(503 days)
SporView 10 Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes. SporView 10 self-contained biological indicators have a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles:
| Sterilization Mode | Temperature | Time |
|---|---|---|
| Gravity | 121°C | 30 minutes |
| Gravity | 132°C | 15 minutes |
| Gravity | 134°C | 4 minutes |
| Gravity - Flash | 132°C | 3 minutes |
| Gravity - Flash | 132°C | 10 minutes |
| Dynamic Air | 121°C | 20 minutes |
| Dynamic Air | 121°C | 30 minutes |
| Dynamic Air | 132°C | 3 minutes |
| Dynamic Air | 132°C | 4 minutes |
| Dynamic Air | 134°C | 4 minutes |
| Dynamic Air | 135°C | 3 minutes |
The SporView 10 Self Contained Steam BI (SCBI) consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carier and a small glass ampoule containing a nutrient broth culture medium containing bromocresol purple as a pH indicator encased in a plastic vial that serves as the culture tube. Biochemical activity of the G. stearothermophilus organism produces acid by-products that cause the media to change color from purple to yellow. A visual pH color change and/or turbidity indicates' a steam sterilization process failure.
SporView® 10 SCBI's are conventional spore growth readout biological indicators specifically designed for rapid and reliable monitoring of steam sterilization processes without the use of enzyme based technology or specific and specialized incubators or monitoring devices.
The provided text describes the 510(k) summary for the SporView® 10 Steam Self Contained Biological Indicator. Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All lots met the FDA's defined acceptance criteria of >97% for a reduced incubation time of 10 hours | Multiple lots of indicators and media were tested, and all lots met this criterion. |
| Resistance | All test results met the defined acceptance criteria. |
| Spore population | All test results met the defined acceptance criteria. |
| Effects of holding time | All test results met the defined acceptance criteria. |
| Stability of the color change | All test results met the defined acceptance criteria. |
| Media Evaporation | All test results met the defined acceptance criteria. |
| Survival Response Time | All test results met the defined acceptance criteria. |
| Effects of carrier and package materials | All test results met the defined acceptance criteria. |
| Media recovery after exposure to a steam cycle of 132°C for 10 minutes | All test results met the defined acceptance criteria. |
| Compliance with ANSVAAMI/SO 11138-1 and ANSVAAMI/ISO 11138-3:2010 | SporView® 10 SCBI's comply with these performance requirements. |
| Compliance with USP requirements for SCBI's | SporView® 10 SCBI's comply with these requirements. |
| Compliance with FDA's Biological Indicator guidance document on Premarket Notification 510(k) Submissions | SporView® 10 SCBI's comply with this document. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Multiple lots of indicators and media were tested" and "Multiple lots of indicators were tested". Specific numerical sample sizes (e.g., number of indicators per lot, number of media samples) are not provided.
- Data Provenance: The testing was performed by SPSmedical Supply Corp. based in Rush, NY, U.S.A. The studies are described as "Non-Clinical Testing" and "Testing was performed in order to validate the indicators label claims and performance characteristics according to the reduced incubation time protocol described in the FDA guidance document". This suggests the tests were conducted in vitro or in a lab setting, not necessarily with human subjects. The details provided are insufficient to determine if the data is retrospective or prospective in the traditional clinical sense, but it is prospective in terms of testing newly manufactured lots.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This type of information is not applicable to this device. The device is a biological indicator for sterilization processes. The ground truth for its performance is established through objective biological and physical testing according to international standards (ANSVAAMI/SO, USP) and FDA guidance, not through expert human interpretation or consensus.
4. Adjudication Method for the Test Set
- This type of information is not applicable to this device. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or test results where ambiguity might exist. For a biological indicator, the "result" (color change, spore growth) is objectively determined.
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
- This type of information is not applicable to this device. MRMC studies are relevant for devices that involve human interpretation of data, often with AI assistance (e.g., AI for radiology). This device is a standalone biological assay.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the described testing is akin to a standalone performance evaluation. The device (biological indicator) is designed to provide an objective result (color change or turbidity indicating sterilization failure) without human interpretation beyond observing the outcome. The testing validates the device's inherent performance characteristics based on biological and chemical principles.
7. The Type of Ground Truth Used
- The ground truth is established through objective biological and chemical principles as defined by international standards (ANSVAAMI/SO 11138-1 and ANSVAAMI/ISO 11138-3:2010), USP requirements, and FDA guidance for biological indicators. This involves measuring parameters like spore population, resistance, and the ability of the media to promote growth or indicate failure after specific sterilization challenges. It is not based on expert consensus, pathology, or outcomes data in the clinical patient sense.
8. The Sample Size for the Training Set
- This type of information is not applicable in the context of this device. The SporView® 10 Steam Self Contained Biological Indicator is a physically manufactured product, not an AI/ML algorithm that requires a "training set" in the computational sense. The "development" and "validation" of the device are based on traditional scientific testing and optimization of its components (spores, media, carrier, etc.).
9. How the Ground Truth for the Training Set was Established
- This type of information is not applicable as there is no "training set" for this biological indicator device in the context of AI/ML development. The "ground truth" for the device's performance characteristics is established through adherence to recognized international and regulatory standards for biological indicators.
§ 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).