(114 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 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 STERRAD VELOCITY Biological Indicator is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and periodic testing of the STERRD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2ºC.
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) if used for frequent monitoring purposes. When using this method, the biological indicator must be cultured in an incubator at 55-60℃ 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 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 or 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 cleared under K170039. 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 4-methylumbelliferyl 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 and is used to distinguish between the positive and negative responses.
The provided text describes the acceptance criteria and a study proving the device meets the acceptance criteria for the STERRAD VELOCITY™ Biological Indicator.
Here's a breakdown of the requested information:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for the device, as outlined by the "Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, Section 10, Test Pack, issued on October 4, 2007," appears to be that the resistance of the subject device must be greater than or equal to the biological models for all claimed STERRAD Cycles. Additionally, all fluorescence-negative results during testing must be obtained in triplicate runs.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Resistance of the subject device is greater than or equal to the biological models for all claimed STERRAD Cycles. (Based on testing outlined in FDA Guidance) | "The study results indicated that the resistance of the subject device was greater than the biological model for all claimed STERRAD Cycles." |
| All fluorescence-negative results obtained in triplicate runs. (Based on testing outlined in FDA Guidance) | "all fluorescence-negative results were obtained in triplicate runs." |
| Overall performance in various STERRAD Cycles (passing results in specific performance studies). | All testing yielded passing results.- Performance Study in STERRAD 100NX (STANDARD and FLEX Cycles, with/without ALLClear Technology): Pass- Performance Study in STERRAD 100NX (EXPRESS Cycle, with/without ALLClear Technology): Pass- Performance Study in STERRAD 100NX (DUO Cycle): Pass- Performance Study in STERRAD NX (STANDARD and ADVANCED Cycles, with/without ALLClear Technology): Pass- Performance Study in STERRAD 100S Cycle: Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "all fluorescence-negative results were obtained in triplicate runs." This implies that for each performance study listed, testing was conducted in triplicate. The exact number of biological indicators (BIs) or runs per condition is not explicitly stated beyond "triplicate runs."
- Data Provenance: The data is from non-clinical performance testing conducted by Advanced Sterilization Products (ASP). There is no explicit mention of the country of origin of the data, but given ASP is based in Irvine, California, it's highly likely the testing was conducted in the United States. The study is inherently prospective as it involves new performance testing of the device for expanded indications.
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. For a biological indicator, the ground truth is typically established by the growth or non-growth of the microbial spores after exposure to a sterilization process, which is an objective measurement. It does not typically involve expert interpretation in the same way as, for example, reading medical images.
4. Adjudication Method for the Test Set
This information is not applicable in the context of biological indicator testing as described. The results (fluorescence-negative or positive, and spore growth/non-growth) are objective measurements based on the device's functionality and the viability of the spores. It does not involve human interpretation that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. The STERRAD VELOCITY™ Biological Indicator is a standalone device for monitoring sterilization processes and its performance is assessed directly, not in conjunction with human interpretation in an MRMC setting.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance study described is essentially a standalone (algorithm only) performance evaluation of the STERRAD VELOCITY™ Biological Indicator. The device, in conjunction with the STERRAD VELOCITY Reader, determines a "positive or negative result" based on the detected fluorescent signal, which is determined using an "algorithm developed for the STERRAD VELOCITY BI." The results presented ("Pass" or "Fail" for the performance studies and the resistance being "greater than" the biological model, and "fluorescence-negative results were obtained in triplicate runs") are indicative of the algorithm's direct performance in identifying effective sterilization.
7. The Type of Ground Truth Used
The ground truth for the biological indicator testing is based on the viability (growth or non-growth) of the Geobacillus stearothermophilus (ATCC 7953) spores after exposure to sterilization cycles, as well as the expected D-value (decimal reduction time) and and absence of growth in fully processed units. This is a biological/microbiological ground truth, directly tied to the primary function of a biological indicator. The "fluorescence-negative" result detected by the reader is directly correlated to the inactivation of spores. The document also mentions the optional visual pH-based color change result after 5-7 days of culture, which further confirms spore viability (or lack thereof).
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This device is a biochemical indicator with an enzymatic detection system, rather than a machine learning or AI model that typically requires a large training dataset for learning patterns from data. The "algorithm developed for the STERRAD VELOCITY BI" likely refers to a pre-defined threshold or logic based on the biochemical reaction, rather than a machine-learned algorithm.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" in the context of machine learning is indicated, the method of establishing ground truth for a training set is not applicable as described in the document. The foundational principles for the device's operation (α-glucosidase enzyme system, spore viability detection) are based on established microbiological and biochemical science. The development of the algorithm would have relied on understanding the relationship between enzyme activity, fluorescence, and spore inactivation, established through scientific studies and threshold determination rather than a traditional machine learning training process with a distinct training set.
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December 27, 2018
Advanced Sterilization Products (ASP) Ms. Sun Choi Principal Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92618
Re: K182404
Trade/Device Name: STERRAD VELOCITY Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 29, 2018 Received: December 31, 2018
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 mav, 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 avare 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.
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elizabeth F. Claverie -S
For Tina Kiang, Ph.D. 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) K182404
Device Name
STERRADVELOCITY™ Biological Indicator
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 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
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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Image /page/3/Picture/0 description: The image shows a logo with a triangle and the letters 'SP' inside a rounded rectangle. The logo is light blue, and there is a registered trademark symbol in the upper right corner. The logo appears to be for a company or organization with the initials 'ASP'.
510(k) Summary
Advanced Sterilization Products STERRAD VELOCITY™ Biological Indicator
General Information
| Submitter Name: | Advanced Sterilization ProductsDivision of Ethicon, Inc., a Johnson & Johnson company |
|---|---|
| Address: | 33 Technology DriveIrvine, CA 92618 |
| Contact Person: | Sun ChoiPrincipal Regulatory Affairs SpecialistPhone: 949-453-6378Email: sjchoi@its.jnj.com |
| Date Prepared: | December 20, 2018 |
| 510(k) Number: | K182404 |
Device Name
| Proprietary Name: | STERRAD VELOCITY™ Biological Indicator |
|---|---|
| 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
-
Primary Predicate Device: STERRAD VELOCITY™ Biological Indicator, K170039 cleared ● June 20, 2017
Note: The subject device is identical to the predicate STERRAD VELOCITY Biological Indicator (K170039). Only the indications for use have been modified to incorporate the periodic testing indication. -
. Reference Device: STERRAD® 100NX DUO Cycle Test Pack, K111391 cleared September 26, 2012
Device Description
The STERRAD VELOCITY Biological Indicator is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and periodic testing of the STERRD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2ºC.
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Image /page/4/Picture/0 description: The image shows a logo with the letters ASP in white against a light blue background. The letters are stylized, with the A being a triangle and the S and P being connected. There is a registered trademark symbol in the upper right corner of the logo. The logo has rounded corners.
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) if used for frequent monitoring purposes. When using this method, the biological indicator must be cultured in an incubator at 55-60℃ 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 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 or 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 cleared under K170039. 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 4-methylumbelliferyl 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 and is used to distinguish between the positive and negative responses.
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 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 Indications for Use statement for the STERRAD VELOCITY Biological Indicator has been expanded to incorporate the periodic testing indication. The subject and its predicate device share the same intended use for monitoring of hydrogen peroxide gas plasma sterilization processes.
Comparison of Technological Characteristics with Predicate Device/Reference Device
The subject 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
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Image /page/5/Picture/0 description: The image shows a logo with the letters "ASP" in a stylized, interconnected design. The letters are white and are set against a rounded, light blue-green background. A registered trademark symbol is visible in the upper right corner of the logo.
table for a comparison of the subject device and predicate device/reference device characteristics, showing the similarities and differences.
| Reference Device | Predicate Device | Subject device | |
|---|---|---|---|
| DeviceCharacteristics | STERRAD 100NX DUOCycle Test Pack(K111391) | STERRAD VELOCITY BI(K170039) | STERRAD VELOCITY BIwith Expanded Indications(K182404) |
| Intended Use | Routine monitoring of thesterilizer cycle (hydrogenperoxide gas plasma) | Monitoring of hydrogenperoxide gas plasmasterilization processes | Same |
| Indications for Use | The STERRAD 100NX DUOCycle Test Pack is used forroutine monitoring of theSTERRAD 100NX DUOSterilization Cycle and is alsoused for the periodic testingof a STERRAD 100NXSystem DUO Cycle, usinghospital-defined loadscontaining devices that do notexceed claims of the cycle.The STERRAD 100NX DUOCycle Test Pack consists of aSTERRAD® CYCLESURE®24 Biological Indicator, vialand cap to hold the BI. | Used as a standard methodfor frequent monitoring of thefollowing STERRADSterilization Systems:• STERRAD 100NX(STANDARD, FLEX,EXPRESS, and DUOCycles) with and withoutALLClear Technology• STERRAD NX(STANDARD andADVANCED Cycles) withand without ALLClearTechnology• STERRAD 100S | Used as a standard methodfor frequent monitoring andperiodic testing of thefollowing STERRADSterilization Systems:• STERRAD 100NX(STANDARD, FLEX,EXPRESS, and DUOCycles) with and withoutALLClear Technology• STERRAD NX(STANDARD andADVANCED Cycles) withand without ALLClearTechnology• STERRAD 100S |
| Organism(Spore, Species,Strain) | GeobacillusstearothermophilusATCC 7953 | GeobacillusstearothermophilusATCC 7953 | Same |
| Viable SporePopulation | $≥ 1x10^6$ CFU/BI | $≥ 1x10^6$ CFU/BI | Same |
| Carrier Material | Glass Fiber | Glass Fiber | Same |
| Device Design | Self-contained biologicalindicator in test packconfiguration | Self-contained biologicalindicator | Same as predicate device |
| ResistanceCharacteristics | Equal to or greater than themost difficult item routinelyprocessed (biological model). | Tested at 5 mg/L hydrogenperoxide:D-value 5mg/L: $≥$ 1 second,using two D-value methods(Survivor Curve and FractionNegative) per ISO 11138-1. | Tested at 5 mg/L hydrogenperoxide:D-value 5mg/L: $≥$ 1 second,using two D-value methods(Survivor Curve andFraction Negative) perISO 11138-1.Equal to or greater than themost difficult itemroutinely processed(biological model). |
| Reference Device | Predicate Device | Subject device | |
| DeviceCharacteristics | STERRAD 100NX DUOCycle Test Pack(K111391) | STERRAD VELOCITY BI(K170039) | STERRAD VELOCITY BIwith Expanded Indications(K182404) |
| Rapid ReadoutTechnology | N/A | The α-glucosidase enzymesystem is generated naturallyduring growth of Geobacillusstearothermophilus. The α-glucosidase enzyme in itsactive state is detected bymeasuring the fluorescenceproduced by the enzymatichydrolysis of a non-fluorescent substrate. Theresultant fluorescent by-product is detected in thereader. The fluorescencesignal is used to determine apositive or negative result. | Same as predicate device |
| IncubationTemperature | 55 - 60°C | 57 +/- 2°C | Same as predicate device |
| ReducedIncubation Time | 24-hour visual pH colorchange results | 30-minute fluorescenceresults read in STERRADVELOCITY Reader andoptional visual pH colorchange results at 5 to 7 days. | Same as predicate device |
| Holding Time | Immediately aftersterilization cycle | Within 2 hours aftersterilization cycle | Same as predicate device |
| Carrier growthinhibition/mediagrowth promotion | No bacteriostatic effects thatinhibit the growth of theindicator microorganism | No bacteriostatic effects thatinhibit the growth of theindicator microorganism | Same |
| Chemical Indicator | Throughput indicator,changes color from red togolden yellow or bronze toindicate exposure to hydrogenperoxide | Type 1 process indicatorchanges color from red/pinkto yellow or yellow withsome red/orange/brown dotsto indicate exposure tohydrogen peroxide. | Same as predicate device |
| Shelf Life | 12 months | 9 months | Same as predicate device |
Substantial Equivalence Comparison Table
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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.
The subject device and its predicate device (STERRAD VELOCITY BI) have the same intended use and indications for use with one modification to the subject device, which is to incorporate the periodic testing indication. Further, the subject device and predicate device share the same technological characteristics.
Non-Clinical Data
Performance testing was conducted to satisfy the requirements for the STERRAD VELOCITY BI with periodic testing indication that is the subject of this 510(k), as outlined in the Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, Section 10, Test Pack, issued on October 4, 2007.
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Image /page/7/Picture/0 description: The image shows a logo with the letters "ASP" in a stylized font. The "A" is represented by a triangle, and the "S" and "P" are connected. The logo is enclosed in a rounded rectangle with a light blue background. There is a registered trademark symbol in the upper right corner of the logo.
The subject device was evaluated for its challenge to all claimed STERRAD Cycles and the resistance of the subject device was compared to the biological models for all claimed STERRAD Cycles.
The study results indicated that the resistance of the subject device was greater than the biological model for all claimed STERRAD Cycles, and all fluorescence-negative results were obtained in triplicate runs. The results demonstrated that the STERRAD VELOCITY BI is qualified for its design and performance for periodic testing indication in all claimed STERRAD Cycles.
All testing yielded passing results. This testing is summarized in the following table.
| Summary of Performance Testing | ||
|---|---|---|
| Performance Testing | Description | Pass / Fail |
| Performance Study inSTERRAD 100NX | Design Evaluation and Performance Qualification for PeriodicTesting in STERRAD 100NX STANDARD and FLEX Cycleswith and without ALLClear Technology | Pass |
| Performance Study inSTERRAD 100NX | Design Evaluation and Performance Qualification for PeriodicTesting in STERRAD 100NX EXPRESS Cycle with and withoutALLClear Technology | Pass |
| Performance Study inSTERRAD 100NX | Design Evaluation and Performance Qualification for PeriodicTesting in STERRAD 100NX DUO Cycle | Pass |
| Performance Study inSTERRAD NX | Design Evaluation and Performance Qualification for PeriodicTesting in STERRAD NX STANDARD and ADVANCEDCycles with and without ALLClear Technology | Pass |
| Performance Study inSTERRAD 100S | Design Evaluation and Performance Qualification for PeriodicTesting in STERRAD 100S Cycle | Pass |
Summary of Performance Testing
Clinical Data
No clinical data was generated in support of this Premarket Notification.
Summary
The subject device and its reference device (STERRAD 100NX DUO Cycle Test Pack) have the same periodic testing indication; however, there are differences in their device designs. The subject device is a self-contained biological indicator, whereas the reference device is a self-contained biological indicator in a test pack configuration. Non-clinical data demonstrates that the use of a test pack configuration is not necessary for the subject device.
Conclusion
The subject device (STERRAD VELOCITY Biological Indicator) is substantially equivalent to the claimed predicate and reference 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).