC61010-1:2001). |
| Pressure Vessel Safety | Compliance with ASME, Section VIII, Division 1 for unfired pressure vessels :2001. | Complies: The device complies with American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels :2001. |
2. Sample size used for the test set and the data provenance
The document indicates that the sterilizer's cycles were "validated to meet the requirements of AAMI/ANSI-5T8-2001" and that "verification studies" were performed.
- Test Set Sample Size:
- PREVAC cycles (fabric test pack): "verified using the fabric test pack, as described in Section 5,5.2 AAMI/ANSI-ST8:2001". The specific number of fabric test packs used is not explicitly stated.
- PREVAC cycles (full load instrument trays): "verified using full load instruments trays [...] according to section 5.5.4 of ANSI/AAMI-ST8: 2001". The specific number of instrument trays used is not explicitly stated.
- FLASH cycles: "verified using the unwrapped instrument tray [...] according to section 5.5.5.1 AAMI/ANSI-ST8:2001 and ANSI/AAMI ST37:1996 section 7.7.3". The specific number of unwrapped instrument trays is not explicitly stated.
- LIQUID cycles: "verified using three 1'000 ml flasks, as described in section 5.5.3 of AAMI/ANSIe ST8:2001". This indicates a minimum of three 1'000 ml flasks were used per test.
- BD cycle: "verified using the Bowie-Dick Test Pack were qualified according to section 5.6 . of AAMI/ANSI-ST8". The number of Bowie-Dick Test Packs is not explicitly stated but implies standard usage per the referenced section.
- Data Provenance: The studies were conducted by SAUTER AG. The data provenance is internal testing and validation performed by the manufacturer in accordance with recognized industry standards (AAMI/ANSI-ST8:2001, ANSI/AAMI ST37:1996, EN285:1996). The context suggests this was prospective testing conducted to validate the device's performance. The country of origin of the data would be associated with the manufacturer, Sauter AG, based in Switzerland.
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 steam sterilizer, not an AI or diagnostic imaging device that requires human expert review for ground truth in the typical sense. The ground truth is established through physical measurements and biological indicator kill rates as defined by established standards (e.g., AAMI/ANSI-ST8:2001).
4. Adjudication method for the test set
This section is not applicable. As stated above, the device's performance is assessed against physical and biological criteria defined by standards, not by human interpretation 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
This section is not applicable. The device is a steam sterilizer, not an AI-assisted diagnostic or interpretation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance described is standalone. The sterilizer operates autonomously based on its programmed cycles, and its effectiveness is validated through its ability to achieve specific physical and biological endpoints (e.g., SAL, temperature, moisture retention). There is no "human-in-the-loop" performance validation in the sense of an algorithm, other than operators configuring and starting the cycles.
7. The type of ground truth used
The ground truth used for the sterilizer's performance validation is based on objective physical and biological parameters defined by recognized standards:
- Sterility Assurance Level (SAL) of 10^-6: Demonstrated via complete kill of biological indicators and calculation of F0 values.
- Time-at-temperature achievement: Verification that specified temperatures were reached and maintained for the required duration.
- Moisture retention: Quantitative measurement of weight increase (for fabric/towel) and visual inspection for wet spots.
- Water loss: Quantitative measurement for liquid cycles.
- Automatic sealing of flask closure: Observed performance for liquid cycles.
- Uniform color change: For the Bowie-Dick test.
- Compliance with safety standards (UL, CSA, ASME).
These are empirical measurements and outcomes directly observable or measurable against defined benchmarks, not subjective expert consensus.
8. The sample size for the training set
This section is not applicable. The Belimed Steam Sterilizer TOP 5000 Series 4-8 is a hardware device with programmed cycles, not an AI/ML algorithm that undergoes "training" on a data set. The cycles are "factory-programmed" and validated through engineering design and physical testing.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated in point 8.
§ 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).