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.

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

The provided document is a 510(k) premarket notification for a medical device called the CELERITY 20 HP Biological Indicator. This device is a sterilization process indicator and, as such, there is no AI/Algorithm component to its function. Therefore, several of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, how training ground truth was established, effect size of human readers with/without AI) are not applicable to this type of device.

Here's the relevant information that can be extracted:

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

Test	Acceptance Criteria	Reported Device Performance
Simulated Use	BI is inactivated when exposed in a worst-case cycle with a worst-case load	No growth of BI

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

Sample Size for Test Set: The document does not specify the exact number of biological indicators (BIs) used in the "Simulated Use" test. However, it implicitly refers to a "worst-case cycle with a worst-case load," which suggests a controlled laboratory setting.
Data Provenance: The study appears to be a laboratory-based performance study conducted by STERIS Corporation (Mentor, OH, USA), as indicated by the "Summary of Nonclinical Tests." It is prospective in nature as it involves testing the device's performance under specified conditions.

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)

Not applicable, as this is a physical biological indicator, not an AI/algorithm-driven device requiring expert interpretation of results for ground truth. The "ground truth" is the known sterility condition of the sterilization cycle.

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

Not applicable. The result of a biological indicator is typically a clear "growth" or "no growth" binary outcome, observed directly by laboratory personnel following established protocols.

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, as this device is a biological indicator, not an AI system.

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

Not applicable, as this device is a biological indicator, not an AI system. The device itself (the biological indicator and its incubator) provides a standalone result (fluorescent signal within 20 minutes) without human-in-the-loop interpretation beyond reading the incubator's output.

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

The ground truth for this device's performance is the known sterility or non-sterility of the sterilization cycle. This is established through controlled laboratory conditions where cycles are designed to either sterilize completely or to represent a "worst-case" scenario that should prevent complete inactivation of the BI. The "no growth of BI" result is then compared against this known condition.

8. The sample size for the training set

Not applicable, as this device does not use an AI/algorithm that requires a training set.

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

Not applicable, as this device does not use an AI/algorithm that requires 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 13, 2018

STERIS Corporation Anthony Piotrkowski Senior Regulatory Affairs Manager 5960 Heisley Road Mentor, Ohio 44060

Re: K181429

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: May 30, 2018 Received: June 1, 2018

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

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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 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,

Elizabeth F. Claverie -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) K181429

Device Name Celerity 20 HP Biological Indicator

Indications for Use (Describe)

When used in conjunction with the VERIFY 20 HP Incubator, the CELERITY 20 HP Biological Indicator 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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Image /page/3/Picture/11 description: The image shows the STERIS logo. The word STERIS is in all caps and in a serif font. Below the word STERIS is an image of several horizontal wavy lines that are blue.

510(k) Summary For K181429 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

Contact: Tony Piotrkowski Senior Manager, Regulatory Affairs

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

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

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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, K172752

3. Description of Device

4. Intended Use/ Indications for Use

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

5. Summary of Technical Characteristics

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

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Feature	CELERITY 20 HP BIK181429	CELERITY 20 HP BIPredicate (K172752)	Comparison
Intended Use	The CELERITYBiological Indicator isused for routinemonitoring, andqualification of the NonLumen, Flexible, Lumenand Fast Non LumenCycles of the V-PRO 1, 1Plus, maX, 60 and maX 2Low TemperatureSterilizers in healthcarefacilities.When used in conjunctionwith the VERIFYCELERITY 20 HPIncubator, the CELERITY20 HP Biological Indicatorprovides a fluorescentresult within 20 minutes.	The CELERITYBiological Indicator isused for routinemonitoring, andqualification of the NonLumen, Flexible, Lumenand Fast Non LumenCycles of the V-PRO 1, 1Plus, maX, 60 and maX 2Low TemperatureSterilizers in healthcarefacilities.When used in conjunctionwith the VERIFYCELERITY 20 HPIncubator, the CELERITY20 HP Biological Indicatorprovides a fluorescentresult within 20 minutes.	Identical
Indicatororganism	Geobacillusstearothermophilus	Geobacillusstearothermophilus	Identical
Mechanismof action	An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within thedefined nutrient media toproduce a fluorescentmoiety.	An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within thedefined nutrient media toproduce a fluorescentmoiety.	Identical
Accessories	Automated incubator /reader	Automated incubator /reader	Identical
Viable sporepopulation	$1.0 - 4.0 \times 10^6$ spore/BI	$1.0 - 4.0 \times 10^6$ spore/BI	Identical
Resistancecharacteristics	Resistance @ 9.1 mg/LH2O2:• D-value > 3 sec• Survival Time ≥ 4 sec• Kill Time ≤ 6 min	Resistance @ 9.1 mg/LH2O2:• D-value > 3 sec• Survival Time ≥ 4 sec• Kill Time ≤ 6 min	Identical
CultureConditions	55- 59°C, media includedin BI, 20-minuteincubation time.	55- 59°C, media includedin BI, 20-minuteincubation time.	Identical
PrimaryPackaging	Direct inoculum on plasticvial, cap with recoverymedia.	Direct inoculum on plasticvial, cap with recoverymedia.	Identical
Processindicator	VERIFY V-PROChemical Indicator(K140515); magenta toyellow color change.	VERIFY V-PROChemical Indicator(K140515); magenta toyellow color change.	Identical
Label	Single-ply on cap edge	Two-ply on top of cap	Same adhesive andsubstrate, different formatand location
Shelf-life	Currently 7 months	Currently 7 months	Real Time Testing Ongoing

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

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K181429

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	Result
Simulated Use	BI is inactivated when exposed in a worst-case cycle with a worst-case load	No growth of BI

Conclusion 7.

The Celerity 20 HP 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, K172752 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).