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

Here's an analysis of the provided text regarding the Celerity Incubator's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
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 Vaporized Hydrogen Peroxide Celerity 5 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 60101-1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1: General Requirements	PASS
Software Validation per IEC 62304	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 provided document does not explicitly state the sample size used for the "Qualification Testing with intended Biological Indicators" which is the most relevant performance test described. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature).

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. The acceptance criterion mentions "7-day grow out per FDA guidance," implying a standard microbiological method for determining growth, which typically doesn't involve "experts" in the sense of clinical reviewers.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. The "7-day grow out" is a definitive biological outcome, not typically subject to adjudication in the same way clinical image reviews might be.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is an incubator for biological indicators, not a diagnostic imaging or AI-assisted diagnostic tool that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance test was done, referred to as "Qualification Testing with intended Biological Indicators." This test assesses the device's ability to accurately detect fluorescence in biological indicators, which is an automated process without human interpretation in the results pathway. The "human factors" test evaluates user interaction, but the core performance related to detecting BI growth is standalone.

7. The Type of Ground Truth Used

The type of ground truth used for the "Qualification Testing with intended Biological Indicators" is biological growth/non-growth, as determined by a "7-day grow out" method. This is a functional, objective ground truth based on the viability of microorganisms.

8. The Sample Size for the Training Set

The document does not provide information on a training set sample size. This is because the Celerity Incubator is a hardware device with embedded software for interpreting biological indicator results based on a known biochemical reaction (fluorescence). It doesn't appear to be an AI/machine learning model in the typical sense that would require a separate training set for algorithm development.

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

As there is no mention of a traditional training set for an AI/ML algorithm, the concept of establishing ground truth for a training set in this context is not applicable or described in the document. The device's operation is based on established principles of fluorescence detection for biological activity, rather than learning from a dataset.

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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 15, 2023

STERIS Corporation Gregory Land Lead Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060

Re: K223715

Trade/Device Name: Celerity Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: May 19, 2023 Received: May 19, 2023

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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,

Christopher K. Dugard -S

for Clarence W. Murray, III, PhD Deputy 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

Submission Number (if known)

K223715

Device Name

Celerity Incubator

Indications for Use (Describe)

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

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/0 description: The image shows the STERIS logo. The word "STERIS" is in all caps and in a serif font. Below the word is a graphic of several horizontal wavy lines in blue.

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 LandLead Regulatory Affairs SpecialistTel: 440-392-7424greg_land@steris.com
Submission Date:	June 13, 2023

K Number: K223715

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

K213881 - Celerity Incubator

3. Device Description

Indications for Use 4.

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.

5. Technological Characteristics Comparison Table

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

Table 1. Technological Characteristics Comparison Table to predicate device

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Summary of Non-Clinical Performance Testing 6.

Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 2.

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Test	Acceptance Criteria	Result
QualificationTesting withintendedBiologicalIndicators	Fluorescent Read meets > 97% alignment with 7-day growout per FDA guidance on reduced incubation time forintended Biological Indicators for Vaporized HydrogenPeroxide Celerity 5 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 60101-1 Safety Requirements for Electrical Equipmentfor Measurement, Control, and Laboratory Use Part 1:General Requirements	PASS
SoftwareValidation perIEC 62304	The software that controls the system was validated anddetermined to operate effectively and as designed.	PASS

Table 2. Performance Testing

7. Conclusion

The Celerity Incubator has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K213881), 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	Proposed DeviceUniversal BiologicalIndicator Incubator	Predicate DeviceCelerity Indicator(K213881)	Comparison
Indicationsfor Use	Use the Celerity Incubator toincubate and automaticallyread STERIS CelerityBiological Indicators for	Use the Celerity Incubator toincubate and automaticallyread STERIS CelerityBiological Indicators for	Same
Feature	Proposed DeviceUniversal BiologicalIndicator Incubator	Predicate DeviceCelerity Indicator(K213881)	Comparison
	Steam and VaporizedHydrogen Peroxidesterilization at 55°C - 60°Cfor a fluorescent result.	Steam and VaporizedHydrogen Peroxidesterilization at 55°C - 60°Cfor a fluorescent result.
Basis ofReadout	Photodiode detectsfluorescence produced byenzymatic activity that resultsfrom viable biologicalindicator 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	5 minutes or 20 minutesdepending on BiologicalIndicator	20 minutes	Similar
FluorescenceDetection	UV LEDs are used to excitethe fluorescent moleculeproduced by enzyme cleavageof the fluorogenic substratecontained in the BI's media.The emitted light is detectedby a photodiode.	UV LEDs are used to excitethe fluorescent moleculeproduced by enzyme cleavageof the fluorogenic substratecontained in the SCBI'smedia. The emitted light isdetected by a photodiode.	Same
Indication ofResults	Positive - audible alarm,visual LED lights and screenNegative - optional alarm,visual indication with LEDlights and LCD screenUser must acknowledgeresults	Positive - audible alarm,visual LED lights and screenNegative - optional alarm,visual indication with LEDlights and LCD screenUser must acknowledgeresults	Same
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 scanner	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 scanner	Same
	Proposed DeviceUniversal BiologicalIndicator Incubator	Predicate DeviceCelerity Indicator(K213881)	Comparison
Feature	and 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 at	and 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 at
	the end of the incubationtime, the result is negative.	the 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	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
	for negative results.	for negative results.