CELERITY 20 Steam Incubator

K173670 · STERIS Corporation · FRC · Feb 12, 2018 · General Hospital

Device Facts

• Record ID: K173670
• Device Name: CELERITY 20 Steam Incubator
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Feb 12, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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

Device Story

The Celerity 20 Steam Incubator is a benchtop reader for Celerity 20 Steam Biological Indicators (BIs). It maintains a constant temperature (55-60 °C) to facilitate the outgrowth of Geobacillus stearothermophilus spores within the BI. The device uses a photodiode to detect increasing fluorescence resulting from enzymatic activity associated with viable microorganisms. The incubator provides automated results within 20 minutes, indicated via LED and print outputs. It is intended for use in clinical settings to verify the efficacy of steam sterilization cycles. By providing rapid detection of sterilization failure, the device allows healthcare providers to take immediate corrective action, ensuring the safety of sterilized instruments.

Clinical Evidence

Bench testing only. Performance testing confirmed the incubator maintains 55-60 °C. Qualification testing with Celerity 20 Steam BIs demonstrated >97% alignment between the 20-minute fluorescent read and 7-day growth results, meeting FDA guidance for reduced incubation time. Additional testing verified correct alarm, LED, and print functions, as well as accurate detection of both full-cycle (negative) and abbreviated-cycle (positive) biological indicator results.

Technological Characteristics

Incubator/reader for biological indicators. Sensing principle: Photodiode detection of fluorescence. Temperature range: 55-60 °C. Power: 90-264 VAC with 12 VDC conversion. Form factor: Benchtop unit. Connectivity: Includes LED and print outputs.

Indications for Use

Indicated for use by healthcare personnel to incubate and automatically read Celerity 20 Steam Biological Indicators at 57 °C to detect viable Geobacillus stearothermophilus microorganisms following steam sterilization processes.

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 Indicator (K171587)

Submission Summary (Full Text)

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February 12, 2018

STERIS Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5976 Heisley Road Mentor, Ohio 44060

Re: K173670

Trade/Device Name: CELERITY 20 Steam Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 29, 2017 Received: November 30, 2017

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation 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) K173670

Device Name Celerity 20 Steam Incubator

Indications for Use (Describe) Use the Celerity 20 Steam Incubate and automatically read Celerity 20 Steam Biological Indicators at 57 °C for a fluorescent result within 20 minutes

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 K173670 Celerity 20 Steam Incubator

### 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: [phone] e-mail: [e-mail]

Submission Date: January 17, 2018

Premarket Notification Number: K173670

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

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## STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173670 Celerity 20 Steam Incubator

#### Device Name 1.

| Trade Name: | Celerity 20 Steam 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 Indicator, (since renamed Celerity 20 HP Incubator)

#### 3. Description of Device

The Celerity 20 Steam Incubator (Incubator) is an incubator/reader designed for use specifically with the Celerity 20 Steam Biological Indicator (BI), subject of a concurrent 510(k) currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus 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.

#### 4. Intended Use/ Indications for Use

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

#### 5. Summary of Technical Characteristics

A comparison of technical characteristics are summarized in Table 5-1.

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### STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173670 Celerity 20 Steam Incubator

| Feature | Celerity Steam Incubator<br>(proposed) | VERIFY Incubator<br>(K71587) Predicate | Comparison |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Use the Celerity 20<br>Steam Incubator to<br>incubate and<br>automatically read<br>Celerity 20 Steam<br>Biological Indicators<br>at 57 °C for a<br>fluorescent result<br>within 20 minutes. | Use the VERIFY<br>Incubator for Assert<br>VH2O2 Self<br>Contained Biological<br>Indicators (Incubator)<br>to incubate and<br>automatically read<br>VERIFY Assert<br>VH2O2 Self-<br>Contained Biological<br>Indicators at 57 °C for<br>a fluorescent result | Identical except for<br>the BI they are meant<br>to read.<br>Testing with the<br>Celerity 20 Steam BI,<br>included in the<br>submission,<br>demonstrates proper<br>performance. |
| Basis of<br>Readout | Photodiode detects<br>fluorescence produced<br>by enzymatic activity<br>that results from<br>growing biological<br>indicator organisms | within 20 minutes.<br>Photodiode detects<br>fluorescence produced<br>by enzymatic activity<br>that results from<br>growing biological<br>indicator organisms | Same |
| Incubation<br>Temperature<br>Range | 55 - 60 °C | 55 - 60 °C | Same |
| Voltage<br>Range | 90 to 264 VAC with<br>12 VDC conversion. | 90 to 264 VAC with<br>12 VDC conversion. | Same |

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

#### 6. Summary of Nonclinical Tests

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.

Table 5-2. Summary of Non-clinical Testing

| Test | Acceptance Criteria | Conclusion |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------|
| Maintenance of<br>Incubation<br>Temperature | Maintain 55-60 °C for a minimum of 20 minutes<br>(incubation time of Celerity 20 Steam BI) | PASS |
| Qualification testing<br>with Celerity 20<br>Steam BI | 20-minute fluorescent read meets >97%<br>alignment with 7-day growth results per FDA<br>guidance on reduced incubation time. | PASS |

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## STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173670 Celerity 20 Steam Incubator

| Test | Acceptance Criteria | Conclusion |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Qualification testing<br>with Celerity 20<br>Steam BI | • Pass testing with BI exposed to full cycle<br>exposure and negative growth result in<br>incubator<br>• Fail testing with BI exposed in abbreviated<br>cycle exposure and positive result in incubator | PASS<br>PASS |
| Alarm, LED and<br>Print function Test | Demonstrate proper function of alarms, LED and<br>print outputs | PASS |

#### 7. Conclusion

The Celerity 20 Steam Incubator has met the established performance criteria. The conclusions drawn from the nonclinical tests performed demonstrate the subject device is as safe, as effective, and performs as well or better than the legally marketed predicate device VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator cleared in K171587 (21 CFR 880.2800, Product code FRC).