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

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Testing Requirement	Acceptance Criteria	Reported Device Performance
Hydrogen Peroxide Dose Response and Sterilization Verification	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	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	BI fluorescence-positive for greater than 97.0% of all growth-positive BIs.	Pass
Verification of BI Holding Time	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	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	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	The modified software meets specifications and functions correctly for the product's intended use.	Pass
Overall Conclusion	The device is as safe, as effective, and performs as well as or better than the legally marketed device STERRAD VELOCITY Biological Indicator (K182404).	Passed

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes for the test sets in each study. It mentions that:

For "Hydrogen Peroxide Dose Response and Sterilization Verification," "Design evaluation and Performance Qualification for Periodic Testing," "Verification of Reduced Incubation Time," and "Verification of BI Holding Time," the device's performance was evaluated by reanalyzing fluorescence results and data collected from previously submitted studies using the modified algorithm. No additional sterilization cycles were performed for these specific re-evaluations. This suggests the data provenance is retrospective, using previously gathered data.
The original provenance of the data used for the reanalysis (e.g., country of origin) is not specified.

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 studies primarily involve analytical testing against established biological and chemical indicators, rather than expert interpretation of medical images or other data requiring clinical expertise.

4. Adjudication Method for the Test Set:

This information is not applicable as the studies are based on analytical measurements (fluorescence readings, growth/no growth, chemical indicator changes) and adherence to set criteria. There is no mention of a human adjudication process for interpreting results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is a biological indicator system used for monitoring sterilization, not a diagnostic AI system that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the studies described are essentially standalone performance evaluations of the STERRAD VELOCITY BI/PCD and Reader. The modified algorithm's ability to accurately read and interpret the biological indicator's fluorescence (without human intervention in the interpretation process) is the core of the verification. The reader automatically determines and displays the result ("Positive" or "Negative").

7. The type of Ground Truth Used:

The ground truth used in these studies is primarily biological/chemical reference standards and established scientific principles:

Biological model: For periodic testing, the BI's resistance is compared to a "biological model," which represents the most difficult item routinely processed.
Sterile BIs (growth and fluorescence): The "growth" outcome of the Geobacillus stearothermophilus spores (or lack thereof) after incubation, and the corresponding fluorescence, serve as the biological ground truth for assessing sterilization effectiveness.
Chemical indicator changes: The color change of the chemical indicator (from red/pink to yellow/orange/brown dots) provides a chemical ground truth for exposure to hydrogen peroxide.
7-day incubation spore growth results: For verifying reduced incubation time, the rapid fluorescence results are compared against the longer, traditional 7-day visual assessment of spore growth, which is a well-established method for confirming biological indicator results.

8. The Sample Size for the Training Set:

This information is not provided. Given that the modification was an update to an existing algorithm based on reanalysis of previous data, and the device is a biological indicator reader rather than a deep learning AI, a distinct "training set" in the context of machine learning might not be applicable or explicitly documented in this way. The algorithm's development would have likely involved extensive testing and refinement, but the specific size or methodology for a formal "training set" is not detailed here.

9. How the Ground Truth for the Training Set was Established:

As with the training set size, the specific methodology for establishing ground truth for any potential "training set" for algorithm development is not detailed. However, it can be inferred that the ground truth would have been established through controlled experiments involving the exposure of biological indicators to varying levels of hydrogen peroxide and subsequent traditional incubation and growth assessment (e.g., the 7-day incubation method mentioned). The previous K182404 submission would have contained details on the initial algorithm's development and associated ground truth.

Summary

{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® 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a logo with the letters 'ASP' in a stylized font. The letters are connected and enclosed within a rounded rectangle shape. There is a registered trademark symbol in the upper right corner of the logo. The logo is a light blue color.

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 KimSr. Regulatory Affairs Program LeadPhone: 949-932-4234Email: elsie.kim@asp.com

Date Prepared: January 22, 2020

Device Name

Proprietary Name:	STERRAD VELOCITY® Biological Indicator/Process Challenge Device andReader
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

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image features a logo with a teal background and white lettering. The logo includes a triangle shape with the letters 'ASP' to the right of the triangle. A registered trademark symbol is located in the upper right corner of the logo.

STERRAD VELOCITY READER

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

{5}------------------------------------------------

Image /page/5/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, and there is a small registered trademark symbol in the upper right corner of the rectangle.

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
DeviceCharacteristics	STERRAD VELOCITY BI(K182404) and Reader	STERRAD VELOCITY BI/PCD andReader with 15-minute fluorescencereadout
Intended Use	Monitoring of hydrogen peroxide gas plasmasterilization processes	Same
Indications for Use	Used as a standard method for frequentmonitoring and periodic testing of the followingSTERRAD Sterilization Systems:• STERRAD 100NX (STANDARD, FLEX,EXPRESS, and DUO Cycles) with andwithout ALLClear Technology• STERRAD NX (STANDARD andADVANCED Cycles) with and withoutALLClear Technology• STERRAD 100S	Same
Organism(Spore, Species,Strain)	Geobacillus stearothermophilusATCC 7953	Same
	Predicate Device	Subject Device
DeviceCharacteristics	STERRAD VELOCITY BI(K182404) and Reader	STERRAD VELOCITY BI/PCD andReader with 15-minute fluorescencereadout
Viable SporePopulation	$\ge$ 1x106 CFU/BI	Same
Carrier Material	Glass Fiber	Same
Device Design	Self-contained biological indicator	Same
ResistanceCharacteristics	Tested at 5 mg/L hydrogen peroxide:D-value 5mg/L: ≥ 1 second, using two D-valuemethods (Survivor Curve and FractionNegative) per ISO 11138-1.Equal to or greater than the most difficult itemroutinely processed (biological model).	Same
Rapid ReadoutTechnology	The α-glucosidase enzyme system is generatednaturally during growth of Geobacillusstearothermophilus. The α-glucosidase enzymein its active state is detected by measuring thefluorescence produced by the enzymatichydrolysis of a non-fluorescent substrate. Theresultant fluorescent by-product is detected in thereader. The fluorescence signal is used todetermine a positive or negative result.	Same
IncubationTemperature	57 +/- 2°C	Same
ReducedIncubation Time	30-minute fluorescence results read inSTERRAD VELOCITY Reader and optionalvisual pH color change results at 5 to 7 days.	15-minute fluorescence results read inSTERRAD VELOCITY Reader andoptional visual pH color change results at 5to 7 days.
Holding Time	Within 2 hours after sterilization cycle	Same
Carrier growthinhibition/mediagrowth promotion	No bacteriostatic effects that inhibit the growthof the indicator microorganism	Same
Chemical Indicator	Type 1 process indicator changes color fromred/pink to yellow or yellow with somered/orange/brown dots to indicate exposure tohydrogen peroxide.	Same
Shelf Life	9 months	Same
Method ofFluorescenceDetection	UV LED, optical filters, with sensing byphotodiode	Same
Indicator ofAdequateSterilization Cycle	"Negative" displayed on LCD Display	Same
Indicators ofPossibleSterilization CycleFailure	"Positive" displayed on LCD Display, AudibleAlarm	Same
Incubation Wells	8 incubation/reader wells	Same
	Predicate Device	Subject Device
Device	STERRAD VELOCITY BI	STERRAD VELOCITY BI/PCD andReader with 15-minute fluorescence
Characteristics	(K182404) and Reader	readout
Voltage Range	100-240 Volts AC (12 Volt DC conversion forinternal circuitry)	Same
Product Safety	UL/IEC 61010-1	Same
EMC Compliance	FCC Part 15, Subpart B, Class A	Same

Technological Characteristic Comparison Table

{6}------------------------------------------------

Image /page/6/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 with curved lines. The logo is enclosed in a rounded rectangle with a light blue fill. There is a registered trademark symbol in the upper right corner of the logo.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image features a logo with the letters 'ASP' in a stylized, interconnected design. The letters are white against a rounded, light blue-green background. A registered trademark symbol is visible in the upper right corner of the logo.

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 DoseResponse and SterilizationVerification	The fluorescence results collectedfor previously submitted doseresponse testing were reanalyzedusing the modified algorithm. Noadditional sterilization cycles wereperformed.	General trend of increasingnumber of sterile BIs (growth andfluorescence) with increasinghydrogen peroxide injectionvolume. All BIs negative forfluorescence and growth at fullcycle.	Pass
Design evaluation andPerformance Qualificationfor Periodic Testing	The fluorescence results collectedfor the previously submitted doseresponse testing were reanalyzedusing the modified algorithm andcompared with the biological modeldata. No additional sterilizationcycles were performed.	Fluorescence results demonstrateequal or greater resistance to thebiological model by comparisonof BI complete inactivation points.The BI shall demonstrate allfluorescence-negative results infull cycle	Pass
Verification of ReducedIncubation Time	The fluorescence data collectedfor the previously submittedreduced incubation timeverification study werereanalyzed using the modifiedalgorithm and compared to the 7-day incubation spore growthresults from the same study. Noadditional sterilization cycleswere performed.	BI fluorescence-positive forgreater than 97.0% of all growth-positive BIs.	Pass

Summary of Non-Clinical Testing

{8}------------------------------------------------

Image /page/8/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.

Performance Testing	Description	Acceptance Criteria	Pass/Fail
Verification of BI HoldingTime	The fluorescence datacollected for the previouslysubmitted holding timeverification study werereanalyzed using themodified algorithm. Noadditional sterilizationcycles were performed.	The number of fluorescence-positive BIs after 2 hours ofholding time is not less than thenumber of fluorescence-positiveBIs read immediately afterexposure to H2O2.	Pass
System Level Error Check	This study verified that theSTERRAD VELOCITY Readerwith the modified softwarealgorithm meets the system levelerror check performancerequirements as defined in theproduct designspecification and systemrequirements for theSTERRAD VELOCITYReader.	The reader shall accuratelyinterrogate the BI or provide anerror message to alert the userwhen the BI is subject to rotationalmovement or handling.	Pass
Operational Vibration	This study verified that theSTERRAD VELOCITY Readerwith the proposed algorithmcontinues to meet therequirements for operationalvibration as defined in theproduct design specification andsystem requirements for theSTERRAD VELOCITY Reader.	The reader shall accuratelyinterrogate the BI when subjectedto random vibration per C-S 1-9711-002 in the 3 orthogonal axesfor the entire incubation cycle.	Pass
Software Verification andValidation	STERRAD VELOCITY ReaderSoftware Verification andValidation, includingCybersecurity Testing	The modified software meetsspecifications and functionscorrectly for the product'sintended 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).

Regulation Number and Section

§ 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).