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510(k) Data Aggregation
(108 days)
The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container 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
Stated values (as determined in a steam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 1.5 minutes at 135°C
The Getinge Assured MI Steam Migrating Integrator is a single use device to monitor steam sterilization cycles. The integrating indicator is designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for sterilization cycles. During steam sterilization, the integrating indicator pellet will migrate into the PASS zone when sterilization conditions have been met.
A paper wick and a steam sensitive chemical pellet containing blue colored dye. A pellet is held within a pocket located at one end of an aluminum foil base. The foil base is adhered to label material that has been bonded with a film. During steam sterilization, the integrating indicator pellet will migrate into the PASS zone when the specified critical parameters of steam sterilization have been met.
The provided text describes the Getinge Assured MI Steam Migrating Integrator, a chemical indicator used to monitor steam sterilization cycles. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Pre-Determined Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Steam Resistometer (BIER vessel) Testing (Pass/Fail at Stated Value) | Pass result at the stated value for each temperature claimed: - 30 Minutes at 121°C - 3.3 minutes at 132°C - 1.5 minutes at 135°C | PASS |
| Steam Resistometer (BIER vessel) Testing (Pass/Fail at Reduced Time) | Failing Result at 15% less time of SV for each temperature claimed | PASS |
| Steam Resistometer (BIER vessel) Testing (Pass/Fail at Reduced Temperature) | Failing Result at 1°C less for each temperature claimed | PASS |
| Hospital Steam Sterilizer Testing | 100% samples passing under passing conditions for each cycle 100% samples failing under failing conditions for each cycle | PASS |
| Dry Heat Testing | Failing result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C) | PASS |
| Side-by-side testing of biological indicator and integrator in steam resistometer | The integrator does not reach its endpoint before the biological indicator is inactivated | PASS |
| Offset/Transference | The indicator agent shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed | PASS |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not specify the exact sample size for the test set (number of integrators used in each test). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
However, for "Hospital Steam Sterilizer Testing," it mentions "an actual sterilization cycle used in a health care facility," which implies real-world, prospective testing. The resistometer testing would typically be conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The ground truth for chemical indicators like this is typically established by the physical and chemical parameters of the sterilization cycle itself (achieving specific temperature, time, and steam conditions), and comparing the indicator's response to these measured parameters or to a biological indicator. There is no mention of human experts establishing ground truth in the context of interpreting the indicator's performance.
4. Adjudication Method for the Test Set
This information is not applicable or provided for this type of device. The determination of "PASS" or "FAIL" for the chemical integrator is based on the physical migration of the pellet into a "PASS" zone, which is a direct, observable, and objective outcome. There is no mention of human adjudication in interpreting the results of the performance tests.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices or imaging analysis where human readers interpret output. The Getinge Assured MI Steam Migrating Integrator is a chemical indicator that provides a direct visual result (pellet migration to "PASS" zone), not an output that requires human interpretation in the same way as an imaging study. There is no AI component involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a chemical indicator, not an algorithm. Its performance is inherent in its physical and chemical properties and its interaction with the sterilization parameters, not through an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for testing the Getinge Assured MI Steam Migrating Integrator is based on:
- Physical and chemical parameters of the sterilization cycle: Measured temperature, time, and steam conditions in a controlled setting (steam resistometer).
- Comparison to a biological indicator (BI): For the side-by-side testing, the performance of the chemical integrator is compared against a biological indicator, which is considered the gold standard for verifying sterilization efficacy. The ground truth is that sterilization conditions must be sufficient to inactivate the biological indicator.
8. The sample size for the training set
This information is not applicable as there is no "training set" for a chemical indicator. Chemical indicators are designed and manufactured based on established chemical and physical principles, not through machine learning or algorithm training.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set.
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