(14 days)
STEAMPlus™ Sterilization Integrators are intended to be used to monitor parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (under the presence of saturated steam). The integrators are intended to be used in steam cycles operating at 121°C - 134°C.
The SPSmedical STEAMPlus™ Steam Integrator is designed to monitor sterilization parameters in steam sterilizers. It is a wicking style integrator which provides a visual indication that proper sterilization parameters were present within the sterilizers' chamber. Once the defined sterilization parameters have been reached the integrators pellet will melt and its dye will migrate from the non safe zone into the integrators safe zone. This will indicate to the user that the defined parameters for the integrator have been met.
Here's a breakdown of the acceptance criteria and study information for the K063799 device, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The text explicitly states that the device was tested in accordance with AAMI/ANSI ST60:1996 - Sterilization of health care products - Chemical indicators - Part 1: General requirements. It also concludes that the device "meets the performance claims for a class 5 integrator according to AAMI/ANSI ST60." While specific quantitative acceptance criteria (e.g., pass/fail rates at certain deviations from sterilization parameters) are not explicitly detailed in the provided summary, the implication is that the device successfully met all requirements of the AAMI/ANSI ST60 standard for a Class 5 integrator.
| Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|
| Conformance to AAMI/ANSI ST60:1996 | The SPSmedical STEAMPlus™ Steam Integrator is a highly reliable and reproducible chemical integrator for steam sterilization processes and meets the performance claims for a Class 5 integrator according to AAMI/ANSI ST60. It is capable of integrating time and temperature into an easy to interpret "Safe Zone" where the pellet only melts and advances into the safe zone when conditions needed for spore death have been reached. |
| Equivalent to Predicate Device | Data has demonstrated that the SPSmedical STEAMPlus™ Steam Integrator is equivalent to the predicate device (3M Thermalog steam sterilization integrator - K813202). |
2. Sample Size and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).
3. Number of Experts and Qualifications
The provided text does not mention the number of experts used to establish ground truth or their qualifications. Given this is a chemical indicator with a clear visual output ("Safe Zone"), it's likely the ground truth was established by direct observation of the chemical reaction in controlled sterilization conditions, rather than expert interpretation of complex data.
4. Adjudication Method
The provided text does not specify any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable. This device is a chemical indicator that provides a visual "safe zone" indication of sterilization parameters being met. It's not a diagnostic tool requiring human interpretation or a comparison of human reader performance with and without AI assistance.
6. Standalone Performance (Algorithm Only)
A standalone (i.e., algorithm only without human-in-the-loop performance) study was not explicitly done or relevant in the sense of a digital algorithm. This device is a physical chemical indicator. Its "performance" is its ability to accurately reflect sterilization parameters through a chemical reaction and visual change. The evaluation of its performance would be against known, controlled sterilization cycles in a lab setting.
7. Type of Ground Truth Used
The ground truth used would be based on direct measurement and verification of sterilization parameters (time, temperature, saturated steam) within the sterilization chamber during the testing of the integrators. The integrator's performance (i.e., whether the pellet melted and migrated to the "safe zone") would then be compared against these established sterilization conditions that are known to achieve microbial kill (spore death).
8. Sample Size for the Training Set
The provided text does not mention a training set sample size. As a non-AI, chemical indicator device, a typical "training set" in the machine learning sense is not applicable. The device's design and manufacturing are based on chemical principles and validation against established standards.
9. How Ground Truth for the Training Set was Established
As with point 8, the concept of a "training set" in an AI/machine learning context is not applicable here. The "ground truth" for the development of such a chemical indicator would be derived from:
- Scientific principles of sterilization: Understanding the time and temperature relationships required for microbial inactivation, particularly spore death, under saturated steam conditions.
- AAMI/ANSI ST60 standard requirements: The standard itself defines performance expectations for Class 5 integrators, which would guide the design and manufacturing of the device.
- Laboratory testing in controlled environments: Repeated experiments in validated steam sterilizers where time, temperature, and steam saturation are precisely controlled and measured, and the integrator's response is observed.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).