(128 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 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, 15 minutes Gravity
- · 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 – Short is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY® STEAM Integrating Indicator - Short is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer 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) area of the viewing 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) area of the viewing window, 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.
This document describes the performance testing and acceptance criteria for the VERIFY® STEAM Integrating Indicator – Short, a chemical indicator used to monitor steam sterilization cycles.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Study Result |
|---|---|---|
| BIER Vessel Testing | ||
| At Stated Values (SV) | Pass result at SV for each temperature claimed: | PASS |
| 26.5 min at 121°C | ||
| 2.7 min at 132 °C | ||
| 1.4 min at 135 °C | ||
| At 15% below SV | Fail result at 15% below SV for each temperature claimed | PASS |
| At 1°C below SV | Fail result at 1°C below SV for each temperature claimed | PASS |
| Simulated Use Testing in Claimed Sterilization Cycles | 100% Pass result under pass conditions | PASS |
| 100% Fail result under fail conditions | PASS | |
| Dry Heat Testing | Fail result when exposed to 140°C dry heat for 30 min | PASS |
| Verification of integrator stated values at biological indicator growth-negative cycle conditions | Integrator does not reach endpoint before the biological indicator is inactivated | PASS |
| Offset/Transference | Integrator shall not transfer or offset | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "Test of 3 Lots" for the BIER Vessel Testing. For Simulated Use Testing, it implies a sufficient number of tests to achieve "100% Pass result under pass conditions" and "100% Fail result under fail conditions." Specific numerical sample sizes for each test condition are not explicitly provided beyond the "3 lots" for BIER testing.
- Data Provenance: The studies were conducted as part of a premarket notification (510(k)) submission to the FDA. This indicates the data is prospective, generated specifically for regulatory approval. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying either U.S. or internationally generated data adhering to U.S. regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This device is a chemical indicator that directly reacts to physical parameters (temperature and time) of a sterilization cycle. The "ground truth" for its performance is established by the controlled physical conditions of the sterilization cycles themselves (e.g., using an ISO 18472-conforming steam resistometer for BIER vessel testing).
- Therefore, the concept of "experts" establishing ground truth in the context of human interpretation of complex medical images (like radiology) does not apply here. The device's pass/fail outcome is based on a direct chemical reaction against predefined physical parameters, not subjective human assessment.
4. Adjudication Method for the Test Set:
- Not applicable. As noted above, the assessment of the device's performance is objective, based on its chemical reaction against controlled physical parameters, rather than requiring human interpretation and adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This device is a chemical indicator, not an AI or imaging diagnostic tool that would be used by human readers for interpretation. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant to this product.
6. Standalone (Algorithm Only) Performance:
- This section describes the standalone performance of the chemical indicator itself. The device is designed to function independently by chemically reacting to sterilization conditions. Its "performance" refers to its ability to accurately reflect whether the critical parameters of a steam sterilization cycle have been met. The entire "Performance Testing" section (Table 5-2) details this standalone performance. For example, "Pass result at SV for each temperature claimed" demonstrates its performance when exposed to the specified sterilization parameters without human intervention for the primary assessment (though humans read the final indicator).
7. Type of Ground Truth Used:
- The ground truth used is based on controlled physical parameters of steam sterilization cycles, as defined by industry standards (e.g., ANSI/AAMI/ISO 11140-1:2014) and governmental guidance (FDA Guidance for Industry and FDA Staff: Premarket [510(k)] Submissions for Chemical Indicators).
- Specifically, this includes:
- Stated Values (SV): Precise temperature and time combinations at which the sterilization is expected to be successful.
- Sub-optimal Conditions: Conditions below the SV (e.g., 15% below SV or 1°C below SV, or "fail conditions" in simulated use testing) where sterilization is expected to fail.
- Biological Indicator Inactivation: Comparison to the known performance of biological indicators which serve as the gold standard for sterilization efficacy.
8. Sample Size for the Training Set:
- This device is a physical/chemical indicator, not a machine learning or AI algorithm that requires a "training set." Its function is based on inherent chemical properties and design, not on learned patterns from data. Therefore, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
§ 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).