The Celerity™ HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow or lighter, when the device has been exposed to the:

· Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
· Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

The Celerity™ HP Multivariable Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:

Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization ● cycle of a V-PRO Low Temperature Sterilization System, or
Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD ● System, including those systems with ALLClear Technology.

The VERIFY® HPU Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to be sterilized to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen, Flexible, Fast Non Lumen, or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System.

The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.
The tape may be used in the following sterilization cycles:

. Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX 2, 60, and s2 Low Temperature Sterilization Systems.
STERRAD® 100S Sterilizer (Default Cycle)
. Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX . Sterilizer without ALLClear.

Device Description

The Celerity "M HP Chemical Indicator is an ISO 11140-1:2014 Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units through a visible change from magenta to orange/vellow or lighter. when the device has been exposed. No changes have been made to the device other than additional testing and updating the labeling for the Specialty Cycle.

The Celerity™ HP Multivariable Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. If the critical variables are achieved, the color of the indicator ink changes from magenta to orange/yellow or lighter yellow when exposed to the V-PRO® Low Temperature Sterilization System cycles or ASP STERRAD® System cycles. The indicator is validated to function as a multiple variable indicator with increased resistance characteristics similar to ISO 11140-1:2014 end points for a Type 4 Vaporized Hydrogen Peroxide (VHP) Chemical Indicator (CI). No changes have been made to the device other than additional testing and updating the labeling for Specialty cycle.

The VERIFY HPU Chemical Indicator (Chemical Indicator) is a Type 1 process indicator in accordance with ANSI/AAMI/ISO 11140-1:2014. The indicators are used in the processing cycles to indicate exposure to the following sterilization cycles in the V-PRO Low Temperature Sterilization Systems. The indicator ink spot on the proposed Chemical Indicator undergoes a color change from magenta to vellow when exposed to the defined processing conditions.

The VERIFY VH2O2 Indicator Tape (Indicator Tape) is a 3/" wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.

AI/ML Overview

The provided text describes premarket notification (510(k)) submissions for four chemical indicators (CIs) used in sterilization processes:

Celerity™ HP Chemical Indicator (CI) (K231488) on pages 3-5.
Celerity™ HP Multivariable Chemical Indicator (CI) (K231488) on pages 6-9.
VERIFY HPU Chemical Indicator (CI) (K231488) on pages 10-12.
VERIFY VH2O2 Indicator Tape (K231488) on pages 13-16.

For each of these devices, the core purpose of the 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, primarily by showing that the indicators function as intended even with an expanded "Indications for Use" to include the "Specialty" sterilization cycle of the V-PRO® Low Temperature Sterilization System.

The information provided does not pertain to a medical device that uses AI or machine learning, nor does it involve human readers/experts interpreting medical images. Instead, it describes performance testing of chemical indicators, which are physical objects designed to change color under specific sterilization conditions. Therefore, the requested information elements such as "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Effect size of human readers improvement with AI," "Stand-alone algorithm performance," "Training set sample size," and "How ground truth for training set was established" are not applicable to this type of device and study.

The acceptance criteria and reported performance for each device are derived from "Simulated Use Testing" and are consistently focused on the physical color change and the indicator's integrity.

Here's a summary of the relevant information provided for each product:

1. Celerity™ HP Chemical Indicator (CI) (K231488)

Acceptance Criteria and Reported Device Performance:

Testing	Acceptance Criteria	Study Result
Simulated Use Testing	Complete color change No reversion	Complete color change No reversion

Study that proves the device meets the acceptance criteria:

Sample Size: Not explicitly stated, but the context implies a sufficient number of indicators were tested to demonstrate consistent performance.
Data Provenance: Not explicitly stated, but the manufacturing facility is in the United Kingdom, and the testing simulates "typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle." This suggests laboratory-based, prospective testing designed to validate performance under specified conditions.
Type of Ground Truth: The ground truth is the physical observation of the color change of the chemical indicator after exposure to the V-PRO maX 2 Sterilizer Specialty cycle, indicating that the sterilization conditions were met. This is a direct physical outcome.

2. Celerity™ HP Multivariable Chemical Indicator (CI) (K231488)

Acceptance Criteria and Reported Device Performance:

Testing	Acceptance Criteria	Study Result
Simulated Use Testing	Complete color change No reversion	Complete color change No reversion

Study that proves the device meets the acceptance criteria:

Sample Size: Not explicitly stated.
Data Provenance: Not explicitly stated, but similar to the previous Celerity CI, implies laboratory-based, prospective testing.
Type of Ground Truth: The ground truth is the physical observation of the color change of the chemical indicator after exposure to the V-PRO maX 2 Sterilizer Specialty cycle, confirming proper function as a multivariable indicator.

3. VERIFY HPU Chemical Indicator (CI) (K231488)

Acceptance Criteria and Reported Device Performance:

Testing	Acceptance Criteria	Study Result
Simulated Use Testing	Complete color change No reversion	Complete color change No reversion

Study that proves the device meets the acceptance criteria:

Sample Size: Not explicitly stated.
Data Provenance: Not explicitly stated, but implies laboratory-based, prospective testing.
Type of Ground Truth: The ground truth is the physical observation of the color change of the chemical indicator (magenta to yellow) after exposure to the V-PRO maX 2 Sterilizer Specialty cycle.

4. VERIFY VH2O2 Indicator Tape (K231488)

Acceptance Criteria and Reported Device Performance:

Testing	Acceptance Criteria	Study Result
Simulated Use Testing	Complete color change Remained adhered after cycle	Complete color change Remained adhered after cycle

Study that proves the device meets the acceptance criteria:

Sample Size: Not explicitly stated.
Data Provenance: Not explicitly stated, but implies laboratory-based, prospective testing. The manufacturing facility is in Buena Park, CA (USA).
Type of Ground Truth: The ground truth is the physical observation of the color change of the indicator tape (pink to peach, yellow or lighter) and its physical integrity (remaining adhered) after exposure to the V-PRO maX 2 Sterilizer Specialty cycle.

Summary of non-applicable AI/ML specific criteria:

Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is based on physical/chemical reaction.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of complex data; rather, direct observation of state change.
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: Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical chemical indicator, not an algorithm.
The sample size for the training set: Not applicable. These are physical devices, not AI models requiring training data.
How the ground truth for the training set was established: Not applicable for the same reason.

In all cases, the primary purpose of the testing described is to confirm that the chemical indicators reliably undergo the expected color change (and adhere, for the tape) when exposed to the specific V-PRO maX 2 Sterilizer Specialty cycle, thereby demonstrating their continued safety and effectiveness for an expanded indication.

Summary

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August 7, 2023

STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor. Ohio 44060

Re: K231488

Trade/Device Name: Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ, QKM Dated: Mav 22, 2023 Received: May 23, 2023

Dear Anthony Piotrkowski:

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, Christopher K. Dugard -2

for Clarence W. Murray, III, Ph.D. 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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STE

510(k) Summary For K231488 CELERITY HP Chemical Indicator (CI)

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Manufacturing Facility

Albert Browne Ltd., a subsidiary of STERIS Corporation Rayns Way Watermead Business Park Syston Leicester LE7 1PF UNITED KINGDOM

Contact:	Anthony Piotrkowski
	Director, Regulatory Affairs
	Telephone: (440) 392-7437
	Fax No: (440) 357-9198
	Tony_piotrkowski@steris.com

May 22, 2023 Submission Date:

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STERIS Traditional 510(k) PREMARKET NOTIFICATION CELERITY HP Chemical Indicator (CI)

1. Predicate Device

Trade Name: Common/Usual Name: Classification: Classification Name: 510(k) Submitter/Holder: 510(k) Number:

Celerity™ HP Chemical Indicator Chemical Indicator Class II Physical/chemical Sterilization Process Indicator STERIS Corporation K192020

2. Device Description

3. Indications for Use:

· Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
· Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

4. Technological Characteristics

The proposed and predicate devices are chemical indicators in accordance with ISO 11140-1:2014 for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The mechanism of action and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta to orange/yellow or lighter yellow.

Feature	Proposed Celerity™ HP Chemical	Predicate: K192020 Celerity HP	Comparison
	Indicator	Chemical Indicator
Intended Use /Indications forUse	The Celerity™ HP Chemical Indicator is aType 1 vaporized hydrogen peroxidesterilization process indicator. It isdesigned to distinguish between processedand unprocessed units, when placed withinpacks to be sterilized, through a visiblechange from red to orange/yellow, whenthe device has been exposed to the Lumen,Non Lumen, Flexible, Fast Non Lumen,Fast or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization	The Celerity™ HP Chemical Indicator is aType 1 vaporized hydrogen peroxidesterilization process indicator. It isdesigned to distinguish between processedand unprocessed units, when placed withinpacks to be sterilized, through a visiblechange from red to orange/yellow, whenthe device has been exposed to the Lumen,Non Lumen, Flexible, Fast Non Lumen orFast sterilization cycle of a V-PRO® LowTemperature Sterilization System, or	The Indicationsfor Use havebeen modifiedin the proposeddevice in orderto include theSpecialtycycles.

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Feature	Proposed Celerity™ HP ChemicalIndicator	Predicate: K192020 Celerity HPChemical Indicator	Comparison
	System, or Standard, Advanced, Express,Flex Scope or Duo cycles of an ASPSTERRAD® System, including thosesystems with ALLClear Technology.	Standard, Advanced, Express, Flex Scopeor Duo cycles of an ASP STERRAD®System, including those systems withALLClear Technology.
Device design –Component	Indicator Ink printed onto polypropylene(indicator) or self-adhesive polypropylene(adhesive label/vial label).	Indicator Ink printed onto polypropylene(indicator) or self-adhesive polypropylene(adhesive label/vial label).	Identical
Indicator agent	Proprietary	Proprietary	Identical
Mechanism ofaction	Proprietary	Proprietary	Identical
Specification	Conforms to ANSI/AAMI/ISO 11140-1:2014 requirements for a VH2O2 Type 1Process Indicator	Conforms to ANSI/AAMI/ISO 11140-1:2014 requirements for a VH2O2 Type1 Process Indicator	Identical
Color change	Magenta to orange/yellow or lighteryellow	Magenta to orange/yellow or lighteryellow	Identical
Endpoint stability	15 months (all versions)	15 months (all versions)	Identical

STERIS Traditional 510(k) PREMARKET NOTIFICATION CELERITY HP Chemical Indicator (CI)

The predicate and proposed devices are identical with regards to all features except for the indications for use. Testing is included in the submission to demonstrate that the CI is an appropriate monitor for the V-PRO maX 2 Sterilizer Specialty cycle.

ನ. Performance Testing

Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.

Table 5-1. Verification Results Summary

Testing	Acceptance Criteria	Study Result
Simulated Use Testing	Complete color changeNo reversion	● Complete color change· No reversion

The results of the performed testing demonstrate that the Celerity™ HP Chemical Indicator performs as intended.

6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device (K192020, Class II as per 21 CFR 880.2800, product code JOJ).

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510(k) Summary For K231488 CELERITY HP Multivariable Chemical Indicator (CI)

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Manufacturing Facility

Albert Browne Ltd., a subsidiary of STERIS Corporation Rayns Way Watermead Business Park Syston Leicester LE7 1PF UNITED KINGDOM

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 Tony piotrkowski@steris.com

May 22, 2023 Submission Date:

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Predicate Device 1.

Trade Name:	Celerity™ HP Chemical Indicator (renamed
	Celerity™ HP Multivariable Chemical Indicator)
Common/Usual Name:	Chemical Indicator
Classification:	Class II
Classification Name:	Physical/chemical Sterilization Process Indicator
510(k) Submitter/Holder:	STERIS Corporation
510(k) Number:	K213262

2. Device Description

3. Indications for Use:

The Celerity™ HP Multivariable Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:

Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization ● cycle of a V-PRO Low Temperature Sterilization System, or
Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD ● System, including those systems with ALLClear Technology.

4. Technological Characteristics

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STERIS Traditional 510(k) PREMARKET NOTIFICATION CELERITY HP Multivariable Chemical Indicator (CI)

Table 4-1. Summary of CI Physical Description and Technological Properties
Feature	Proposed: Celerity™ Multivariable HP Chemical Indicator	Predicate: Celerity™ HP Chemical Indicator K213262	Comparison
Intended Use /Indications forUse	The Celerity™ HP Chemical Indicator is avaporized hydrogen peroxide multivariablechemical indicator. It is designed forroutine monitoring of the following cycles:• Lumen, Non Lumen, Flexible, FastNon Lumen, Fast or Specialtysterilization cycle of a V-PRO® LowTemperature Sterilization System, or• Standard, Advanced, Express, Flex Scopeor Duo cycles of an ASP STERRAD®System, including those systems withALLClear Technology.	The Celerity™ HP Chemical Indicator is avaporized hydrogen peroxide multivariablechemical indicator. It is designed forroutine monitoring of the following cycles:• Lumen, Non Lumen, Flexible, FastNon Lumen or Fast sterilization cycleof a V-PRO® Low TemperatureSterilization System, orStandard, Advanced, Express, Flex or Duocycles of an ASP STERRAD® System,including those systems with ALLClearTechnology.	The IntendedUse of has beenmodified in theproposed deviceto include theSpecialty Cycleof the V-PROmaX 2.
Devicedesign	Proprietary Indicator Ink printed ontopolypropylene.	Proprietary Indicator Ink printed ontopolypropylene.	Identical
Indicatoragent	Proprietary	Proprietary	Identical
Mechanismof action	Proprietary	Proprietary	Identical
Criticalparameters	4.7 mg/L - VH2O229 second - exposure time50 °C - exposure Temperature	4.7 mg/L - VH2O229 second - exposure time50 °C - exposure Temperature	Identical
Color change	Magenta to orange/yellow or lighter yellow	Magenta to orange/yellow or lighter yellow	Identical
Endpointstability	15 months	15 months	Identical

		Table 4-1. Summary of CI Physical Description and Technological Properties

న. Performance Testing

Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.

Table 5-1. Verification Results Summary

Testing	Acceptance Criteria	Study Result
Simulated Use Testing	• Complete color change• No reversion	• Complete color change• No reversion

The results of the performed testing demonstrate that the Celerity™ HP Chemical Indicator performs as intended.

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6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device (K213262, Class II as per 21 CFR 880.2800, product code QKM).

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Image /page/10/Picture/0 description: The image shows the STERIS logo. The word STERIS is in a bold, sans-serif font at the top of the image. Below the word STERIS is a graphic of several horizontal, wavy lines in blue. The lines are stacked on top of each other, creating a visual effect of water waves.

510(k) Summary For K231488 VERIFY HPU Chemical Indicator (CI)

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Manufacturing Facility

Albert Browne Ltd., a subsidiary of STERIS Corporation Rayns Way Watermead Business Park Syston Leicester LE7 1PF UNITED KINGDOM

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 Tony piotrkowski@steris.com

May 22, 2023 Submission Date:

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1. Predicate Device

Trade Name: Common/Usual Name: Classification: Classification Name: 510(k) Submitter/Holder: 510(k) Number:

VERIFY HPU Chemical Indicator Chemical Indicator Class II Physical/chemical Sterilization Process Indicator STERIS Corporation K172746

2. Device Description

3. Indications for Use:

4. Technological Characteristics

Feature	Proposed: VERIFY HPUChemical Indicator	Predicate: VERIFY HPU ChemicalIndicator (K172746)	Comparison
Intended Use	The VERIFY® HPU Chemical Indicator isa Type 1 vaporized hydrogen peroxidesterilization process indicator. It isdesigned to distinguish between processedand unprocessed units when placed withinpacks to be sterilized to indicate, through avisible change from magenta to yellow,when the device has been exposed to theLumen, Non Lumen, Flexible, Fast NonLumen, or Specialty sterilization cycle of a	The VERIFY® HPU Chemical Indicator isa Type 1 vaporized hydrogen peroxidesterilization process indicator. It isdesigned to distinguish between processedand unprocessed units when placed withinpacks to be sterilized to indicate, through avisible change from magenta to yellow,when the device has been exposed to theLumen, Non Lumen, Flexible or Fast Non	The Intended Usehas been modifiedin the proposeddevice in order toinclude theSpecialty Cycle

Table 4-1. Comparison of the Proposed VERIFY HPU Chemical Indicator with the Predicate

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STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY HPU Chemical Indicator (CI)

Feature	Proposed: VERIFY HPUChemical Indicator	Predicate: VERIFY HPU ChemicalIndicator (K172746)	Comparison
	V-PRO® Low Temperature SterilizationSystem	Lumen sterilization cycle of a V-PRO®Low Temperature Sterilization System
Device design -components	Proprietary Indicator Ink printed onto spun-bonded polyolefin, (indicator) or self-adhesive spun-bonded polyolefin (indicatorlabel).	Proprietary Indicator Ink printed onto spun-bonded polyolefin, (indicator) or self-adhesive spun-bonded polyolefin (indicatorlabel).	Identical
Sterilizationmethod	Vaporized Hydrogen Peroxide	Vaporized Hydrogen Peroxide	Identical
Endpointspecifications	No Endpoint Specifications (Type 1Process Indicator)	No Endpoint Specifications (Type 1Process Indicator)	Identical
Shelf-life	9 months (both versions)	9 months (both versions)	Identical

న. Performance Testing

Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.

Table 5-1. Verification Results Summary

Testing	Acceptance Criteria	Study Result
Simulated Use Testing	• Complete color change• No reversion	• Complete color change• No reversion

The results of the performed testing demonstrate that the VERIFY HPU Chemical Indicator performs as intended.

6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device (K172746, Class II as per 21 CFR 880.2800, product code JOJ).

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STERIS®

Image /page/13/Picture/1 description: The image shows a logo with a series of horizontal, wavy lines stacked on top of each other. The lines are all the same color, a light blue, and they create a sense of depth and movement. The logo is simple and abstract, and it could be used to represent a variety of things, such as water, waves, or sound.

510(k) Summary For K231488 VERIFY VH2O2 Indicator Tape

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Manufacturing Facility

Hi-Tech Products 8530 Roland Street Buena Park, CA 90621

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 Tony piotrkowski(@steris.com

Submission Date: May 22, 2023

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1. Predicate Device

Trade Name: Common/Usual Name: Classification: Classification Name: 510(k) Submitter/Holder: 510(k) Number:

VERIFY VH2O2 Indicator Tape Chemical Indicator Class II Physical/chemical Sterilization Process Indicator STERIS Corporation K183293

2. Device Description

3. Indications for Use:

The tape may be used in the following sterilization cycles:

. Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX 2, 60, and s2 Low Temperature Sterilization Systems.
STERRAD® 100S Sterilizer (Default Cycle)
. Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX . Sterilizer without ALLClear.

4. Technological Characteristics

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STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY VH2O2 Indicator Tape

Feature	Proposed: VERIFY VH2O2 Indicator Tape	Predicate: VERIFY VH2O2 IndicatorTape (K183293)	Comparison
Intended UseincludingSterilizationMethod andCycles	The Indicator Tape is intended to secure itemswrapped in synthetic wrap materials until usedand to distinguish between processed andunprocessed units through a color changefrom the start color (pink) to peach, yellow orlighter. The Indicator Tape is also intended tobe used as an external process indicator whenapplied to synthetic wrap materials and/orTyvek pouches.The tape may be used in the followingsterilization cycles:Lumen, Non Lumen, Flexible, Fast NonLumen, Fast, and Specialty Cycles of theV-PRO: 1, 1 Plus, maX, maX 2, 60, ands2 Low Temperature SterilizationSystems.STERRAD® 100S Sterilizer (DefaultCycle)Standard and Advanced Cycles of theSTERRAD® NX Sterilizer with orwithout ALLClearStandard, Flex Scope, Express and DUOCycles of the STERRAD® 100NX	The Indicator Tape is intended to secure itemswrapped in synthetic wrap materials until usedand to distinguish between processed andunprocessed units through a color changefrom the start color (pink) to peach, yellow orlighter. The Indicator Tape is also intended tobe used as an external process indicator whenapplied to synthetic wrap materials and/orTyvek pouches.The tape may be used in the followingsterilization cycles:Lumen, Non Lumen, Fast Non Lumen,Fast and Flexible Cycles of the V-PRO:1, 1 Plus, maX, maX 2 and s2 LowTemperature Sterilization Systems.STERRAD® 100S Sterilizer (DefaultCycle)Standard and Advanced Cycles of theSTERRAD® NX Sterilizer with orwithout ALLClearStandard, Flex Scope, Express and DUOCycles of the STERRAD® 100NX	The IntendedUse of has beenmodified toinclude theSpecialty Cycleof the V-PROmaX 2.Inclusion of theV-PRO 60. TheIndicator Tapewas cleared foruse in the V-PRO 60 inK172753 butwasinadvertentlyleft off theindications inK183293
	Sterilizer without ALLClear	Sterilizer without ALLClear
ChemicalIndicatorAgent andPerformanceSpecification	The indicator agent is a vaporized hydrogenperoxide reactive ink that meets therequirement specified in ANSI/AAMI/ISO11140-1:2014 for a Type 1 Process Indicatorfor a vaporized hydrogen peroxide process	The indicator agent is a vaporized hydrogenperoxide reactive ink that meets therequirement specified in ANSI/AAMI/ISO11140-1:2014 for a Type 1 Process Indicatorfor a vaporized hydrogen peroxide process	Identical
End PointSpecification	Tape: Pink to Peach/Yellow	Tape: Pink to Peach/Yellow	Identical
DeviceDesign	Tape: 3/4" wide by 60 yards long crepe(masking) tape which is wound around a 3"core. A hydrogen peroxide reactive ink is laiddown on the non-adhesive surface. The ink isprotected from transfer to the adhesive via acoating.	Tape: 3/4" wide by 60 yards long crepe(masking) tape which is wound around a 3"core. A hydrogen peroxide reactive ink is laiddown on the non-adhesive surface. The ink isprotected from transfer to the adhesive via acoating.	Identical
Shelf Life	24 months	24 months	Identical
PerformanceLimitations(taken frominstructionsfor use)	Do not overlap the tape onto itself as this mayprevent the underlying layer from beingappropriately exposed to hydrogen peroxideresulting in a failed indicator response.	Do not overlap the tape onto itself as this mayprevent the underlying layer from beingexposed to hydrogen peroxide resulting in afailed indicator response.	Identical

Table 4.1 Comparison of the Proposed VERIFY | VH2O2 Indicator Tape with the Predicate

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STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY VH2O2 Indicator Tape

ട്. Performance Testing

Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.

Table 5-8. Verification Results Summary

Testing	Acceptance Criteria	Study Result
Simulated Use Testing	• Complete color change• Remain adhered after cycle	• Complete color change• Remained adhered after cycle

The results of the performed testing demonstrate that the VERIFY [VH2O2 Indicator Tape performs as intended.

6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device (K183293, Class II as per 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).