← Product Code [FRC](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FRC) · K173629
# CELERITY 20 Steam Process Challenge Device for Gravity Cycles (K173629)
_STERIS Corporation · FRC · Feb 21, 2018 · General Hospital · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FRC/K173629
## Device Facts
- **Applicant:** STERIS Corporation
- **Product Code:** [FRC](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FRC.md)
- **Decision Date:** Feb 21, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.2800
- **Device Class:** Class 2
- **Review Panel:** General Hospital
## 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.
## Regulatory 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](/device/K170070.md))
## Submission Summary (Full Text)
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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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
## 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)
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# 510(k) Summary For CELERITY 20 Steam Process Challenge Device for Gravity Cycles
## Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
## Manufacturing Facility
STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax No: (440) 392-7896
Tony Piotrkowski Contact:
Telephone: (440) 392-7437 Fax No: e-mail: tony_piotrkowski.@steris.com
January 23, 3018 Submission Date:
Premarket Notification Number: K173629
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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#### Device Name 1.
| Trade Name: | CELERITY 20 Steam Process Challenge Device for
Gravity Cycles |
|------------------------|------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator Pack (PCD) |
| Device Classification: | Class II |
| Classification Name: | Sterilization Process Indicator
(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.
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# K173629 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 Steam Process Challenge Device for Gravity Cycles
| Feature | Celerity Gravity PCD
(K173629) Proposed | Assert Gravity PCD
(K170070) Predicate | Comparison |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended
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 | The VERIFY™
ASSERT™ STEAM
Process Challenge Device
for Gravity Cycles is used
for qualification, routine
microbial monitoring, and
cycle monitoring of steam
sterilizers.
The validated steam
sterilization cycles
include:
· 250°F (121°C) 30-
minute gravity
· 270°F (132°C) 15-
minute gravity
The VERIFY Assert Self-
Contained Indicator within
the Process challenge
device must be used with
the VERIFY Incubator for
Assert Self Contained
Biological Indicators.
When used in conjunction
with the VERIFY
Incubator for Assert Self
Contained Biological
Indicators, the VERIFY
Assert Self-Contained
Indicator within the
Process challenge device
provides a fluorescent
result within 40 minutes. | Both are intended for
monitoring steam
sterilization cycles. |
| General
Design | Indicators are sealed in
plastic tray with channel
to limit steam
penetration/air removal. | Indicators are sealed in
plastic tray with channel
to limit steam
penetration/air removal. | The PCD housing is
identical for the two
devices |
| Biological
Indicator | Celerity 20 Steam
Biological Indicator
(20-minute fluorescent
result) | Verify Assert Self
Contained Biological
Indicator (40-minute
fluorescent result) | Both contain 510(k)
Biological Indicators with
rapid fluorescent results. |
| Chemical
Integrator | Chemical Integrator | Chemical Integrator | Both contain the same
chemical integrator |
| Means to
distinguish
processed
PCD from
unprocessed | Proposed device's
internal integrator is
visible through the
pack. | Proposed device's
internal integrator is
visible through the
pack. | Same |
# Table 5-1. Summary of PCD Physical Description and Technological Properties
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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
the performance of the BI in the AAMI reference
pack in their respective sterilization processes | PASS |
| | • Performance of the chemical integrator in the PCD
is equivalent to the performance of the chemical
integrator in AAMI reference pack in their | PASS |
| | respective processes
PCD provides an equivalent or greater challenge
than the AAMI standardized test pack | PASS |
| BI in pack vs BI
outside of pack | PCD provides a greater challenge to the process than
the BI itself. | PASS |
| CI in pack vs CI
outside of pack | PCD provides a greater challenge to the process than
the integrator by itself. | PASS |
| Chemical Integrator | Chemical integrator does not reach endpoint before BI
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).
---
**Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FRC/K173629](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FRC/K173629)
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