Celerity Incubator

K223715 · STERIS Corporation · FRC · Jun 15, 2023 · General Hospital

Device Facts

• Record ID: K223715
• Device Name: Celerity Incubator
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Jun 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Indications for Use

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.

Device Story

Celerity Incubator is a benchtop device for incubating and reading fluorescent biological indicators (BIs) used in steam and vaporized hydrogen peroxide sterilization. The device features 8 wells arranged in 2 banks of 4, maintained at 59°C. Operation involves scanning the BI barcode, which triggers the system to apply the appropriate algorithm. The device uses UV LEDs to excite fluorescent molecules produced by enzymatic activity (a-glucosidase) within the BI, with a photodiode detecting the emitted light. Results are displayed via LCD screen, LED indicators (red for positive/failure, green for negative), and audible alarms. The device provides automated, rapid readout (5 or 20 minutes depending on the BI) to confirm sterilization cycle effectiveness. It is intended for use in clinical settings to assist healthcare providers in monitoring sterilization processes.

Clinical Evidence

Bench testing only. Performance was validated by comparing the fluorescent readout of the Celerity Incubator against 7-day growth out methods per FDA guidance. Results demonstrated >97% alignment for intended biological indicators. Additional testing included human factors validation, electromagnetic compatibility (IEC 60601-1-2:2014), electrical safety (IEC 61010-1), and software validation (IEC 62304).

Technological Characteristics

Benchtop incubator with 8 wells; 100-240 VAC power with 12 VDC conversion; UV LED excitation source; photodiode detection; factory-calibrated; operates at 59°C (-4°C/+1°C tolerance); barcode scanner input; LCD/LED/audible alarm output; 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 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 Incubator (K213881)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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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## 510(k) Summary For Celerity Incubator

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

| Contact: | Mr. Gregory Land<br>Lead Regulatory Affairs Specialist<br>Tel: [phone]<br>[e-mail] |
|------------------|-----------------------------------------------------------------------------------------------------|
| 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

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.

#### 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.

| Feature | Proposed Device<br>Universal Biological<br>Indicator Incubator | Predicate Device<br>Celerity Indicator<br>(K213881) | Comparison |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications<br>for Use | Use the Celerity Incubator to<br>incubate and automatically<br>read STERIS Celerity<br>Biological Indicators for | Use the Celerity Incubator to<br>incubate and automatically<br>read STERIS Celerity<br>Biological Indicators for | Same |
| Feature | Proposed Device<br>Universal Biological<br>Indicator Incubator | Predicate Device<br>Celerity Indicator<br>(K213881) | Comparison |
| | Steam and Vaporized<br>Hydrogen Peroxide<br>sterilization at 55°C - 60°C<br>for a fluorescent result. | Steam and Vaporized<br>Hydrogen Peroxide<br>sterilization at 55°C - 60°C<br>for a fluorescent result. | |
| 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 | 20 minutes | Similar |
| 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 SCBI's<br>media. The emitted light is<br>detected 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<br>the system's barcode scanner | 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 | Same |
| | Proposed Device<br>Universal Biological<br>Indicator Incubator | Predicate Device<br>Celerity Indicator<br>(K213881) | Comparison |
| Feature | 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 | 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 | |
| | the end of the incubation<br>time, the result is negative. | the end of the incubation<br>time, the result is negative. | |
| | 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 | 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 | |
| | for negative results. | for negative results. | |

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 |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 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 Vaporized Hydrogen<br>Peroxide Celerity 5 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 60101-1 Safety Requirements for Electrical Equipment<br>for Measurement, Control, and Laboratory Use Part 1:<br>General Requirements | PASS |
| Software<br>Validation per<br>IEC 62304 | 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 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.