The Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles (PCD), contains a Celerity 20 Steam Biological Indicator (BI) and a VERIFY Steam Integrating Indicator - Short, sealed within a plastic tray with foil cover. The tray has a molded channel which serves as the tortuous pathway for air removal/steam penetration during steam sterilization. The PCD is designed and validated to be equivalent to the standard 16-towel test pack described in ANSI/AAMI ST79.

AI/ML Overview

The STERIS Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles underwent nonclinical testing to demonstrate its performance and substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Simulated Use
Performance of BI in PCD vs. AAMI pack	Performance of the BI in the PCD is equivalent to the performance of the BI in the AAMI reference pack in their respective sterilization processes.	PASS
Performance of chemical integrator in PCD vs. AAMI pack	Performance of the chemical integrator in the PCD is equivalent to the performance of the chemical integrator in AAMI reference pack in their respective processes.	PASS
Challenge level of PCD vs. AAMI pack	PCD provides an equivalent or greater challenge than the AAMI standardized test pack.	PASS
BI in pack vs. BI outside of pack	PCD provides a greater challenge to the process than the BI itself.	PASS
CI in pack vs. CI outside of pack	PCD provides a greater challenge to the process than the integrator by itself.	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. However, it indicates "Performance testing" was completed, implying a sufficient number of samples were tested to draw conclusions.

The data provenance is from nonclinical testing conducted by STERIS Corporation. The document does not specify country of origin for the data, but STERIS Corporation is based in Mentor, OH, USA. The study is prospective in nature, as it is testing a new device's performance against established standards.

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

This type of information is generally not applicable to the performance testing of a Process Challenge Device (PCD). The "ground truth" in this context is established by adherence to recognized standards like ANSI/AAMI ST79, which defines the challenging conditions that a sterilization process indicator should withstand. The performance is measured objectively through indicators (Biological Indicators and Chemical Integrators) directly, rather than relying on expert subjective evaluation of a test set.

4. Adjudication Method for the Test Set

Not applicable. The performance is objectively measured based on the response of the biological and chemical indicators. There is no human adjudication of "results" in the typical sense. The indicators either show inactivation/pass (for biological indicators) or appropriate color change/pass (for chemical integrators), or they do not.

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 associated with diagnostic imaging or similar devices where multiple human readers interpret results, and the AI's impact on their performance is assessed. This is not relevant for a sterilization process indicator.

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

Yes, the studies performed are standalone studies. The performance of the device (PCD containing a Biological Indicator and a Chemical Integrator) is evaluated directly against established standards and predicate devices without human interpretation as part of its core function. The "algorithm" here is the physical design of the PCD and the response of the indicators within it.

7. The Type of Ground Truth Used

The ground truth used is based on established industry standards and regulatory requirements, specifically:

ANSI/AAMI ST79: "Comprehensive guide to steam sterilization and sterility assurance in health care facilities." This standard defines the 'AAMI standardized test pack' which serves as a reference for challenge levels.
The inherent performance characteristics of Biological Indicators (BI) (e.g., spore inactivation) and Chemical Integrators (CI) (e.g., color change at specific sterilization parameters).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. This is a physical device that relies on chemical and biological reactions, not a machine learning algorithm that requires a training dataset.

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

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

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

February 21, 2018

STERIS Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060

Re: K173626

Trade/Device Name: Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 22, 2017 Received: November 24, 2017

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. 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Michael J. Ryan -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K173626

Device Name

CELERITY 20 Steam Process Challenge Device for Dynamic Air Removal Cycles

Indications for Use (Describe)

The Celerity™ 20 Steam Challenge Pack is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers.

The validated steam sterilization cycles include:

270°F (132°C) 4-minute dynamic air removal (Prevac, SFPP) .
275°F (135°C) 3-minute dynamic air removal (Prevac, SFPP) .

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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Image /page/3/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol (®) to the right of the word. Below the word "STERIS" is a graphic of several horizontal, wavy lines in blue, resembling water waves.

510(k) Summary For Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Manufacturing Facility

STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax No: (440) 392-7896

Contact: Anthony Piotrkowski Senior Manager Regulatory Affairs

Telephone: (440) 392-7437 (440) 639-6258 Fax No: e-mail: tony_piotrkowski@steris.com

Submission Date: January 23, 2018

Premarket Notification Number: K173626

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

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K173626 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles

Device Name 1.

Trade Name:	Celerity 20 Steam Process Challenge Device forDynamic Air Removal Cycles
Common/usual Name:	Biological Indicator Pack (PCD)
Device Classification:	Class II
Classification Name:	Sterilization Process Indicator(21 CFR 880.2800, FRC)

2. Predicate Device

3M Attest Super Rapid 5 Steam-Plus Challenge Pack K121593

Reference Device: Verify Assert Steam Process Challenge Device, K162945

3. Description of Device

4. Intended Use/ Indications for Use

The Celerity™ 20 Steam Challenge Pack is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers. The validated steam sterilization cycles include:

270°F (132°C) 4-minute dynamic air removal (Prevac, SFPP)
275°F (135°C) 3-minute dynamic air removal (Prevac, SFPP)

5. Summary of Technical Characteristics

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

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Feature	Celerity PCD(K173626) Proposed	Attest 41482V(K121593) Predicate	Comparison
IntendedUse	The Celerity 20STEAM ProcessChallenge Device isused for qualification,routine microbialmonitoring, and loadmonitoring of steamsterilizers.The validated steamsterilization cyclesinclude:• 270F (132°C), 4-minute dynamicair removal;(Prevac, SFPP)• 275F(135°C), 3-minnute dynamicair removal;(Prevac, SFPP)	Use 3M Attest SuperRapid 5 Steam-PlusChallenge Pack inconjunction with the3M Attest Auto-reader 490 to qualifyor monitor dynamicair removal(prevacuum) steamsterilization cycles of4 minutes at 270 F(132 C) and 3 minutesat 275 F (135 C).The 3M Attest SuperRapid ReadoutBiological Indicatorcontained within thechallenge packprovides a finalfluorescent result in 1hour. An optionalvisual pH colorchange result isobserved in 48 hours.	Both are intended formonitoring 270F(132C), 4-minutedynamic air removal275F(135C), 3-minnutedynamic air removal,steam sterilizationcycles.
GeneralDesign	Indicators are sealedin plastic tray withchannel to limit steampenetration/airremoval.	Layers of medicalindex cards, some ofwhich are die-cut tocontain indicators,overwrapped andsecured with a label.	Both the devices arecontained in a steambarrier. Simulated usetesting demonstratedequivalence
BiologicalIndicator	Celerity 20 SteamBiological Indicator(20-minutefluorescent result)	Attest 1492VBiological Indicator(1-hour fluorescentresult)	Both contain 510(k)-cleared BiologicalIndicators with rapidfluorescent results.
ChemicalIntegrator	VERIFY STEAMIntegrating Indicator-Short	SteriGage ChemicalIntegrator	Both contains 510(k)-cleared chemicalintegrators
Means todistinguishprocessedPCD fromunprocessed	Proposed device'sinternal integrator isvisible through thepack.	External processindicator. Yellow tobrown color changewhen exposed tosteam	Both have a means todistinguish processedPCD from unprocessed

Table 5-1. Summary of PCD Physical Description and Technological Properties

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K173626 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles

The Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles is identical to the reference device VERIFY Assert Steam Process Challenge Device except for the biological indicator within the device. The difference in the biological indicator allows the Celerity BI to have a 20-minute read (versus 40-minutes for the reference device). The different BI also requires a different reader.

6. Summary of Nonclinical Tests

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.

Test	Acceptance Criteria	Conclusion
Simulated Use	• Performance of the BI in the PCD is equivalent tothe performance of the BI in the AAMI referencepack in their respective sterilization processes	PASS
	• Performance of the chemical integrator in the PCDis equivalent to the performance of the chemicalintegrator in AAMI reference pack in theirrespective processes	PASS
	• PCD provides an equivalent or greater challengethan the AAMI standardized test pack	PASS
BI in pack vs BIoutside of pack	PCD provides a greater challenge to the process thanthe BI itself.	PASS
CI in pack vs CIoutside of pack	PCD provides a greater challenge to the process thanthe integrator by itself.	PASS

Table 5-2. Summary of Non-clinical Testing

7. Conclusion

The Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles has met the established performance criteria. The results of the studies performed demonstrate that the biological indicator performs as intended, and based on the nonclinical tests performed, the subject device is as effective, and performs at least as safely and effectively as the legally marketed predicate devices, Class II (21 CFR 880.2800, Product code FRC).

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).