(166 days)
The STERRAD VELOCITY™ Biological Indicator, in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring STERRAD Sterilization Systems: · STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear™ Technology
• STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear™ Technology
· STERRAD® 100S
The STERRAD VELOCITY Biological Indicator is a self-contained biological indicator (BI), used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring of the STERRD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2℃.
The STERRAD VELOCITY BI can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple). When using this method, the biological indicator must be cultured in an incubator at 55-60°C for 5 to 7 days to get a final visual result.
The STERRAD VELOCITY BI consists of a glass fiber disc containing a minimum of 1 x 10° Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow with some red/orange/brown dots when exposed to hydrogen peroxide.
The STERRAD VELOCITY Reader is designed to automatically read the STERRAD VELOCITY BI to obtain the final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2℃. The STERRAD VELOCITY Reader utilizes the fluorometric enzymatic assay method to detect the enzyme activity from the BI and the fluorescence emitted from the BI is converted into a voltage. This voltage reading is then used by the fluorescence algorithm in the Reader to determine the final fluorescence result.
There are eight individual BI incubation wells in the STERRAD VELOCITY Reader. Its heater system is designed to maintain the biological indicators at 57 ± 2℃ to promote the outgrowth of the indicator organisms. Each well contains an ultraviolet light source that excites fluorescence in the growth medium, and a photodetector to detect that fluorescence.
The STERRAD VELOCITY Reader features a touch screen for an effective user interface. Directly under each well is a well number illuminated by a well status indicator light. Three colors (white, green, and red) and two states (off and solid line) are used for the indicator light on the touch screen to show the status of the BI processing. The Reader has a thermoplastic exterior which makes it easy to clean and maintain. A built-in barcode scanner coupled with network connectivity makes maintaining sterilization records easy.
The STERRAD VELOCITY BI and Reader have intended capability for "ecosystem" connectivity and integration. This system is intended to allow communication among STERRAD Sterilizers with ALLClear™ Technology.
Here's a breakdown of the acceptance criteria and study information for the STERRAD VELOCITY™ Biological Indicator and Reader based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Study Goal) | Reported Device Performance |
|---|---|---|
| STERRAD VELOCITY BI | ||
| Spore Population Determination | Verification of performance characteristics for spore population (Specific numerical acceptance not provided, implied to meet ISO standards). | Pass |
| D-value Determination | D-value at 5 mg/L hydrogen peroxide: ≥ 1 second, using two D-value methods (Survivor Curve and Fraction Negative) per ISO 11138-1. | Pass |
| Test Organism Characterization | Verification of Geobacillus stearothermophilus (ATCC 7953). | Pass |
| Reduced Incubation Time (RIT) Study | Verification of reduced incubation time: 30 minutes for fluorescence results and 5 to 7 days for spore growth results. | Pass (Successfully verified 30-minute RIT for fluorescence and 5-7 days for visual pH change) |
| Growth Inhibition Study | Verification that carrier and primary packaging materials do not have bacteriostatic effects that inhibit the growth of the indicator microorganism, Geobacillus stearothermophilus. | Pass |
| Holding Time Assessment | Verification that labeled holding time does not have adverse effects on the resistance characteristics for the BI growth results or the fluorescence response characteristics for the fluorescence results. | Pass |
| Chemical Indicator Functionality Study | Verification of functionality of the chemical indicator (CI) as a Type 1 process indicator. | Pass (Verified as a Type 1 process indicator) |
| BI Performance in STERRAD 100NX | Verification of performance in monitoring STERRAD 100NX STANDARD, FLEX, EXPRESS, and DUO Cycles. | Pass |
| BI Performance in STERRAD NX | Verification of performance in monitoring STERRAD NX STANDARD and ADVANCED Cycles. | Pass |
| BI Performance in STERRAD 100S | Verification of performance in monitoring STERRAD 100S Cycle. | Pass |
| Impact of ALLClear™ Technology | Verification that the load conditioning feature of the STERRAD 100NX and NX with ALLClear Technology has no statistically significant impact on the STERRAD VELOCITY BI. | Pass |
| Shelf Life Study (Real Time) | Verification that the STERRAD VELOCITY BI meets its end of shelf life requirements. | Pass (6 months shelf life) |
| STERRAD VELOCITY READER | ||
| Electrical Safety | Compliance with IEC/EN 61010-1:2010, IEC/EN 61010-2-010:2014, UL 61010-1:2012, UL 61010-2-010:2015, CAN/CSA-C22.2 No. 61010-1-12 (2012), CAN/CSA-22.2 No. 61010-2-010:15 (2015). | Electrically safe when operated and maintained according to user's guide, compliant with listed standards. |
| Electromagnetic Compatibility (EMC) | Compliance with Radiated and Conducted Emissions per US Code of Federal Regulations (CFR), Title 47, Part 15, Subpart B (Class A) (i.e., FCC Part 15, Subpart B; ICES-003; ANSI C63.4:2014). | Compliant for Radiated Emissions (Class A) and Conducted Emissions (Class A). |
| Software V&V | Unit, Integration, and System level testing successfully completed, adhering to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005." | Unit, Integration, and System level testing successfully completed; documentation provided to FDA. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (number of biological indicators or test runs) used for each individual performance test (e.g., D-value determination, RIT study, performance in various sterilizers). However, it implies that the testing was rigorous enough to satisfy the requirements of ISO 11138-1:2006 and FDA guidance.
The data provenance is retrospective, as these are non-clinical lab performance tests conducted by the manufacturer for regulatory submission. The country of origin of the data is not specified, but the manufacturer is Advanced Sterilization Products (ASP), located in Irvine, California, USA, suggesting the studies were likely conducted in the US or in facilities compliant with US standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
This information is not provided in the document. The "ground truth" for the biological indicator's performance is established by scientific methods for spore viability, resistance characteristics (D-value), enzyme activity, and growth inhibition, rather than expert interpretation of results. For electrical safety and EMC, the ground truth is established by adherence to recognized national and international standards by accredited testing bodies.
4. Adjudication Method for the Test Set
This information is not applicable/provided for these types of non-clinical laboratory performance studies. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation of medical images/data, where discrepancies between readers need to be resolved. The "results" of these tests (e.g., Pass/Fail, numerical measurements) are objectively determined by the methodology described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) and the AI's assistance to human readers is evaluated. The STERRAD VELOCITY™ Biological Indicator and Reader is a system for objectively monitoring sterilization processes, not a diagnostic tool requiring human interpretation for its primary function.
6. Standalone Performance
Yes, a standalone (algorithm only) performance was done. The entire suite of "Non-Clinical Data" presented details the performance of the STERRAD VELOCITY™ Biological Indicator and Reader system independently. The Reader's algorithm determines the final fluorescence result without human-in-the-loop interpretation for its primary function of determining BI positivity/negativity within 30 minutes. The BI's performance (spore population, D-value, RIT, etc.) is also evaluated systematically.
7. Type of Ground Truth Used
The ground truth used for the scientific performance testing of the Biological Indicator is based on objective scientific measurements and established microbiological and sterilization standards. This includes:
- Microbiological assays: For spore population determination, growth inhibition, and characterization of Geobacillus stearothermophilus.
- Sterilization kinetics: For D-value determination (using Holcomb-Spearman-Karber Procedure (HSKP) and Survivor Curve method as per ISO 11138-1).
- Enzymatic activity measurements: Fluorescence detection and its correlation to spore outgrowth.
- Physical and Chemical Testing: For chemical indicator functionality and real-time shelf life studies.
- Compliance with recognized standards: For electrical safety (e.g., IEC/EN 61010-1) and EMC (e.g., FCC Part 15, Subpart B).
8. Sample Size for the Training Set
The document does not contain information about a "training set" in the context of machine learning. The STERRAD VELOCITY™ Biological Indicator and Reader is not described as an AI/machine learning device that requires a training set in the conventional sense. Its "algorithm" is for fluorescence detection and conversion of voltage readings to positive/negative results, based on established biological and enzymatic principles, not necessarily learned from a large dataset. If there was any internal calibration or parameter setting, the details are not provided.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit mention of a "training set" for an AI/machine learning model as understood in typical AI device submissions, this information is not applicable and not provided in the document. The device's operational parameters and decision thresholds would have been established through a combination of scientific principles, engineering design, and empirical testing against known positive and negative controls.
§ 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).