The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1° C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-52007 Standard Test Pack and the drain temperature at the beginning of the final minute cycle. the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for 134°C for 3.5 minutes with a 2 minute dry time.

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132° C pre-vacuum steam sterlization cycles utilizing a biological indicator or both a biological and integrating indicator from the following list.

3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
. 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company
Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
. Celerity 20 Steam Biological Indicator
. VERIFY STEAM Integrating Indicator

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterlization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY STEAM Integrating Indicator.

The VERIFY All-In-One STEAM Resuable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Biological Indicator catalog number 1292 can be used for routine monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Resuable Test Pack.

Device Description

The VERIFY All-in-One STEAM Reusable Test Pack (formerly identified as the Dana Reusable Test Pack) consists of a reusable aluminum tube with a tortuous path challenge for air removal and steam penetration. The VERIFY All-in-One STEAM Reusable Test Pack will be used with the Celerity 20 Steam Biological Indicator (subject of a separate, concurrent 510(k) premarket notification) with or without the VERIFY STEAM Integrating Integrator (cleared under K152630).

The Celerity 20 Steam Biological Indicator monitors the critical parameters of steam sterilization cycles by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity Steam Incubator in 20 minutes to confirm viability of the biological indicator at the end of a steam sterilization process. Both the Celerity 20 Steam Biological Indicator and Incubator are subjects of separate 510(k) premarket notifications.

The VERIFY STEAM Integrating Integrator (cleared in K152630) is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY |STEAM Integrating Integrator may be included in the pack and processed according to the pack's instructions for use.

The user will place the assembled VERIFY All-in-One STEAM Reusable Test Pack containing the Celerity 20 Steam Biological Indicator with or without the VERIFY STEAM Integrating Integrator into the sterilizer chamber and perform a 4-minute 270°F pre-vacuum steam sterilization cycle.

At the end of the cycle, the user will remove the Celerity 20 Steam Biological Indicator and the VERIFY |STEAM Integrating Integrator from the pack. The Celerity 20 Steam Biological Indicator can either be immediately activated or held at room temperature for a maximum of 72 hours (3 days) prior to activation by twisting the cap and thus puncturing the cap to release the contained media. The activated BI is incubated at 55-60°C in the Celerity Steam Incubator for a final determination of viability within 20 minutes of incubation.

The VERIFY |STEAM Integrating Integrator will be evaluated for a passing or failing result by observing the dark bar of the device. If the dark bar enters the ACCEPT (OK) window, the integrator is read as a PASS. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL.

AI/ML Overview

The provided text describes the acceptance criteria and a summary of non-clinical tests for the VERIFY™ All-in-One STEAM Reusable Test Pack. Here's a breakdown of the information you requested, based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Test Name	Acceptance Criteria	Reported Device Performance (Conclusion)
Simulated Use	Performance of the BI in the Reusable Test Pack is equivalent to the performance of the BI in the AAMI 16 towel test pack.	PASS
Simulated Use	Performance of the chemical integrator in the Reusable Test Pack is equivalent to the performance of the chemical integrator in the AAMI 16 towel test pack.	PASS
Simulated Use	Reusable Test Pack provides an equivalent or greater challenge than the AAMI 16 towel test pack.	PASS
BI in pack vs BI outside of pack	Reusable Test Pack provides a greater challenge to the process than the BI itself.	PASS
CI in pack vs CI outside of pack	Reusable Test Pack provides a greater challenge to the process than the integrator by itself.	PASS

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes used for the non-clinical tests. It also does not directly state the provenance (e.g., country of origin, retrospective or prospective) of the data. Given the nature of these tests for a sterilization indicator, it's highly likely they are conducted in a laboratory setting, making them a form of prospective, controlled testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The tests seem to rely on observable outcomes (e.g., BI viability, chemical integrator color change), which are typically objective and may not require expert adjudication in the same way as, for instance, image interpretation.

4. Adjudication method for the test set:

The document does not specify an adjudication method (like 2+1, 3+1). The "Conclusion" column in the table simply states "PASS," implying a direct assessment against the acceptance criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is a medical device for sterilization monitoring, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed.

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

The device is a physical test pack for sterilization. It does not involve an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not performed. The performance described is for the physical indicator device itself.

7. The type of ground truth used:

The ground truth for these tests appears to be based on:

Performance of the Biological Indicator (BI): In this context, the ground truth for BI performance would be the viability or non-viability of the spores, determined by incubation and observation, which is a direct measure of sterilization effectiveness against microbial life.
Performance of the Chemical Integrator (CI): The ground truth for CI performance is the visual assessment of dye migration or color change against predefined criteria, indicating the achievement of sterilization conditions.
AAMI 16 towel test pack: This is a recognized standard challenge test pack, used as a comparative benchmark to establish the "equivalent or greater challenge" of the VERIFY pack.

8. The sample size for the training set:

This device is not an AI/ML model, so the concept of a "training set" is not applicable. The device's performance is established through physical testing, not machine learning.

9. How the ground truth for the training set was established:

As mentioned above, the device is not an AI/ML model, so the concept of a "training set" and establishing ground truth for it is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 28, 2018

STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060

Re: K173633

Trade/Device Name: VERIFY™ All-in-One STEAM Reusable Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: January 26, 2018 Received: January 29, 2018

Dear Jennifer Nalepka:

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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/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,

Michael J. Ryan -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) K173633

Device Name

VERIFY All-In-One STEAM Reusable Test Pack

Indications for Use (Describe)

The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is desing the air removal efficiency of pre-vacuum sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1° C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-52007 Standard Test Pack and the drain temperature at the beginning of the final minute cycle. the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for 134°C for 3.5 minutes with a 2 minute dry time.

3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
. 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company
Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
. Celerity 20 Steam Biological Indicator
. VERIFY STEAM Integrating Indicator

Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D)

X | Over-The-Counter Use (21 CFR 801 Subpart C)

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STERIS®

510(k) Summary For VERIFY™ All-in-One STEAM Reusable Test Pack

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Manufacturing Facility

STERIS Corporation Franklin Park Facility 11457 Melrose Ave. Franklin Park, IL 60131 Phone: (847) 455-2881

Jennifer Nalepka Contact: Senior Regulatory Affairs Specialist

Telephone: (440) 392-7458 Fax No: (440) 357-9189 e-mail: jennifer_nalepka@steris.com

February 21, 2018 Submission Date:

Premarket Notification Number: K173633

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

Trade Name:	VERIFY™ All-in-One STEAM Reusable Test Pack
Common/usual Name:	Biological Indicator Challenge Pack
Device Classification:	Class II
Classification Name:	Indicator, Biological Sterilization Process(21 CFR 880.2800, FRC)

2. Predicate Device

K133267 Dana Reusable Test Pack

Description of Device 3.

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activated BI is incubated at 55-60°C in the Celerity Steam Incubator for a final determination of viability within 20 minutes of incubation.

4. Intended Use/ Indications for Use

The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of prevacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 1140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device for 134°C for 3.5 minutes with a 2 minute dry time.

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4minute 270°F/132°C pre-vacuum steam sterilization cycles utilizing a biological indicator, integrating indicator or both a biological and integrating indicator from the following list.

. 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
3M ATTEST Super Rapid Read Biological Indicators catalog number ● 1492V manufactured by 3M Company
Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
Celerity 20 Steam Biological Indicator
VERIFY |STEAM | Integrating Indicator

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY |STEAM Integrating Indicator.

The VERIFY All-In-One STEAM Reusable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Readout Biological Indicator catalog number 1292 can be used for routine

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monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.

5. Summary of Technical Characteristics

A comparison of technical characteristics are summarized in Table 5-1.

Feature	VERIFY All-In-OneSTEAM Reusable TestPack(K173633)	Dana Reusable TestPack(K133267)	Comparison
Intended Use /Indication forUse	The VERIFY All-In-OneSTEAM Reusable TestPack, when used with aVERIFY Bowie DickIndicator Strip, is designedfor testing the air removalefficiency of pre-vacuumsteam sterilizers. Theindicator will demonstratecomplete dye migrationwhen proper sterilizationconditions are met andproper vacuum isachieved. If there isinadequate vacuum suchthat would result in a 2°C(+1°C/-0°C) temperaturedifference between thecenter of theANSI/AAMI/ISO 1140-5:2007 Standard Test Packand the drain temperatureat the beginning of thefinal minute of a three anda half minute cycle, theindicator will demonstrateincomplete dye migration(incomplete color changein the indicator window).The test parameters usedfor validating this devicefor 134°C for 3.5 minuteswith a 2 minute dry time.VERIFY All-In-OneSTEAM Reusable TestPack is designed tochallenge steamsterilization process in	The Dana Reusable TestPack is designed tochallenge steamsterilization process inhealthcare facilities. It isintended to be used forroutine monitoring of pre-vacuum steam sterilizationcycles. It is validated to beused in 4 minute 270°Fpre-vacuum steamsterilization cycles with a3M Attest Super RapidReadout BiologicalIndicator 1492V alongwith or without SteriScanIntegrators.	The proposed and predicatedevices are identical. Thecurrent premarketnotification is to add the useof the Celerity 20 SteamBiological Indicator(submitted in a separate,concurrent premarketnotification) in the VERIFYAll-In-One STEAMReusable Test Pack.The following claims for useof the VERIFY All-In-OneReusable Test Pack havebeen previously cleared:Bowie Dick Indicator whenused with the VERIFYBowie Dick Indicator Strip(K120592)Routine Monitoring of a 4-minute 270°F/132°C pre-vacuum steam sterilizationcycle when used with:• 3M ATTEST Rapid ReadoutBiological Indicatorscatalog number 1292manufactured by 3MCompany (K092944)• Smart-Read EZTest SelfContained BiologicalIndicators for steammanufactured byMesaLabs, Inc.(K130135)
Feature	VERIFY All-In-OneSTEAM Reusable TestPack(K173633)	Dana Reusable TestPack(K133267)	Comparison
	healthcare facilities. It isintended to be used forroutine monitoring of pre-vacuum steam sterilizationcycles. It is validated tobe used in 4-minute270°F/132°C pre-vacuumsteam sterilization cyclesutilizing a biologicalindicator, integratingindicator or both abiological and integratingindicator from thefollowing list.3M ATTEST RapidRead BiologicalIndicators catalognumber 1292manufactured by 3MCompany 3M ATTEST SuperRapid Read BiologicalIndicators catalognumber 1492Vmanufactured by 3MCompany Smart-Read EZTestSelf ContainedBiological Indicatorsfor steam manufacturedby MesaLabs, Inc. Celerity 20 SteamBiological Indicator VERIFY STEAMIntegrating Indicator		VERIFY STEAMIntegrating Indicator(K102761) Routine Monitoring of a 10-minute 270°F/132°C pre-vacuum steam sterilizationcycle when used with theadditional polypropylenesleeve assembly and the 3MATTEST Rapid ReadoutBiological Indicator catalognumber 1292 (K103321)NOTE: In previoussubmissions, the VERIFYAll-In-One STEAMReusable Pack was referredto as the Dana Reusable TestPack and the VERIFYSTEAM IntegratingIntegrator was called theSteriScan Integrator.
	VERIFY All-In-OneSTEAM Reusable TestPack is designed tochallenge the steamsterilization process inhealthcare facilities. It isintended to be used forroutine monitoring of pre-vacuum steam sterilizationcycles. It is validated tobe used in 4-minute270°F/132°C pre-vacuumsteam sterilization cycles
Feature	VERIFY All-In-OneSTEAM Reusable TestPack(K173633)	Dana Reusable TestPack(K133267)	Comparison
	STEAM IntegratingIndicator.The VERIFY All-In-OneSTEAM Reusable TestPack employing the All-in-One PV10 Assembly (adisposable polypropylenesleeve assembly) with a3M ATTEST RapidReadout BiologicalIndicator catalog number1292 can be used forroutine monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilizationcycles. The polypropylenesleeve assembly isintended to be used onlywith the VERIFY All-In-One STEAM ReusableTest Pack.
GeneralDesign	Aluminum chamber thatcan be sealed at one endusing a removablealuminum plug. The otherend has a permanentlypressed in aluminum capwith a precision machinedspiral that provides atortuous path for airremoval. The aluminumchamber is large enough tocontain a biologicalindicator and chemicalindicator.	Aluminum chamber thatcan be sealed at one endusing a removablealuminum plug. The otherend has a permanentlypressed in aluminum capwith a precision machinedspiral that provides atortuous path for airremoval. The aluminumchamber is large enough tocontain a biologicalindicator and chemicalindicator.	Identical configuration

Table 5-1 Summary of pack Physical Description and Technological Properties

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Feature	VERIFY All-In-OneSTEAM Reusable TestPack(K173633)	Dana Reusable TestPack(K133267)	Comparison
BiologicalIndicator	3M ATTEST Rapid Read BiologicalIndicators catalog number 1292manufactured by 3M Company 3M ATTEST Super Rapid Read BiologicalIndicators catalog number 1492Vmanufactured by 3M Company Smart-Read EZTest Self ContainedBiological Indicators for steam manufacturedby MesaLabs, Inc. Celerity 20 Steam Biological Indicator	3M ATTEST Super RapidRead Biological Indicatorscatalog number 1492Vmanufactured by 3MCompany	The proposed and predicatedevices are identical. Thecurrent premarketnotification is to add the useof the Celerity 20 SteamBiological Indicator(submitted in a separate,concurrent premarketnotification) in the VERIFYAll-In-One STEAMReusable Test Pack.The following BIs werecleared in previoussubmissions: 3M ATTEST Rapid ReadBiological Indicatorscatalog number 1292manufactured by 3MCompany (K092944) Smart-Read EZTest SelfContained BiologicalIndicators for steammanufactured byMesaLabs, Inc.(K130135)
ChemicalIndicator	VERIFY STEAMIntegrating Indicator	VERIFY STEAMIntegrating Indicator(previously branded as theSteriscan IntegratingIntegrator)	Same

6. Summary of Nonclinical Tests

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.

Test	Acceptance Criteria	Conclusion
Simulated Use	Performance of the BI in the Reusable Test Pack isequivalent to the performance of the BI in the AAMI 16towel test pack.	PASS
	Performance of the chemical integrator in the ReusableTest Pack is equivalent to the performance of the chemicalintegrator in the AAMI 16 towel test pack.	PASS
	Reusable Test Pack provides an equivalent or greaterchallenge than the AAMI 16 towel test pack.	PASS
BI in pack vs BI outsideof pack	Reusable Test Pack provides a greater challenge to theprocess than the BI itself.	PASS

Table 5-2. Summary of Non-clinical Testing

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Test	Acceptance Criteria	Conclusion
CI in pack vs CI outside of pack	Reusable Test Pack provides a greater challenge to the process than the integrator by itself.	PASS

7. Conclusion

The VERIFY All-in-One STEAM Reusable Test Pack has met the established performance criteria. Based on the conclusions drawn from the intended use, technological characteristics and nonclinical tests demonstrate that the subject device is as safe, as effective, and performs at least as well as the legally marketed predicate device, Dana Reusable Test Pack cleared in K133267 Class II (21 CFR 880.2800, Product code FRC).

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).