(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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2017
Advanced Sterilization Products (asp) Sun Choi Senior Regulatory Affairs Program Lead 33 Technology Drive Irvine, California 92618
Re: K170039
Trade/Device Name: STERRAD VELOCITY™ Biological Indicator and Reader Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: May 19, 2017 Received: May 22, 2017
Dear Sun Choi:
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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Lori A. Wiggins -S6
Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170039
Device Name
STERRAD VELOCITY™ Biological Indicator and Reader
Indications for Use (Describe)
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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Registration Use (Part 81 CFR 801 Subpart D) On-The-Spot Use (81 CFR 801 Subpart G) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows a logo with the letters "ASP" in a stylized font. The letters are white and are set against a rounded, light blue background. There is a registered trademark symbol in the upper right corner of the logo.
510(k) Summary
Advanced Sterilization Products STERRAD VELOCITY™ Biological Indicator and Reader
General Information
| Submitter Name: | Advanced Sterilization ProductsDivision of Ethicon, Inc., a Johnson & Johnson company |
|---|---|
| Address: | 33 Technology DriveIrvine, CA 92618 |
| Contact Person: | Sun ChoiSenior Regulatory Affairs Program LeadPhone: 949-453-6378Email: sjchoi@its.jnj.com |
| Date Prepared: | June 8, 2017 |
| 510(k) Number: | K170039 |
Device Name
| Proprietary Name: | STERRAD VELOCITY™ Biological Indicator 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 Devices
- Primary Predicate: ● STERRAD® CYCLESURE® 24 Biological Indicator, K151971 cleared October 29, 2015
- 3M Attest™ Rapid Readout Biological Indicator 1295 and 3M Attest™ Auto-Reader 490H, K140392 cleared August 13, 2014, and K152060 cleared December 1, 2015
Device Description
STERRAD VELOCITY BIOLOGICAL INDICATOR
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℃.
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Image /page/4/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and are set against a blue-green background. The logo is enclosed in a rounded rectangle shape, and there is a small registered trademark symbol in the upper right corner.
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 BI has the same α-glucosidase enzyme system for the fundamental scientific technology as the predicate device, 3M Attest™ Rapid Readout Biological Indicator 1295. 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 4methylumbelliferyl (4-MU) moieties of 4-methylumbelliferyl a-D-glucopyranoside (a-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 α-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 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 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.
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Image /page/5/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and outlined in a thin white line, set against a light blue background. The logo is enclosed in a rounded rectangle shape, and there is a small circled "R" symbol in the upper right corner, indicating a registered trademark.
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.
Intended Use/Indications for Use
The STERRAD VELOCITY Biological Indicator, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring 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 indications for use statement for the STERRAD VELOCITY Biological Indicator and Reader is identical to those of the predicate devices with minor exceptions related to the inclusion of the recently cleared STERRAD ALLClear Technology, and removal of obsoleted STERRAD 50 and 200 Sterilizers.
These exceptions do not affect the safety and effectiveness of the subject device relative to its predicates. Both the subject and predicate devices share intended use for monitoring of hydrogen peroxide gas plasma sterilization processes.
Comparison of Technological Characteristics with Predicate Device
The subject and predicate devices have technological characteristics based on their use in the monitoring of hydrogen peroxide gas plasma sterilization processes. The following technological characteristics are the same for both the subject device and predicate devices:
- . BI design: Self-contained biological indicator
- . Test organism: Geobacillus stearothermophilus (ATCC 7953)
- Viable spore population: ≥ 106 CFU/BI ●
- . Rapid readout technology: The a-glucosidase enzyme, generated naturally during growth of Geobacillus stearothermophilus, is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate (α-MUG). The resultant fluorescent byproduct (4-MU) is detected in the reader and the fluorescence signal is used to determine a positive or negative BI result.
- Carrier material for spore disc: Glass fiber ●
- . Materials used for BI components (vial, cap, and insert): Transparent thermoplastic polymer for vial and insert, and opaque thermoplastic polymer for cap
- . Method of fluorescence detection: UV LED, optical filters, with sensing by photodiode
Some technological differences exist between the subject and predicate devices as listed below. However, these differences were successfully assessed through performance testing and do not raise any questions of safety and effectiveness. Therefore, the subject device is as safe and effective as the predicate devices.
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Image /page/6/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and are set against a light blue background. The logo is enclosed in a rounded rectangle shape. There is a registered trademark symbol in the upper right corner of the logo.
- . Resistance characteristics: The use of 5 mg/L hydrogen peroxide that is within the range used for the two predicates (2.5 mg/L and 10 mg/L); and the choice of two out of three recommended test methods as specified in ISO 11138-1:2006, Section 6.4.1.
- Incubation temperature: The temperatures used by the subject and predicate devices are within the temperature range of the optimal growth of test organism, Geobacillus stearothermophilus (ATCC 7953).
- . Reduced incubation time (RIT): The RIT of the subject device (30 minutes) has been successfully verified through performance testing.
- Chemical indicator: The chemical indicator for the subject device has been verified to be a . Type 1 process indicator through performance testing.
Refer to the following Table for a comparison of predicate and proposed device characteristics.
| Predicate Devices | Subject device | ||
|---|---|---|---|
| Device Characteristics | 3M Attest™ Rapid ReadoutBiological Indicator 1295(K140392 and K152060) | STERRADCYCLESURE 24 BI(K151971) | STERRADVELOCITY BI |
| Intended Use | Same as STERRADCYCLESURE 24 BI | Monitoring of hydrogen peroxidegas plasma sterilization processes | Same as STERRADCYCLESURE 24 BI |
| Indications for Use | Used in conjunction with the 3MAttest Auto-Reader 490H as astandard method of routinemonitoring of vaporized hydrogenperoxide sterilization processesin:• STERRAD 100S• STERRAD NX(STANDARD andADVANCED Cycles)• STERRAD 100NX(STANDARD, FLEX,EXPRESS and DUO Cycles) | Used as a standard method forfrequent monitoring of thefollowing STERRADSterilization Systems and hasbeen validated for use in healthcare facilities:• STERRAD 100S• STERRAD 50• STERRAD 200• STERRAD NX• STERRAD 100NX(STANDARD, FLEX andEXPRESS Cycles) | Used as a standard method forfrequent monitoring of thefollowing STERRADSterilization Systems:• STERRAD® 100NX(STANDARD, FLEX,EXPRESS, and DUO Cycles)with and withoutALLClear™ Technology• STERRAD NX®(STANDARD andADVANCED Cycles) withand without ALLClear™Technology• STERRAD® 100S |
| Organism(Spore, Species, Strain) | Geobacillus stearothermophilustraceable to ATCC™ 7953 | Same | Same |
| Viable Spore Population | $≥ 1x106 CFU/BI$ | Same | Same |
| Carrier Material | PET (Polyethylene terephthalate) | Glass Fiber | Same as STERRADCYCLESURE 24 BI |
| ResistanceCharacteristics: | Tested at 10 mg/L vaporizedhydrogen peroxideD-value $10 mg/L ≥ 1 second$Survival Time $≥ 5 seconds$Kill Time: 7 minutes | Tested at 2.5 mg/L hydrogenperoxideD-value $2.5 mg/L: ≥ ~1 second$Survival Time: calculated basedon D-valueKill Time: 60 seconds | Tested at 5 mg/L hydrogenperoxideD-value $5mg/L: ≥ 1 second$ , usingtwo D-value methods (SurvivorCurve and Fraction Negative)per ISO 11138-1 |
Biological Indicator Substantial Equivalence Comparison Table
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| Predicate Devices | Subject device | ||
|---|---|---|---|
| 3M Attest™ Rapid ReadoutBiological Indicator 1295(K140392 and K152060) | STERRADCYCLESURE 24 BI(K151971) | STERRADVELOCITY BI | |
| Device Characteristics | |||
| Rapid ReadoutTechnology | 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. | N/A | Same as 3M predicate |
| Incubation Temperature | 60 +/- 2°C | 55 - 60°C | 57 +/- 2°C |
| Reduced IncubationTime | 4-hour fluorescence results readon 3M 490H Auto-reader | 24-hour visual pH color changeresults | 30-minute fluorescence resultsread in STERRAD VELOCITYReader and optional visual pHcolor change results at 5 to 7days |
| Chemical Indicator | H2O2 sensitive ink; appears blueuntil processed, then appearspink | Throughput indicator, changescolor from red to golden yellowor bronze to indicate exposure tohydrogen peroxide | Type 1 process indicatorchanges color from red/pink toyellow or yellow with somered/orange/brown dots toindicate exposure to hydrogenperoxide |
| Shelf Life | 18 months | 12 months | 6 months |
Reader Substantial Equivalence Table
| Predicate Device | Subject device | |
|---|---|---|
| Device Characteristics | 3M Attest™ 490H Auto-Reader (K140392) | STERRAD VELOCITY Reader |
| Intended Use | Used to incubate and automatically read the 3M Attest™ 1295 Rapid Readout Biological Indicator at 60°C for a final fluorescence result at 4 hours. | Used to incubate and automatically read the STERRAD VELOCITY Biological Indicator at 57°C for a final fluorescence result in 30 minutes. |
| Incubation Temperature | 60 +/- 2°C | 57 +/- 2°C |
| Basis of Rapid Readout | Fluorescence of biological indicator medium | Same |
| Use with Biological Indicators | 3M Attest™ Rapid Readout Biological Indicator 1295 | STERRAD VELOCITY BI |
| Method of Fluorescence Detection | UV LED, optical filters, with sensing by photodiode | Same |
| Indicator of AdequateSterilization Cycle | (-) on LCD Display | Same ("Negative" displayed on LCD Display) |
| Indicators of PossibleSterilization Cycle Failure | (+) on LCD Display, Audible Alarm | Same ("Positive" displayed on LCD Display, Audible Alarm) |
| Incubation Wells | 10 incubation/reader wells | 8 incubation/reader wells |
| 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 |
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Image /page/8/Picture/0 description: The image features a logo with the letters 'ASP' prominently displayed. The letters are stylized and interconnected, with the 'A' resembling a triangle and the 'S' and 'P' forming a continuous, flowing line. The entire logo is rendered in a light blue color, and a small registered trademark symbol is visible in the upper right corner.
Non-Clinical Data
STERRAD VELOCITY BIOLOGICAL INDICATOR
Performance testing was conducted to satisfy the requirements for the STERRAD VELOCITY BI that is the subject of this submission, as outlined in the Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions Document issued on: October 4, 2007, and ISO 11138-1:2006, Sterilization of health care products – Biological indicators - Part 1: General requirements. All testing yielded passing results. This testing is summarized in the following Table.
| Performance Testing | Description | Pass/Fail |
|---|---|---|
| Spore PopulationDetermination | Verification of performance characteristics for spore population. | Pass |
| D-value Determination | Verification of D-values using Holcomb-Spearman-KarberProcedure (HSKP) and Survivor Curve method. | Pass |
| Test OrganismCharacterization | Verification of Geobacillus stearothermophilus (ATCC 7953). | Pass |
| Reduced Incubation Time(RIT) Study | Verification of reduced incubation time: 30 minutes forfluorescence results and 5 to 7 days for spore growth results. | Pass |
| Growth Inhibition Study | Verification that carrier and primary packaging materials do nothave bacteriostatic effects that inhibit the growth of the indicatormicroorganism, Geobacillus stearothermophilus. | Pass |
| Holding Time Assessment | Verification that labeled holding time does not have adverseeffects on the resistance characteristics for the BI growth results orthe fluorescence response characteristics for the fluorescenceresults. | Pass |
| Chemical IndicatorFunctionality Study | Verification of functionality of the chemical indicator (CI) as aType 1 process indicator. | Pass |
| BI Performance Study inSTERRAD 100NX | Verification of performance in monitoring STERRAD 100NXSTANDARD, FLEX, EXPRESS, and DUO Cycles. | Pass |
| BI Performance Study inSTERRAD NX | Verification of performance in monitoring STERRAD NXSTANDARD and ADVANCED Cycles. | Pass |
| BI Performance Study inSTERRAD 100S | Verification of performance in monitoring STERRAD 100SCycle. | Pass |
| Impact of Load Conditioning(ALLClear Technology)Feature on STERRADVELOCITY BI | Verification that the load conditioning feature of the STERRAD100NX and NX with ALLClear Technology has no statisticallysignificant impact on the STERRAD VELOCITY BI. | Pass |
| Shelf Life Study (Real Time) | Verification that the STERRAD VELOCITY BI meets its end ofshelf life requirements. | Pass |
Summary of Performance Testing
STERRAD VELOCITY READER
Electrical Safety testing was conducted to verify compliance to the standards listed below. The testing provides a standardized level of assurance that the system is electrically safe when operated and maintained in accordance with the STERRAD VELOCITY Reader User's Guide.
- . IEC/EN 61010-1:2010; Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
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- . IEC/EN 61010-2-010:2014: Safety requirements for electrical equipment for measurement. control, and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
- . UL 61010-1:2012; UL Standard for Safety Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements
- UL 61010-2-010:2015; UL Standard for Safety Requirements for Electrical Equipment for . Measurement, Control and Laboratory Use – Part 2-010: Particular Requirements for Laboratory Equipment for the Heating of Materials
- . CAN/CSA-C22.2 No. 61010-1-12 (2012); Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements
- CAN/CSA-22.2 No. 61010-2-010:15 (2015); Safety requirements for electrical equipment for . measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
Electromagnetic Compatibility testing was completed to verify compliance of Radiated and Conducted Emissions per US Code of Federal Regulations (CFR), Title 47, Part 15, Subpart B (Class A). Test results met the requirements of the regulation and standards as shown in the following table:
| Test Description | Standards | Test Result |
|---|---|---|
| Radiated EmissionsClass A | FCC Part 15, Subpart BICES-003ANSI C63.4:2014 | Compliant |
| Conducted EmissionsClass A | FCC Part 15, Subpart BICES-003ANSI C63.4:2014 | Compliant |
Software Verification and Validation Testing was conducted and documentation was provided within the submission as recommended by Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005. Unit, Integration, and System level testing were successfully completed.
Clinical Data
No clinical data was generated in support of this Premarket Notification.
Summarv
The STERRAD VELOCITY BI and Reader and its predicate devices, the STERRAD CYCLESURE 24 Biological Indicator and the 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Auto-Reader 490H, have the same intended use and indications for use with minor exceptions that are related to the incorporation of new product clearances and removal of obsolete products. Further, the subject device and predicate devices largely share the same technological characteristics, i.e., some technological differences exist: however, these differences were successfully assessed through performance testing, and do not raise any questions of safety and effectiveness. Therefore, the subject device is as safe and effective as the predicate devices.
Conclusion
The subject devices (STERRAD VELOCITY Biological Indicator and Reader) are substantially equivalent to the claimed predicate devices.
§ 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).