(94 days)
The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles:
- 250°F/121°C, 30 minutes Gravity
- 270°F/132°C, 4 minutes Dynamic Air Removal
- 270°F/132°C, 5 minutes Dynamic Air Removal
- 270°F/132°C, 6 minutes Dynamic Air Removal
- 270°F/132°C, 7 minutes Dynamic Air Removal
- 270°F/132°C, 8 minutes Dynamic Air Removal
- 270°F/132°C, 9 minutes Dynamic Air Removal
- 270°F/132°C, 10 minutes Dynamic Air Removal
- 270°F/132°C, 15 minutes Gravity
- 273°F/134°C, 4 minutes Dynamic Air Removal
- 275°F/135°C, 3 minutes Dynamic Air Removal
- 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles (IUSS):
- 270°F/132°C, 4 minutes Dynamic Air Removal
- 270°F/132°C, 3 minutes Gravity
- 270°F/132°C, 10 minutes Gravity
- 275°F/135°C, 3 minutes Dynamic Air Removal
- 275°F/135°C, 3 minutes Gravity
- 275°F/135°C, 10 minutes Gravity
The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.
The VERIFY STEAM Integrating Indicator 5CM is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator 5CM is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.
The provided text is a 510(k) summary for a medical device (VERIFY STEAM Integrating Indicator and VERIFY STEAM Integrating Indicator 5CM), which focuses on demonstrating substantial equivalence to a predicate device based on nonclinical performance data. It is not an AI/ML device, and therefore, the information requested in the prompt regarding AI/ML specific criteria (such as training set, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.
However, I can extract the acceptance criteria and stated device performance for this non-AI/ML medical device from the provided text.
Here's the relevant information presented in the format requested, with explicit notes about the inapplicability of AI/ML specific criteria:
Acceptance Criteria and Device Performance (for a non-AI/ML device)
1. Table of Acceptance Criteria and the Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Simulated Use Testing in Claimed Sterilization Cycles | 100% pass under pass conditions | PASS (met 100% pass condition) |
| Simulated Use Testing in Claimed Sterilization Cycles | 100% fail under fail conditions | PASS (met 100% fail condition) |
| Parallel performance as biological indicator | Integrator does not reach endpoint before the biological indicator is inactivated | PASS (integrator did not reach endpoint before BI inactivation) |
Note: The "reported device performance" is given as "PASS" in the document, indicating that the device successfully met the stated acceptance criteria for each test.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the test set experiments (Simulated Use Testing, Parallel performance as biological indicator). It only indicates "100% pass" and "100% fail" which implies that, for the tests conducted, all units observed performed as expected.
Regarding data provenance:
- The tests are described as "Simulated Use Testing" and "Parallel performance as biological indicator." This suggests the data was generated in a controlled laboratory or testing environment simulating real-world conditions.
- The document does not specify the country of origin of the data providers or if it was retrospective or prospective data, as these concepts are generally not applicable to the non-clinical testing of a chemical indicator device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable as the device is a chemical indicator for sterilization. Its "ground truth" is established by physical and chemical properties and calibrated against known sterilization parameters and biological indicators, not by human expert interpretation of images or data. No human experts are involved in establishing the "ground truth" for the performance of this type of device in the context of the described tests.
4. Adjudication Method for the Test Set
This question is not applicable as there is no human interpretation or subjective assessment involved that would require adjudication for this type of device testing. The results (pass/fail for the indicator's chemical reaction) are objective.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This question is not applicable. This is not an AI-assisted diagnostic or interpretive device. There are no human readers whose performance is being compared with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a physical chemical indicator, not an algorithm or software. Its performance is inherent to its design and chemical properties.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established by:
- Pre-defined sterilization cycle parameters (temperature, time, pressure – i.e., "pass conditions").
- Pre-defined under-sterilization conditions (e.g., "stated value -15% time and/or -1°C" – i.e., "fail conditions").
- The performance of a biological indicator (BI), which is the gold standard for demonstrating sterilization efficacy by showing inactivation of highly resistant bacterial spores. The integrator's performance is compared to the BI's performance, ensuring the integrator does not "pass" before the BI is inactivated.
8. The Sample Size for the Training Set
This question is not applicable. This is a physical chemical indicator, not an AI/ML device that requires a "training set." Its design and functionality are based on chemical engineering principles, not machine learning from data.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reasons as #8.
§ 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).