(178 days)
Not Found
No
The document describes a "fluorescence algorithm" used to interpret the signal from the biological indicator. While this is an algorithm, the description does not indicate the use of AI or ML techniques for its development or operation. The focus is on a direct correlation between enzyme activity and fluorescence, interpreted by a defined algorithm, not a learning system.
No
Explanation: This device is used for monitoring and testing sterilization systems, not for treating any medical condition or directly impacting patient health.
No
This device is intended for monitoring and testing sterilization systems, not for diagnosing medical conditions in patients. It assesses the effectiveness of a sterilization process, which is a quality control function.
No
The device description clearly details physical components like a biological indicator (BI) with a glass fiber disc, glass ampoule, vial, cap, and chemical indicator, as well as a STERRAD VELOCITY Reader which is a physical device with incubation wells, a heater system, UV light source, photodetector, touch screen, and barcode scanner. While software is mentioned as being modified, the core device is a hardware system.
Based on the provided text, the STERRAD VELOCITY® Biological Indicator/Process Challenge Device, in conjunction with the STERRAD VELOCITY Reader, is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "frequent monitoring and periodic testing of the following STERRAD Sterilization Systems". This involves testing the effectiveness of a sterilization process, which is a critical aspect of ensuring the safety of medical devices.
- Device Description: The device contains a biological indicator (spores) and a growth medium. The process involves exposing the biological indicator to the sterilization process and then incubating it to determine if the spores have been inactivated. This is a classic method for assessing the efficacy of sterilization, which falls under the scope of IVD devices used for quality control and monitoring in healthcare settings.
- Mechanism of Action: The device utilizes a biological and chemical reaction (spore outgrowth and enzymatic activity detected by fluorescence or pH change) to provide a result about the effectiveness of the sterilization process. This is an in vitro test, meaning it is performed outside of a living organism.
While the device doesn't directly diagnose a disease in a patient, it is used to monitor and validate a process (sterilization) that is essential for patient safety in a healthcare environment. Devices used for quality control and monitoring of processes related to patient care, especially those involving biological indicators and chemical reactions, are often classified as IVDs.
N/A
Intended Use / Indications for Use
STERRAD VELOCITY® Biological Indicator/Process Challenge Device, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the following 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
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The STERRAD VELOCITY Biological Indicator (BI) /Process Challenge Device (PCD) is a selfcontained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and periodic testing of the STERRAD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 15 minutes at the incubation temperature of 57 ± 2ºC.
The STERRAD VELOCITY BI/PCD can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple) if used for frequent monitoring purposes. 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/PCD consists of a glass fiber disc containing a minimum of 1 x 100 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 BI/PCD has the same a-glucosidase enzyme system for the fundamental scientific technology as the predicate device cleared under K182404. The a-glucosidase enzyme, which is generated naturally during growth of G. stearothermophilus and released during spore germination, hydrolyzes the bond between the glucose and 4-methylumbelliferyl (4-MU) moieties of 4methylumbelliferyl a-D-glucopyranoside (α-MUG). In the combined state, α-MUG is not fluorescent. Once the bond between the glucose and 4-MU is hydrolyzed, the 4-MU component becomes fluorescent when excited with UV light. Therefore, the a-glucosidase enzyme in its active state can be detected by measuring the fluorescence produced by the enzymatic hydrolysis of a-MUG.
The resultant fluorescent by-product (4-MU), is detected by the Reader and the fluorescent signal is used to determine the positive or negative result of the biological indicator. The measured enzyme activity is reduced upon exposure to hydrogen peroxide. As the enzyme activity is directly correlated with the spore outgrowth, the reduction of the enzyme activity below a certain level indicates that all spores have been inactivated. The level of the fluorescence response is determined using the algorithm developed for the STERRAD VELOCITY BI/PCD and is used to distinguish between the positive and negative responses.
The STERRAD VELOCITY Reader is designed to automatically read the STERRAD VELOCITY BI/PCD to obtain the final fluorescence result in 15 minutes at the incubation temperature of 57 ± 2℃. The STERRAD VELOCITY Reader utilizes the fluorometric 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 Reader of the subject device has the same hardware and uses same fundamental scientific technology as the predicate device cleared under K182404. Only the algorithm for fluorescence reading has been modified in the subject device to reduce the fluorescence readout time from 30 minutes to 15 minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification testing was conducted in support of the modification to the STERRAD VELOCITY BIPCD and Reader that is the subject of this submission; all testing yielded passing results.
Performance Testing: Hydrogen Peroxide Dose Response and Sterilization Verification
Description: The fluorescence results collected for previously submitted dose response testing were reanalyzed using the modified algorithm. No additional sterilization cycles were performed.
Acceptance Criteria: General trend of increasing number of sterile BIs (growth and fluorescence) with increasing hydrogen peroxide injection volume. All BIs negative for fluorescence and growth at full cycle.
Results: Pass
Performance Testing: Design evaluation and Performance Qualification for Periodic Testing
Description: The fluorescence results collected for the previously submitted dose response testing were reanalyzed using the modified algorithm and compared with the biological model data. No additional sterilization cycles were performed.
Acceptance Criteria: Fluorescence results demonstrate equal or greater resistance to the biological model by comparison of BI complete inactivation points. The BI shall demonstrate all fluorescence-negative results in full cycle
Results: Pass
Performance Testing: Verification of Reduced Incubation Time
Description: The fluorescence data collected for the previously submitted reduced incubation time verification study were reanalyzed using the modified algorithm and compared to the 7-day incubation spore growth results from the same study. No additional sterilization cycles were performed.
Acceptance Criteria: BI fluorescence-positive for greater than 97.0% of all growth-positive BIs.
Results: Pass
Performance Testing: Verification of BI Holding Time
Description: The fluorescence data collected for the previously submitted holding time verification study were reanalyzed using the modified algorithm. No additional sterilization cycles were performed.
Acceptance Criteria: The number of fluorescence-positive BIs after 2 hours of holding time is not less than the number of fluorescence-positive BIs read immediately after exposure to H2O2.
Results: Pass
Performance Testing: System Level Error Check
Description: This study verified that the STERRAD VELOCITY Reader with the modified software algorithm meets the system level error check performance requirements as defined in the product design specification and system requirements for the STERRAD VELOCITY Reader.
Acceptance Criteria: The reader shall accurately interrogate the BI or provide an error message to alert the user when the BI is subject to rotational movement or handling.
Results: Pass
Performance Testing: Operational Vibration
Description: This study verified that the STERRAD VELOCITY Reader with the proposed algorithm continues to meet the requirements for operational vibration as defined in the product design specification and system requirements for the STERRAD VELOCITY Reader.
Acceptance Criteria: The reader shall accurately interrogate the BI when subjected to random vibration per C-S 1-9711-002 in the 3 orthogonal axes for the entire incubation cycle.
Results: Pass
Performance Testing: Software Verification and Validation
Description: STERRAD VELOCITY Reader Software Verification and Validation, including Cybersecurity Testing
Acceptance Criteria: The modified software meets specifications and functions correctly for the product's intended use.
Results: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
STERRAD VELOCITY Biological Indicator, K182404
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
January 23, 2020
Advanced Sterilization Products (ASP) Elsie Kim Sr. Regulatory Affairs Program Lead 33 Technology Drive Irvine, California 92618
Re: K192025
Trade/Device Name: STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: December 20, 2019 Received: December 23, 2019
Dear Elsie Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Sreekanth Gutala, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192025
Device Name
STERRAD VELOCITY® Biological Indicator/Process Challenge Device and Reader
Indications for Use (Describe)
STERRAD VELOCITY® Biological Indicator/Process Challenge Device, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the following 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
| . | Comprehensive and consisted and the commended to the commendent of the commendent of the commendent of concession of consistences and | STATUTION CONSULTION CONSULTION CONSULTION COLLEGION COLLECTION COLLECTION COLLECTION COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION | |
|---|---|---|---|
| Type of Use (Select one or both, as applicable) |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K192025 510(k) Summary
Advanced Sterilization Products, Inc. STERRAD VELOCITY® Biological Indicator/Process Challenge Device and Reader
This summary of 510(k) information is being submitted per 21 CFR 807.92.
General Information
| Submitter Name: | Advanced Sterilization Products |
|---|---|
| Address | 33 Technology Drive, |
| Irvine, CA 92618 | |
| Contact Person: | Elsie Kim |
| Sr. Regulatory Affairs Program Lead | |
| Phone: 949-932-4234 | |
| Email: elsie.kim@asp.com |
Date Prepared: January 22, 2020
Device Name
| Proprietary Name: | STERRAD VELOCITY® Biological Indicator/Process Challenge Device and
Reader |
|----------------------|-------------------------------------------------------------------------------|
| Common Name: | Biological Indicator |
| Classification Name: | Biological Sterilization Process Indicator |
| Device Class: | Class II |
| Product Code: | FRC |
| CFR Section: | 21 CFR 880.2800 |
Predicate Device
Predicate Device: STERRAD VELOCITY Biological Indicator, K182404 cleared December 27, 2018
Description
STERRAD VELOCITY Biological Indicator/Process Challenge Device
The STERRAD VELOCITY Biological Indicator (BI) /Process Challenge Device (PCD) is a selfcontained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and periodic testing of the STERRAD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 15 minutes at the incubation temperature of 57 ± 2ºC.
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The STERRAD VELOCITY BI/PCD can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple) if used for frequent monitoring purposes. 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/PCD consists of a glass fiber disc containing a minimum of 1 x 100 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 BI/PCD has the same a-glucosidase enzyme system for the fundamental scientific technology as the predicate device cleared under K182404. The a-glucosidase enzyme, which is generated naturally during growth of G. stearothermophilus and released during spore germination, hydrolyzes the bond between the glucose and 4-methylumbelliferyl (4-MU) moieties of 4methylumbelliferyl a-D-glucopyranoside (α-MUG). In the combined state, α-MUG is not fluorescent. Once the bond between the glucose and 4-MU is hydrolyzed, the 4-MU component becomes fluorescent when excited with UV light. Therefore, the a-glucosidase enzyme in its active state can be detected by measuring the fluorescence produced by the enzymatic hydrolysis of a-MUG.
The resultant fluorescent by-product (4-MU), is detected by the Reader and the fluorescent signal is used to determine the positive or negative result of the biological indicator. The measured enzyme activity is reduced upon exposure to hydrogen peroxide. As the enzyme activity is directly correlated with the spore outgrowth, the reduction of the enzyme activity below a certain level indicates that all spores have been inactivated. The level of the fluorescence response is determined using the algorithm developed for the STERRAD VELOCITY BI/PCD and is used to distinguish between the positive and negative responses.
STERRAD VELOCITY READER
The STERRAD VELOCITY Reader is designed to automatically read the STERRAD VELOCITY BI/PCD to obtain the final fluorescence result in 15 minutes at the incubation temperature of 57 ± 2℃. The STERRAD VELOCITY Reader utilizes the fluorometric 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 Reader of the subject device has the same hardware and uses same fundamental scientific technology as the predicate device cleared under K182404. Only the algorithm for
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fluorescence reading has been modified in the subject device to reduce the fluorescence readout time from 30 minutes to 15 minutes.
Intended Use/Indications for Use
The STERRAD VELOCITY® Biological Indicator/Process Challenge Device, in conjunction with the STERRAD VELOCITY® Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the following 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 intended use of the modified device, as described in the labeling, has not changed as a result of the modification which is the subject of this submission.
The name of the device is changed from STERRAD VELOCITY Biological Indicator to STERRAD VELOCITY Biological Indicator/Process Challenge Device (or BIPCD) as the periodic testing indication was cleared for the predicate device under K182404.
Comparison of Technological Characteristics with Predicate Device
The modified device and predicate device have the same technological characteristics based on their use in the monitoring of hydrogen peroxide gas plasma sterilization processes. Refer to the following table for a comparison of the modified device and predicate device characteristics, showing the similarities and differences.
| Predicate Device | Subject Device | |
|---|---|---|
| Device | ||
| Characteristics | STERRAD VELOCITY BI | |
| (K182404) and Reader | STERRAD VELOCITY BI/PCD and | |
| Reader with 15-minute fluorescence | ||
| readout | ||
| Intended Use | Monitoring of hydrogen peroxide gas plasma | |
| sterilization processes | Same | |
| Indications for Use | Used as a standard method for frequent | |
| monitoring and periodic testing of the following | ||
| 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 | Same | |
| Organism | ||
| (Spore, Species, | ||
| Strain) | Geobacillus stearothermophilus | |
| ATCC 7953 | Same | |
| Predicate Device | Subject Device | |
| Device | ||
| Characteristics | STERRAD VELOCITY BI | |
| (K182404) and Reader | STERRAD VELOCITY BI/PCD and | |
| Reader with 15-minute fluorescence | ||
| readout | ||
| Viable Spore | ||
| Population | $\ge$ 1x106 CFU/BI | Same |
| Carrier Material | Glass Fiber | Same |
| Device Design | Self-contained biological indicator | Same |
| Resistance | ||
| Characteristics | Tested at 5 mg/L hydrogen peroxide: | |
| D-value 5mg/L: ≥ 1 second, using two D-value | ||
| methods (Survivor Curve and Fraction | ||
| Negative) per ISO 11138-1. | ||
| Equal to or greater than the most difficult item | ||
| routinely processed (biological model). | Same | |
| Rapid Readout | ||
| Technology | The α-glucosidase enzyme system is generated | |
| naturally during growth of Geobacillus | ||
| stearothermophilus. The α-glucosidase enzyme | ||
| in its active state is detected by measuring the | ||
| fluorescence produced by the enzymatic | ||
| hydrolysis of a non-fluorescent substrate. The | ||
| resultant fluorescent by-product is detected in the | ||
| reader. The fluorescence signal is used to | ||
| determine a positive or negative result. | Same | |
| Incubation | ||
| Temperature | 57 +/- 2°C | Same |
| Reduced | ||
| Incubation Time | 30-minute fluorescence results read in | |
| STERRAD VELOCITY Reader and optional | ||
| visual pH color change results at 5 to 7 days. | 15-minute fluorescence results read in | |
| STERRAD VELOCITY Reader and | ||
| optional visual pH color change results at 5 | ||
| to 7 days. | ||
| Holding Time | Within 2 hours after sterilization cycle | Same |
| Carrier growth | ||
| inhibition/media | ||
| growth promotion | No bacteriostatic effects that inhibit the growth | |
| of the indicator microorganism | Same | |
| Chemical Indicator | Type 1 process indicator changes color from | |
| red/pink to yellow or yellow with some | ||
| red/orange/brown dots to indicate exposure to | ||
| hydrogen peroxide. | Same | |
| Shelf Life | 9 months | Same |
| Method of | ||
| Fluorescence | ||
| Detection | UV LED, optical filters, with sensing by | |
| photodiode | Same | |
| Indicator of | ||
| Adequate | ||
| Sterilization Cycle | "Negative" displayed on LCD Display | Same |
| Indicators of | ||
| Possible | ||
| Sterilization Cycle | ||
| Failure | "Positive" displayed on LCD Display, Audible | |
| Alarm | Same | |
| Incubation Wells | 8 incubation/reader wells | Same |
| Predicate Device | Subject Device | |
| Device | STERRAD VELOCITY BI | STERRAD VELOCITY BI/PCD and |
| Reader with 15-minute fluorescence | ||
| Characteristics | (K182404) and Reader | readout |
| Voltage Range | 100-240 Volts AC (12 Volt DC conversion for | |
| internal circuitry) | Same | |
| Product Safety | UL/IEC 61010-1 | Same |
| EMC Compliance | FCC Part 15, Subpart B, Class A | Same |
Technological Characteristic Comparison Table
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The modified device and its predicate device have the same intended use and indications for use.
The sole difference between the predicate and modified device relates to the decreased time to read, associated with an update to the Reader to include a 15-minute fluorescence readout algorithm. The modified and predicate devices have identical technological characteristics.
Summarv of Non-Clinical Testing
Verification testing was conducted in support of the modification to the STERRAD VELOCITY BIPCD and Reader that is the subject of this submission; all testing yielded passing results. This testing is summarized in the following table.
| Performance Testing | Description | Acceptance Criteria | Pass/Fail |
|---|---|---|---|
| Hydrogen Peroxide Dose | |||
| Response and Sterilization | |||
| Verification | The fluorescence results collected | ||
| for previously submitted dose | |||
| response testing were reanalyzed | |||
| using the modified algorithm. No | |||
| additional sterilization cycles were | |||
| performed. | General trend of increasing | ||
| number of sterile BIs (growth and | |||
| fluorescence) with increasing | |||
| hydrogen peroxide injection | |||
| volume. All BIs negative for | |||
| fluorescence and growth at full | |||
| cycle. | Pass | ||
| Design evaluation and | |||
| Performance Qualification | |||
| for Periodic Testing | The fluorescence results collected | ||
| for the previously submitted dose | |||
| response testing were reanalyzed | |||
| using the modified algorithm and | |||
| compared with the biological model | |||
| data. No additional sterilization | |||
| cycles were performed. | Fluorescence results demonstrate | ||
| equal or greater resistance to the | |||
| biological model by comparison | |||
| of BI complete inactivation points. | |||
| The BI shall demonstrate all | |||
| fluorescence-negative results in | |||
| full cycle | Pass | ||
| Verification of Reduced | |||
| Incubation Time | The fluorescence data collected | ||
| for the previously submitted | |||
| reduced incubation time | |||
| verification study were | |||
| reanalyzed using the modified | |||
| algorithm and compared to the 7- | |||
| day incubation spore growth | |||
| results from the same study. No | |||
| additional sterilization cycles | |||
| were performed. | BI fluorescence-positive for | ||
| greater than 97.0% of all growth- | |||
| positive BIs. | Pass |
Summary of Non-Clinical Testing
8
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| Performance Testing | Description | Acceptance Criteria | Pass/Fail |
|---|---|---|---|
| Verification of BI Holding | |||
| Time | The fluorescence data | ||
| collected for the previously | |||
| submitted holding time | |||
| verification study were | |||
| reanalyzed using the | |||
| modified algorithm. No | |||
| additional sterilization | |||
| cycles were performed. | The number of fluorescence- | ||
| positive BIs after 2 hours of | |||
| holding time is not less than the | |||
| number of fluorescence-positive | |||
| BIs read immediately after | |||
| exposure to H2O2. | Pass | ||
| System Level Error Check | This study verified that the | ||
| STERRAD VELOCITY Reader | |||
| with the modified software | |||
| algorithm meets the system level | |||
| error check performance | |||
| requirements as defined in the | |||
| product design | |||
| specification and system | |||
| requirements for the | |||
| STERRAD VELOCITY | |||
| Reader. | The reader shall accurately | ||
| interrogate the BI or provide an | |||
| error message to alert the user | |||
| when the BI is subject to rotational | |||
| movement or handling. | Pass | ||
| Operational Vibration | This study verified that the | ||
| STERRAD VELOCITY Reader | |||
| with the proposed algorithm | |||
| continues to meet the | |||
| requirements for operational | |||
| vibration as defined in the | |||
| product design specification and | |||
| system requirements for the | |||
| STERRAD VELOCITY Reader. | The reader shall accurately | ||
| interrogate the BI when subjected | |||
| to random vibration per C-S 1- | |||
| 9711-002 in the 3 orthogonal axes | |||
| for the entire incubation cycle. | Pass | ||
| Software Verification and | |||
| Validation | STERRAD VELOCITY Reader | ||
| Software Verification and | |||
| Validation, including | |||
| Cybersecurity Testing | The modified software meets | ||
| specifications and functions | |||
| correctly for the product's | |||
| intended use. | Pass |
Clinical Data
No clinical data was generated in support of this Premarket Notification.
Conclusions
The conclusions drawn from the performance tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device STERRAD VELOCITY Biological Indicator (K182404).