Celerity Incubator

K250061 · STERIS Corporation · FRC · Feb 6, 2025 · General Hospital

Device Facts

• Record ID: K250061
• Device Name: Celerity Incubator
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Feb 6, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended 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.

Device Story

Celerity Incubator is a benchtop device used to incubate and monitor biological indicators (BIs) for steam and vaporized hydrogen peroxide sterilization. The device features 8 wells arranged in 2 banks of 4, preset to 59°C. The operator scans the BI barcode, which instructs the system to apply the appropriate incubation algorithm. During incubation, UV LEDs excite fluorescent molecules produced by enzymatic activity (a-glucosidase) in viable organisms; a photodiode detects the emitted light. The device provides results via visual LED indicators (red for positive/failure, green for negative), an LCD screen, and an audible alarm. Positive results indicate potential sterilization cycle failure, requiring operator acknowledgment. The device is intended for use in clinical settings to verify sterilization process effectiveness.

Clinical Evidence

Bench testing only. Performance was validated by comparing fluorescent read results against 7-day growth out methods per FDA guidance for reduced incubation time. The device demonstrated ≥ 97% alignment with 7-day growth out results for Celerity 5 HP and Celerity 20 HP Biological Indicators. Software validation confirmed effective operation.

Technological Characteristics

Benchtop incubator with 8 wells; 100-240 VAC power with 12 VDC conversion; 55-60°C operating range. Sensing principle: UV LED excitation and photodiode detection of fluorescence. Barcode scanner for input. Visual (LED/LCD) and audible output. Factory calibrated. Software-controlled.

Indications for Use

Indicated for use by healthcare personnel to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization processes at 55°C-60°C to detect fluorescent results indicating sterilization efficacy.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• Celerity Incubator (K223715)

Submission Summary (Full Text)

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February 6, 2025

STERIS Corporation Karly Eitzman Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K250061

Trade/Device Name: Celerity Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: January 8, 2025 Received: January 10, 2025

Dear Karly Eitzman:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Digitally signed by Stephen A. Anisko -S Stephen A. Anisko -S
Stephen A. Anisko -S Stephen A. Anisko -S
Stephen A. Anisko -S Date: 2025.02.06 17:3 Date: 2025.02.06 17:39:07 -05'00'

for: Christopher K. Dugard Division Director DHT4C: Division of Infection Control 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)

K250061

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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# 510(k) Summary For Celerity Incubator

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Mrs. Karly Eitzman Contact: Regulatory Affairs Specialist Tel: [phone] karly [e-mail]

Submission Date: January 8, 2025

K Number: K250061

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: | Reader/Incubator |
| Classification Name: | Biological Sterilization Process Indicator |
| Classification Number: | 21 CFR 880.2800 |
| Product Code: | FRC |

#### 2. Predicate Device

K223715 – Celerity Incubator

#### 3. 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.

#### 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.

#### 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

| Feature | Proposed Device<br>Celerity Incubator | Predicate Device<br>Celerity Incubator<br>(K223715) | Comparison |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications<br>for Use | Use the Celerity Incubator to<br>incubate and automatically<br>read STERIS Celerity | Use the Celerity Incubator to<br>incubate and automatically<br>read STERIS Celerity | Same |
| Feature | Proposed Device<br>Celerity Incubator | Predicate Device<br>Celerity Incubator<br>(K223715) | Comparison |
| | Biological Indicators for<br>Steam and Vaporized<br>Hydrogen Peroxide<br>sterilization at 55°C - 60°C<br>for a fluorescent result. | Biological Indicators for<br>Steam and Vaporized<br>Hydrogen Peroxide<br>sterilization at 55°C - 60°C<br> | |
| Basis of<br>Readout | Photodiode detects<br>fluorescence produced by<br>enzymatic activity that results<br>from viable biological<br>indicator organisms. | Photodiode detects<br>fluorescence produced by<br>enzymatic activity that results<br>from viable biological<br>indicator organisms. | Same |
| Incubation<br>Temperature<br>Range | 55 - 60 °C | 55 - 60 °C | Same |
| Voltage<br>Range | 100-240 VAC with 12 VDC<br>conversion | 100-240 VAC with 12 VDC<br>conversion | Same |
| Test Capacity | 8 wells | 8 wells | Same |
| Calibration | Factory calibration - no<br>calibration by customer | Factory calibration - no<br>calibration by customer | Same |
| Incubation<br>Time | 5 minutes or 20 minutes,<br>depending on Biological<br>Indicator | 5 minutes or 20 minutes,<br>depending on the Biological<br>Indicator | Same |
| Fluorescence<br>Detection | UV LEDs are used to excite<br>the fluorescent molecule<br>produced by enzyme cleavage<br>of the fluorogenic substrate<br>contained in the BI's media.<br>The emitted light is detected<br>by a photodiode. | UV LEDs are used to excite<br>the fluorescent molecule<br>produced by enzyme cleavage<br>of the fluorogenic substrate<br>contained in the BI's media.<br>The emitted light is detected<br>by a photodiode. | Same |
| Indication of<br>Results | Positive - audible alarm,<br>visual LED lights and screen<br>Negative – optional alarm,<br>visual indication with LED<br>lights and LCD screen<br>User must acknowledge<br>results | Positive – audible alarm,<br>visual LED lights and screen<br>Negative - optional alarm,<br>visual indication with LED<br>lights and LCD screen<br>User must acknowledge<br>results | Same |
| System<br>Operation | The reader/incubator wells<br>are arranged in 2 banks of 4<br>wells and preset to 59°C. The<br>user scans the barcode on the<br>label of an activated BI using | The reader/incubator wells<br>are arranged in 2 banks of 4<br>wells and preset to 59°C. The<br>user scans the barcode on the<br>label of an activated BI using | Same |
| Feature | Proposed Device<br>Celerity Incubator | Predicate Device<br>Celerity Incubator<br>(K223715) | Comparison |
| | the system's barcode scanner<br>and places it into an open<br>well. The system detects the<br>well the BI was placed into<br>and begins measurement of<br>fluorescence; a blinking<br>yellow light indicates the<br>incubation is in process and<br>the read initiated. The | the system's barcode scanner<br>and places it into an open<br>well. The system detects the<br>well the BI was placed into<br>and begins measurement of<br>fluorescence; a blinking<br>yellow light indicates the<br>incubation is in process and<br>the read initiated. The | |
| | System uses information from<br>the barcode to apply the<br>appropriate algorithm to the<br>well. A "positive" reading is<br>interpreted as an indication of<br>a potential sterilization cycle<br>failure. A "positive" finding<br>is indicated to the user by red<br>light on the front panel<br>adjacent to the well, by an<br>audible alarm, and by text<br>displayed on the LCD screen.<br>The alarm must be muted by<br>the operator when a positive<br>result is obtained. The LCD<br>screen provides instructions<br>for the user to turn off the<br>alarm for that specific BI.<br>Should another BI become<br>"positive", the alarm will<br>sound again and the above<br>actions are repeated. | System uses information from<br>the barcode to apply the<br>appropriate algorithm to the<br>well. A "positive" reading is<br>interpreted as an indication of<br>a potential sterilization cycle<br>failure. A "positive" finding<br>is indicated to the user by red<br>light on the front panel<br>adjacent to the well, by an<br>audible alarm, and by text<br>displayed on the LCD screen.<br>The alarm must be muted by<br>the operator when a positive<br>result is obtained. The LCD<br>screen provides instructions<br>for the user to turn off the<br>alarm for that specific BI.<br>Should another BI become<br>"positive", the alarm will<br>sound again and the above<br>actions are repeated. | |
| | If the result is not positive at<br>the end of the incubation<br>time, the result is negative.<br>Negative results are identified<br>by a green light on the front<br>panel adjacent to the well<br>with the "negative" BI and by<br>text on the LCD. In addition,<br>an optional alarm is available<br>for negative results. | If the result is not positive at<br>the end of the incubation<br>time, the result is negative.<br>Negative results are identified<br>by a green light on the front<br>panel adjacent to the well<br>with the "negative" BI and by<br>text on the LCD. In addition,<br>an optional alarm is available<br>for negative results. | |

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#### Summary of Non-Clinical Performance Testing 6.

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

| Test | Acceptance Criteria | Result |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Software Validation | The software that controls the system was validated<br>and determined to operate effectively and as designed. | Pass |
| Qualification Testing<br>with intended<br>Biological Indicators | Fluorescent Read meets ≥ 97% alignment with 7-day<br>grow out per FDA guidance on Reduced Incubation<br>Time for intended Celerity 5 HP Biological Indicators<br>and Celerity 20 HP Biological Indicators | Pass |
| Recognition of<br>additional barcodes | Incubator reads barcodes correctly | 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 (K223715), Class II (21 CFR 880.2800), product code FRC.