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510(k) Data Aggregation
(417 days)
The STERRAD® 50/100S/200 Test Pack is used for routine monitoring of the STERRAD® 50, STERRAD® 100S and STERRAD® 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads containing devices that do not exceed claims of the cycle.
The STERRAD® 50/100S/200 Test Pack consists of a pouch which holds a closed vial containing a STERRAD® CYCLESURE® 24 Biological Indicator (BI) and silicon mats. The vial and its corresponding cap have defined orifices.
Here's an analysis of the provided text regarding the acceptance criteria and study for the STERRAD® 50/100S/200 Test Pack:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating "at least as resistant" performance compared to a biological model, and the chemical indicator functioning "appropriately." The study focuses on proving substantial equivalence to predicate devices, rather than meeting specific numerical performance thresholds in a typical diagnostic sense.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biological Indicator Resistance: Test Pack must be at least as resistant to the sterilization process as the biological model (based on survival curves). | Passed: Survivor curves for Test Packs assembled from three lots of CYCLESURE® 24 Biological Indicator (BI) exposed to varying hydrogen peroxide doses in STERRAD® 100S, 50, or 200 Cycles were compared to the biological model's curves. The data showed the Test Pack was at least as resistant as the biological model. |
| Biological Indicator Resistance: Test Pack must be at least as resistant to the sterilization process as the biological model (based on fraction negative data). | Passed: Fraction negative data collected using Test Packs (from three lots of CYCLESURE® 24 BI) exposed to increasing volumes of hydrogen peroxide in STERRAD® 100S, 50, or 200 Cycles indicated the Test Pack configuration was at least as resistant as the biological model. |
| Chemical Indicator Functionality: Chemical indicator in the Test Pack configuration must be appropriate. | Passed: Indicative functionality of the chemical indicator in a STERRAD® 50/100S/200 Test Pack configuration was evaluated using half-cycle parameters of the STERRAD® 100S, STERRAD®50, and STERRAD® 200 Cycles and was determined to be appropriate. |
| Overall Performance: Device functions as intended in the specified sterilizers. | Passed: Design Evaluation and Performance Qualification studies were performed for the STERRAD® 50/100S/200 Test Pack in the STERRAD® 50, STERRAD® 100S, and STERRAD® 200 Sterilizers, and all passed. Functional Compatibility Testing of STERRAD® Test Pack Reusable Components also passed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Test Packs assembled from three lots of CYCLESURE® 24 Biological Indicator (BI)" were used for both survival curve and fraction negative data collection. The exact number of test packs within each batch or for each exposure condition is not specified.
- Data Provenance: The data appears to be prospective as it involves controlled experimental exposures of the test packs to sterilizers to evaluate their resistance. The country of origin of the data is not explicitly stated but is implicitly associated with the manufacturer (Advanced Sterilization Products, Irvine, CA, USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of device (biological indicator/test pack for sterilization) does not typically involve human expert interpretation for establishing ground truth in the same way a diagnostic imaging AI might. The "ground truth" here is the scientifically established biological model for the sterilization resistance and the physical/chemical properties of the indicator. Therefore, the concept of "experts establishing ground truth" in the traditional sense is not directly applicable.
Instead of human experts, the standard for comparison (ground truth) is the "biological model developed for their respective cycles." This model represents the scientifically validated susceptibility of microorganisms to the sterilization process.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is based on a "biological model" and scientific measurement, not on human consensus or adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a scientific and engineering performance study rather than a clinical multi-reader study. The device is a sterilization indicator, not a diagnostic tool requiring human interpretation comparison.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, this is essentially a standalone performance study. The device's performance (resistance to sterilization, chemical indicator change) is evaluated directly against established scientific models and performance criteria without human intervention in the primary measurement of its function. The "algorithm" here is the physical and chemical design of the indicator responding to the sterilization process.
7. Type of Ground Truth Used
The ground truth used is a scientifically established biological model representing the resistance of microorganisms to the sterilization process, combined with physical-chemical properties for the chemical indicator. This is based on validated scientific principles of sterilization efficacy.
8. Sample Size for the Training Set
Not applicable. This device is a passive indicator/test pack, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its performance is inherent in its design and manufacturing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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