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 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

Here's an analysis of the provided information to answer your questions about acceptance criteria and the study that proves the device meets them:

Device: Celerity 20 Steam Biological Indicator

1. A table of acceptance criteria and the reported device performance

Based on the document, only one performance test is explicitly mentioned with an acceptance criterion and conclusion:

Test	Acceptance Criteria	Reported Device Performance/Conclusion
Simulated Use	Demonstrate no growth when exposed to a full cycle	Full cycle - no growth

The document also lists several technical characteristics for the Celerity 20 Steam Biological Indicator (modified) and compares them to the predicate device. While these aren't explicitly stated as "acceptance criteria" in the same way as the "Simulated Use" test, they represent performance parameters that the device is expected to meet and does meet, often being "Identical" to the predicate.

For completeness, here's a combined table including those technical characteristics as implicit acceptance criteria if one assumes they must match the predicate:

Feature	Acceptance Criteria (typically matching predicate)	Reported Device Performance
Simulated Use	Demonstrate no growth when exposed to a full cycle	Full cycle - no growth
Indicator organism	> 90% similarity to ATCC 7953 Geobacillus stearothermophilus	> 90% similarity to ATCC 7953 Geobacillus stearothermophilus (Identical to predicate)
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 (Identical to predicate)
Accessories	Automated incubator / reader	Automated incubator / reader (Identical to predicate)
Viable spore population	1.0 - 4.0 x 10^6 spore/SCBI	1.0 - 4.0 x 10^6 spore/SCBI (Identical to predicate)
Resistance	D121 ≥ 1.5 min D132 ≥ 10 s D135 ≥ 8 s	D121 ≥ 1.5 min D132 ≥ 10 s D135 ≥ 8 s (Identical to predicate)
Survival Time	Meets the longer of FDA and ISO 11138-3 requirements	Meets the longer of FDA and ISO 11138-3 requirements (Identical to predicate)
Kill Time	Meets the shorter of FDA and ISO 11138-3 requirements	Meets the shorter of FDA and ISO 11138-3 requirements (Identical to predicate)
Hold time	Up to 72 h	Up to 72 h (Identical to predicate)
Carrier growth inhibition / media growth	Positive growth of less than 100 spores after primary packaging and media are subject to worst case steam exposure	Positive growth of less than 100 spores after primary packaging and media are subject to worst case steam exposure (Identical to predicate)
Culture Conditions	55- 59 °C, media included in SCBI, 20-minute incubation time.	55- 59 °C, media included in SCBI, 20-minute incubation time. (Identical to predicate)
Primary Packaging	Direct inoculum on plastic vial, cap with recovery media.	Direct inoculum on plastic vial, cap with recovery media. (Identical to predicate, though the cap label changed, this refers to the fundamental structure)
Shelf Life	10 months (predicate)	10 months (Identical to predicate, but the note states "Shelf-life testing is ongoing", implying this is the target or current demonstrated shelf life, not necessarily a completed test definitively proving the full 10 months for the modified device if testing is still ongoing at the time of submission)
Cap label	Single-ply label on cap edge, Process indicator on label	Single-ply label on cap edge, Process indicator on label (Differs from predicate, which had a two-ply label on cap top. This is a design change, not a performance criterion in the same way, but noted for comparison.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for the "Simulated Use" test or any other specific test. It also does not provide information about the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This type of information is not applicable to a biological indicator device. The "ground truth" for a biological indicator is determined by the presence or absence of microbial growth, which is an objective biological outcome rather than an expert interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As noted above, the determination of microbial growth is objective, not requiring human adjudication.

5. 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

Not applicable. This device is a biological indicator, not an AI-assisted diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a biological indicator, not an algorithm. Its performance is inherent to its biological and chemical properties. The Celerity™ Steam Incubator provides an automated fluorescent result, which could be considered a "standalone" reading, but it's not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for relevant tests (like viability, resistance, survival, kill time, and simulated use) is based on the presence or absence of microbial growth (Geobacillus stearothermophilus), which is an objective biological outcome. This is determined through standard microbiological techniques.

8. The sample size for the training set

Not applicable. This device is a biological indicator, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

9. How the ground truth for the training set was established

Not applicable. No training set is involved for this type of device.

Summary

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STERIS Corporation Tony Piotrkowski Senior Regulatory Affairs Manager 5960 Heisley Rd Mentor, Ohio 44060

Re: K181686

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: June 25, 2018 Received: June 26, 2018

Dear Tony 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

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 medical devices and radiation-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.

Clarence W. Murray lii III -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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Indications for Use

510(k) Number (if known) K181686

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 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: July 18, 2018

Premarket Notification Number: K181686

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
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 Steam Biological Indicator, K173634

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.

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5. Summary of Technical Characteristics

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

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

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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.

Table 5-2. Summary of Non-clinical Testing

Test	Acceptance Criteria	Conclusion
Simulated Use	Demonstrate no growth when exposed to afull cycle	Full cycle - no growth

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, K173634 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).

Feature	Celerity 20 Steam SCBI(modified)	Celerity 20 Steam SCBIPredicate (K173634)	Comparison
IntendedUse	The Celerity 20 SteamBiological Indicator is used forroutine monitoring,qualification testing, loadmonitoring and product testingof the following steamsterilization cycles:• Dynamic Air Removal270°F (132°C) 4 minutes• Dynamic Air Removal275°F (135°C) 3 minutes• Gravity 250°F (121°C) 30minutes• Gravity 270°F (132°C) 15minutes.When used in conjunctionwith the Celerity™ SteamIncubator, the Incubatorprovides a fluorescent resultwithin 20 minutes.	The Celerity 20 SteamBiological Indicator is used forroutine monitoring,qualification testing, loadmonitoring and product testingof the following steamsterilization cycles:• Dynamic Air Removal270°F (132°C) 4 minutes• Dynamic Air Removal275°F (135°C) 3 minutes• Gravity 250°F (121°C) 30minutes• Gravity 270°F (132°C) 15minutes.When used in conjunctionwith the Celerity™ SteamIncubator, the Incubatorprovides a fluorescent resultwithin 20 minutes.	Identical
Indicatororganism	> 90% similarity to ATCC7953 Geobacillusstearothermophilus	> 90% similarity to ATCC7953 Geobacillusstearothermophilus	Identical
Mechanismof action	An enzyme, which is producedby the organism, reacts with afluorogenic substrate withinthe defined nutrient media toproduce a fluorescent moiety	An enzyme, which is producedby the organism, reacts with afluorogenic substrate withinthe defined nutrient media toproduce a fluorescent moiety	Identical
Accessories	Automated incubator / reader	Automated incubator / reader	Identical
Viable sporepopulation	1.0 - 4.0 x 106 spore/SCBI	1.0 - 4.0 x 106 spore/SCBI	Identical
Resistance	D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s	D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s	Identical
SurvivalTime	Meets the longer of FDA andISO 11138-3 requirements	Meets the longer of FDA andISO 11138-3 requirements	Identical
Kill Time	Meets the shorter of FDA andISO 11138-3 requirements	Meets the shorter of FDA andISO 11138-3 requirements	Identical
Hold time	Up to 72 h	Up to 72 h	Identical
Carriergrowthinhibition /mediagrowth	Positive growth of less than100 spores after primarypackaging and media aresubject to worst case steamexposure	Positive growth of less than100 spores after primarypackaging and media aresubject to worst case steamexposure	Identical
Feature	Celerity 20 Steam SCBI(modified)	Celerity 20 Steam SCBIPredicate (K173634)	Comparison
CultureConditions	55- 59 °C, media included inSCBI, 20-minute incubationtime.	55- 59 °C, media included inSCBI, 20-minute incubationtime.	Identical
PrimaryPackaging	Direct inoculum on plasticvial, cap with recovery media.	Direct inoculum on plasticvial, cap with recovery media.	Identical
Shelf Life	10 months	10 months	Shelf-life testing isongoing
Cap label	Single-ply label on cap edgeProcess indicator on label	Two-ply label on cap topProcess indicator on label	Same adhesive,process indicator inkand substrate differentformat and location