The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

250°F/121°C, 30 minutes Gravity
270°F/132°C, 4 minutes Dynamic Air Removal
270°F/132°C, 5 minutes Dynamic Air Removal
270°F/132°C, 6 minutes Dynamic Air Removal
270°F/132°C, 7 minutes Dynamic Air Removal
270°F/132°C, 8 minutes Dynamic Air Removal
270°F/132°C, 9 minutes Dynamic Air Removal
270°F/132°C, 10 minutes Dynamic Air Removal
270°F/132°C, 15 minutes Gravity
273°F/134°C, 4 minutes Dynamic Air Removal
275°F/135°C, 3 minutes Dynamic Air Removal
275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

270°F/132°C, 4 minutes Dynamic Air Removal
270°F/132°C, 3 minutes Gravity
270°F/132°C, 10 minutes Gravity
275°F/135°C, 3 minutes Dynamic Air Removal
275°F/135°C, 3 minutes Gravity
275°F/135°C, 10 minutes Gravity

Device Description

The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

The VERIFY STEAM Integrating Indicator 5CM is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator 5CM is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (VERIFY STEAM Integrating Indicator and VERIFY STEAM Integrating Indicator 5CM), which focuses on demonstrating substantial equivalence to a predicate device based on nonclinical performance data. It is not an AI/ML device, and therefore, the information requested in the prompt regarding AI/ML specific criteria (such as training set, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.

However, I can extract the acceptance criteria and stated device performance for this non-AI/ML medical device from the provided text.

Here's the relevant information presented in the format requested, with explicit notes about the inapplicability of AI/ML specific criteria:

Acceptance Criteria and Device Performance (for a non-AI/ML device)

1. Table of Acceptance Criteria and the Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance (Conclusion)
Simulated Use Testing in Claimed Sterilization Cycles	100% pass under pass conditions	PASS (met 100% pass condition)
Simulated Use Testing in Claimed Sterilization Cycles	100% fail under fail conditions	PASS (met 100% fail condition)
Parallel performance as biological indicator	Integrator does not reach endpoint before the biological indicator is inactivated	PASS (integrator did not reach endpoint before BI inactivation)

Note: The "reported device performance" is given as "PASS" in the document, indicating that the device successfully met the stated acceptance criteria for each test.

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

The document does not explicitly state the numerical sample size used for the test set experiments (Simulated Use Testing, Parallel performance as biological indicator). It only indicates "100% pass" and "100% fail" which implies that, for the tests conducted, all units observed performed as expected.

Regarding data provenance:

The tests are described as "Simulated Use Testing" and "Parallel performance as biological indicator." This suggests the data was generated in a controlled laboratory or testing environment simulating real-world conditions.
The document does not specify the country of origin of the data providers or if it was retrospective or prospective data, as these concepts are generally not applicable to the non-clinical testing of a chemical indicator device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable as the device is a chemical indicator for sterilization. Its "ground truth" is established by physical and chemical properties and calibrated against known sterilization parameters and biological indicators, not by human expert interpretation of images or data. No human experts are involved in establishing the "ground truth" for the performance of this type of device in the context of the described tests.

4. Adjudication Method for the Test Set

This question is not applicable as there is no human interpretation or subjective assessment involved that would require adjudication for this type of device testing. The results (pass/fail for the indicator's chemical reaction) are objective.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This question is not applicable. This is not an AI-assisted diagnostic or interpretive device. There are no human readers whose performance is being compared with or without AI assistance.

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

This question is not applicable. This is a physical chemical indicator, not an algorithm or software. Its performance is inherent to its design and chemical properties.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established by:

Pre-defined sterilization cycle parameters (temperature, time, pressure – i.e., "pass conditions").
Pre-defined under-sterilization conditions (e.g., "stated value -15% time and/or -1°C" – i.e., "fail conditions").
The performance of a biological indicator (BI), which is the gold standard for demonstrating sterilization efficacy by showing inactivation of highly resistant bacterial spores. The integrator's performance is compared to the BI's performance, ensuring the integrator does not "pass" before the BI is inactivated.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical chemical indicator, not an AI/ML device that requires a "training set." Its design and functionality are based on chemical engineering principles, not machine learning from data.

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

This question is not applicable for the same reasons as #8.

Summary

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January 21, 2022

STERIS Corporation Jennifer Nalepka Lead Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K213412

Trade/Device Name: VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator રુદ્ભ Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: October 18, 2021 Received: October 19, 2021

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. 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.

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/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 mediation-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 Clarence W. Murray, III, 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

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Indications for Use

510(k) Number (if known) K213412

Device Name VERIFY STEAM Integrating Indicator

Indications for Use (Describe)

The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterlilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

· 250°F/121°C, 30 minutes Gravity
· 270ºF/132ºC. 4 minutes Dynamic Air Removal
· 270°F/132°C, 5 minutes Dynamic Air Removal
· 270°F/132°C, 6 minutes Dynamic Air Removal
· 270°F/132°C, 7 minutes Dynamic Air Removal
· 270°F/132°C, 8 minutes Dynamic Air Removal
· 270°F/132°C, 9 minutes Dynamic Air Removal
· 270°F/132°C, 10 minutes Dynamic Air Removal
· 270°F/132°C, 15 minutes Gravity
· 273°F/134°C, 4 minutes Dynamic Air Removal
· 275°F/135°C, 3 minutes Dynamic Air Removal
· 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 3 minutes Gravity
· 270°F/132°C, 10 minutes Gravity
· 275°F/135°C, 3 minutes Dynamic Air Removal
· 275°F/135°C, 3 minutes Gravity
· 275°F/135°C, 10 minutes Gravity

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.

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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:

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Indications for Use

510(k) Number (if known) K213412

Device Name VERIFY STEAM Integrating Indicator 5CM

Indications for Use (Describe)

The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

· 250°F/121°C, 30 minutes Gravity
· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 5 minutes Dynamic Air Removal
· 270°F/132°C, 6 minutes Dynamic Air Removal
· 270°F/132°C, 7 minutes Dynamic Air Removal
· 270°F/132°C, 8 minutes Dynamic Air Removal
· 270°F/132°C, 9 minutes Dynamic Air Removal
· 270°F/132°C, 10 minutes Dynamic Air Removal
· 270°F/132°C, 15 minutes Gravity
· 273°F/134°C, 4 minutes Dynamic Air Removal
· 275°F/135°C, 3 minutes Dynamic Air removal
· 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 3 minutes Gravity
· 270°F/132°C, 10 minutes Gravity
· 275°F/135°C, 3 minutes Dynamic Air Removal
· 275°F/135°C, 3 minutes Gravity
· 275°F/135°C, 10 minutes Gravity

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.

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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.

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."

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Image /page/6/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is written in a bold, serif font. Below the word is a graphic of several horizontal wavy lines stacked on top of each other. The lines are blue.

510(k) Summary for VERIFY STEAM INTEGRATING Indicator K213412

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600

Manufacturing Facility

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

Contact: Jennifer Nalepka, M.S. Lead Regulatory Affairs Specialist Phone: (440) 392-7458 Email: jennifer_nalepka@steris.com

Submission Date: January 18, 2022

Premarket Notification Number: K213412

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

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1. Device Name

Trade Name:	VERIFY STEAM Integrating Indicator
Classification/usual Name:	Indicator, physical/chemical sterilization process
Device Classification:	II
Classification Name:	Indicator, physical/chemical sterilization process
Classification Number:	21 CFR 880.2800
Product Code:	JOJ

2. Predicate Device

VERIFY STEAM Integrating Indicator, K152630

3. Description of Device

4. Intended Use/Indications for Use

Steam Sterilization Cycles:

250°F/121°C, 30 minutes Gravity
270°F/132°C, 4 minutes Dynamic Air Removal ●
270°F/132°C, 5 minutes Dynamic Air Removal ●
270°F/132°C, 6 minutes Dynamic Air Removal
270°F/132°C, 7 minutes Dynamic Air Removal
270°F/132°C, 8 minutes Dynamic Air Removal ●
270°F/132°C, 9 minutes Dynamic Air Removal ●
270°F/132°C. 10 minutes Dynamic Air Removal
. 270°F/132°C, 15 minutes Gravity
273°F/134°C, 4 minutes Dynamic Air Removal
275°F/135°C, 3 minutes Dynamic Air Removal ●
275°F/135°C, 10 minutes Gravity ●

Steam Sterilization Cycles (IUSS):

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270°F/132°C, 4 minutes Dynamic Air Removal ●
270°F/132°C, 3 minutes Gravity
270°F/132°C, 10 minutes Gravity ●
275°F/135°C, 3 minutes Dynamic Air Removal ●
275°F/135°C, 3 minutes Gravity
275°F/135°C, 10 minutes Gravity .

5. Summary of Technological Characteristics

A comparison of technical characteristics are summarized in Table 1.

	VERIFY STEAM	VERIFY STEAM
Feature	Integrating Indicator(K213412)	Integrating Indicator(K152630)	Comparison
Intended Use	The integrating indicator isdesigned to chemically reactover time with the criticalparameters of a steamsterilization cycle within aspecified tolerance. Theintegrating indicator strip isintended to be placed in eachpack, pouch, container, tray orother containment device tofunction as an independentmonitor of critical parameters forthe following sterilizationcycles:Steam Sterilization Cycles:• 250°F/121°C, 30 minutesGravity• 270°F/132°C, 4 minutesDynamic Air Removal• 270°F/132°C, 5 minutesDynamic Air Removal• 270°F/132°C, 6 minutesDynamic Air Removal• 270°F/132°C, 7 minutesDynamic Air Removal• 270°F/132°C, 8 minutesDynamic Air Removal• 270°F/132°C, 9 minutesDynamic Air Removal• 270°F/132°C, 10 minutesDynamic Air Removal	The integrating indicator isdesigned to chemically reactover time with the criticalparameters of steam sterilizationcycle within a specifiedtolerance. The integratingindicator strip is intended to beplaced in each pack, pouch,container, tray or othercontainment device to functionas an independent monitor ofcritical parameters for thefollowing sterilization cycles:Steam Sterilization Cycles:• 250°F/121°C, 30 minutesGravity• 270°F/132°C, 4 minutesDynamic Air Removal• 270°F/132°C, 15 minutesGravity• 275°F/135°C, 3 minutesDynamic Air Removal• 275°F/135°C, 10 minutesGravitySteam Sterilization Cycles(IUSS):• 270°F/132°C, 4 minutesDynamic Air Removal• 270°F/132°C, 3 minutesGravity	Similar, theproposeddevice hasadditionalcycle claims.
Feature	VERIFY STEAMIntegrating Indicator(K213412)	VERIFY STEAMIntegrating Indicator(K152630)	Comparison
	273°F/134°C, 4 minutesDynamic Air Removal 275°F/135°C, 3 minutesDynamic Air Removal 275°F/135°C, 10 minutesGravity Steam Sterilization Cycles(IUSS): 270°F/132°C, 4 minutesDynamic Air Removal 270°F/132°C, 3 minutesGravity 270°F/132°C, 10 minutesGravity 275°F/135°C, 3 minutesDynamic Air Removal 275°F/135°C, 3 minutesGravity 275°F/135°C, 10 minutesGravity	275°F/135°C, 3 minutesDynamic Air Removal 275°F/135°C, 3 minutesGravity 275°F/135°C, 10 minutesGravity
Device Design– components	Backing material with embossedcavity containing temperaturesensitive chemical and coloringdye, wicking strip, covered withlaminated paper containinglabeling and windows.	Backing material with embossedcavity containing temperaturesensitive chemical and coloringdye, wicking strip, covered withlaminated paper containinglabeling and windows.	Identical
Indicatoragent	Proprietary formulation	Proprietary formulation	Identical
Sterilizationmethod andcycles	Steam Sterilization Cycles: 250°F/121°C, 30 minutesGravity 270°F/132°C, 4 minutesDynamic Air Removal 270°F/132°C, 5 minutesDynamic Air Removal 270°F/132°C, 6 minutesDynamic Air Removal 270°F/132°C, 7 minutesDynamic Air Removal 270°F/132°C, 8 minutesDynamic Air Removal 270°F/132°C, 9 minutesDynamic Air Removal 270°F/132°C, 10 minutesDynamic Air Removal	Steam Sterilization Cycles: 250°F/121°C, 30 minutesGravity 270°F/132°C, 4 minutesDynamic Air Removal 270°F/132°C, 15 minutesGravity 275°F/135°C, 3 minutesDynamic Air Removal 275°F/135°C, 10 minutesGravity Steam Sterilization Cycles(IUSS): 270°F/132°C, 4 minutesDynamic Air Removal	Similar, theproposeddevice hasadditionalcycle claims.
	VERIFY STEAMIntegrating Indicator(K213412)	VERIFY STEAMIntegrating Indicator(K152630)	Comparison
Feature	270°F/132°C, 15 minutesGravity 273°F/134°C, 4 minutesDynamic Air Removal 275°F/135°C, 3 minutesDynamic Air Removal 275°F/135°C, 10 minutesGravity Steam Sterilization Cycles(IUSS): 270°F/132°C, 4 minutesDynamic Air Removal 270°F/132°C, 3 minutesGravity 270°F/132°C, 10 minutesGravity 275°F/135°C, 3 minutesDynamic Air Removal 275°F/135°C, 3 minutesGravity 275°F/135°C, 10 minutesGravity	270°F/132°C, 3 minutesGravity 270°F/132°C, 10 minutesGravity 275°F/135°C, 3 minutesDynamic Air Removal 275°F/135°C, 3 minutesGravity 275°F/135°C, 10 minutesGravity
Mechanism ofaction	Proprietary	Proprietary	Identical
Endpointspecification	The end point is determined bythe migration of the steamsensitive dye to an area markedACCEPT (OK) on the indicator.Endpoint is reached at the statedvalue (SV) for each claimedtemperature. Endpoint is notreached at the stated value -15%time and/or -1°C.	The end point is determined bythe migration of the steamsensitive dye to an area markedACCEPT (OK) on the indicator.Endpoint is reached at the statedvalue (SV) for each claimedtemperature. Endpoint is notreached at the stated value -15%time and/or -1°C.	Identical
Comparisonof integratorstated valuesat biologicalindicatorgrowth-negative cycleconditions	Integrator does not reachendpoint before the biologicalindicator is inactivated.	Integrator does not reachendpoint before the biologicalindicator is inactivated.	Identical
Shelf life	5 years	5 years	Identical
Standard/Guidance	Conforms to:• Guidance for Industry andFDA Staff: Premarket	Conforms to:• Guidance for Industry andFDA Staff: Premarket	Identical
Feature	VERIFY STEAMIntegrating Indicator(K213412)	VERIFY STEAMIntegrating Indicator(K152630)	Comparison
	Notification [510(k)]Submissions for ChemicalIndicators• ANSI/AAMI/ISO 11140-1:2014: Sterilization ofHealth Care Products –Chemical Indicators – Part 1:General Requirements	Notification [510(k)]Submissions for ChemicalIndicators• ANSI/AAMI/ISO 11140-1:2014: Sterilization ofHealth Care Products –Chemical Indicators – Part 1:General Requirements

Table 1. Summary of SCBI Physical Description and Technological Properties

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STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY STEAM Integrating Indicator and VERIFY STEAM Integrating Indicator 5CM

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STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY |STEAM Integrating Indicator and VERIFY |STEAM Integrating Indicator 5CM

6. Summary of Nonclinical Tests

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

Test	Acceptance Criteria	Conclusion
Simulated Use Testing inClaimed Sterilization Cycles	100% pass under passconditions100% fail under failconditions	PASS
Parallel performance asbiological indicator	Integrator does not reachendpoint before thebiological indicator isinactivated	PASS

Table 2. Summary of nonclinical testing

7. Conclusion

Based on the intended use, technological characteristics and nonclinical performance data, the subject device (K213412) is as safe, as effective, and performs as well or better than the legally marketed predicate device (K152630), Class II (21 CFR 880.2800), product code JOJ.

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Image /page/12/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue.

510(k) Summary for VERIFY STEAM INTEGRATING Indicator 5CM

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600

Manufacturing Facility

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

Contact: Jennifer Nalepka, M.S. Lead Regulatory Affairs Specialist Phone: (440) 392-7458 Email: jennifer_nalepka@steris.com

Submission Date: January 18, 2022

Premarket Notification Number: K213412

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

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1. Device Name

Trade Name:	VERIFY STEAM Integrating Indicator 5CM
Classification/usual Name:	Indicator, physical/chemical sterilization process
Device Classification:	II
Classification Name:	Indicator, physical/chemical sterilization process
Classification Number:	21 CFR 880.2800
Product Code:	JOJ

2. Predicate Device

VERIFY |STEAM| Integrating Indicator - Short, K162631

3. Description of Device

4. Intended Use/Indications for Use

Steam Sterilization Cycles:

250°F/121°C, 30 minutes Gravity
270°F/132°C, 4 minutes Dynamic Air Removal ●
270°F/132°C, 5 minutes Dynamic Air Removal ●
270°F/132°C, 6 minutes Dynamic Air Removal ●
270°F/132°C, 7 minutes Dynamic Air Removal ●
270°F/132°C, 8 minutes Dynamic Air Removal ●
270°F/132°C, 9 minutes Dynamic Air Removal
270°F/132°C, 10 minutes Dynamic Air Removal
270°F/132°C, 15 minutes Gravity ●
273°F/134°C, 4 minutes Dynamic Air Removal ●
275°F/135°C, 3 minutes Dynamic Air Removal
275°F/135°C, 10 minutes Gravity

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Steam Sterilization Cycles (IUSS):

270°F/132°C, 4 minutes Dynamic Air Removal .
270°F/132°C, 3 minutes Gravity ●
270°F/132°C, 10 minutes Gravity ●
275°F/135°C, 3 minutes Dynamic Air Removal ●
275°F/135°C, 3 minutes Gravity ●
275°F/135°C, 10 minutes Gravity .

5. Summary of Technological Characteristics

A comparison of technical characteristics are summarized in Table 1.

			Table 1. Summary of the Integrating Indicator Physical Description and Technological
Properties

Feature	VERIFY STEAMIntegrating Indicator 5CM(K213412)	VERIFY STEAMIntegrating Indicator -Short(K162631)	Comparison
Intended Use	The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:250°F/121°C, 30 minutes Gravity 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 5 minutes Dynamic Air Removal 270°F/132°C, 6 minutes Dynamic Air Removal 270°F/132°C, 7 minutes Dynamic Air Removal 270°F/132°C, 8 minutes Dynamic Air Removal 270°F/132°C, 9 minutes Dynamic Air Removal 270°F/132°C, 10 minutes Dynamic Air Removal	The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:250°F/121°C, 30 minutes Gravity 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutes Dynamic Air Removal	Similar, the proposed device has additional cycle claims.
Feature	VERIFY STEAMIntegrating Indicator 5CM(K213412)	VERIFY STEAMIntegrating Indicator -Short(K162631)	Comparison
Device Design– components	Backing material with embossedcavity containing temperaturesensitive chemical and coloringdye, wicking strip, covered withlaminated paper containinglabeling and windows.	Backing material with embossedcavity containing temperaturesensitive chemical and coloringdye, wicking strip, covered withlaminated paper containinglabeling and windows.	Identical
Indicatoragent	Proprietary formulation	Proprietary formulation	Identical
Sterilizationmethod andcycles	Steam Sterilization Cycles:• 250°F/121°C, 30 minutesGravity• 270°F/132°C, 4 minutesDynamic Air Removal• 270°F/132°C, 5 minutesDynamic Air Removal• 270°F/132°C, 6 minutesDynamic Air Removal• 270°F/132°C, 7 minutesDynamic Air Removal• 270°F/132°C, 8 minutesDynamic Air Removal• 270°F/132°C, 9 minutesDynamic Air Removal• 270°F/132°C, 15 minutesGravity• 273°F/134°C, 4 minutesDynamic Air Removal• 275°F/135°C, 3 minutesDynamic Air Removal• 275°F/135°C, 10 minutesGravitySteam Sterilization Cycles(IUSS):• 270°F/132°C, 4 minutesDynamic Air Removal• 270°F/132°C, 3 minutesGravity• 270°F/132°C, 10 minutesGravity• 275°F/135°C, 3 minutesDynamic Air Removal• 275°F/135°C, 3 minutesGravity• 275°F/135°C, 10 minutesGravity	Steam Sterilization Cycles:• 250°F/121°C, 30 minutesGravity• 270°F/132°C, 4 minutesDynamic Air Removal• 270°F/132°C, 15 minutesGravity• 270°F/132°C, 3 minutesGravity• 270°F/132°C, 10 minutesGravity• 275°F/135°C, 3 minutesDynamic Air Removal• 275°F/135°C, 10 minutesGravity• 275°F/135°C, 3 minutesGravitySteam Sterilization Cycles(IUSS):	Similar, theproposeddevice hasadditionalcycle claims.
Feature	VERIFY STEAMIntegrating Indicator 5CM(K213412)	VERIFY STEAMIntegrating Indicator -Short(K162631)	Comparison
	• 270°F/132°C, 10 minutesDynamic Air Removal• 270°F/132°C, 15 minutesGravity• 273°F/134°C, 4 minutesDynamic Air Removal• 275°F/135°C, 3 minutesDynamic Air Removal• 275°F/135°C, 10 minutesGravitySteam Sterilization Cycles (IUSS):• 270°F/132°C, 4 minutesDynamic Air Removal• 270°F/132°C, 3 minutesGravity• 270°F/132°C, 10 minutesGravity• 275°F/135°C, 3 minutesDynamic Air Removal• 275°F/135°C, 3 minutesGravity• 275°F/135°C, 10 minutesGravity	• 270°F/132°C, 4 minutesDynamic Air Removal• 270°F/132°C, 3 minutesGravity• 270°F/132°C, 10 minutesGravity• 275°F/135°C, 3 minutesDynamic Air Removal• 275°F/135°C, 3 minutesGravity• 275°F/135°C, 10 minutesGravity
Mechanism of action	Proprietary	Proprietary	Identical
Endpointspecification	The end point is determined bythe migration of the steamsensitive dye to an area markedACCEPT (OK) on the indicator.Endpoint is reached at the statedvalue (SV) for each claimedtemperature. Endpoint is notreached at the stated value -15%time and/or -1°C.	The end point is determined bythe migration of the steamsensitive dye to an area markedACCEPT (OK) on the indicator.Endpoint is reached at the statedvalue (SV) for each claimedtemperature. Endpoint is notreached at the stated value -15%time and/or -1°C.	Identical
Comparisonof integratorstated valuesat biologicalindicatorgrowth-negative cycleconditions	Integrator does not reachendpoint before the biologicalindicator is inactivated.	Integrator does not reachendpoint before the biologicalindicator is inactivated.	Identical
Feature	VERIFY STEAMIntegrating Indicator 5CM(K213412)	VERIFY STEAMIntegrating Indicator -Short(K162631)	Comparison
Standard/Guidance	Conforms to:• Guidance for Industry andFDA Staff: PremarketNotification [510(k)]Submissions for ChemicalIndicators• ANSI/AAMI/ISO 11140-1:2014: Sterilization ofHealth Care Products –Chemical Indicators – Part 1:General Requirements	Conforms to:• Guidance for Industry andFDA Staff: PremarketNotification [510(k)]Submissions for ChemicalIndicators• ANSI/AAMI/ISO 11140-1:2014: Sterilization ofHealth Care Products –Chemical Indicators – Part 1:General Requirements	Identical

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STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY |STEAM Integrating Indicator and VERIFY |STEAM Integrating Indicator 5CM

6. Summary of Nonclinical Tests

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

Test	Acceptance Criteria	Conclusion
Simulated Use Testing inClaimed Sterilization Cycles	100% pass under passconditions	PASS
Simulated Use Testing inClaimed Sterilization Cycles	100% fail under failconditions	PASS
Parallel performance asbiological indicator	Integrator does not reachendpoint before thebiological indicator isinactivated	PASS

Table 2. Summary of nonclinical testing

7. Conclusion

Based on the intended use, technological characteristics and nonclinical performance data, the subject device (K213412) is as safe, as effective, and performs as well or better than the legally marketed predicate device (K162631), Class II (21 CFR 880.2800), product code JOJ.

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).