The Celerity 20 STEAM Biological Indicator for IUSS is used for monitoring and qualification testing of the following steam sterilization cycles: Gravity 270°F (132°C) 3 minutes Gravity 270°F (132°C) 10 minutes Gravity 275°F (135°C) 3 minutes Gravity 275°F (135°C) 10 minutes.

When used in conjunction with the Celerity STEAM 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 for IUSS, a Class II medical device used for monitoring and qualification testing of steam sterilization cycles. The document is a 510(k) Premarket Notification from the FDA, indicating a submission for substantial equivalency to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The core of the device's validation is presented in "Table 5-2. Summary of Non-clinical Testing" on page 7.

Test	Acceptance Criteria	Reported Device Performance
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	D132 ≥ 10 s; D135 ≥ 8 s	PASS
Survival Time	Meets FDA requirements	132 C ≥ 1 min; 135 C ≥ 0.667 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 8 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
Shelf-life	Population, resistance, RIT and media must meet above criteria at each stability time point	PASS at 3 months (ongoing)

Study Details:

Based on the provided document, the study is a non-clinical performance testing of a biological indicator (BI) to demonstrate its efficacy in monitoring steam sterilization cycles. This is not a human clinical trial involving patients.

Sample Size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the numerical sample sizes for each test (e.g., number of BIs tested for RIT, viable spore population, etc.). It only provides "PASS" or quantitative results (e.g., survival times).
- Data Provenance: The data is generated from non-clinical laboratory testing performed by STERIS Corporation. The document does not specify the country of origin of the data beyond STERIS being a US-based company with manufacturing facilities listed in Mentor, Ohio. The studies are prospective in nature, as they involve performing new tests to evaluate the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device. The ground truth for a biological indicator is typically established by physical and microbiological testing against established standards (e.g., ISO, FDA guidance) and the known resistance of the Geobacillus stearothermophilus spores to steam sterilization. It does not involve human experts judging images or patient outcomes. The "ground truth" for each test is the defined acceptance criterion (e.g., specific spore population count, survival time, kill time).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 or 3+1 are used in studies where human readers (e.g., radiologists) interpret data or images, and their interpretations are compared and resolved by consensus. This is a non-clinical laboratory study evaluating a physical device's performance against predefined technical specifications.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human interpretation is involved. This document describes a biological indicator, which is a physical device used to confirm sterilization, not an AI or diagnostic tool that assists human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a form of "standalone" performance was effectively done. The tests summarized in Table 5-2 evaluate the device's intrinsic performance (e.g., spore population, resistance, incubation time accuracy) as a standalone product. The device itself (the biological indicator with its integrated media and "reporter enzyme") produces the fluorescent result, which is then read by the Celerity STEAM Incubator. The incubator provides the final "fluorescent result within 20 minutes," which is an automated, objective output based on the biochemical reaction within the BI. There is no human interpretation of the BI's "result" other than observing the presence or absence of fluorescence from the incubator.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is established by physical and microbiological standards and controlled laboratory conditions.
  - For viable spore population and resistance (D-values): Ground truth is based on established microbiological methods (e.g., dilution plating, plate counts) to quantify spore numbers and then exposing them to precisely controlled steam conditions to determine their resistance, in line with ISO and FDA guidance for BIs.
  - For Reduced Incubation Time (RIT): The ground truth is the "conventional incubation time of 7 days," meaning the BI is incubated for 7 days to definitively confirm growth or no growth, and this result is compared to the 20-minute fluorescent reading.
  - For Survival Time and Simulated Use: The ground truth is the presence or absence of viable spores after exposure to defined steam sterilization parameters (abbreviated cycle for growth, full cycle for kill) confirmed by subsequent incubation.
The sample size for the training set:
- Not applicable/Not specified in this document. This document describes the performance testing for regulatory submission (510(k)). For a traditional medical device (like this biological indicator), there isn't typically a "training set" in the machine learning sense. Device development and optimization prior to this stage would involve extensive internal R&D, but the data presented here is from verification and validation testing, not a training set for an AI model.
How the ground truth for the training set was established:
- Not applicable. As explained above, there's no "training set" in the AI sense for this type of device. The specifications and performance thresholds for biological indicators are established through scientific principles of microbiology, sterilization efficacy, and adherence to international standards (e.g., ISO 11138 series) and regulatory guidance from bodies like the FDA.

Summary

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January 8, 2021

STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5976 Heislev Rd Mentor, Ohio 44060

Re: K202721

Trade/Device Name: Celerity 20 Steam Biological Indicator for IUSS Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: December 10, 2020 Received: December 11, 2020

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

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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) 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 (OS) 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. Acting 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) K202721

Device Name

Celerity 20 STEAM Biological Indicator for IUSS

Indications for Use (Describe) The Celerity 20 STEAM Biological Indicator for IUSS is used for monitoring and qualification testing of the following steam sterilization cycles: Gravity 270°F (132°C) 3 minutes Gravity 270°F (132°C) 10 minutes Gravity 275°F (135°C) 3 minutes Gravity 275°F (135°C) 10 minutes.

When used in conjunction with the Celerity STEAM 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 Celerity 20 Steam Biological Indicator for IUSS

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 Director, Regulatory Affairs

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

Submission Date: January 8, 2021

Premarket Notification number: K202721

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

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1. Device Name

Trade Name:	Celerity 20 Steam Biological Indicator for IUSS
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

3M Attest 1491 Super Rapid Readout Biological Indicator, K103277

3. Reference Device

Celerity 20 Steam Biological Indicator, cleared under K173634 and modified under K181686

4. Description of Device

Intended Use/ Indications for Use ട്.

The Celerity 20 STEAM Biological Indicator for IUSS is used for monitoring and qualification testing of the following steam sterilization cycles:

Gravity 270°F (132°C) 3 minutes ●
Gravity 270°F (132°C) 10 minutes ●
Gravity 275°F (135°C) 3 minutes ●
Gravity 275°F (135°C) 10 minutes.

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

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K202721 Celerity 20 Steam Biological Indicator for IUSS

Summary of Technical Characteristics 6.

A comparison of technical characteristics of the proposed device to the predicate are summarized in Table 5-1.

	Celerity SCBI for IUSS(proposed)	K103277 Attest 1491(Predicate)	Comparison	Feature	Celerity SCBI for IUSS(proposed)	K173634 Celerity 20Steam BI (Reference)	Comparison
Feature				IntendedUse	The Celerity 20 STEAMBiological Indicator forIUSS is used for monitoringand qualification testing ofthe following steamsterilization cycles:Gravity 270°F (132°C) 3minutesGravity 270°F (132°C) 10minutesGravity 275°F (135°C) 3minutesGravity 275°F (135°C) 10minutes.When used in conjunctionwith the Celerity STEAMIncubator, the Incubatorprovides a fluorescent resultwithin 20 minutes.	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 fluorescentresult within 20 minutes.	Both are intended formonitoring steamsterilization cycles.The Celerity BI for IUSS isspecifically for gravity IUSScycles. Testing is providedin this 510(k) to demonstratesuitable performance ingravity IUSS cycles.
IntendedUse	The Celerity 20 STEAMBiological Indicator forIUSS is used for monitoringand qualification testing ofthe following steamsterilization cycles:Gravity 270°F (132°C) 3minutesGravity 270°F (132°C) 10minutesGravity 275°F (135°C) 3minutesGravity 275°F (135°C) 10minutes.When used in conjunctionwith the Celerity STEAMIncubator, the Incubatorprovides a fluorescent resultwithin 20 minutes.	Use 3M Attest 1491 SuperRapid Read BiologicalIndicator in conjunctionwith the 3M Attest Auto-reader 490 to monitor thecycles below.Gravity DisplacementIUSS (Flash):270°F(132°C) 3 minutes;270°F(132°C) 10 minutes;275°F(135°C) 3 minutes;275°F(135°C) 10 minutes.The 3M Attest 1491 SuperRapid Readout BiologicalIndicator provides a finalfluorescent result in 30minutes. An optional visualpH color change result isobserved in 24 hours.	Both are intended formonitoring the same steamsterilization 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	Identical
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	Identical
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	Both use the same reader
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 - 4.0 x 106 spore/SCBI	Identical
Viable sporepopulation	1.0 - 4.0 x 106 spore/SCBI	≥ 1.0 x 106 spore/SCBI	Both proposed and predicatemeet criteria of the FDA	Resistance	D132 ≥ 10 sD135 ≥ 8 s	D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s	Identical at the twotemperatures for which theproposed device is indicated
Resistance	D132 ≥ 10 sD135 ≥ 8 s	D132 ≥ 10 sD135 ≥ 8 s	guidance on BiologicalIndicator 510(k)	CultureConditions	55- 59 °C, media includedin SCBI, 20-minuteincubation time.	55- 59 °C, media includedin SCBI, 20-minuteincubation time.	Identical
CultureConditions	55- 59 °C, media includedin SCBI, 20-minuteincubation time.	55- 59 °C, media includedin SCBI, 30 minuteincubation time.	RIT Testing and ISO 11138media testing verifiesperformance	PrimaryPackaging	Direct inoculum on plasticvial, cap with recoverymedia.	Direct inoculum on plasticvial, cap with recoverymedia.	Identical
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. Proposed vs Predicate Physical Description and Technological Properties

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K202721 Celerity 20 Steam Biological Indicator for IUSS

A comparison of technical characteristics of the proposed device to the predicate are summarized in Table 5-2.

Table 5-2. Proposed vs Reference Physical Description and Technological Properties

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7. Summary of Nonclinical Tests

Performance testing 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 20-minute results with theconventional incubation time of 7 days	PASS
Viable sporepopulation	1.0 - 4.0 x 106 spore/SCBI	PASS
Resistance	$D_{132} ≥ 10 s$$D_{135} ≥ 8 s$	PASS
Survival Time	Meets FDA requirements	$132 C ≥ 1 min$$135 C ≥ 0.667 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 within8 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
Shelf-life	Population, resistance, RIT and media mustmeet above criteria at each stability timepoint	PASS at 3 months(ongoing)

Table 5-2. Summary of Non-clinical Testing

7. Conclusion

The conclusion drawn from the nonclinical tests performed demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K103277 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).