Celerity HP Incubator

K190297 · STERIS Corporation · FRC · May 14, 2019 · General Hospital

Device Facts

• Record ID: K190297
• Device Name: Celerity HP Incubator
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: May 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Use the Celerity HP Incubator to incubate and automatically read Celerity 20 HP Biological Indicators at 57 °C for a fluorescent result within 20 minutes.

Device Story

The Celerity HP Incubator is a benchtop reader/incubator used to monitor sterilization efficacy. It accepts Celerity 20 HP Biological Indicators (BIs) containing Geobacillus stearothermophilus. The device maintains a constant 57 °C temperature to facilitate enzyme-based outgrowth of the microorganisms. An internal photodiode detects fluorescence generated by enzyme cleavage of a substrate within the BI. The device features 8 incubation wells; users initiate the process by inserting a BI and pressing an 'ACTION' button. Results are displayed via front-panel LED lights (red for positive/failure, green for negative/pass), an audible alarm, and an LCD screen. Positive results indicate potential sterilization cycle failure, requiring operator acknowledgment. The device is intended for use by healthcare personnel to verify sterilization performance.

Clinical Evidence

Bench testing only. Performance verification included electrical safety (UL 61010-1, UL 61010-2-010), electromagnetic compatibility (IEC 61326-1, FCC Part 15), and functional testing of alarms, LEDs, and output systems. All tests met established acceptance criteria.

Technological Characteristics

Benchtop incubator/reader with 8 wells. Sensing principle: UV LED excitation and photodiode detection of fluorescence. Temperature range: 55-60 °C. Power: 100-240 VAC with 12 VDC conversion. Factory calibrated. Compliance: IEC 61010-1, IEC 61010-2-010, IEC 61326, FCC Part 15.

Indications for Use

Indicated for use in clinical or healthcare settings to incubate and automatically read Celerity 20 HP Biological Indicators at 57 °C to detect viable Geobacillus stearothermophilus microorganisms following a sterilization process.

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

• VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicators (K171587)

Reference Devices

• Celerity 20 Steam Incubator (K173670)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

May 14, 2019

Steris Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060

Re: K190297

Trade/Device Name: Celerity HP Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: April 16, 2019 Received: April 17, 2019

Dear Anthony Piotrkowski:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

David Krause, PhD Acting Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K190297

Device Name Celerity HP Incubator

Indications for Use (Describe)

Use the Celerity HP Incubate and automatically read Celerity 20 HP Biological Indicators at 57 °C for a fluorescent result within 20 minutes.

| Type of Use (Select one or both, as applicable) | <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# STERIS®

# 510(k) Summary For Celerity HP Incubator K190297

### Sponsor Facility

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

# Manufacturing Facility

STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact: Anthony Piotrkowski

Telephone: [phone] Fax No: e-mail: [e-mail]

February 8, 2019 Submission Date:

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

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### Device Name 1.

| Trade Name: | Celerity HP Incubator |
|------------------------|-----------------------------------------------------------------------|
| Common/usual Name: | Incubator/Reader (accessory to Biological Indicator) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process<br>(21 CFR 880.2800, FRC) |

### 2. Predicate Device

K171587 - VERIFY® Incubator for Assert™ |VH2O2 Self-Contained Biological Indicators (name changed to Celerity HP Incubator after clearance)

### 3. Reference Device

K173670 - Celerity 20 Steam Incubator

### 4. Description of Device

Celerity HP Incubator (Incubator) is an incubator/reader designed for use specifically with the Celerity 20 HP Biological Indicator (BI). The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus which is detected by an enzyme that cleaves the a substrate leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the BI is detected by the incubator/reader and indicates the presence of viable test microorganisms.

### ട. Intended Use/ Indications for Use

Use the Celerity HP Incubator to incubate and automatically read Celerity 20 HP Biological Indicators at 57 ℃ for a fluorescent result within 20 minutes.

### 6. Summary of Technical Characteristics

Comparisons of technical characteristics versus the predicate and reference devices are summarized in Tables 5-1 and 5-2 respectively.

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# Table 5-1 Summary of Incubator Physical Description and Technological Properties vs Predicate

| Feature | VERIFY Incubator for Assert<br>VH2O2 SCBI<br>(predicate K171587) | Celerity HP Incubator<br>(modified) | Comparison |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Intended Use | Use the Celerity HP Incubator to<br>incubate and automatically read<br>VERIFY Assert VH2O2 Self-<br>Contained Biological Indicators at<br>57 °C for a fluorescent result<br>within 20 minutes. | Use the Celerity HP Incubator to<br>incubate and automatically read<br>Celerity HP Biological Indicators<br>at 57 °C for a fluorescent result<br>within 20 minutes. | Same<br>indications<br>for use – the<br>name of the<br>incubator<br>has changed. |
| Basis of<br>Readout | Photodiode detects fluorescence<br>produced by enzymatic activity<br>that results from growing<br>biological indicator organisms | Photodiode detects fluorescence<br>produced by enzymatic activity<br>that results from growing<br>biological 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 calibration<br>by customer | Factory calibration – no calibration<br>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 by<br>enzyme cleavage of the<br>fluorogenic substrate contained in<br>the SCBI's media. The emitted<br>light is detected by a photodiode. | UV LEDs are used to excite the<br>fluorescent molecule produced by<br>enzyme cleavage of the<br>fluorogenic substrate contained in<br>the SCBI's media. The emitted<br>light is detected by a photodiode. | Same |
| Compliance | Electrical Safety and EMC Testing<br>• IEC 61010-1 (2010) Third Ed<br>• IEC 61010-2-010 (2013) Third<br>Ed<br>Electromagnetic compatibility<br>• USA Title 47, Code of Federal<br>Regulations (2007) for:<br>o Radiated Emissions (FCC<br>Part 15, Subpart B, Class A)<br>o Conducted Emissions (FCC<br>Part 15, Subpart B, Class A)<br>• IEC 61326:2013 -<br>• EN 55011:2009, Inc. A1:2010<br>• EN 61000-3-2:2006, Inc.<br>A1:2009 and A2:2009<br>EN 61000-3-3:2013 | Electrical Safety and EMC Testing<br>• IEC 61010-1 (2010) Third Ed<br>• IEC 61010-2-010 (2013) Third<br>Ed<br>Electromagnetic compatibility<br>• USA Title 47, Code of Federal<br>Regulations (2007) for:<br>o Radiated Emissions (FCC<br>Part 15, Subpart B, Class A)<br>o Conducted Emissions (FCC<br>Part 15, Subpart B, Class A)<br>• IEC 61326:2013 -<br>• EN 55011:2009, Inc. A1:2010<br>• EN 61000-3-2:2006, Inc.<br>A1:2009 and A2:2009<br>EN 61000-3-3:2013 | Same |
| Indication of<br>Results | Positive - audible alarm, visual<br>LED lights and screen<br>Negative - no alarm, visual<br>indication with LED lights and<br>LCD screen<br>User must acknowledge results | Positive - audible alarm, visual<br>LED lights and screen<br>Negative - no alarm, visual<br>indication with LED lights and<br>LCD screen<br>User must acknowledge results | Same |
| Feature | VERIFY Incubator for Assert<br>VH2O2 SCBI<br>(predicate K171587) | Celerity HP Incubator<br>(modified) | Comparison |
| System<br>Operation | The reader/incubator wells are<br>arranged in 2 banks of 4 wells and<br>preset to 57℃. The measurement<br>of fluorescence is initiated by<br>placement of a VERIFY Assert<br>SCBI into any of the incubation<br>wells and pressing the adjacent<br>"ACTION" button.<br>When an SCBI is placed into a<br>well, the auto-reader detects its<br>presence. Upon pressing the button<br>associated with that well, a<br>blinking yellow light indicates that<br>incubation is in process and the<br>read initiated.<br>A "positive" reading is interpreted<br>as an indication of a potential<br>sterilization cycle failure. A<br>"positive" finding is indicated to<br>the user by red light on the front<br>panel adjacent to the well, by an<br>audible alarm, and by text<br>displayed on the LCD screen. The<br>alarm must be muted by the<br>operator when a positive result is<br>obtained. The LCD screen<br>provides instructions for the user to<br>turn off the alarm for that specific<br>SCBI.<br>Should another BI become<br>"positive", the alarm will sound<br>again and the above actions are<br>repeated.<br>If the result is not positive at the<br>end of the incubation time, the<br>result is negative. Negative results<br>are identified by a green light on<br>the front panel adjacent to the well<br>with the "negative" BI and by text<br>on the LCD. | The reader/incubator wells are<br>arranged in 2 banks of 4 wells and<br>preset to 57℃. The measurement<br>of fluorescence is initiated by<br>placement of a VERIFY Assert<br>SCBI into any of the incubation<br>wells and pressing the adjacent<br>"ACTION" button.<br>When an SCBI is placed into a<br>well, the auto-reader detects its<br>presence. Upon pressing the button<br>associated with that well, a<br>blinking yellow light indicates that<br>incubation is in process and the<br>read initiated.<br>A "positive" reading is interpreted<br>as an indication of a potential<br>sterilization cycle failure. A<br>"positive" finding is indicated to<br>the user by red light on the front<br>panel adjacent to the well, by an<br>audible alarm, and by text<br>displayed on the LCD screen. The<br>alarm must be muted by the<br>operator when a positive result is<br>obtained. The LCD screen<br>provides instructions for the user to<br>turn off the alarm for that specific<br>SCBI.<br>Should another BI become<br>"positive", the alarm will sound<br>again and the above actions are<br>repeated.<br>If the result is not positive at the<br>end of the incubation time, the<br>result is negative. Negative results<br>are identified by a green light on<br>the front panel adjacent to the well<br>with the "negative" BI and by text<br>on the LCD. | Same |

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## Table 5-2 Summary of Incubator Physical Description and Technological Properties vs. Reference Device

| Feature | Celerity Steam Incubator<br>(Reference K173670) | Celerity HP Incubator<br>(modified) | Comparison |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Intended Use | Use the Celerity 20 Steam<br>Incubator to incubate and<br>automatically read Celerity 20<br>Steam Biological Indicators at 57<br>°C for a fluorescent result within<br>20 minutes. | Use the Celerity HP Incubator to<br>incubate and automatically read<br>Celerity HP Biological Indicators<br>at 57 °C for a fluorescent result<br>within 20 minutes. | Same<br>operating<br>temperature<br>and read<br>time |
| Feature | Celerity Steam Incubator<br>(Reference K173670) | Celerity HP Incubator<br>(modified) | Comparison |
| Basis of<br>Readout | Photodiode detects fluorescence<br>produced by enzymatic activity<br>that results from growing<br>biological indicator organisms | Photodiode detects fluorescence<br>produced by enzymatic activity<br>that results from growing<br>biological indicator organisms | Same |
| Incubation<br>Temperature<br>Range | 55 - 60 °C | 55 - 60 °C | Same |
| Voltage<br>Range | 90 to 264 VAC with 12 VDC<br>conversion. | 100-240 VAC with 12 VDC<br>conversion. | Proposed<br>within range<br>of reference |
| Test capacity | 8 wells | 8 wells | Same |
| Calibration | Factory calibration – no calibration<br>by customer | Factory calibration – no calibration<br>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 by<br>enzyme cleavage of the<br>fluorogenic substrate contained in<br>the SCBI's media. The emitted<br>light is detected by a photodiode. | UV LEDs are used to excite the<br>fluorescent molecule produced by<br>enzyme cleavage of the<br>fluorogenic substrate contained in<br>the SCBI's media. The emitted<br>light is detected by a photodiode. | Same |
| Compliance | Electrical Safety and EMC Testing<br>IEC 61010-1 (2010) Third Ed IEC 61010-2-010 (2013) Third Ed Electromagnetic compatibility USA Title 47, Code of Federal Regulations (2007) for: Radiated Emissions (FCC Part 15, Subpart B, Class A) Conducted Emissions (FCC Part 15, Subpart B, Class A) IEC 61326:2013 - EN 55011:2009, Inc. A1:2010 EN 61000-3-2:2006, Inc. A1:2009 and A2:2009 EN 61000-3-3:2013 | Electrica…