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 chad 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

The provided text describes the CELERITY 20 HP Challenge Pack, a device used for qualification testing of the V-PRO Low Temperature Sterilization System. The description focuses on demonstrating substantial equivalence to a predicate device (K173488).

Here's an analysis of the provided information concerning acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Simulated Use Test:
"Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions (Fast Non Lumen Cycle of V-PRO maX 2 Sterilizer)"

Reported Device Performance:
"PASS: All CI complete change. All BI inactivated."

Table format:

Test	Acceptance Criteria	Reported Device Performance
Simulated Use	Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions (Fast Non Lumen Cycle of V-PRO maX 2 Sterilizer)	PASS: All CI complete change. All BI inactivated.

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

The provided document (K220473 510(k) Summary) does not explicitly state the numerical sample size for the "Simulated Use" test. It only provides a qualitative conclusion ("All CI complete change, All BI inactivated").

Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given that it's a 510(k) submission for a medical device's performance, it would typically involve prospective testing to demonstrate the device's functionality.

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

This information is not provided in the document. The device in question is a sterilization process indicator (Biological Indicator Challenge Pack). Ground truth for a biological indicator is typically established by physical/biological testing (e.g., observing the chemical indicator color change and culturing the biological indicator to check for bacterial inactivation), not by human expert interpretation in the way one might assess medical images. Therefore, the concept of "experts" in the context of establishing ground truth for this specific device's test set may not directly apply as it would for, say, a diagnostic imaging AI.

4. Adjudication Method for the Test Set

This information is not applicable/not provided in the context of this device. The assessment of a chemical indicator's color change or a biological indicator's inactivation is typically a direct observation/measurement, not subject to human interpretation discrepancies that would require adjudication among multiple readers.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or imaging devices where human readers interpret medical images, and the study evaluates how AI assistance impacts their performance. The CELERITY 20 HP Challenge Pack is a physical indicator for sterilization, not an imaging or diagnostic device involving human interpretation of complex data.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable in the conventional sense for this device. The CELERITY 20 HP Challenge Pack is a physical indicator. Its "performance" is its ability to accurately signal sterilization success or failure. The test described, "Simulated Use," is essentially a standalone performance test of the device under specific conditions. There's no "algorithm" in the typical software sense, nor a "human-in-the-loop" that would interact with an algorithm. The human interaction involves observing the chemical indicator change and incubating the biological indicator.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on direct physical and biological outcomes:

Chemical Indicator (CI) complete change: This indicates that the chemical indicator underwent the expected color transformation due to exposure to the sterilization process.
Biological Indicator (BI) inactivated: This means that the spores within the biological indicator were successfully killed by the sterilization process, confirmed by the absence of growth after incubation.

These are established physical and biological endpoints, not subjective expert consensus, pathology, or population outcomes data in the way one might see for a diagnostic medical device.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The CELERITY 20 HP Challenge Pack is a physical device, a "Biological Indicator Challenge Pack," not a machine learning or AI-based device that would require training data or a training set. Its design and functionality are based on chemical and biological principles for indicating sterilization efficacy.

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

As stated above, this question is not applicable since the device is not an AI/ML product and does not have a "training set."

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 Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.

March 18, 2022

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

Re: K220473

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: February 17, 2022 Received: February 18, 2022

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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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 531-542 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 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, Ph.D. 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) K220473

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

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K220473 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 Director, Regulatory Affairs

Telephone: (440) 392-7437 (440) 357-9189 Fax No: e-mail: tony piotrkowski@steris.com

February 17, 2022 Submission Date:

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

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STERIS SPECIAL 510(k) PREMARKET NOTIFICATION 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:	Indicator, Biological Sterilization Process(21 CFR 880.2800, FRC)

2. Predicate Device

CELERITY 20 HP Challenge Pack K173488 Note: K183294 is the most recent clearance for the CELERITY 20 HP Challenge pack but this submission specifically addresses the original clearance under K173488.

3. Description of Device

4. Intended Use/ Indications for Use

The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospitaldefined 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.

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5. Summary of Technological Characteristics

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

Feature	CELERITY pack(proposed)	CELERITY Pack(K173488) Predicate	Comparison
Intended Use /Indication for Use	The CELERITY 20 HP ChallengePack is intended for qualificationtesting of the V-PRO LowTemperature Sterilization Systemfollowing installation, relocation,malfunctions or major repairs and forroutine requalification testing.The Challenge Pack is placed in anotherwise empty sterilizer chamber; ahospital-defined challenge load is notincluded.The challenge pack is not intended forroutine monitoring of the V-PROSterilizers. It has been tested andvalidated solely for use in periodictesting of the sterilizers.	The CELERITY 20 HP ChallengePack is intended for qualificationtesting of the V-PRO LowTemperature Sterilization Systemfollowing installation, relocation,malfunctions or major repairs and forroutine requalification testing.The Challenge Pack is placed in anotherwise empty sterilizer chamber; ahospital-defined challenge load is notincluded.The challenge pack is not intended forroutine monitoring of the V-PROSterilizers. It has been tested andvalidated solely for use in periodictesting of the sterilizers.	Same
General Design	Sealed sterilization pouch containingSCBI, CI and barrier material.	Sealed sterilization pouch containingSCBI, CI and barrier material.	Same
BiologicalIndicator	Celerity 20 HP Biological Indicator	Celerity 20 HP Biological Indicator	Same
ChemicalIndicator	VERIFY HPU Chemical Indicator	VERIFY HPU Chemical Indicator	Same
Means todistinguishprocessed packfrom unprocessed	Proposed device's internal indicator isvisible through the pack.	Proposed device's internal indicator isvisible through the pack.	Same
Requiredaccessories	CELERITY HP Incubator	CELERITY HP Incubator	Same

Table 5-1 Summary of nack Physical Description and Technological Pronerties

6. Summarv of Nonclinical Tests

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

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

Test	Acceptance Criteria	Conclusion
Simulated Use	Demonstrate the pack shows passing results in worst-caseload under worst-case sterilization conditions (Fast NonLumen Cycle of V-PRO maX 2 Sterilizer)	PASSAll CI complete changeAll BI inactivated

Tahle 5-2 Sr clinical Testi f N

7. Conclusion

The conclusion drawn from the non-clinical performance test demonstrate that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device, K173488, 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).