(73 days)
The Celerity 10 STEAM Chemical Indicator is intended for use in dynamic air removal steam sterilization cycles operating at 270°F/132°C for 10 minutes. The Celerity 10 STEAM Chemical Indicator that changes colors from yellow to blue/purple when exposed to these cycle conditions.
The Celerity 10 STEAM Chemical Indicators are Type 6 emulating indicators. Type 6 indicators are cycle verification indicators which are designed to react to all critical variables for specific sterilization cycles.
They are designed to be placed in the center of each pack (e.g. tray, protective case, approved rigid sterilization container) to be sterilized and change color from yellow to blue/purple when the critical sterilization parameters have been met (270°F /132°C for 10 minutes).
They shall be printed onto white polypropylene with a polypropylene laminate and dimensions of 140 x 22 mm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Celerity™ 10 STEAM Chemical Indicator:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing | Acceptance Criteria Reported | Reported Device Performance |
|---|---|---|
| ISO 11140-1 Testing | Meet requirements defined in ANSI/AAMI/ISO 11140-1:2014 along with additional FDA requirements for Type 6 emulating indicators. | PASS |
| Simulated Use Testing | Demonstrate color change when exposed to a full cycle and no/incomplete color change when exposed to an abbreviated cycle. | PASS |
| Shelf Life for 36 months | Meet performance specifications at each time point after storage in different environments. | PASS |
| Endpoint Color Stability for 12 months | Meet performance specifications at each time point after storage in typical conditions. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (ISO 11140-1, Simulated Use, Shelf Life, Endpoint Color Stability). It generally refers to "performance testing" being conducted.
The data provenance is not specified in terms of country of origin. The study appears to be retrospective as it's a submission for a 510(k) premarket notification, indicating the testing has already been completed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a chemical indicator, the ground truth is typically established by physical parameters (e.g., temperature, time) in a controlled resistometer, not by expert human interpretation.
4. Adjudication Method for the Test Set
This is not applicable as the determination of whether the chemical indicator met "color change" or "no/incomplete color change" is a direct visual assessment against a defined standard, not an expert panel adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Celerity™ 10 STEAM Chemical Indicator is a sterilization process indicator, not a diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, a "standalone" performance evaluation was done. The device itself (the chemical indicator) is the "algorithm," and its performance is evaluated based on its physical and chemical reaction to specific sterilization conditions. There is no human interpretation or "human-in-the-loop" once the indicator is exposed to the sterilization cycle to determine the result; the color change is designed to be unambiguously observable. The testing aimed to confirm this automatic performance.
7. The Type of Ground Truth Used
The ground truth used for this device is based on physical parameters and established international standards. Specifically:
- ISO 11140-1:2014: This standard defines the requirements for chemical indicators.
- ANSI/AAMI ISO 18472: A resistometer conforming to this standard was used, which provides precise control over sterilization parameters (temperature, time, steam quality) to create the "ground truth" sterilization conditions.
- Defined Sterilization Cycle: The indicator is designed for a specific cycle: 270°F/132°C for 10 minutes. This precise set of physical conditions constitutes the ground truth for a successful sterilization process that the indicator should confirm.
- Abbreviated Cycle: For the simulated use testing, an "abbreviated cycle" also serves as a precisely defined ground truth for a failed or incomplete sterilization, where the indicator should not show a full color change.
8. The Sample Size for the Training Set
This concept is not applicable to this device. The Celerity™ 10 STEAM Chemical Indicator is a physical-chemical device, not an AI or software-based system that uses a "training set." Its design and formulation are based on chemical principles and engineering, not machine learning or data training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
§ 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).