The Celerity 10 STEAM Chemical Indicator is intended for use in dynamic air removal steam sterilization cycles operating at 270°F/132°C for 10 minutes. The Celerity 10 STEAM Chemical Indicator that changes colors from yellow to blue/purple when exposed to these cycle conditions.

Device Description

The Celerity 10 STEAM Chemical Indicators are Type 6 emulating indicators. Type 6 indicators are cycle verification indicators which are designed to react to all critical variables for specific sterilization cycles.

They are designed to be placed in the center of each pack (e.g. tray, protective case, approved rigid sterilization container) to be sterilized and change color from yellow to blue/purple when the critical sterilization parameters have been met (270°F /132°C for 10 minutes).

They shall be printed onto white polypropylene with a polypropylene laminate and dimensions of 140 x 22 mm.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Celerity™ 10 STEAM Chemical Indicator:

1. Table of Acceptance Criteria and Reported Device Performance

Testing	Acceptance Criteria Reported	Reported Device Performance
ISO 11140-1 Testing	Meet requirements defined in ANSI/AAMI/ISO 11140-1:2014 along with additional FDA requirements for Type 6 emulating indicators.	PASS
Simulated Use Testing	Demonstrate color change when exposed to a full cycle and no/incomplete color change when exposed to an abbreviated cycle.	PASS
Shelf Life for 36 months	Meet performance specifications at each time point after storage in different environments.	PASS
Endpoint Color Stability for 12 months	Meet performance specifications at each time point after storage in typical conditions.	PASS

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

The document does not explicitly state the specific sample sizes used for each test (ISO 11140-1, Simulated Use, Shelf Life, Endpoint Color Stability). It generally refers to "performance testing" being conducted.

The data provenance is not specified in terms of country of origin. The study appears to be retrospective as it's a submission for a 510(k) premarket notification, indicating the testing has already been completed.

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

This information is not provided in the document. For a chemical indicator, the ground truth is typically established by physical parameters (e.g., temperature, time) in a controlled resistometer, not by expert human interpretation.

4. Adjudication Method for the Test Set

This is not applicable as the determination of whether the chemical indicator met "color change" or "no/incomplete color change" is a direct visual assessment against a defined standard, not an expert panel adjudication process.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Celerity™ 10 STEAM Chemical Indicator is a sterilization process indicator, not a diagnostic device.

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

Yes, in essence, a "standalone" performance evaluation was done. The device itself (the chemical indicator) is the "algorithm," and its performance is evaluated based on its physical and chemical reaction to specific sterilization conditions. There is no human interpretation or "human-in-the-loop" once the indicator is exposed to the sterilization cycle to determine the result; the color change is designed to be unambiguously observable. The testing aimed to confirm this automatic performance.

7. The Type of Ground Truth Used

The ground truth used for this device is based on physical parameters and established international standards. Specifically:

ISO 11140-1:2014: This standard defines the requirements for chemical indicators.
ANSI/AAMI ISO 18472: A resistometer conforming to this standard was used, which provides precise control over sterilization parameters (temperature, time, steam quality) to create the "ground truth" sterilization conditions.
Defined Sterilization Cycle: The indicator is designed for a specific cycle: 270°F/132°C for 10 minutes. This precise set of physical conditions constitutes the ground truth for a successful sterilization process that the indicator should confirm.
Abbreviated Cycle: For the simulated use testing, an "abbreviated cycle" also serves as a precisely defined ground truth for a failed or incomplete sterilization, where the indicator should not show a full color change.

8. The Sample Size for the Training Set

This concept is not applicable to this device. The Celerity™ 10 STEAM Chemical Indicator is a physical-chemical device, not an AI or software-based system that uses a "training set." Its design and formulation are based on chemical principles and engineering, not machine learning or data training.

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

This is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized caduceus. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 10, 2018

STERIS Corporation Eileen McCafferty Senior Regulatory Affairs Specialist 5960 Heisley Rd. Mentor, Ohio 44060

Re: K182724

Trade/Device Name: Celerity™ 10 STEAM Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: September 27, 2018 Received: September 28, 2018

Dear Eileen McCafferty:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 medical devices and radiation-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,

Clarence W. Murray lii III -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

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Indications for Use

510(k) Number (if known) K182724

Device Name Celerity™ 10 STEAM Chemical Indicator

Indications for Use (Describe)

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

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

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STE

510(k) Summary For K182724 Celerity™ 10 STEAM Chemical Indicator

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

Contact:

Eileen McCafferty Senior Regulatory Affairs Specialist Telephone: (440) 392-7189 Fax No: (440) 357-9198 Email: eileen.mccafferty@STERIS.com

Submission Date: September 27, 2018

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

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1. Device Name

Trade Name:	Celerity™ 10	STEAM Chemical Indicator
Models:	PCC058
Common Name:	Chemical Indicator.
Classification Name:	Physical/chemical sterilization process indicator
Classification	21 CFR 880.2800(b)
Product Code	JOJ

2. Predicate Device

STERIS VERIFY 270F 4 Indicator (K070461)

3. Device Description

The Celerity 10 |STEAM Chemical Indicators are Type 6 emulating indicators. Type 6 indicators are cycle verification indicators which are designed to react to all critical variables for specific sterilization cycles.

They shall be printed onto white polypropylene with a polypropylene laminate and dimensions of 140 x 22 mm.

4. Indications for Use:

The Celerity 10 STEAM Chemical Indicator is intended for use in dynamic air removal steam sterilization cycles operating at 270°F/132°C for 10 minutes. The Celerity 10 STEAM Chemical Indicator is a Type 6 indicator that changes colors from yellow to blue/purple when exposed to these cycle conditions.

5. Technological Characteristic Comparison Table

A comparison of technical characteristics is summarized in Table 5-1.

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 10 STEAM CHEMICAL INDICATOR

Feature	ProposedCelerity 10 STEAMChemical Indicator	Predicate K070461STERIS VERIFY 270F 4Indicator	Comparison
Intended use	The Celerity 10 STEAMChemical Indicator is intendedfor use in dynamic air removalsteam sterilization cyclesoperating at 270°F/132°C for10 minutes. The Celerity 10STEAM Chemical Indicator isa Type 6 indicator that changescolors from yellow toblue/purple when exposed tothese cycle conditions.	The VERIFY® SteamIndicators are chemicalindicators intended for use byhealth care providers toaccompany products beingsterilized through asterilization procedure. Theindicators change color fromyellow to blue/purple whentemperature of the designatedsteam sterilization cycle. Theperformance of the VERIFY®Steam Indicators exceeds thatof biological indicator kill andmeets the requirements ofANSI/AAMI / ISO 11140-1:2005 for Class 6 steamindicators.	Both devices havethe same colorchanges whenexposed to theproper steamsterilization cycle,however theproposed devicehas a newindication for usein a dynamic airremoval steamsterilization cycleat 270°F/132°Cfor 10 minutes.Wording has beenupdated for theproposed devicefrom Class 6 toType 6 to matchtheANSI/AAMI/ISO11140-1:2014revision.
Device design-components	Printed indicator ink onto whitepolypropylene with apolypropylene laminate anddimensions of 140 x 22 mm.	Printed indicator ink ontowhite polypropylene with apolypropylene laminate anddimensions of 143 x 22 mm.	Identical exceptfor a minordimensiondifference of 3mm in length.
Indicator agent	Proprietary pH sensitiveindicator ink	Proprietary pH sensitiveindicator ink	Identical
Sterilizationmethod andcycles	Dynamic air removal STEAMsterilization	Dynamic air removal STEAMsterilization	Identical
Mechanism ofaction	Chemical pH dependent	Chemical pH dependent	Identical
EndpointSpecifications(Stated Value)	270°F (132°C) / 10 minutes	270°F / 4 minutes	The proposeddevice is designedfor a 10 minutecycle rather than 4minutes.
Feature	ProposedCelerity 10 STEAMChemical Indicator	Predicate K070461STERIS VERIFY 270F 4Indicator	Comparison
Disposable	Yes	Yes	Identical
Shelf-life	3 years	3 years	Identical

Table 5-1. Device comparison table.

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 10 STEAM CHEMICAL INDICATOR

Summary of Non-Clinical Performance Testing 6.

Performance testing was conducted to verify that the proposed indicator meets the requirements for Type 6 emulating indicators as defined in ANSI/AAMI ISO 11140-1:2014 and additional FDA requirements using a resistometer conforming to ANSI/AAMI ISO 18472. Additional testing was completed to simulate typical in-use applications and to verify shelf life and the endpoint color stability. Table 5-2 summarizes this non-clinical testing.

Testing	Acceptance Criteria	Conclusion
ISO 11140-1Testing	Meet requirements defined inANSI/AAMI/ISO 11140-1:2014 along withadditional FDA requirements for Type 6emulating indicators	PASS
Simulated UseTesting	Demonstrate color change when exposed to afull cycle and no/incomplete color changewhen exposed to an abbreviated cycle	PASS
Shelf Life for36 months	Meet performance specifications at each timepoint after storage in different environments	PASS
Endpoint ColorStability for 12months	Meet performance specifications at each timepoint after storage in typical conditions	PASS

Table 5-2. Performance Testing Summary Table

7. Conclusion

The Celerity 10 STEAM Chemical Indicator has met the established performance criteria. 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 (K070461), Class II (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).