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510(k) Data Aggregation
(276 days)
SPSmedical Supply Corp. A Division of Cantel Medical
The SporView® VH2O2 BI is a self-contained biological indicator intended for use in the following STERRAD® sterilization system:
• STERRAD® 100NX® (Standard Cycle)
The SporView® VH2O2 Bl is a self-contained biological indicator (SCBI) designed to monitor hydrogen peroxide sterilization efficacy in healthcare facilities, specifically within a STERRAD® 100NX® Standard Cycle. Each unit consists of a glass fiber disc inoculated with a minimum of 10° spores of Geobacillus stearothermophilus ATCC® 7953 and a hermetically sealed glass ampoule of modified growth medium, both contained within a polypropylene vial with a polypropylene filter lined within the top of a polypropylene cap. A chemical process indicator on the vial label allows for differentiation between processed and unprocessed units. Following exposure to the sterilization cycle, the Bl is activated by squeezing the sides of the vial, causing the media ampoule to break and immerse the inoculated carrier in growth medium. The Bl is then incubated at 55 - 60°C for 24 hours. The growth medium, comprised of soybean casein digest broth modified with bromocresol purple (a pH indicator), remains purple and free of turbidity if the sterilization cycle was effective. Spore growth produces acidic waste (carbonic acid) which causes a shift down in pH (acidic) within the growth medium, transitioning the media from a purple to a yellow color and/or exhibiting turbidity which both indicate a failed sterilization cycle.
The provided document describes the SporView® VH2O2 BI, a self-contained biological indicator designed to monitor hydrogen peroxide sterilization. The document presents performance data to demonstrate the device's substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance
| Study Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Spore Population | Assay to demonstrate spore population of the BI meets specification of ≥1.0 x 10^6. | Pass |
| D Value Determination | Assessment to demonstrate subject device meets the D value specification of ≥1 second. | Pass |
| Survival and Kill Response | Assessment to demonstrate the subject device meets the survival specification of ≥ 6 seconds and the kill specification of ≤ 6 minutes. | Pass |
| Effect of Holding Time | Evaluation of 24 hour holding time prior to incubation on resistance characteristics of subject BI. Holding time resistance characteristics met the D value specification and were equivalent to the original resistance characteristics. | Pass |
| Reduced Incubation Time | Determination of the minimum incubation time for the subject device. Subject device exhibited 30% to 80% growth following partial cycle exposure, resulted in a ≥97% correlation between the results observed at 24 hours and the results observed at seven days for a reduced incubation time of 24 hours. | Pass |
| Verification of Growth Media Color Change | Assessment to verify stability of growth media color change. Subject device growth media exhibited a color change to yellow, which did not revert to the original color of purple following incubation. | Pass |
| Suitability of Carrier and Primary Packaging Materials | Suitability testing of carrier and primary packaging materials of the subject device. Carrier and primary packaging material did not absorb sterilant or show degradative effects when exposed to worst case cycle conditions. | Pass |
| Shelf Life Testing | Verification of subject device's performance characteristics (spore population, D value, survival and kill response, RIT, and media color change stability) for 9 month labeled product shelf life. | Pass |
| Sterilization Cycle Performance Validation | Simulated use test to demonstrate no growth of subject device after exposure to half and full sterilization cycles under worst case conditions. | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., spore population, D value, survival/kill response). However, it implies that sufficient samples were tested to demonstrate compliance with the defined acceptance criteria.
The data provenance is from nonclinical tests performed by the manufacturer, Crosstex/SPSmedical. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's a submission to the FDA for a new device, the testing would generally be prospective and conducted under controlled laboratory conditions.
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. For biological indicators, the "ground truth" is typically established by the inherent biological and chemical properties of the spores and growth media, as measured by established laboratory standards and protocols, rather than expert human interpretation of results in the same way medical imaging might require. The "experts" would be the scientists and technicians conducting the tests according to standardized methods.
4. Adjudication method for the test set
This information is not applicable in the conventional sense. The "adjudication" is based on the objective measurement of biological and chemical parameters (e.g., spore count, D-value, color change) against predefined specifications. There is no mention of human-expert adjudication of results as would be found in diagnostic studies.
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
An MRMC comparative effectiveness study was not performed. This type of study is typically relevant for medical imaging or diagnostic devices where human readers (e.g., radiologists) interpret results, and the device might offer AI assistance. Biological indicators for sterilization assurance do not involve human "readers" interpreting complex results from the device itself in a clinical diagnostic setting.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to this device. The SporView® VH2O2 BI is a physical biological indicator that provides a visual output (color change or turbidity). Its performance is inherently "standalone" in that it functions without a human actively making a diagnostic interpretation based on complex data. The human interaction is limited to observing the physical change and interpreting its meaning based on the device's design (purple = sterile, yellow = not sterile). There is no "algorithm" in the sense of software processing data for a diagnostic outcome.
7. The type of ground truth used
The ground truth used is primarily objective laboratory data derived from standardized biological and chemical assays. This includes:
- Spore population counts: Direct measurement of the number of viable spores.
- Survival/Kill Response: Observation of spore viability after exposure to specific sterilization parameters for defined periods (absence or presence of growth).
- D-value determination: A measure of the resistance of the spores to the sterilizing agent, calculated from experimental data.
- Growth media color change: A direct chemical indicator of metabolic activity (spore growth).
- Stability and material suitability testing: Physical chemistry and material science tests.
This ground truth is established through rigorous, controlled laboratory experiments adhering to industry standards for biological indicator testing.
8. The sample size for the training set
This information is not applicable as the SporView® VH2O2 BI is not an AI/machine learning device that requires a training set. Its performance is based on its inherent biological and chemical properties, not learned patterns from data.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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