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, when the device has been exposed to the:

· Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast 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™ Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:

· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast 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 STERRAD NX and 100NX with ALLClear Technology.

The VERIFY V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:

· Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast 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 STERRAD NX and 100NX with ALLClear Technology.

Device Description

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 through a visible change from magenta to orange/yellow or lighter, when the device has been exposed to the:

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

The Celerity "10 HP Chemical indicator is provided in three formats:

Version 1: Celerity™ Chemical Indicator (CI) .
. Version 2: Celerity™ Vaporized |VH2O2 Process Indicator Adhesive Label (PI)
Version 3: VERIFY V24 Self-Contained Biological Indicator Vial Label (PI)

The three formats differ in their intended location inside the load to be sterilized. Version 1 is to be placed inside a pack to be sterilized. Version 2 is to be affixed to the outside of a pack by means of the adhesive back. Version 3 is to be affixed to the outside of a Self-Contained Biological Indicator by means of the adhesive back.

The proposed devices are manufactured by application of the indicator ink by printing onto a substrate in a variety of shapes in three constructions:

Construction C Polypropylene ●
Construction B - Spun-bonded polyolefin with an adhesive and a glassine backing paper
Construction D - polypropylene with an adhesive and a glassine backing paper.

The proposed devices will consist of one of the above substrates with an indicator ink printed thereon.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Testing Category	Methodology	Acceptance Criteria	Study Result
Type 1 Performance Testing	ANSI/AAMI/ISO 11140-1:2014	- When exposed to VHP Resistometer cycles at the Fail parameters (Test Points 2 and 3): 100% Celerity™ HP Chemical Indicator stripes must show a FAIL result.- When exposed to VHP Resistometer cycles at the Pass condition (Test Point 1): Minimum 90% Celerity™ HP Chemical Indicator stripes must show a PASS result.	Pass
Simulated Use Testing	Internal Method Used	- When exposed to V-PRO maX Non Lumen 1/84 cycles with ≥50 lb load (Fail condition): 100% Celerity™ HP Chemical Indicator stripes must show a FAIL result.- When exposed to V-PRO and STERRAD cycles with the worst case loads: Minimum 90% Celerity™ HP Chemical Indicator stripes must show a PASS result.	Pass
Fluorescent Light Stability Testing	Internal Method & ANSI/AAMI/ISO 11140-1:2014	- Indicator start color to remain unchanged after exposure to fluorescent lighting for ≥ 30 days before processing.- When exposed to VHP Resistometer cycles at the Fail parameters following exposure to fluorescent lighting for ≥ 30 days: 100% of Indicators tested must show a FAIL results (non-visible color change or color change to another color except orange/yellow).- When exposed to VHP Resistometer cycles at the PASS parameters following exposure to fluorescent lighting for ≥ 30 days: Minimum 90% Indicators tested must show a PASS result (orange/yellow or lighter).	Pass
Temperature Extremes Exposure (Freeze/Thaw) Testing	Internal Method & ANSI/AAMI/ISO 11140-1:2014	- Indicator start color to remain unchanged after exposure to extreme temperatures before processing.- When exposed to VHP Resistometer cycles at the Fail parameters following exposure to extreme temperatures: 100% of Indicators tested must show a FAIL results (non-visible color change or color change to another color except orange/yellow).- When exposed to VHP Resistometer cycles at the PASS parameters following exposure to extreme temperatures: Minimum 90% Indicators tested must show a PASS result (orange/yellow or lighter).	Pass
Transference Testing	ANSI/AAMI/ISO 11140-1:2014	- Indicators placed between a piece of the same substrate and held together with tape, then processed in a double V-PRO maX 2 Lumen cycle (no load) and evaluated for off-set, bleed and migration.	Pass
		- Samples with reference and text ink processed in a double V-PRO maX 2 Lumen cycle (no load) and evaluated for smearing, discoloration and fading.	Pass
Adhesion Stability (Vials) Testing	Internal Method Used	- When exposed to two consecutive V-PRO maX 2 Lumen cycles: • 0% samples show bleeding of the adhesive• 100% must be firmly affixed• 0% must show signs of peeling• Minimum 90% must show a PASS result	Pass
Shelf Life Testing	ANSI/AAMI/ISO 11140-1:2014	- After the process indicator has been aged: Minimum of 90% of indicators must PASS Type 1 PASS conditions.- After the process indicator has been aged: 100% of indicators must FAIL.	Pass
Post-Processing Stability Testing	Internal Method Used	- Indicator processed ink color remains unchanged for a minimum of 6 months following exposure to a PASS or FAIL cycle.	Pass

2. Sample Size and Data Provenance for Test Set:

The document does not explicitly state the specific sample sizes (number of indicators) used for each individual test in the performance studies. However, for "Type 1 Performance Testing", "Simulated Use Testing", "Fluorescent Light Stability Testing", "Temperature Extremes Exposure Testing", "Shelf Life Testing", and "Adhesion Stability (Vials) Testing", the acceptance criteria mention percentages (e.g., "100% Celerity™ HP Chemical Indicator stripes", "Minimum 90% Celerity™ HP Chemical Indicator stripes"). This implies that multiple indicators were tested for each condition.

The data provenance is not explicitly stated in terms of country of origin. The manufacturing facility is in the United Kingdom, but the testing may have occurred elsewhere. The studies are described in the context of a 510(k) submission, which typically involves prospective testing designed to meet regulatory requirements.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

This information is not provided. The performance testing for these chemical indicators relies on objective color changes and adherence to established standards (ANSI/AAMI/ISO 11140-1:2014), rather than expert interpretation of the results. The 'ground truth' is the objective physical change of the chemical indicator based on exposure to sterilization conditions.

4. Adjudication Method for the Test Set:

Not applicable. The performance testing for chemical indicators is based on objective observable color changes and compliance with quantitative standards, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret images or other data, and the comparison is how AI assistance affects their diagnostic accuracy. Chemical indicators, like the Celerity™ HP, are designed for direct visual interpretation of a color change, not complex interpretation by multiple human readers.

6. Standalone (Algorithm Only) Performance Study:

Yes, the studies described are standalone performance studies of the chemical indicator itself. The device is a "Type 1 vaporized hydrogen peroxide sterilization process indicator" that provides a direct visual cue (color change) to indicate exposure to sterilization conditions. Its performance is evaluated based on its intrinsic ability to change color accurately under specific conditions, without human interpretation beyond basic color recognition.

7. Type of Ground Truth Used:

The ground truth used is primarily based on physical exposure to defined sterilization conditions (VHP Resistometer cycles at specific "Fail parameters" and "Pass condition", and various V-PRO and STERRAD cycles with worst-case loads). The observable color change (or lack thereof) in the chemical indicator is then compared against these known exposure conditions to determine if the indicator provides an accurate visual signal according to the standard.

8. Sample Size for Training Set:

Not applicable. Chemical indicators are passive devices that rely on a chemical reaction for their function, not on machine learning algorithms that require a "training set" of data.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".

September 5, 2019

STERIS Corporation Gregory Land Sr Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44077

Re: K192020

Trade/Device Name: Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label Regulation Number: 21 CFR 21CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: August 28, 2019 Received: August 29, 2019

Dear Gregory Land:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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)

K192020

Device Name Celerity HP Chemical Indicator

Indications for Use (Describe)

· Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

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Indications for Use

510(k) Number (if known)

K192020

Device Name Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label

Indications for Use (Describe)

· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast 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 STERRAD NX and 100NX with ALLClear Technology.

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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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Indications for Use

510(k) Number (if known)

K192020

Device Name VERIFY V24 Self-Contained Biological Indicator Vial Label

Indications for Use (Describe)

· Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast 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 STERRAD NX and 100NX with ALLClear Technology.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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/5/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in large, bold, black font at the top of the image. Below the word STERIS is a graphic of several horizontal wavy lines in shades of blue. The STERIS logo is simple and modern.

510(k) Summary For Celerity™ HP Chemical Indicator

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 Chancery House Rayns Way Watermead Business Park System Leicester LE7 1PF United Kingdom

Contact: Gregory Land Senior Regulatory Affairs Specialist Telephone: (440) 392-7424 Fax No: (440) 357-9198

Greg_Land@steris.com

Submission Date: September 5, 2019

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

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1. Predicate Device and Reference Device

1.1 Predicate Device

Trade Name:	Celerity™ HP Chemical Indicator & VERIFY V24Self-Contained Biological Indicator Vial Label
Common/Usual Name:	Chemical Indicator
Classification:	Class II
Classification Name:	Physical/chemical sterilization process indicator
510(k) Submitter/Holder:	STERIS Corporation
510(k) Number:	K183295

1.2 Reference Device

Trade Name:	VERIFY® V-PRO 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:	K172746

2. Device Description

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

The Celerity "10 HP Chemical indicator is provided in three formats:

Version 1: Celerity™ Chemical Indicator (CI) .
. Version 2: Celerity™ Vaporized |VH2O2 Process Indicator Adhesive Label (PI)
Version 3: VERIFY V24 Self-Contained Biological Indicator Vial Label (PI)

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Table 1 below contains information related to the different constructions and use locations of the 3 versions of the proposed device.

Version 1, the Celerity™ HP Chemical Indicator (CI) 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 magenta to orange/vellow or lighter, when the device has been exposed to the:

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

Version 2, The Celerity™ Vaporized | VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:

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

Version 3, the VERIFY® V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the SCBI has been exposed to the:

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

2.1 Physical Description - Design, Construction, Components

The proposed devices are manufactured by application of the indicator ink by printing onto a substrate in a variety of shapes in three constructions:

Construction C Polypropylene ●
Construction B - Spun-bonded polyolefin with an adhesive and a glassine backing paper

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● Construction D - polypropylene with an adhesive and a glassine backing paper.

The proposed devices will consist of one of the above substrates with an indicator ink printed thereon.

Note that for Constructions B and D, the glassine backing paper serves as a carrier for the label and is removed from the VERIFY® V24 Self-Contained Biological Indicator Vial Label and Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label prior to affixing to a surface and processing.

Table 1 Correlates the three versions of the device to the constructions of substrates.

	Version 1:Celerity™Chemical Indicator	Version 2:Vaporized VH2O2Process IndicatorAdhesive Label	Version 3: VERIFY®V24 Self-ContainedBiological IndicatorVial Label
Construction	C	B or D	B or D
Use Location	Within pack	Affixed to outside ofpack	Affixed to outside ofSelf-ContainedBiological Indicator

Table 1: Construction Materials and Use Locations

3. Indications for Use: Indications for Use – Celerity™ HP Chemical Indicator 3.1

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 magenta to orange/yellow or lighter, when the device has been exposed to the:

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

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Indications for Use – Celerity™ Vaporized VH2O2 Process Indicator 3.2 Adhesive Label

The Celerity™ Vaporized | H2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:

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

Indications for Use – VERIFY® V24 Self-Contained Biological Indicator 3.3 Vial Label

The VERIFY® V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the SCBI has been exposed to the:

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

4. Technological Characteristics

The proposed and predicate devices are Type 1 single use process 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 or red to orange/vellow, respectively.

Table 2 contains a comparison of technological characteristics and specifications of the proposed Celerity™ HP Chemical Indicator to Predicate 1, Celerity™ HP Chemical Indicator & VERIFY V24 Self-Contained Biological Indicator Vial Label.

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Feature	ProposedCelerity™ HP ChemicalIndicatorConstructionsB, C and D	K183295Celerity™ HP ChemicalIndicatorConstructions B and C	Comparison
Indications forUse –Celerity™ HPChemicalIndicator	The Celerity™ HP ChemicalIndicator is a Type 1 vaporizedhydrogen peroxide sterilizationprocess indicator. It is designedto distinguish between processedand unprocessed units, whenplaced within packs to besterilized, through a visiblechange from magenta toorange/yellow or lighter, whenthe device has been exposed tothe:Lumen, Non Lumen, Flexible,Fast Non Lumen or Faststerilization cycle of a V-PRO®Low Temperature SterilizationSystem, orStandard, Advanced, Express,Flex or Duo cycles of an ASPSTERRAD® System, includingthose systems with ALLClearTechnology.	The Celerity™ HP ChemicalIndicator is a Type 1 vaporizedhydrogen peroxide sterilizationprocess indicator. It is designedto distinguish between processedand unprocessed units, whenplaced within packs to besterilized, through a visiblechange from red toorange/yellow, when the devicehas been exposed to the:Lumen, Non Lumen, Flexible,Fast Non Lumen or Faststerilization cycle of a V-PRO®Low Temperature SterilizationSystem, orStandard, Advanced, Express,Flex or Duo cycles of an ASPSTERRAD® System, includingthose systems with ALLClearTechnology.	Similar
Feature	ProposedCelerity™ HP ChemicalIndicatorConstructionsB, C and D	K183295Celerity™ HP ChemicalIndicatorConstructions B and C	Comparison
Indicationsfor Use –VERIFY®V24 Self-ContainedBiologicalIndicatorVial Label	The V24 Self-ContainedBiological Indicator Vial Label isa Type 1 vaporized hydrogenperoxide sterilization processindicator. It is designed todistinguish between processedand unprocessed SCBIs, whilstaffixed to SCBI vials to besterilized, through a visiblechange from magenta toorange/yellow or lighter, whenthe SCBI has been exposed tothe: Lumen, Non Lumen,Flexible, Fast Non Lumen or Faststerilization cycle of a V-PRO®Low Temperature SterilizationSystem, or Standard, Advanced,Express, Flex or Duo cycles of anASP STERRAD® System,including those systems withALLClear Technology.	The V24 Self-ContainedBiological Indicator Vial Label isa Type 1 vaporized hydrogenperoxide sterilization processindicator. It is designed todistinguish between processedand unprocessed SCBIs, whilstaffixed to SCBI vials to besterilized, through a visiblechange from red toorange/yellow, when the SCBIhas been exposed to the: Lumen,Non Lumen, Flexible, Fast NonLumen or Fast sterilization cycleof a V-PRO® Low TemperatureSterilization System, or Standard,Advanced, Express, Flex or Duocycles of an ASP STERRAD®System, including those systemswith ALLClear Technology.	Similar
Indicationsfor Use –Celerity™VaporizedVH2O2ProcessIndicatorAdhesiveLabel	The Celerity™ VaporizedVH2O2 Process IndicatorAdhesive Label is a Type 1vaporized hydrogen peroxidesterilization process indicator. Itis designed to distinguishbetween processed andunprocessed packs, whilstaffixed to packs to be sterilized,through a visible change frommagenta to orange/yellow orlighter, when the pack has beenexposed to the: Lumen, NonLumen, Flexible, Fast NonLumen or Fast sterilization cycleof a V-PRO® Low TemperatureSterilization System, orStandard, Advanced, Express,Flex or Duo cycles of an ASPSTERRAD® System, includingthose systems with ALLClearTechnology.	The V24 Self-ContainedBiological Indicator Vial Label isa Type 1 vaporized hydrogenperoxide sterilization processindicator. It is designed todistinguish between processedand unprocessed SCBIs, whilstaffixed to SCBI vials to besterilized, through a visiblechange from red toorange/yellow, when the SCBIhas been exposed to the: Lumen,Non Lumen, Flexible, Fast NonLumen or Fast sterilization cycleof a V-PRO® Low TemperatureSterilization System, or Standard,Advanced, Express, Flex or Duocycles of an ASP STERRAD®System, including those systemswith ALLClear Technology.	Similar
Feature	ProposedCelerity™ HP ChemicalIndicatorConstructionsB, C and D	K183295Celerity™ HP ChemicalIndicatorConstructions B and C	Comparison
Device design-components	Indicator Ink printed spun-bondedpolyolefin with an adhesive and aglassine backing (Construction B)polypropylene (Construction C)and polypropylene substrate withan adhesive supplied and abacking paper (Construction D)	Indicator Ink printed onto spun-bonded polyolefin with anadhesive and a glassine backing(Construction B) andpolypropylene (Construction C)	Similar
Indicatoragent	Non-transferable indicator ink ofproprietary formulation whichchanges color when exposed toVH2O2	Non-transferable indicator ink ofproprietary formulation whichchanges color when exposed toVH2O2	Same
Sterilizationmethod andcycles	Vaporized Hydrogen Peroxide inthe V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60, V-PROmaX 2, V-PRO s 2 LowTemperature Sterilizers and ASPSTERRAD 100S, NX and 100NXSystem, including those systemswith ALLClear Technology.	Vaporized Hydrogen Peroxide inthe V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60, V-PROmaX 2, V-PRO s 2 LowTemperature Sterilizers and ASPSTERRAD 100S, NX and 100NXSystem, including those systemswith ALLClear Technology.	Same
Endpointspecifications	No Endpoint Specifications(Type 1 Process Indicator)	No Endpoint Specifications(Type 1 Process Indicator)	Same
Side by sidetesting withbiologicalindicators?	No	No	Same
Specification	Conforms to ANSI/AAMI/ISO11140-1:2014 requirements for aVH2O2 Type 1 ProcessIndicator	Conforms to ANSI/AAMI/ISO11140-1:2014 requirements for aVH2O2 Type 1 ProcessIndicator	Same

Table 2. Device Comparison to Predicate 1, Celerity™ HP Chemical Indicator & VERIFY V24 Self-Contained Biological Indicator Vial Label

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Summary

The predicate and proposed devices are identical with regards to all features except for the materials. The differences between the proposed Celerity™ HP Chemical Indicator (Version 1) and the predicate Celerity™ HP Chemical Indicator (K183295, Construction C) are limited to a change in the indicator ink. The mechanism of action is the same. The starting color was amended from Red to Magenta and the endpoint when exposed to the defined processing conditions, was amended to "orange/yellow or lighter.

The differences between the proposed VERIFY V24 Self-Contained Biological Indicator Vial Label to the predicate VERIFY V24 Self-Contained Biological Indicator

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Vial Label (K183295, Construction B) are limited to a change to the indicator ink and the addition of a substrate, polypropylene with an adhesive back and a glassine backing paper (Construction D). The mechanism of action is the same. The starting color was amended from Red to Magenta and the endpoint when exposed to the defined processing conditions, was amended to "orange/yellow or lighter.

Version 3 of the proposed device, the Celerity™ Vaporized | VH2O2 Process Indicator Adhesive Label is similar to the predicates VERIFY V24 Self-Contained Biological Indicator Vial Label, K183295. The differences between the proposed and the predicate device are limited to a change to the indicator ink and the addition of a substrate (Construction D); the later two changes are the subject of this submission. The mechanism of action is the same. The starting color was amended from Red to Magenta and the endpoint when exposed to the defined processing conditions, was amended to "orange/yellow or lighter.

ട്. Performance Testing

Performance testing was conducted to verify that the proposed Celerity™ HP Chemical Indicator meets the requirements for Type 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2014. Additional testing was completed to simulate typical in-use applications.

Table 4 summarizes the verification activities that were performed. with their respective Report Name and result to demonstrate that the proposed Celerity™ HP Chemical Indicator is safe and effective. These studies confirm that the proposed device's performance meets the requirements of its pre-defined acceptance criteria and intended uses, and qualify the proposed device for use in the V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60, V-PRO maX 2 and V-PRO s 2 Low Temperature Sterilization Systems and Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

Table 4. Verification Results Summary

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Testing	Methodology	Acceptance Criteria	StudyResult
Type 1 PerformanceTesting	ANSI/AAMI/ISO11140-1:2014	When exposed to VHPResistometer cycles atthe Fail parameters(Test Points 2 and 3):100% Celerity™ HPChemical Indicatorstripes must show aFAIL result.	Pass
		When exposed to VHPResistometer cycles atthe Pass condition(Test Point 1):Minimum 90%Celerity™ HPChemical Indicatorstripes must show aPASS result.	Pass
Simulated UseTesting	Internal MethodUsed	When exposed to V-PRO maX Non Lumen1/84 cycles with ≥50lb load (Failcondition): 100%Celerity™ HPChemical Indicatorstripes must show aFAIL result.	Pass
		When exposed to V-PRO and STERRADcycles with the worstcase loads: Minimum90% Celerity™ HPChemical Indicatorstripes must show aPASS result	Pass
Testing	Methodology	Acceptance Criteria	StudyResult
Fluorescent LightStability Testing	Internal Method&ANSI/AAMI/ISO11140-1:2014	Indicator start color toremain unchangedafter exposure tofluorescent lighting for≥ 30 days beforeprocessing.	Pass
		When exposed to VHPResistometer cycles atthe Fail parametersfollowing exposure tofluorescent lighting for≥ 30 days: 100% ofIndicators tested mustshow a FAIL results(non-visible colorchange or colorchange to anothercolor exceptorange/yellow	Pass
		When exposed to VHPResistometer cycles atthe PASS parametersfollowing exposure tofluorescent lighting for≥ 30 days: Minimum90% Indicators testedmust show a PASSresult (orange/yellowor lighter)	Pass
TemperatureExtremes Exposure(Freeze/Thaw)Testing	Internal Method&ANSI/AAMI/ISO11140-1:2014	Indicator start color toremain unchangedafter exposure toextreme temperaturesbefore processing	Pass
Testing	Methodology	Acceptance Criteria	StudyResult
		When exposed to VHPResistometer cycles atthe Fail parametersfollowing exposure toextreme temperatures:100% of Indicatorstested must show aFAIL results (non-visible color change orcolor change toanother color exceptorange/yellow	Pass
		When exposed to VHPResistometer cycles atthe PASS parametersfollowing exposure toextreme temperatures:Minimum 90%Indicators tested mustshow a PASS result(orange/yellow orlighter)	Pass
Transference Testing	ANSI/AAMI/ISO11140-1:2014	Indicators placedbetween a piece of thesame substrate andheld together withtape, then processed ina double V-PRO maX2 Lumen cycle (noload) and evaluatedfor off-set, bleed andmigration.	Pass
Testing	Methodology	Acceptance Criteria	StudyResult
		Samples withreference and text inkprocessed in a doubleV-PRO maX 2 Lumencycle (no load) andevaluated forsmearing,discoloration andfading	Pass
Adhesion Stability(Vials)Testing	Internal MethodUsed	When exposed to twoconsecutive V-PROmaX 2 Lumen cycles:• 0% samplesshow bleeding of theadhesive• 100% must befirmly affixed• 0% must showsigns of peeling• Minimum 90%must show a PASSresult	Pass
Shelf Life Testing	ANSI/AAMI/ISO11140-1:2014	After the processindicator has beenaged: Minimum of90% of indicatorsmust PASS Type 1PASS conditions.	Pass
		After the processindicator has beenaged: 100% ofindicators must FAIL	Pass
Testing	Methodology	Acceptance Criteria	StudyResult
Post-ProcessingStability Testing	Internal MethodUsed	Indicator processedink color remainsunchanged for aminimum of 6 monthsfollowing exposure toa PASS or FAIL cycle	Pass

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The results of the Celerity™ HP Chemical Indicator performance testing demonstrate that all three models of the device, Celerity™ HP Chemical Indicator (Construction C), V24 Self-Contained Biological Indicator Vial Label and Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label (Constructions B and D), perform 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 as well as or better than the legally marketed predicate device (K183295, 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).