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 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.

A version of the Celerity™ HP Chemical Indicator (CI) may be utilized on the V24 Self-Contained Biological Indicator Vial Label and 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 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

. 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.

A version of the Celerity™ HP Chemical Indicator may be utilized on the V24 Self-Contained Biological Indicator Vial Label and 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 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 those systems with ALLClear Technology

The CI is composed of the following components:

Substrate ●
Indicator Ink

The PI is composed of the following components

Substrate
Indicator Ink
Adhesive ●
Backing Paper

AI/ML Overview

This document describes the Celerity™ HP Chemical Indicator (CI), a Type 1 vaporized hydrogen peroxide sterilization process indicator. The device is designed to distinguish between processed and unprocessed units through a visible color change from red to orange/yellow when exposed to specific sterilization cycles of V-PRO® Low Temperature Sterilization Systems and ASP® STERRAD® Systems.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test Name	Description / Standard	Reported Device Performance
Type 1 Performance Testing	Conformance to ANSI/AAMI/ISO 11140-1:2014 requirements for a Type 1 Hydrogen Peroxide Chemical Indicator.	Pass
Simulated Use Testing	Simulation of typical in-use applications to verify performance.	Pass
Fluorescent Light Stability Testing	Assessment of indicator stability under fluorescent light exposure.	Pass
Temperature Extremes Exposure (Freeze/Thaw) Testing	Evaluation of indicator performance after exposure to extreme temperatures.	Pass
Transference Testing	Evaluation to ensure ink does not transfer from the indicator to other materials.	Pass
Adhesion Stability (Vials) Testing	Evaluation of the adhesive's stability for the version used on Self-Contained Biological Indicator Vial Labels.	Pass
Shelf Life Testing	Determination of the product's stability and performance over its intended shelf life.	Pass
Post-Processing Stability Testing	Evaluation of the indicator's stability and color integrity after being processed through sterilization cycles.	Pass

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

The document does not explicitly state the sample sizes used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). However, it implies that the testing was conducted by STERIS Corporation or its subsidiary Albert Browne Ltd., located in the United Kingdom. Given the nature of chemical indicator testing, it is likely that the testing involved multiple samples for each stress/condition investigated. The studies are non-clinical performance data, implying these were laboratory-based experiments.

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

This information is not applicable to a chemical indicator device. The "ground truth" for chemical indicators is based on whether the indicator changes color in response to specific sterilization parameters (e.g., presence of hydrogen peroxide) and according to established international standards (ANSI/AAMI/ISO 11140-1:2014). This is a physical or chemical reaction, not a subjective interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The color change of a chemical indicator is a direct, observable outcome, not subject to human adjudication in the same way as, for example, image interpretation. The "adjudication" is essentially a pass/fail determination based on the observable color change as per the device's design and specified standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for devices that rely on human interpretation, such as imaging AI algorithms, to assess the impact of the device on reader performance. Chemical indicators do not involve human interpretation in this manner.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance tests of the chemical indicator itself. The device is a "Type 1 process indicator," meaning it provides a visual confirmation of exposure to the sterilization process. Its function is entirely automated in terms of its chemical reaction to sterilization conditions; there is no "human-in-the-loop" performance aspect in the mechanism of the indicator itself. Its performance is assessed purely on its ability to change color accurately under specified conditions.

7. The Type of Ground Truth Used

The ground truth used for this chemical indicator's performance evaluation is based on controlled exposure to validated sterilization cycles and conformance to established international standards (ANSI/AAMI/ISO 11140-1:2014). The expected color change (red to orange/yellow) when exposed to these conditions, and the lack of change when not exposed, constitutes the ground truth.

8. The Sample Size for the Training Set

No training set is mentioned or applicable. Chemical indicators operate based on chemical reactions; they do not involve machine learning algorithms that require training data.

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

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

Summary

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

K183295

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:

Gregory Land Senior Regulatory Affairs Specialist

Telephone: (440) 392-7424 Fax No: (440) 357-9198 Greg_land@steris.com

December 21, 2018 Submission Date:

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

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1. Predicate 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 Scope or Duo cycles of an ASP ● STERRAD® System, including those systems with ALLClear Technology.

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

2.1 Physical Description - Design, Construction, Components

The CI is composed of the following components:

Substrate ●
Indicator Ink

The PI is composed of the following components

Substrate
Indicator Ink
Adhesive ●
Backing Paper

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The Substrate material for the CI is polypropylene (Construction C). The substrate for the PI (Construction B) is spun-bonded polyolefin with and adhesive back and a glassine backing paper. The glassine backing paper serves as a carrier for the label and is removed prior to use of the PI.

The Indicator Ink is the same for both substrates of the CI (Construction C) and the PI (Construction B). The composition of the indicator ink is not known as it is a proprietary formulation, product code INK-PF2-RY, sold by Crosstex International, Inc. of Rush, NY.

3. Indications for Use:

. 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.

. 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.

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 ink, 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 yellow.

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Table 1 contains a comparison of technological characteristics and specifications of the proposed Celerity™ HP Chemical Indicator Constructions B and C to the predicate Verify® V-PRO Chemical Indicator – Version 1C and 2C.

Feature	K183295Proposed CelerityTM HPChemical Indicator (CI)	K172746VERIFY® V-PROChemical IndicatorVersions 1C and 2C	Comparison
Intended use	The CelerityTM HPChemical Indicator is aType 1 vaporized hydrogenperoxide sterilizationprocess indicator. It isdesigned to distinguishbetween processed andunprocessed units, whenplaced within packs to besterilized, through a visiblechange from red toorange/yellow, when thedevice has been exposed tothe: Lumen, Non Lumen,Flexible, Fast Non Lumenor Fast sterilization cycle ofa V-PRO® LowTemperature SterilizationSystem, or Standard,Advanced, Express, FlexScope or Duo cycles of anASP® STERRAD®System, including thosesystems with ALLClearTechnology.A version of the CelerityTMHP Chemical Indicator maybe utilized on the V24 Self-Contained BiologicalIndicator Vial Label and isa Type 1 vaporizedhydrogen peroxidesterilization processindicator. It is designed todistinguish betweenprocessed and unprocessedSCBIs, whilst affixed toSCBI vials to be sterilized,through a visible changefrom red to orange/yellow,when the SCBI has beenexposed to the: Lumen,Non Lumen, Flexible, FastNon Lumen or Fast	The VERIFY® HPUChemical Indicator is aType 1 vaporizedhydrogen peroxidesterilization processindicator. It is designedto distinguish betweenprocessed andunprocessed units whenplaced within packs to besterilized to indicate,through visible changefrom magenta to yellow,when the device has beenexposed to the Lumen,Non-Lumen, Flexible orFast Non Lumensterilization cycle of a V-PRO® Low TemperatureSterilization System.The VERIFY® VaporizedVH2O2 ProcessIndicator Adhesive Labelis Type 1 vaporizedhydrogen peroxidesterilization processindicator. It is designedto distinguish betweenprocessed andunprocessed units, whenaffixed to packs to besterilized, through avisible color change frommagenta to yellow, whenthe pack has beenexposed to the Lumen,Non Lumen, Flexible orFast Non Lumensterilization cycle of a V-PRO® Low TemperatureSterilization System.	The Intended Usehas beenmodified in theproposed devicein order toinclude the FastCycle of the V-Pro s 2 Device.Additional use inthe Standard,Express, FlexScope or Duocycles of anASP®STERRAD®System, includingthose systemswith ALLClearTechnology.Have been added.
	K183295	K172746	Comparison
Feature	Proposed Celerity™ HPChemical Indicator (CI)	VERIFY® V-PROChemical IndicatorVersions 1C and 2C
	sterilization cycle of a V-PRO® Low TemperatureSterilization System, orStandard, Advanced,Express, Flex Scope or Duocycles of an ASPSTERRAD® System,including STERRAD NXand 100NX with ALLClearTechnology.
Devicedesign -components	Indicator Ink printed ontospun-bonded polyolefin withan adhesive and a glassinebacking (Construction B) andpolypropylene (ConstructionC)	Indicator Ink printed ontospun-bonded polyolefin(Version 1C) and spun bondedpolyolefin with an adhesiveand a glassine backing(Version 2C)	The proposed devicecontains the samecomponents as thepredicate device forConstruction B vsVersion 2C.Construction Cdiffers from Version1C in the materialfor the substrate.The predicate isspun-bondedpolyolefin and theproposed device ispolypropylene.
Indicatoragent	Non-transferable indicator inkof proprietary formulationwhich changes color whenexposed to VH2O2	Non-transferable indicator inkof proprietary formulationwhich changes color whenexposed to VH2O2	Same
Sterilizationmethod andcycles	Vaporized Hydrogen Peroxidein the V-PRO 1, V-PRO 1Plus, V-PRO maX, V-PRO 60,V-PRO maX 2, V-PRO s 2Low Temperature Sterilizersand ASP STERRAD 110S,NX and 100NX System,including those systems withALLClear Technology.	Vaporized Hydrogen Peroxidein the V-PRO 1, V-PRO 1Plus, V-PRO maX, V-PRO 60and V-PRO max 2 LowTemperature Sterilizers	The sterilizationcycles for the V-PRO s 2 and ASPSTERRAD 110S,NX and 100NXSystems, includingthose systems withALLClearTechnology, arebeing added for theproposed device.
Endpointspecifications	No Endpoint Specifications(Type 1 Process Indicator)	No Endpoint Specifications(Type 1 Process Indicator)	Same
Feature	K183295Proposed CelerityTM HPChemical Indicator (CI)	K172746VERIFY® V-PROChemical IndicatorVersions 1C and 2C	Comparison
Side by sidetesting withbiologicalindicators?	No	No	Same
Specification	Conforms toANSI/AAMI/ISO 11140-1:2014 requirements for aType 1 Hydrogen PeroxideChemical Indicator	Conforms toANSI/AAMI/ISO 11140-1:2005 requirements for aClass 1 Hydrogen PeroxideChemical Indicator	Proposed deviceconforms to themost recent versionof the standard.

Table 1. Device Comparison Table

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STERIS Abbreviated 510(k) PREMARKET NOTIFICATION

CELERITY HP Chemical Indicator (CI)

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

Summarv

The predicate and proposed devices are identical with regards to all features except for the indications for use and materials. The differences between the proposed Celerity™ HP Chemical Indicator and the predicate device are limited to a change in the indicator ink, material in construction C and the proposed claims to include the V-PRO s 2 Low Temperature Sterilization System and associated Lumen, Non Lumen, Flexible and Fast Cycles, and the ASP® STERRAD® 110S, NX and 100NX Systems and associated Standard, Advanced, Express, Flex Scope and Duo cycles with ALLClear technology. The differences between the proposed VERIFY V24 Self-Contained Biological Indicator Vial Label and the predicate device are limited to a change in the indicator ink and the proposed claims to include the V-PRO s 2 Low Temperature Sterilization System and associated Lumen, Non Lumen, Flexible and Fast Cycles, and the ASP® STERRAD® 110S, NX and 100NX Systems and associated Standard, Advanced, Express, Flex Scope and Duo cycles with ALLClear technology.

ട. Performance Testing

Performance testing was conducted to verify that the proposed VERIFY® V-PRO 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 2 summarizes the verification activities that were performed, with their respective Report Name, location in the submission 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 predefined 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 ASP STERRAD 110S, NX and 100NX Systems, including those systems with ALLClear Technology.

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Testing	Report	StudyResult
Type 1 PerformanceTesting	RDP186-VER1	Pass
Simulated Use Testing	RDP186-VAL1	Pass
Fluorescent LightStability Testing	RDP186-VER2	Pass
Temperature ExtremesExposure (Freeze/Thaw)Testing	RDP186-VER4	Pass
Transference Testing	RDP186-VER3	Pass
Adhesion Stability(Vials)Testing	RDP186-SSL3	Pass
Shelf Life Testing	E120-SSL1	Pass
Post-Processing StabilityTesting	RDP186-SSL1	Pass

Table 2. Verification Results Summary

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 perform at least as safely and effectively as the legally marketed predicate device (K172746, Class II (21 CFR 880.2800), product code JOJ.

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Indications for Use

510(k) Number (if known) K183295

Device Name Celerity HP Chemical Indicator (CI)

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.

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

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January 4, 2019

Steris Corporations Gregory Land Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K183295

Trade/Device Name: Celerity HP Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: November 26, 2018 Received: November 27, 2018

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elizabeth F. Claverie -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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).