(237 days)
The Emu-Chex™ Sterilization Indicator is an emulating indicator intended to be used by a health care provider to monitor steam sterilization processes. Ennu-Chex" Sterilization Indicator comes in three varieties; for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in pro-vacuum steam sterilization processes operating at 132°C for 4 minutes and 135°C for 3 minutes.
The Emu-Chex™ Sterilization Indicators can be placed together with items to be steam sterifized. The indicator changes color from blue-green to brown when the sterilization cycle is complete. The performance of the Enni-Chex" Sterilization Indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating indicators.
The Emu-Chex™ Sterilization Indicator is a chemical sterilization indicator for steam sterilizers that complies with ANSI/AAMI/ISO 11140-1:2005, Sterilization of health care products - Chemical indicators - Part 1 : General requirements, emulating indicators. The variety of Emu-Chex sterilization indicators includes those for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in prevacuum steam sterilization process operating at 132° C for 4 minutes and 135° C for 3 minutes. No lead or heavy metals or their compounds are added in the production of the indicator.
Here's a breakdown of the acceptance criteria and study information for the Emu-Chex™ Sterilization Indicator based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI/ISO 11140-1:2005 (for emulating indicators) | "The performance of the Emu-Chex™ Sterilization Indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating indicators." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The provided document does not mention the use of experts to establish ground truth for the test set. For a chemical indicator, the ground truth is typically established by physical parameters of the sterilization cycle (e.g., temperature, time, steam presence) rather than human interpretation.
4. Adjudication Method for the Test Set
The provided document does not describe any adjudication method. This is consistent with the nature of a chemical indicator, where the outcome (color change) is a direct physical response.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (e.g., imaging AI) and not for simple color-changing chemical indicators.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described is effectively a standalone performance evaluation of the chemical indicator. The device's performance is assessed based on its physical response (color change) to specific sterilization conditions, without human interpretation as part of the primary functional assessment.
7. The Type of Ground Truth Used
The ground truth used for this device is based on physical parameters of the sterilization process as defined by the ANSI/AAMI/ISO 11140-1:2005 standard. This standard sets specific conditions (e.g., 121°C for 20 minutes, 132°C for 4 minutes, 135°C for 3 minutes) at which an emulating indicator must demonstrate a color change, and conditions under which it must not change color (to indicate an incomplete cycle).
8. The Sample Size for the Training Set
The provided document does not mention a "training set" in the context of this device. Chemical indicators are typically developed through chemical formulation and empirical testing rather than machine learning or algorithmic training.
9. How the Ground Truth for the Training Set Was Established
As there is no concept of a "training set" for this type of device, the question of how its ground truth was established is not applicable. The development process would involve chemical engineering and validation against established scientific principles and standards for sterilization efficacy.
§ 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).