Celerity Incubator

K213881 · STERIS Corporation · FRC · Jul 21, 2022 · General Hospital

Device Facts

• Record ID: K213881
• Device Name: Celerity Incubator
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Jul 21, 2022
• Decision: SESE
• Submission Type: Traditional
• 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

The Celerity Incubator is a benchtop device used to incubate and automatically read STERIS Celerity Biological Indicators (BIs) for steam and vaporized hydrogen peroxide sterilization. The device features 8 incubation wells arranged in two banks. The user scans the BI barcode, which informs the system of the appropriate algorithm to apply, and places the BI into a well. The device maintains an incubation temperature of 55°C-60°C. It uses UV LEDs to excite fluorescent molecules produced by enzymatic activity (a-glucosidase) within the BI, and a photodiode to detect the emitted light. Results are displayed via LCD screen, LED lights, and audible alarms. A positive result indicates potential sterilization failure, requiring operator acknowledgment. The device is intended for use in clinical settings to provide rapid (20-minute) sterilization monitoring.

Clinical Evidence

Bench testing only. Performance was validated by comparing the device's fluorescent read results against 7-day growth out methods, achieving ≥ 97% alignment per FDA guidance for reduced incubation time biological indicators. Additional testing included temperature maintenance verification (55°C-60°C), human factors validation, electromagnetic compatibility (IEC 60601-1-2:2014), and electrical safety (IEC 60601-1).

Technological Characteristics

Benchtop incubator with 8 wells; 100-240 VAC power with 12 VDC conversion; UV LED excitation source; photodiode fluorescence detector; factory-calibrated; barcode scanner for input; LCD/LED/audible alarm output. Complies with IEC 60601-1 and IEC 60601-1-2.

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 cycle 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 HP Incubator (K190297)

Reference Devices

• Celerity Steam Incubator (K173670)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax No: [phone]

Contact:

Mr. Gregory Land Senior Regulatory Affairs Specialist Tel: [phone] Fax: [phone] 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

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.

#### 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 Device<br>Universal Biological<br>Indicator Incubator<br>(K213881) | Predicate Device<br>Celerity 20 HP Indicator<br>(K190297) | Comparison |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications<br>for Use | Use the Celerity Incubator to<br>incubate and automatically read<br>STERIS Celerity Biological<br>Indicators for Steam and<br>Vaporized Hydrogen Peroxide<br>sterilization at 55°C - 60°C for a<br>fluorescent result. | Use the Celerity HP Incubator<br>to incubate and automatically<br>read Celerity 20 HP Biological<br>Indicators at 57°C for a<br>fluorescent result within 20<br>minutes. | Similar |
| Basis of<br>Readout | Photodiode detects fluorescence<br>produced by enzymatic activity<br>that results from viable<br>biological 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 | 20 minutes | 20 minutes | Same |
| Fluorescence<br>Detection | UV LEDs are used to excite the<br>fluorescent molecule produced<br>by enzyme cleavage of the<br>fluorogenic substrate contained<br>in the BI's media. The emitted<br>light is detected 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 SCBI's media.<br>The emitted light is detected<br>by a photodiode. | Same |
| Indication of<br>Results | Positive - audible alarm, visual<br>LED lights and screen Negative<br>- optional alarm, visual<br>indication with LED lights and<br>LCD screen<br>User must acknowledge 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 results | Same |
| Feature | Subject Device<br>Universal Biological<br>Indicator Incubator<br>(K213881) | Predicate Device<br>Celerity 20 HP Indicator<br>(K190297) | Comparison |
| 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<br>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<br>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.<br>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, an optional alarm is available | The reader/incubator wells<br>are arranged in 2 banks of 4<br>wells and preset to 57°C. The<br>measurement of fluorescence<br>is initiated by placement of a<br>Celerity HP BI into any of the<br>incubation wells and pressing<br>the adjacent "ACTION”<br>button.<br>When an SCBI is placed into<br>a well, the auto-reader detects<br>its presence. Upon pressing<br>the button associated with<br>that well, a blinking yellow<br>light indicates that incubation<br>is in process and the read<br>initiated.<br>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> | Similar |
| Feature | Subject Device<br>Universal Biological<br>Indicator Incubator<br>(K213881) | Predicate Device<br>Celerity 20 HP Indicator<br>(K190297) | Comparison |
| | for negative results. | for negative results. User<br>must 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 of<br>Incubation<br>Temperature | Temperature of BIs is maintained between 55°C - 60°C<br>during incubation. Temperatures were observed over a<br>60min period and during a 1min loss of power. | PASS |
| Qualification<br>Testing with<br>intended<br>Biological<br>Indicators | Fluorescent Read meets ≥ 97% alignment with 7-day grow<br>out per FDA guidance on reduced incubation time for<br>intended Biological Indicators for both Steam and Vaporized<br>Hydrogen Peroxide Celerity Biological Indicators | PASS |
| Human Factors | Typical users are capable of following the written<br>instructions for use to correctly use the Celerity Incubators. | PASS |
| Electromagnetic<br>Compatibility | IEC 60601-1-2:2014 General Requirements for Basic Safety<br>and Essential Performance - Collateral Standard:<br>Electromagnetic Compatibility - Requirements and Tests | PASS |
| Electrical Safety<br>Conformance | IEC 60601-1 Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance | PASS |
| Software<br>Validation | The software that controls the system was validated and<br>determined 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.