The CELERITY 20 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.

The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.

Device Description

The CELERITY 20 HP Challenge Pack (pack), is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems. The pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The user places the pack into the V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the CELERITY 20 HP Biological Indicator* (BI) contained in the pack are retrieved. The CI is assessed for a passing color change immediately and the BI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The BI is activated by sealing the vial and thus puncturing the cap to release the contained media.

The activated SCBI is incubated at 55-60 ℃ in the CELERITY HP Incubator** for a final determination of viability within 20 minutes of incubation.

AI/ML Overview

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	Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions	PASS
Cycle-Specific Testing	The pack provides an equivalent or greater challenge to the claimed cycle than the biological model under worst-case conditions.	PASS

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance testing... has been completed" and implies that these tests were conducted by the manufacturer for regulatory submission.

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

This information is not provided in the document. The tests seem to be laboratory-based performance evaluations against specific criteria rather than expert-based assessments.

4. Adjudication Method for the Test Set

This information is not provided as the tests appear to be objective performance evaluations (pass/fail) rather than requiring adjudication for subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and its Effect Size

An MRMC comparative effectiveness study was not performed or reported in this document. The device is a sterilization process indicator, not an AI-assisted diagnostic tool that would typically involve human readers.

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

The device itself is a "Biological Indicator Challenge Pack" which is a physical product, not a software algorithm. The "performance" being tested is its ability to accurately indicate sterilization conditions. Therefore, a standalone algorithm-only performance study is not applicable in this context. The "incubation" part involves a device (CELERITY HP Incubator) that reads the biological indicator, which is a form of automated assessment, but not an "algorithm only" study in the typical sense of AI.

7. The Type of Ground Truth Used

The ground truth for the "Simulated Use" and "Cycle-Specific Testing" appears to be established through:

Worst-case sterilization conditions: This refers to the scientific and engineering parameters that define a minimal challenge for sterilization.
Biological model: This likely refers to the known and established resistance of the biological indicator organism (e.g., bacterial spores) to the sterilization process. The acceptance criteria imply a biochemical or microbiological ground truth (i.e., whether the biological indicator's spores are killed or not under defined conditions).

8. The Sample Size for the Training Set

This product is a physical device (sterilization indicator), not an AI model that requires a training set. Therefore, the concept of a "training set" and its sample size is not applicable.

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

As explained above, a training set is not applicable for this device.

Summary

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 1, 2018

STERIS Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5976 Heisley Rd Mentor, Ohio 44060

Re: K173488

Trade/Device Name: CELERITY 20 HP Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: January 31, 2018 Received: February 1, 2018

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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 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,

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)

K173488

Device Name CELERITY 20 HP Challenge Pack

Indications for Use (Describe)

The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.

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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STERIS®

510(k) Summary For CELERITY 20 HP Challenge Pack

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 Fax No: (440) 357-9189 e-mail: tony_piotrkowski@steris.com

Submission Date: January 31, 2018

Premarket Notification Number: K173488

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

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173488 CELERITY 20 HP Challenge Pack

Device Name 1.

Trade Name:	CELERITY 20 HP Challenge Pack
Common/usual Name:	Biological Indicator Challenge Pack
Device Classification:	Class II
Classification Name:	Sterilization Process Indicator(21 CFR 880.2800, FRC)

2. Predicate Device

VERIFY V24 Biological Indicator Challenge Pack K140499

3. Description of Device

The BI is activated by sealing the vial and thus puncturing the cap to release the contained media.

The activated SCBI is incubated at 55-60 ℃ in the CELERITY HP Incubator** for a final determination of viability within 20 minutes of incubation.

4. Intended Use/ Indications for Use

The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospitaldefined challenge load is not included.

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173488 CELERITY 20 HP Challenge Pack

The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.

5. Summary of Technical Characteristics

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

Feature	CELERITY pack	VERIFY Pack	Comparison
IntendedUse /Indicationfor Use	(K173488) ProposedThe CELERITY 20 HPChallenge Pack isintended forqualification testing ofthe V-PRO LowTemperatureSterilization Systemfollowinginstallation, relocation,malfunctions or majorrepairs and for routinerequalification testing.The Challenge Pack isplaced in an otherwiseempty sterilizerchamber; a hospital-defined challenge load isnot included.The challenge pack isnot intended for routinemonitoring of the V-PRO Sterilizers. It hasbeen tested and validatedsolely for use in periodictesting of the sterilizers.	(K140499) PredicateThe VERIFY V24Biological IndicatorChallenge Pack isintended forqualification testing ofthe Lumen, Non Lumenand Flexible Cycles inV-PRO LowTemperatureSterilization Systemsfollowing installation,relocation, malfunctionsor major repairs.The challenge pack isplaced in an otherwiseempty sterilizerchamber; a hospital-defined challenge load isnot included.The challenge pack isnot intended for routinemonitoring of V-PROSterilizers. It has beentested and validatedsolely for use in periodictesting of the Sterilizers.	An additional cycle, FastNon Lumen, has beenadded to indications. TheBI and CI in the pack aswell the predicatechallenge pack arecurrently under review toadd this claim. Testing isprovided in thissubmission todemonstrate suitableperformance in theadditional cycle.Proposed device hasadditional wording toclarify that the pack canbe used for routinerequalification.
GeneralDesign	Sealed sterilizationpouch containing SCBI,CI and barrier material.	Sealed sterilizationpouch containing SCBI,CI and barrier material.	Same configuration
BiologicalIndicator	Celerity 20 HPBiological Indicator*(K171504)	Verify V24 SCBI(K140708)	Both have 510(k)-cleared BI with reducedincubation time.
ChemicalIndicator	VERIFY HPU ChemicalIndicator	VERIFY HPU ChemicalIndicator	Same
Means todistinguish	Proposed device'sinternal indicator isvisible through the pack.	Proposed device'sinternal indicator isvisible through the pack.	Same

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173488 CELERITY 20 HP Challenge Pack

Feature	CELERITY pack(K173488) Proposed	VERIFY Pack(K140499) Predicate	Comparison
processedpack fromunprocessed
Requiredaccessories	CELERITY HPIncubator** (K171587)	VERIFY Activator	Proposed device requiresthe incubator to read andreport final result butdoes not require aseparate activator. Use ofthe incubator with theSCBI contained withinthe pack was part ofK171587.

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	Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions	PASS
Cycle-Specific Testing	The pack provides an equivalent or greater challenge to the claimed cycle than the biological model under worst-case conditions.	PASS

Table 5-2. Summary of Non-Clinical Testing

7. Conclusion

The CELERITY 20 HP Challenge Pack has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as the legally marketed predicate device, K140499, Class II (21 CFR 880.2800, Product code FRC).

The Celerity 20 HP Biological Indicator was cleared in K171504 under the name "VERIFY Assert VH2O2 Self Contained Biological Indicator"

** The Celerity HP Incubator was cleared in K171587 under the name "VERIFY Incubator for Assert VH2O2 SCBI"

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).