CELERITY 20 Steam Process Challenge Device for Gravity Cycles

K173629 · STERIS Corporation · FRC · Feb 21, 2018 · General Hospital

Device Facts

• Record ID: K173629
• Device Name: CELERITY 20 Steam Process Challenge Device for Gravity Cycles
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Feb 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Indications for Use

The Celerity 20 Steam Challenge Pack is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers. The validated steam sterilization cycles include: 250°F (121°C) 30-minute gravity . 270°F (132°C) 15-minute gravity .

Device Story

Celerity 20 Steam Process Challenge Device (PCD) monitors steam sterilizer performance; consists of Celerity 20 Steam Biological Indicator (BI) and chemical integrator sealed in plastic tray with molded channel. Channel creates tortuous pathway simulating air removal/steam penetration challenges of standard 16-towel test pack (ANSI/AAMI ST79). Used in clinical settings to verify sterilization efficacy; healthcare personnel place PCD in sterilizer load. After cycle, BI provides fluorescent result (20-minute) indicating microbial inactivation; chemical integrator provides visual confirmation of sterilization conditions. PCD ensures sterilization parameters met; helps prevent use of improperly processed instruments; benefits patient by reducing risk of healthcare-associated infections.

Clinical Evidence

Bench testing only. Performance testing compared the PCD against AAMI reference packs and verified the BI and chemical integrator performance within the PCD. Results confirmed the PCD provides a greater challenge than the BI or integrator alone, and that the chemical integrator does not reach its endpoint before the BI is inactivated. All performance criteria met.

Technological Characteristics

Plastic tray housing with molded channel for tortuous path air removal/steam penetration. Contains Celerity 20 Steam Biological Indicator and chemical integrator. Designed to meet ANSI/AAMI ST79 standard for 16-towel test packs. Passive device; no energy source or software.

Indications for Use

Indicated for qualification, routine microbial monitoring, and load monitoring of steam sterilizers using 250°F (121°C) 30-minute gravity or 270°F (132°C) 15-minute gravity cycles.

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 Assert STEAM Process Challenge Device for Gravity Cycles (K170070)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 21, 2018

STERIS Corporation Anthony Piotrkowski 5976 Heislev Rd Mentor, Ohio 44060

Re: K173629

Trade/Device Name: CELERITY 20 Steam Process Challenge Device for Gravity Cycles Regulation Number: 21 CFR 880,2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 22, 2017 Received: November 24, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

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 medical devices and radiation-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

{2}------------------------------------------------

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

## K173629

### Device Name

CELERITY 20 Steam Process Challenge Device for Gravity Cycles

IThe Celerity 20 Steam Challenge Pack is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers.

The validated steam sterilization cycles include:

- 250°F (121°C) 30-minute gravity .
- 270°F (132°C) 15-minute gravity .

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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water waves.

# 510(k) Summary For CELERITY 20 Steam Process Challenge Device for Gravity Cycles

## 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]

Tony Piotrkowski Contact:

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

January 23, 3018 Submission Date:

Premarket Notification Number: K173629

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

{4}------------------------------------------------

#### Device Name 1.

| Trade Name: | CELERITY 20 Steam Process Challenge Device for<br>Gravity Cycles |
|------------------------|------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator Pack (PCD) |
| Device Classification: | Class II |
| Classification Name: | Sterilization Process Indicator<br>(21 CFR 880.2800, FRC) |

#### 2. Predicate Device

VERIFY Assert STEAM Process Challenge Device for Gravity Cycles, K170070

#### 3. Description of Device

Celerity 20 Steam Process Challenge Device for Gravity Cycles (PCD), contains a Celerity 20 Steam Biological Indicator (SCBI) and a steam chemical integrator, sealed within a plastic tray with foil cover. The tray has a molded channel which serves as the tortuous pathway for air removal/steam penetration during steam sterilization. The PCD is designed and validated to be equivalent to the standard 16-towel test pack described in ANSI/AAMI ST79. The proposed and predicate are identical except for the BI in the PCD.

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

The Celerity 20 Steam Challenge Pack is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers.

The validated steam sterilization cycles include:

- 250°F (121°C) 30-minute gravity
- . 270°F (132°C) 15-minute gravity

#### ട. Summary of Technical Characteristics

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

{5}------------------------------------------------

# K173629 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 Steam Process Challenge Device for Gravity Cycles

| Feature | Celerity Gravity PCD<br>(K173629) Proposed | Assert Gravity PCD<br>(K170070) Predicate | Comparison |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended<br>Use | The Celerity 20 Steam<br>Challenge Pack is used<br>for qualification, routine<br>microbial monitoring,<br>and load monitoring of<br>steam sterilizers.<br>The validated steam<br>sterilization cycles<br>include:<br>· 250°F (121°C) 30-<br>minute gravity<br>· 270°F (132°C) 15-<br>minute gravity | The VERIFY™<br>ASSERT™ STEAM<br>Process Challenge Device<br>for Gravity Cycles is used<br>for qualification, routine<br>microbial monitoring, and<br>cycle monitoring of steam<br>sterilizers.<br>The validated steam<br>sterilization cycles<br>include:<br>· 250°F (121°C) 30-<br>minute gravity<br>· 270°F (132°C) 15-<br>minute gravity<br>The VERIFY Assert Self-<br>Contained Indicator within<br>the Process challenge<br>device must be used with<br>the VERIFY Incubator for<br>Assert Self Contained<br>Biological Indicators.<br>When used in conjunction<br>with the VERIFY<br>Incubator for Assert Self<br>Contained Biological<br>Indicators, the VERIFY<br>Assert Self-Contained<br>Indicator within the<br>Process challenge device<br>provides a fluorescent<br>result within 40 minutes. | Both are intended for<br>monitoring steam<br>sterilization cycles. |
| General<br>Design | Indicators are sealed in<br>plastic tray with channel<br>to limit steam<br>penetration/air removal. | Indicators are sealed in<br>plastic tray with channel<br>to limit steam<br>penetration/air removal. | The PCD housing is<br>identical for the two<br>devices |
| Biological<br>Indicator | Celerity 20 Steam<br>Biological Indicator<br>(20-minute fluorescent<br>result) | Verify Assert Self<br>Contained Biological<br>Indicator (40-minute<br>fluorescent result) | Both contain 510(k)<br>Biological Indicators with<br>rapid fluorescent results. |
| Chemical<br>Integrator | Chemical Integrator | Chemical Integrator | Both contain the same<br>chemical integrator |
| Means to<br>distinguish<br>processed<br>PCD from<br>unprocessed | Proposed device's<br>internal integrator is<br>visible through the<br>pack. | Proposed device's<br>internal integrator is<br>visible through the<br>pack. | Same |

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

{6}------------------------------------------------

Any differences between the predicate and proposed device are addressed through the testing described in Section 18 of this submission.

#### 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.

| Test | Acceptance Criteria | Conclusion |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Simulated Use | • Performance of the BI in the PCD is equivalent to<br>the performance of the BI in the AAMI reference<br>pack in their respective sterilization processes | PASS |
| | • Performance of the chemical integrator in the PCD<br>is equivalent to the performance of the chemical<br>integrator in AAMI reference pack in their | PASS |
| | respective processes<br>PCD provides an equivalent or greater challenge<br>than the AAMI standardized test pack | PASS |
| BI in pack vs BI<br>outside of pack | PCD provides a greater challenge to the process than<br>the BI itself. | PASS |
| CI in pack vs CI<br>outside of pack | PCD provides a greater challenge to the process than<br>the integrator by itself. | PASS |
| Chemical Integrator | Chemical integrator does not reach endpoint before BI<br>is inactivated. | PASS |

Table 5-2. Summary of Non-clinical Testing

#### 7. Conclusion

The Celerity 20 Steam Process Challenge Device for Gravity Cycles has met the established performance criteria. The results of the studies demonstrate that the biological indicator performs as intended, and based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as the legally marketed predicate device, VERIFY Assert STEAM Process Challenge Device for Gravity Cycles, cleared in K170070 (21 CFR 880.2800, Product code FRC).