The Celerity 20 Steam Biological Indicator is used for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization cycles:

Dynamic Air Removal 270°F (132°C) 4 minutes
Dynamic Air Removal 275°F (135°C) 3 minutes
Gravity 250°F (121°C) 30 minutes
Gravity 270°F (132°C) 15 minutes.
When used in conjunction with the Celerity™ Steam Incubator, the Incubator provides a fluorescent result within 20 minutes.

Device Description

The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader. Celerity 20 Steam Incubator in 20 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the native organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

AI/ML Overview

The provided text describes the CELERITY 20 Steam Biological Indicator and its performance testing to demonstrate substantial equivalence to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Reduced Incubation Time (RIT) Testing	Meets FDA's requirement of > 97% alignment of the 40-minute results with the conventional incubation time of 7 days	PASS
Viable spore population	1.0 - 4.0 x 10^6 spore/SCBI	2.3 - 2.5 x 10^6 spore/SCBI
Resistance	D121 ≥ 1.5 min D132 ≥ 10 s D135 ≥ 8 s	D121 ≥ 2.53 min D132 ≥ 46 s D135 ≥ 37 s
Survival Time	Meets the longer of FDA and ISO 11138-3 requirements	121 C ≥ 11.11 min 132 C ≥ 3.42 min 135 C ≥ 2.77 min
Kill Time	Meets the shorter of FDA and ISO 11138-3 requirements	121 C ≤ 31.81 min 132 C ≤ 8.62 min 135 C ≤ 7.11 min
Carrier growth inhibition / media growth promotion	Positive growth of less than 100 spores after primary packaging and media are subject to worst case steam exposure	PASS
Hold Time	Performance not affected if incubated within 72 hours of exposure to steam sterilization	PASS
Simulated Use	Demonstrate growth when exposed to abbreviated cycle and all kill in a full cycle	Abbreviated cycle - growth Full cycle - no growth

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

The document does not explicitly state the specific "sample size" for each test set in numerical terms (e.g., number of biological indicators tested for RIT). It generally refers to "performance testing" and implicitly describes the methodologies rather than raw counts.

Data Provenance: The studies were conducted by STERIS Corporation, the manufacturer, as part of their premarket notification to the FDA. The nature of the tests (e.g., RIT, Resistance, Survival/Kill Time, Simulated Use) implies controlled laboratory and simulated clinical environments rather than human patient data from a specific country. Therefore, it's not applicable in the same way as a clinical trial. It's a prospective evaluation of the device's technical performance.

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

This information is not provided because the device is a biological indicator for sterilization processes, not a diagnostic device requiring expert interpretation of results. The "ground truth" (e.g., whether sterilization occurred, spore viability) is determined by the inherent biological and chemical properties of the indicator and reference standards (e.g., ISO 11138-3, FDA guidance) rather than subjective expert consensus.

4. Adjudication Method for the Test Set

Not applicable for this type of device. The results are objective (fluorescence detected by an automated reader, growth/no growth, D-value calculation, etc.) and adhere to predetermined technical criteria. There is no subjective interpretation requiring adjudication among experts.

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, and the goal is to evaluate the impact of AI on their performance. The CELERITY 20 Steam Biological Indicator is an automated indicator with no direct human-in-the-loop performance component in the diagnostic sense.

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

Yes, the studies described are essentially "standalone" performance evaluations of the device. The device itself, in conjunction with its specific incubator, provides a fluorescent result. The tests (RIT, Viable spore population, Resistance, etc.) evaluate the intrinsic performance of the biological indicator and its detection system without human interpretation as a primary outcome. The "algorithm" here refers to the biological and chemical reaction, and the automated detection by the Celerity™ Steam Incubator.

7. The Type of Ground Truth Used

The ground truth is established through:

Biological and Chemical Standards: The viability of Geobacillus stearothermophilus spores and their resistance to steam are well-established biological principles and standards.
International Standards: References to ISO 11138-3 are frequently made for resistance, survival, and kill time requirements.
FDA Guidance: The RIT testing specifically refers to FDA's requirements.
Reference Methods: The "conventional incubation time of 7 days" serves as a reference for establishing the accuracy of the reduced incubation time.
Controlled Sterilization Cycles: For tests like "Simulated Use," the ground truth is predefined by subjecting the indicators to known "abbreviated" (fail) and "full" (pass) sterilization cycles.

8. The Sample Size for the Training Set

This information is not provided. Biological indicators, unlike AI algorithms for image analysis, do not typically undergo a "training set" development in the machine learning sense. Their performance is based on established biological and physical principles, manufacturing consistency, and validation against known standards.

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

As there is no "training set" in the context of an AI algorithm, this question is not applicable. The device's inherent design and manufacturing process are developed to meet the established biological and regulatory standards, which serve as the "ground truth" for its intended function.

Summary

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February 12, 2018

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

Re: K173634

Trade/Device Name: CELERITY 20 Steam Biological Indicator 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 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)

K173634

Device Name

CELERITY 20 Steam Biological Indicator

Indications for Use (Describe)

The Celerity 20 Steam Biological Indicator is used for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization cycles:

· Dynamic Air Removal 270°F (132°C) 4 minutes
· Dynamic Air Removal 275°F (135°C) 3 minutes
· Gravity 250°F (121°C) 30 minutes
· Gravity 270°F (132°C) 15 minutes.

When used in conjunction with the Celerity™ Steam Incubator, the Incubator provides a fluorescent result within 20 minutes.

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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510(k) Summary For K173634 Celerity 20 Steam 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

Contact: Tony Piotrkowski Senior Manager, Regulatory Affairs

Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tpiotrko@steris.com

Submission Date: January 17, 2018

Premarket Notification Number: K173634

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

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173634 Celerity 20 Steam Biological Indicator

Device Name 1.

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

Predicate Device 2.

3M Attest Super Rapid Readout Biological Indicator, K121484

3. Description of Device

4. Intended Use/ Indications for Use

The Celerity 20 Steam Biological Indicator is used for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization cycles:

· Dynamic Air Removal 270°F (132°C) 4 minutes
· Dynamic Air Removal 275°F (135°C) 3 minutes
· Gravity 250°F (121°C) 30 minutes
· Gravity 270°F (132°C) 15 minutes.

When used in conjunction with the Celerity™ Steam Incubator, the Incubator provides a fluorescent result within 20 minutes.

ട. Summary of Technical Characteristics

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

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Feature	Celerity SCBI(proposed)	Attest 1492V(K121484)	Comparison
IntendedUse	The Celerity 20 SteamBiological Indicator (BI) isfor routine monitoring,qualification testing andproduct testing of thefollowing steamsterilization processes:270F, 4-minute dynamicair removal; 275F, 3-minute dynamic airremoval; 250 F, 30-minutegravity; 270, 15-minutesgravity.When used in conjunctionwith the Celerity 20 SteamIncubator, the Celerity 20Steam Biological Indicatorprovides a fluorescent resultwithin 20 minutes.	Use 3M Attest Super RapidReadout BiologicalIndicator 1492V inconjunction with the 3MAttest Auto-reader 490 toqualify or monitor dynamicair removal (prevacuum)steam sterilization cyclesof 4 minutes at 270 F (132C) and 3 minutes at 275 F(135 C).The 3M Attest Super RapidReadout BiologicalIndicator 1492V provides afinal fluorescent result in 1hour. An optional visualpH color change result isobserved in 48 hours.	Both are intended formonitoring steamsterilization cycles.The Celerity BI is claimingadditional cycles comparedto the predicate. Simulateduse testing in sterilizers witha load under pass and failconditions demonstrateperformance of the CelerityBI in these additional cycles.The Celerity BI has a shorterclaimed readout time.Reduced Incubation Time(RIT) testing per the FDAguidance demonstrates theread time is appropriate.
Indicatororganism	> 90% similarity to ATCC7953 Geobacillusstearothermophilus	> 90% similarity to ATCC7953 Geobacillusstearothermophilus	Same criteria
Mechanismof action	An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within the definednutrient media to produce afluorescent moiety	An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within the definednutrient media to produce afluorescent moiety	Same mechanism
Accessories	Automated incubator /reader	Automated incubator /reader	RIT testing performed withthe proposedincubator/reader.
Viable sporepopulation	1.0 - 4.0 x 106 spore/SCBI	> 1.0 x 106 spore/SCBI	Both proposed and predicate
Resistance	D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s	D132 ≥ 10 sD135 ≥ 8 s	meet criteria of ISO 11138-3and FDA guidance
CultureConditions	55- 59 °C, media includedin SCBI, 20-minuteincubation time.	55- 59 °C, media includedin SCBI, 60 minuteincubation time.	RIT Testing and ISO 11138media testing verifiesperformance
PrimaryPackaging	Direct inoculum on plasticvial, cap with recoverymedia.	Inoculated paper in plasticvial with cap and glassampoule with recoverymedia in capped vial.	Similar configuration.Component testing per ISO11138-1 Annex Bdemonstrates packaging iscompatible with indicatorand sterilization process.

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

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173634 Celerity 20 Steam Biological Indicator

Summary of Nonclinical Tests 6.

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

Test	Acceptance Criteria	Conclusion
ReducedIncubation Time(RIT) Testing	Meets FDA's requirement of > 97%alignment of the 40-minute results with theconventional incubation time of 7 days	PASS
Viable sporepopulation	1.0 - 4.0 x 106 spore/SCBI	2.3 - 2.5 x 106spore/SCBI
Resistance	D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s	D121 ≥ 2.53 minD132 ≥ 46 sD135 ≥ 37 s
Survival Time	Meets the longer of FDA and ISO 11138-3requirements	121 C ≥ 11.11 min132 C ≥ 3.42 min135 C ≥ 2.77 min
Kill Time	Meets the shorter of FDA and ISO 11138-3requirements	121 C ≤ 31.81 min132 C ≤ 8.62 min135 C ≤ 7.11 min
Carrier growthinhibition / mediagrowth promotion	Positive growth of less than 100 spores afterprimary packaging and media are subject toworst case steam exposure	PASS
Hold Time	Performance not affected if incubated within72 hours of exposure to steam sterilization	PASS
Simulated Use	Demonstrate growth when exposed toabbreviated cycle and all kill in a full cycle	Abbreviated cycle - growthFull cycle - no growth

Table 5-2. Summary of Non-clinical Testing

7. Conclusion

The Celerity 20 Steam Biological Indicator has met the established performance criteria. The conclusions drawn from the nonclinical tests performed demonstrate the subject device is as safe, as effective, and performs as well or better than the legally marketed predicate device, K121424 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).