The CELERITY 20 HP Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities.

When used in conjunction with the VERIFY CELERITY 20 HP Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes.

Device Description

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, CELERITY 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

AI/ML Overview

Based on the provided text, here's a detailed description of the acceptance criteria and the study proving the device meets them:

Device: CELERITY 20 HP Biological Indicator (K172752)

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
New Testing for K172752:
BI Simulated Use in the V-PRO maX 2 Sterilizer Fast Non Lumen Cycle	All BIs processed in full cycles will be negative for growth	PASS
Previously Submitted Testing (K171504) for the Identical BI:
Reduced Incubation Time (RIT) Testing	Meets FDA's requirement of > 97% alignment of the 20-minute results with the conventional incubation time of 7 days	PASS
Viable spore population	1.0 – 4.0 x 10^6 spore/SCBI	PASS
Resistance (D-value) at 9.1 mg/L H2O2	D-value > 3 sec	PASS
Survival Time at 9.1 mg/L H2O2	Survival Time ≥ 4 sec	PASS
Kill Time at 9.1 mg/L H2O2	Kill Time ≤ 6 min	PASS
Carrier growth inhibition / media growth promotion	Positive growth of less than 100 spores inoculated after primary packaging and media were subjected to worst case VHP exposure	PASS
Hold Time	Performance not affected if incubated within 72 hours of exposure to VHP sterilization	PASS
Simulated Use (for previously cleared features)	Demonstrate no growth when exposed to worst-case cycles	PASS

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not explicitly state the numerical sample size for each test. However, it indicates that for the "BI Simulated Use in the V-PRO maX 2 Sterilizer Fast Non Lumen Cycle" test, "All BIs processed in full cycles" were evaluated. This implies quantitative measurements were taken on a set of BIs.
Data Provenance: The studies are described as "Performance testing" and "Nonclinical Tests" submitted by Steris Corporation. There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective; however, given they are non-clinical hardware tests, they would inherently be prospective laboratory experiments.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This device is a biological indicator (hardware) for sterilization processes and its performance is measured against objective criteria (e.g., spore viability, D-value, growth/no growth), not subjective expert interpretation of output data like medical images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation where multiple human readers assess cases and their interpretations need to be reconciled to establish a ground truth. For a biological indicator, the "ground truth" is determined by objective biological and chemical measurements (e.g., spore growth, fluorescent signal detection).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study assesses the impact of an AI device on human reader performance, usually in diagnostics like radiology. The CELERITY 20 HP Biological Indicator is a standalone device that provides an objective result for sterilization efficacy, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed. All tests mentioned in the table (Resistance, Survival Time, Kill Time, Reduced Incubation Time, Viable Spore Population, Carrier Growth Inhibition/Media Growth Promotion, Hold Time, and Simulated Use) represent standalone performance evaluations of the Biological Indicator itself, with its specified incubator/reader providing the result. The device's performance is determined by its inherent biological and chemical properties.

7. Type of Ground Truth Used

The ground truth used is based on:

Biological Activity: The presence or absence of Geobacillus stearothermophilus spore growth, which indicates sterilization failure.
Physical/Chemical Measurements: D-values, survival times, kill times, and spore population counts determined through standard microbiological and sterilization efficacy testing methods.
Objective Readouts: The fluorescent signal detected by the CELERITY 20 HP Incubator within 20 minutes, indicating viability or non-viability.

8. Sample Size for the Training Set

Not applicable. This device is a biological indicator, not an AI device developed using machine learning that requires a training set. Its functionality is based on direct biological and chemical reactions.

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

Not applicable, as no training set was used for this type of device.

Summary

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February 9, 2018

Steris Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K172752

Trade/Device Name: CELERITY 20 HP Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: September 11,2017 Received: January 10, 2018

Dear Jennifer Nalepka:

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 (ifknown)

K172752

Device Name CELERITY 20 HP Biological Indicator

Indications for Use (Describe)

The CELERITY Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities.

When used in conjunction with the VERIFY CELERITY 20 HP Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes.

Type of Use (Selectone orboth, as applicable)

D Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-CounterUse(21CFR801SubpartC)

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510(k)Summary For K172752 CELERITY 20 HP Biological Indicator

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

Jennifer Nalepka Contact: Senior Regulatory Affairs Specialist

Telephone: (440) 392-7458 (440) 357-9198 Fax No: jennifer_nalepka@steris.com e-mail:

September 11, 2017 Submission Date:

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

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator

1. Device Name

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

2. Predicate Device

CELERITY 20 HP Biological Indicator. K171504 (previously named "VERIFY Assert VH2O2 Self-Contained Biological Indicator")-Note: The BI is identical to that provided in K171504 only the indications for use have been changed.

3. Description of Device

4. Intended Use/ Indications for Use

When used in conjunction with the CELERITY 20 HP Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes.

ട്. Summary of Technical Characteristics

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

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator

Table 5-1. SCBI Physical Description and Technological Properties vs the Predicate
Device

Feature	CELERITY 20 HP BI (proposed)	CELERITY 20 HP BI Predicate (K171504)	Comparison
Intended Use	The CELERITY 20 HP Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizer in healthcare facilities.When used in conjunction with the CELERITY Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes.	The CELERITY 20 HP Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizer in healthcare facilities.When used in conjunction with the CELERITY Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes.	The proposed and predicate devices are identical. The Fast Non Lumen Cycle is a new cycle in the V-PRO maX 2 Low Temperature Sterilizer, which has been submitted in a separate premarketnotification.The proposed indications for use include information about the incubator/reader and read time that are supported through testing in accordance with FDA guidance for BI 510(k).
Indicator organism	Geobacillus stearothermophilus	Geobacillus stearothermophilus	Same
Mechanism of action	An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.	An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.	Same
Accessories	Automated incubator / reader	Automated incubator / reader	Same
Viable spore population	$1.0 - 4.0 \times 10^6$ spore/BI	$1.0 - 4.0 \times 10^6$ spore/BI	Both contain greater than $10^6$ spores/BI.
Resistance characteristics	Resistance @ 9.1 mg/L H2O2:• D-value > 3 sec• Survival Time ≥ 4 sec• Kill Time ≤ 6 min	Resistance @ 9.1 mg/L H2O2:• D-value > 3 sec• Survival Time ≥ 4 sec• Kill Time ≤ 6 min	Same
Culture Conditions	55-59°C, media included in BI, 20-minute incubation time.	55-59°C, media included in BI, 20-minute incubation time.	RIT Testing and ISO 11138-1 media testing verifies performance
Primary Packaging	Direct inoculum on plastic vial, cap with recovery media.	Direct inoculum on plastic vial, cap with recovery media.	Same
Process indicator	VERIFY V-PRO Chemical Indicator (K140515); magenta to yellow color change.	VERIFY V-PRO Chemical Indicator (K140515); magenta to yellow color change.	Same
Shelf-life	Currently 3 months	Currently 3 months	Real-time testing ongoing

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Note: The BI is identical to that provided in K171504 only the indications for use have been changed.

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.

	Table 5-2. Summary of Non-clinical Testing

Test	Acceptance Criteria	Conclusion
BI Simulated Use in the V-PRO maX2 Sterilizer Fast Non Lumen Cycle	All BIs processed in full cycles will benegative for growth	PASS

Performance testing of the predicate in V-PRO Sterilizers has been previously submitted in K171504. A summary of the testing can be found in Table 5-3.

Table 5-3. Summary of Non-clinical Testing Previously Submitted in K171504.

Test	Acceptance Criteria	Conclusion
Reduced IncubationTime (RIT) Testing	Meets FDA's requirement of > 97% alignment of the20-minute results with the conventional incubationtime of 7 days	PASS
Viable sporepopulation	$1.0 – 4.0 x 10^6$ spore/SCBI	PASS
Resistance	D-value > 3 sec	PASS
Survival Time	Survival Time $\geq$ 4 sec	PASS
Kill Time	Kill Time $\leq$ 6 min	PASS
Carrier growthinhibition / mediagrowth promotion	Positive growth of less than 100 spores inoculatedafter primary packaging and media were subjected toworst case VHP exposure	PASS
Hold Time	Performance not affected if incubated within 72 hoursof exposure to VHP sterilization	PASS
Simulated Use	Demonstrate no growth when exposed to worst-casecycles	PASS

7. Conclusion

Based on the intended use, technological characteristics and the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, the CELERITY 20 HP Biological Indicator (cleared in K171504) 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).