(89 days)
No
The device description and performance studies focus on the physical design and biological/chemical indicators for steam sterilization monitoring, with no mention of AI or ML.
No
This device is a process challenge device used to monitor and qualify steam sterilizers, not to treat a medical condition or ailment. It is a quality control tool for sterilization processes.
No
This device is used for monitoring the effectiveness of steam sterilizers, not for diagnosing medical conditions in patients. It is a process challenge device for sterility assurance.
No
The device description clearly outlines physical components (plastic tray, foil cover, biological indicator, chemical indicator) and their function in a steam sterilization process challenge. It is a hardware device.
Based on the provided information, the Celerity™ 20 Steam Challenge Pack is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "qualification, routine microbial monitoring, and load monitoring of steam sterilizers." This is related to the sterilization process of medical devices, not for diagnosing a condition or disease in a patient using a sample from the human body.
- Device Description: The device contains a biological indicator and a chemical indicator within a plastic tray designed to simulate a challenging sterilization load. These components are used to assess the effectiveness of the sterilization process, not to analyze a biological sample for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample from the human body (blood, urine, tissue, etc.).
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Using reagents or assays to detect specific analytes.
The device is clearly intended to monitor and validate the performance of a steam sterilizer, which is a process used to prepare medical devices for use on patients. This falls under the category of sterilization process indicators, not in vitro diagnostics.
N/A
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:
- 270°F (132°C) 4-minute dynamic air removal (Prevac, SFPP) .
- 275°F (135°C) 3-minute dynamic air removal (Prevac, SFPP) .
Product codes
FRC
Device Description
The Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles (PCD), contains a Celerity 20 Steam Biological Indicator (BI) and a VERIFY Steam Integrating Indicator - Short, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2.
| 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 | ||
| respective processes | PASS | |
| • 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 |
The Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles has met the established performance criteria. The results of the studies performed demonstrate that the biological indicator performs as intended, and based on the nonclinical tests performed, the subject device is as effective, and performs at least as safely and effectively as the legally marketed predicate devices, Class II (21 CFR 880.2800, Product code FRC).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).
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February 21, 2018
STERIS Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060
Re: K173626
Trade/Device Name: Celerity 20 Steam Process Challenge Device for Dynamic Air Removal 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
1
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.
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K173626
Device Name
CELERITY 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
Indications for Use (Describe)
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:
- 270°F (132°C) 4-minute dynamic air removal (Prevac, SFPP) .
- 275°F (135°C) 3-minute dynamic air removal (Prevac, SFPP) .
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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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 "STERIS" is a graphic of several horizontal, wavy lines in blue, resembling water waves.
510(k) Summary For Celerity 20 Steam Process Challenge Device for Dynamic Air Removal 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
Contact: Anthony Piotrkowski Senior Manager Regulatory Affairs
Telephone: (440) 392-7437 (440) 639-6258 Fax No: e-mail: tony_piotrkowski@steris.com
Submission Date: January 23, 2018
Premarket Notification Number: K173626
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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K173626 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
Device Name 1.
| Trade Name: | Celerity 20 Steam Process Challenge Device for
Dynamic Air Removal 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
3M Attest Super Rapid 5 Steam-Plus Challenge Pack K121593
Reference Device: Verify Assert Steam Process Challenge Device, K162945
3. Description of Device
The Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles (PCD), contains a Celerity 20 Steam Biological Indicator (BI) and a VERIFY Steam Integrating Indicator - Short, 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.
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:
- 270°F (132°C) 4-minute dynamic air removal (Prevac, SFPP)
- 275°F (135°C) 3-minute dynamic air removal (Prevac, SFPP)
5. Summary of Technical Characteristics
A comparison of technical characteristics are summarized in Table 5-1.
5
| Feature | Celerity PCD
(K173626) Proposed | Attest 41482V
(K121593) Predicate | Comparison |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The Celerity 20
STEAM Process
Challenge Device is
used for qualification,
routine microbial
monitoring, and load
monitoring of steam
sterilizers.
The validated steam
sterilization cycles
include:
• 270F (132°C), 4-
minute dynamic
air removal;
(Prevac, SFPP)
• 275F(135°C), 3-
minnute dynamic
air removal;
(Prevac, SFPP) | Use 3M Attest Super
Rapid 5 Steam-Plus
Challenge Pack in
conjunction with the
3M Attest Auto-
reader 490 to qualify
or monitor dynamic
air removal
(prevacuum) steam
sterilization cycles of
4 minutes at 270 F
(132 C) and 3 minutes
at 275 F (135 C).
The 3M Attest Super
Rapid Readout
Biological Indicator
contained within the
challenge pack
provides a final
fluorescent result in 1
hour. An optional
visual pH color
change result is
observed in 48 hours. | Both are intended for
monitoring 270F
(132C), 4-minute
dynamic air removal
275F(135C), 3-minnute
dynamic air removal,
steam sterilization
cycles. |
| General
Design | Indicators are sealed
in plastic tray with
channel to limit steam
penetration/air
removal. | Layers of medical
index cards, some of
which are die-cut to
contain indicators,
overwrapped and
secured with a label. | Both the devices are
contained in a steam
barrier. Simulated use
testing demonstrated
equivalence |
| Biological
Indicator | Celerity 20 Steam
Biological Indicator
(20-minute
fluorescent result) | Attest 1492V
Biological Indicator
(1-hour fluorescent
result) | Both contain 510(k)-
cleared Biological
Indicators with rapid
fluorescent results. |
| Chemical
Integrator | VERIFY STEAM
Integrating Indicator-
Short | SteriGage Chemical
Integrator | Both contains 510(k)-
cleared chemical
integrators |
| Means to
distinguish
processed
PCD from
unprocessed | Proposed device's
internal integrator is
visible through the
pack. | External process
indicator. Yellow to
brown color change
when exposed to
steam | Both have a means to
distinguish processed
PCD from unprocessed |
Table 5-1. Summary of PCD Physical Description and Technological Properties
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K173626 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
The Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles is identical to the reference device VERIFY Assert Steam Process Challenge Device except for the biological indicator within the device. The difference in the biological indicator allows the Celerity BI to have a 20-minute read (versus 40-minutes for the reference device). The different BI also requires a different reader.
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 | ||
| respective processes | PASS | |
| • 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 |
Table 5-2. Summary of Non-clinical Testing
7. Conclusion
The Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles has met the established performance criteria. The results of the studies performed demonstrate that the biological indicator performs as intended, and based on the nonclinical tests performed, the subject device is as effective, and performs at least as safely and effectively as the legally marketed predicate devices, Class II (21 CFR 880.2800, Product code FRC).