Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a fluorescent result.

Device Description

The Celerity Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The BI is incubated at 59°C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.

AI/ML Overview

The provided document describes the STERIS Celerity Incubator, a device designed to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Maintenance of Incubation Temperature	Temperature of BIs is maintained between 55°C - 60°C during incubation. Temperatures were observed over a 60min period and during a 1min loss of power.	PASS
Qualification Testing with intended Biological Indicators	Fluorescent Read meets ≥ 97% alignment with 7-day grow out per FDA guidance on reduced incubation time for intended Biological Indicators for both Steam and Vaporized Hydrogen Peroxide Celerity Biological Indicators.	PASS
Human Factors	Typical users are capable of following the written instructions for use to correctly use the Celerity Incubators.	PASS
Electromagnetic Compatibility	IEC 60601-1-2:2014 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.	PASS
Electrical Safety Conformance	IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.	PASS
Software Validation	The software that controls the system was validated and determined to operate effectively and as designed.	PASS

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

The document does not explicitly state the sample size used for the test set of biological indicators in the "Qualification Testing with intended Biological Indicators". It mentions "intended Biological Indicators for both Steam and Vaporized Hydrogen Peroxide Celerity Biological Indicators." No specific numbers are provided for these tests.

The data provenance (e.g., country of origin, retrospective or prospective) is not specified.

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

The document does not mention the use of human experts or their qualifications for establishing ground truth for the biological indicator testing. The ground truth appears to be based on a "7-day grow out" method, which is a laboratory standard for sterility verification rather than expert human interpretation.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1, none) is mentioned, as the validation process does not involve expert interpretation or subjective assessment that would require such a method.

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

No MRMC comparative effectiveness study was done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data. The Celerity Incubator is an automated device for reading biological indicators.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The "Qualification Testing with intended Biological Indicators" directly evaluates the automated fluorescent read of the device against a 7-day grow out method. This demonstrates the device's algorithmic performance in identifying viable organisms without human intervention in the result interpretation.

7. Type of Ground Truth Used

The type of ground truth used for the "Qualification Testing with intended Biological Indicators" is 7-day grow out. This is a standard microbiological method to determine if a sterilization process has been successful by attempting to culture any surviving microorganisms over a 7-day period.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is because the Celerity Incubator is not an AI/machine learning model that requires a "training set" in the traditional sense. It's an automated device performing a specific detection function based on established scientific principles (fluorescence of enzymatic activity).

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

As there is no mention of a training set or an AI/machine learning model, the concept of establishing ground truth for a training set is not applicable to this device as described. The device's functionality relies on physical and chemical reactions and subsequent detection, rather than learning from a dataset.

Summary

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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 21, 2022

STERIS Corporation Gregory Land Senior Regulatory Affairs Specialist 5960 Heislev Road Mentor, Ohio 44060

Re: K213881

Trade/Device Name: Celerity Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: Class II Product Code: FRC Dated: July 5, 2022 Received: July 6, 2022

Dear Gregory Land:

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, PhD 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) K213881

Device Name Celerity Incubator

Indications for Use (Describe)

Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C-60°C for a fluorescent result.

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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STEI

510(k) Summary For Celerity Incubator

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:

Mr. Gregory Land Senior Regulatory Affairs Specialist Tel: 440-392-7424 Fax: 440-357-9198 greg land(@steris.com

Submission Date: July 21, 2022

K Number: K213881

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

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1. Device Name

Trade Name:	Celerity Incubator
Device Class:	Class II
Common/usual Name:	Incubator
Classification Name:	Indicator, Biological Sterilization Process
Classification Number:	21 CFR 880.2800
Product Code:	FRC

2. Predicate Device

K190297 – Celerity HP Incubator

3. Reference Device

K173670 - Celerity Steam Incubator

4. Device Description

4. Indications for Use

Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a fluorescent result.

ನ. Technological Characteristics Comparison Table

A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.

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Feature	Subject DeviceUniversal BiologicalIndicator Incubator(K213881)	Predicate DeviceCelerity 20 HP Indicator(K190297)	Comparison
Indicationsfor Use	Use the Celerity Incubator toincubate and automatically readSTERIS Celerity BiologicalIndicators for Steam andVaporized Hydrogen Peroxidesterilization at 55°C - 60°C for afluorescent result.	Use the Celerity HP Incubatorto incubate and automaticallyread Celerity 20 HP BiologicalIndicators at 57°C for afluorescent result within 20minutes.	Similar
Basis ofReadout	Photodiode detects fluorescenceproduced by enzymatic activitythat results from viablebiological indicator organisms.	Photodiode detectsfluorescence produced byenzymatic activity that resultsfrom viable biologicalindicator organisms.	Same
IncubationTemperatureRange	55 - 60 °C	55 - 60 °C	Same
VoltageRange	100-240 VAC with 12 VDCconversion	100-240 VAC with 12 VDCconversion	Same
Test Capacity	8 wells	8 wells	Same
Calibration	Factory calibration - nocalibration by customer	Factory calibration - nocalibration by customer	Same
IncubationTime	20 minutes	20 minutes	Same
FluorescenceDetection	UV LEDs are used to excite thefluorescent molecule producedby enzyme cleavage of thefluorogenic substrate containedin the BI's media. The emittedlight is detected by a photodiode.	UV LEDs are used to excitethe fluorescent moleculeproduced by enzyme cleavageof the fluorogenic substratecontained in the SCBI's media.The emitted light is detectedby a photodiode.	Same
Indication ofResults	Positive - audible alarm, visualLED lights and screen Negative- optional alarm, visualindication with LED lights andLCD screenUser must acknowledge results	Positive - audible alarm,visual LED lights and screenNegative - optional alarm,visual indication with LEDlights and LCD screenUser must acknowledge results	Same
Feature	Subject DeviceUniversal BiologicalIndicator Incubator(K213881)	Predicate DeviceCelerity 20 HP Indicator(K190297)	Comparison
SystemOperation	The reader/incubator wellsare arranged in 2 banks of 4wells and preset to 59°C. Theuser scans the barcode on thelabel of an activated BI usingthe system's barcode scannerand places it into an openwell. The system detects thewell the BI was placed intoand begins measurement offluorescence; a blinkingyellow light indicates theincubation is in process andthe read initiated. TheSystem uses information fromthe barcode to apply theappropriate algorithm to thewell. A "positive" reading isinterpreted as an indication ofa potential sterilization cyclefailure. A "positive" findingis indicated to the user by redlight on the front paneladjacent to the well, by anaudible alarm, and by textdisplayed on the LCD screen.The alarm must be muted bythe operator when a positiveresult is obtained. The LCDscreen provides instructionsfor the user to turn off thealarm for that specific BI.Should another BI become"positive", the alarm willsound again and the aboveactions are repeated.If the result is not positive atthe end of the incubationtime, the result is negative.Negative results are identifiedby a green light on the frontpanel adjacent to the wellwith the "negative" BI and bytext on the LCD. In addition, an optional alarm is available	The reader/incubator wellsare arranged in 2 banks of 4wells and preset to 57°C. Themeasurement of fluorescenceis initiated by placement of aCelerity HP BI into any of theincubation wells and pressingthe adjacent "ACTION”button.When an SCBI is placed intoa well, the auto-reader detectsits presence. Upon pressingthe button associated withthat well, a blinking yellowlight indicates that incubationis in process and the readinitiated.A "positive" reading isinterpreted as an indication ofa potential sterilization cyclefailure. A "positive" findingis indicated to the user by red	Similar
Feature	Subject DeviceUniversal BiologicalIndicator Incubator(K213881)	Predicate DeviceCelerity 20 HP Indicator(K190297)	Comparison
	for negative results.	for negative results. Usermust acknowledge results.

Table 1. Technological Characteristics Comparison Table to predicate device

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6. Summary of Non-Clinical Performance Testing

Testing was performed to evaluate performance and demonstrate that device met the acceptance criteria shown in Table 2.

Test	Acceptance Criteria	Result
Maintenance ofIncubationTemperature	Temperature of BIs is maintained between 55°C - 60°Cduring incubation. Temperatures were observed over a60min period and during a 1min loss of power.	PASS
QualificationTesting withintendedBiologicalIndicators	Fluorescent Read meets ≥ 97% alignment with 7-day growout per FDA guidance on reduced incubation time forintended Biological Indicators for both Steam and VaporizedHydrogen Peroxide Celerity Biological Indicators	PASS
Human Factors	Typical users are capable of following the writteninstructions for use to correctly use the Celerity Incubators.	PASS
ElectromagneticCompatibility	IEC 60601-1-2:2014 General Requirements for Basic Safetyand Essential Performance - Collateral Standard:Electromagnetic Compatibility - Requirements and Tests	PASS
Electrical SafetyConformance	IEC 60601-1 Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance	PASS
SoftwareValidation	The software that controls the system was validated anddetermined to operate effectively and as designed.	PASS

Table 2. Performance Testing

7. Conclusion

The conclusions drawn from the non-clinical performance data demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K190297), 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).