(83 days)
SporView® 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 operating at 121℃ and 132℃ gravity displacement, 132℃ flash gravity displacement and 121°C - 134°C prevacuum cycles.
The SPSmedical SporView® biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing Tryptic Soy Broth with Bromnocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SporView® Steam Self-Contained Biological Indicator:
This document describes a 510(k) premarket notification for a Class II medical device, a biological indicator used in sterilization. It focuses on demonstrating substantial equivalence to a predicate device, rather than a novel claim requiring extensive clinical trials or complex AI performance metrics. Therefore, many of the typical acceptance criteria and study details for AI/software devices (like expert adjudication, MRMC studies, or training set details) are not applicable here.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from "label claims and performance characteristics") | Reported Device Performance |
|---|---|---|
| Resistance | Met defined criteria for resistance to steam sterilization. | "All test results met the defined acceptance criteria." |
| Spore Population | Met defined criteria for the number of spores inoculated onto the carrier. | "All test results met the defined acceptance criteria." |
| Media Recovery in Extended Steam Sterilization Cycles | Met defined criteria for the ability of the media to recover spores after extended exposure. | "All test results met the defined acceptance criteria." |
| Effects of Holding Time | Met defined criteria for performance after various holding times. | "All test results met the defined acceptance criteria." |
| Reduced Incubation Period | Met defined criteria for performance within a reduced incubation timeframe. | "All test results met the defined acceptance criteria." |
| Stability of Color Change | Met defined criteria for the stability and clarity of the pH indicator's color change. | "All test results met the defined acceptance criteria." |
| Media Evaporation | Met defined criteria for minimal media evaporation. | "All test results met the defined acceptance criteria." |
| Effects of Carrier and Package Materials | Met defined criteria for the materials not adversely affecting performance. | "All test results met the defined acceptance criteria." |
| Equivalence to Predicate Device | Intended to monitor steam cycles from 121°C to 134°C, utilize same bacterial strain, same carrier material, virtually same media, similar size/shape, same activation, same incubation temperature. | "Supportive data has demonstrated that the SPSmedical SporView® Steam Self-Contained Biological Indicator is equivalent to the legally marketed predicate device." |
Note: The document states that "All test results met the defined acceptance criteria" generally, but does not provide specific numerical values for each criterion. The criteria listed above are inferred from the types of non-clinical testing performed to validate the device's label claims and performance characteristics.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for each specific test (e.g., number of indicators tested for resistance). It mentions "Multiple lots of indicators were tested."
- Sample Size: Not explicitly stated as a numerical value, but described as "Multiple lots of indicators."
- Data Provenance: The testing was "Non-Clinical Testing" performed by the manufacturer, SPSmedical Supply Corp., in the USA (Rush, NY). The document does not specify if the testing was retrospective or prospective, but given it's for a new product, it would inherently be prospective in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a biological indicator; its performance is measured against objective laboratory standards (e.g., spore count, resistance to sterilization, color change) rather than requiring expert interpretation like in image-based diagnostics.
4. Adjudication Method for the Test Set
Not applicable. The performance is determined by objective scientific measurements, not by human adjudication of ambiguous findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study is not relevant for a biological indicator device. It is designed to demonstrate equivalence through non-clinical laboratory testing, not to compare human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in essence. The documented testing (resistance, spore population, media recovery, etc.) is the standalone performance of the biological indicator itself, as it functions independently within the sterilization process. There is no "human-in-the-loop" component to its primary function or performance assessment.
7. The Type of Ground Truth Used
The ground truth for this device is based on established scientific principles and standards for biological indicators, including:
- Microbiological Standards: Known characteristics of Geobacillus stearothermophilus spores (e.g., population, D-value, Z-value).
- Sterilization Cycle Parameters: Objective measurements of temperature, pressure, and time in steam sterilization cycles.
- Chemical Indicators: The physical and chemical properties of the Tryptic Soy Broth with Bromnocresol Purple pH indicator, which changes color based on microbial growth.
- Regulatory Standards: Compliance with relevant FDA regulations (e.g., 21 CFR 880.2800) and consensus standards for biological indicators.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its function is based on biological and chemical reactions, not learned patterns from data.
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).