(100 days)
Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 10% Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.
Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.
Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow for CD42 to indicate that the conditions of the cycle have been met.
Terragene Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
The self-contained biological indicator and chemical processing indicators are intended for use with the STERLINK™ FPS-15s Plus when operating in chamber mode.
Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are singleuse Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier, and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT96 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. The Bionova® BT96 Biological Indicators have been designed for monitoring of Vaporized Hydrogen Peroxide sterilization processes when used in conjunction with Bionova® IC10/20FR, IC10/20FRLCD or MiniBio Auto-Readers Incubators.
Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.
Cintape® CT40 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper and plastic.
The provided text describes a 510(k) premarket notification for sterilization process indicators (biological and chemical) for use with a specific sterilizer. The study is a non-clinical performance test, and as such, several of the requested sections regarding AI/human reader performance, ground truth establishment, and training sets are not applicable.
Here's an analysis of the acceptance criteria and study as presented:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implicitly defined by the "Pass" result, meaning the device met the requirements of the referenced standard or guidance document. The actual quantitative thresholds for "Pass" are not detailed in this summary but would be specified within the referenced standards (e.g., ANSI/AAMI/ISO 11138-1:2017).
| Test Performed | Referenced Standard/Guidance | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Self-Contained Biological Indicator (BT96) | |||
| Viable spore population assay | ANSI/AAMI/ISO 11138-1:2017 | Met the requirements of the standard | Pass |
| Resistance characteristics study | ANSI/AAMI/ISO 11138-1:2017 | Met the requirements of the standard | Pass |
| Carrier and primary packaging materials evaluation | ANSI/AAMI/ISO 11138-1:2017 | Met the requirements of the standard | Pass |
| Holding time assessment | Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions | Met the requirements of the guidance | Pass |
| Reduced incubation time validation test | Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions | Met the requirements of the guidance | Pass |
| Recovery protocols: Recovery medium test | ANSI/AAMI/ISO 11138-1:2017 | Met the requirements of the standard | Pass |
| Visual readout stability: Visual inspection test | ANSI/AAMI/ISO 11138-1:2017 | Met the requirements of the standard | Pass |
| Shelf life study | ANSI/AAMI/ISO 11138-1:2017 | Met the requirements of the standard (Demonstrated 2 years) | 2 years |
| Resistance Validation for Biological Indicator | ISO 11138-1:2017 | Met the requirements of the standard | Pass |
| BI & Test Pack Validation | Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions | Met the requirements of the guidance | Pass |
| Chemical Indicator (CD42, CT40) | |||
| Performance characteristics obtained from resistometer | Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators / ANSI/AAMI/ISO 11140-1:2014 | Met the requirements of the guidance/standard | Pass |
| Biocompatibility | Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators / ANSI/AAMI/ISO 11140-1:2014 | Met the requirements of the guidance/standard | Pass |
| Endpoint stability | ANSI/AAMI/ISO 11140-1:2014 | Met the requirements of the standard | Pass |
| Shelf life study | Premarket Notification [510(k)] Submissions for Chemical Indicators | Met the requirements of the guidance (Demonstrated 5 years) | 5 years |
| Chemical Indicator Validation | ANSI/AAMI/ISO 11140-1:2014 | Met the requirements of the standard | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test. However, the tests are non-clinical, laboratory-based studies rather than human subject trials. The data provenance would be the laboratory where these tests were conducted, likely in South Korea (Plasmapp Co., Ltd. is based there, and Terragene® S.A. is the manufacturer). These studies are inherently prospective in nature as they involve testing the devices against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a non-clinical performance study of sterilization indicators, not a study evaluating human interpretation of medical images or diagnoses. The "ground truth" for these tests is defined by the physical or chemical standards and performance requirements outlined in the referenced ANSI/AAMI/ISO standards and FDA guidance documents.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method in this type of non-clinical performance testing. The tests yield objective, quantitative or qualitative results (e.g., spore kill, color change, D-value measurements) that are then compared against predefined criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This is a non-clinical performance study of sterilization process indicators, not a diagnostic device that would involve human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. The device itself (the biological and chemical indicators) is not an "algorithm" in the typical sense of AI. The performance tests evaluate the physical and chemical characteristics of the indicators in a standalone manner against the specified standards, without human intervention in the measurement of their performance (though human technicians certainly perform the tests).
7. The Type of Ground Truth Used
The ground truth used for these performance studies is based on established industry standards and regulatory guidance documents. Specifically:
- ANSI/AAMI/ISO 11138-1:2017: Sterilization of Health Care Products - Biological Indicators - Part 1: General Requirements.
- ANSI/AAMI/ISO 11140-1:2014: Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements.
- FDA Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions.
- FDA Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators.
These standards define the expected performance characteristics (e.g., spore population, resistance, color change properties, stability) that the devices must meet.
8. The Sample Size for the Training Set
Not applicable. This is a non-clinical performance study of physical devices, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI model, there is no training set and therefore no ground truth established for one. The "ground truth" for the device's acceptable performance is defined by the rigorous specifications and testing protocols within the aforementioned international standards and FDA guidance documents.
§ 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).