(115 days)
Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes:
· Gravity-displacement Steam Sterilization Cycles
132 °C, 25 minutes
132 °C, 15 minutes
132 °C, 10 minutes
135 °C, 10 minutes
· Dynamic-air-removal Steam Sterilization Cycles
132 °C, 4 minutes
135 °C, 3 minutes
Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes:
· Gravity-displacement Steam Sterilization Cycles
132 °C, 25 minutes
132 °C, 15 minutes
132 °C, 10 minutes
135 °C, 10 minutes
· Dynamic-air-removal Steam Sterilization Cycles
132 °C. 4 minutes
135 °C. 3 minutes
Terragene® Bionova® Photon Auto-reader Incubator (BPH) incubates at 60°C and reads the Terragene® Bionova® Photon Biological Indicator (BT225) which is a 7-second readout Self-Contained Biological Indicator (SCBI) inoculated with a minimum of 106 viable Geobacillus stearothermophilus bacterial spores.
Bionova® Photon Process Challenge Devices consist of a disposable pre-assembled package as outlined in ANSI/AAMI ST79:2017 which contain a Bionova® Photon Biological Indicator (BT225), a Record Card and a chemical integrator that gives instant visible indication that sterilizing conditions have been reached. Each Bionova® Photon PCD consists of a stack of porous cards holding a Self-Contained Biological Indicator (SCBI) that contains a population of Geobacillus stearothermophilus ATCC®7953 spores on a carrier as well as growth indicator medium contained in a glass ampoule. Each SCBI has a process indicator on the label that changes from pink to brown when exposed to steam. These PCDs present a challenge to the sterilization process equivalent to the 16-towel process challenge device (PCD) recommended by the Associate for the Advancement of Medical Instrumentation (AAMI).
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Performance |
|---|---|---|
| Performance study comparison of Bionova® Photon Process Challenge Devices to the standalone biological and integrator indicators | Bionova® Photon Process Challenge Devices (PCD225-2 and PCD225-C) provide a greater challenge than the Bionova® Photon BT225 SCBI and Bionova® PCDBI-2-RC /Integron® IT26-C chemical integrator themselves. | Passed |
| Performance study comparison of Bionova® Photon Process Challenge Devices to the AAMI 16-Towel Test Pack | The response of Bionova® Photon BT225 SCBI and Bionova® PCDBI-2-RC /Integron® IT26-C chemical integrators inside the Bionova® Photon Process Challenge Devices (PCD225-2 and PCD225-C) should be equivalent to the performance of the same indicators in the 16-towel ANSI/AAMI ST79:2017 user-assembled test pack for steam sterilization processes. | Passed |
| Performance study of the chemical integrators in the Bionova® Photon Process Challenge Devices compared to AAMI reference biological indicator test packs | Chemical integrators within the Bionova® Photon PCD should show pass results under passing conditions while under failing conditions, the chemical integrators should show fail results. These results should be consistent with the outcome of the Bionova® Photon BT225 Biological Indicator within the standard test packs. | Passed |
| Performance study comparison of Bionova® Photon Process Challenge Devices to the predicate devices in claimed cycles | Bionova® Photon Process Challenge Devices (PCD225-2 and PCD225-C) should demonstrate equivalent performance to the Bionova® PCD224-2 and PCD224-C. | Passed |
| Performance Study for Bionova® Photon Process Challenge Devices in claimed cycles | Bionova® Photon Process Challenge Devices (PCD225-2 and PCD225-C) perform as intended in claimed cycles. | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (number of devices or test runs) used for each performance study. It only mentions "Performance study" in the test descriptions.
The data provenance is not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies are related to the performance of sterilization indicators and likely involve laboratory testing rather than human expert interpretation of results for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the studies involve objective physical and biological tests, not human interpretation that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a sterilization indicator, not a diagnostic imaging device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance tests of the device (Process Challenge Device and its components) in various sterilization cycle conditions. The device's performance (e.g., color change of chemical integrator, fluorescence of biological indicator) is directly observed and compared to established standards or other devices.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Established standards: Specifically, ANSI/AAMI ST79:2017 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities) for comparison against the 16-towel test pack.
- Known sterilization conditions: Labs would define "passing" and "failing" sterilization cycles for testing accuracy.
- Performance of predicate device: The predicate device (K191021) served as a benchmark for equivalent performance.
- Intrinsic BI and CI performance: The standalone biological and chemical indicators' known performance characteristics establish a baseline for comparison with the PCD.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical diagnostic tool (sterilization indicator), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is 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).