The Celerity™ HP 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 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.

Device Description

The Celerity™ HP 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 multivariable indicator claims.

AI/ML Overview

The provided text describes the acceptance criteria and study results for the CELERITY HP Chemical Indicator, a medical device used to monitor sterilization cycles. Here's a breakdown of the information requested:

Acceptance Criteria and Device Performance

1. Table of acceptance criteria and the reported device performance:

Testing	Purpose	Acceptance Criteria	Study Result
Multivariable CI Performance Testing	Demonstrates that the indicator reacts to all critical variables (time, temperature, and sterilant concentration) of the sterilization process.	Pass testing per Table 8 of ISO 11140-1:2014 (complete color change)	Pass. All CI show a complete color change.
		Fail testing per Table 8 of ISO 11140-1:2014 (incomplete color change)	Pass. All CI show an incomplete color change.
Endpoint color stability	Demonstrates that the processed indicator color does not significantly change over the labeled time period.	Color remains stable	Pass. Color stable up to 15 months.
Simulated Use Testing (Leveraged from K192020)	Demonstrates that the indicator performs as expected in a commercial sterilizer with worst-case load.	Complete color change in a full cycle. Incomplete color change in an abbreviated cycle.	Pass. Complete color change in a full cycle. Incomplete color change in an abbreviated cycle.

Regarding the other information, the provided text does NOT contain details about the following aspects, which are typically relevant for AI/ML-based medical devices or studies involving human readers:

2. Sample size used for the test set and the data provenance: This information is not explicitly stated. The study refers to "All CI" for the multivariable performance, implying a batch of Chemical Indicators were tested. The provenance (country of origin, retrospective/prospective) is also not detailed, though the manufacturing facility is in the United Kingdom.

3. Number of experts used to establish the ground truth for the test set and their qualifications: This device is a chemical indicator that shows a color change, not an AI/ML system requiring expert interpretation of images. Therefore, expert consensus on ground truth in that context is not applicable. The "ground truth" here is the physical reaction of the chemical indicator to specific sterilization parameters as defined by ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a chemical indicator.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical chemical indicator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical chemical indicator.

7. The type of ground truth used: The ground truth for this device's performance is established by ISO 11140-1:2014 standards for chemical indicators and verified by subjecting the indicators to controlled sterilization conditions with specified time, temperature, and sterilant concentration. The "complete color change" and "incomplete color change" are the physical manifestations defining the ground truth.

8. The sample size for the training set: Not applicable. This is an engineered chemical product, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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 seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

January 7, 2022

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

Re: K213262

Trade/Device Name: CELERITY HP Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: QKM Dated: December 7, 2021 Received: December 8, 2021

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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542 of the Act); 21 CFR 1000-1050.

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-

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,

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213262

Device Name Celerity™ HP Chemical Indicator

Indications for Use (Describe)

The Celerity™ HP 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 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.

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

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

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STI

510(k) Summary For 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

Submission Date:	January 6, 2022
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K213262 510K number:

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

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STERIS Traditional 510(k) PREMARKET NOTIFICATION K213262 CELERITY HP Chemical Indicator (CI)

1. Predicate Device

Trade Name:	3M™ Attest™ Vaporized Hydrogen Peroxide Tri-MetricChemical Indicator 1348/1348E
Common/Usual Name:	Chemical Indicator Classification:
	Class II
Classification Name:	Physical/chemical sterilization processindicator
510(k) Submitter/Holder:	3M Corporation
510(k) Number:	K203284

2. Device Description

3. Indications for Use

The Celerity™ HP 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 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 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 similar and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change.

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STERIS Traditional 510(k) PREMARKET NOTIFICATION K213262 CELERITY HP Chemical Indicator (CI)

Feature	Proposed: Celerity™ HP	Predicate: K203284, 3M Attest	Comparison
	Chemical Indicator	Tri-Metric Chemical Indicator
Intended Use /Indications forUse	The Celerity™ HP ChemicalIndicator is a vaporized hydrogenperoxide multivariable chemicalindicator. It is designed forroutine monitoring of thefollowing cycles:• Lumen, Non Lumen,Flexible, Fast Non Lumen orFast sterilization cycle of a V-PRO® Low TemperatureSterilization System, or• Standard, Advanced, Express,Flex or Duo cycles of an ASPSTERRAD® System, includingthose systems with ALLClearTechnology.	Use the 3MTM Attest™ VaporizedHydrogen Peroxide Tri-Metric ChemicalIndicator 1348/1348E for pack controlmonitoring of the following hydrogenperoxide sterilization sterilizers andcycles: STERRAD® 100S System,STERRAD® NX® System (Standard andAdvanced cycles), STERRAD® NX®System with AllClear™ Technology(Standard and Advanced cycles),STERRAD® 100NX® System (Standard,Flex, Express and Duo cycles)STERRAD® 100NX® System withAllClear™ Technology (Standard, Flex,Express and Duo cycles) vaporizedhydrogen peroxide sterilizers andSTERIS® V-PRO® 1 (Lumen cycle),STERIS® V-PRO® 1 Plus (Lumen andNon-Lumen cycles) and STERIS® V-PRO® maX Low TemperatureSterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS®V-PRO® 60 Temperature SterilizationSystem (Lumen, Non-Lumen andFlexible cycles), STERIS® V-PRO®maX 2 Temperature Sterilization System(Lumen, Non-Lumen, Flexible, and FastNon-lumen cycles), STERIS® V- PRO®s2 Low Temperature SterilizationSystem (Lumen, Non- Lumen, Flexible,and Fast cycles)	Both predicate and subjectindicators are used formonitoring the sameSTERRAD and V-PROsterilization cycles.
Device design	Indicator Ink printedonto polypropylene.	The 3MTM Attest™ VaporizedHydrogen Peroxide Tri-MetricChemical Indicator 1348/1348E is achemical indicator consisting of a non-cellulose based coated indicator stripsensitive to vaporized hydrogenperoxide, contained in a film laminate	Both proposed and predicatedevices have a VH2O2reactive ink on a non-cellulosic substrate thatdemonstrates a color changewhen exposed to VH2O2.
Indicator agent	Proprietary	Proprietary	Both proposed andpredicate devices have aVH2O2 reactive ink thatdemonstrates a colorchange when exposed toVH2O2.
Criticalparameters	4.7 mg/L - VH2O229 second - exposure time50 °C - exposure Temperature	5.1 mg/L - VH2O21 minute - exposure time50 °C - exposure Temperature	Both proposed andpredicate devices onlyreact when all the variablesare reached.
Color change	Magenta to orange/yellow orlighter yellow	Blue to pink with a moving dye front	Both proposed andpredicate devices use colorchanges that are the sameas other cleared devices.
Endpointstability	15 months	At least one month (4 weeks)	Both proposed and predicatedevices include labeling toindicate endpoint stability.

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

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STERIS Traditional 510(k) PREMARKET NOTIFICATION K213262 CELERITY HP Chemical Indicator (CI)

The predicate and proposed devices are similar in terms of basic scientific technology and indications for use. Testing is included in the submission to demonstrate that the proposed CI meets the criteria of a multivariable indicator and to extend the endpoint color stability. The multivariable indicator claims change the product code from JOJ to QKM. Both product codes are under regulation number 21 CFR 880.2800.

.. Performance Testing

Performance testing was conducted to verify that the proposed Celerity CI meets the requirements for multivariable chemical indicator using the Type 4 vaporized hydrogen peroxide sterilization indicator requirements defined in ANSI/AAMI/ISO 11140-1:2014. In addition, ongoing endpoint color stability testing has demonstrated stability throughout 15 months, so the labeling has been updated to reflect this.

Testing	Purpose	Acceptance Criteria	Study Result
Multivariable CIPerformanceTesting	Demonstrates that the indicatorreacts to all critical variables	Pass testing per Table 8of ISO 11140-1:2014	Pass. All CI show acomplete color change
	(time, temperature and sterilantconcentration) of thesterilization process.	Fail testing per Table 8of ISO 11140-1:2014	Pass. All CI show anincomplete color change
Endpoint colorstability	Demonstrates that theprocessed indicator color doesnot significantly change overthe labeled time period.	Color remains stable	Pass. Color stable up to15 months
Simulated UseTesting(Leveraged fromK192020)	Demonstrates that the indicatorperforms as expected in acommercial sterilizer withworst-case load.	Complete color change ina full cycle.Incomplete color changein an abbreviated cycle.	Pass.Complete color change ina full cycle.Incomplete color changein an abbreviated cycle.

Table 5-1. Verification Results Summary

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

6. Conclusion

The conclusion drawn from the non-clinical test demonstrate that the subject device is as safe, as effective and perform as well as or better that the legally marketed predicate device (K203284, Class II as per 21 CFR 880.2800, product code QKM).

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).