(74 days)
Not Found
No
The description focuses on standard biological indicator incubation and fluorescence detection, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device is used to incubate and read biological indicators to determine if sterilization processes have been effective, not to directly treat patients or affect their health.
No.
Explanation:
The device is an incubator/reader for biological indicators used to assess the effectiveness of sterilization processes, not to diagnose medical conditions in patients. It detects the presence of viable test microorganisms to confirm sterility, which is a quality control function.
No
The device description clearly states it is an "incubator/reader" and describes physical components and functions like maintaining temperature and detecting fluorescence, indicating it is a hardware device with integrated software.
Based on the provided information, the Celerity 20 Steam Incubator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to incubate and read biological indicators (BIs) used to monitor the effectiveness of steam sterilization cycles. This is a quality control process for sterilization equipment, not a diagnostic test performed on a patient sample to diagnose a disease or condition.
- Device Description: The device detects the presence of viable microorganisms in a biological indicator, which is a test system for sterilization efficacy, not a patient sample.
- Anatomical Site and Patient Age Range: These are listed as "Not Applicable," further indicating that the device is not used in a clinical diagnostic context involving patients.
- Predicate Device: The predicate device is also an incubator for a biological indicator used in sterilization monitoring.
IVD devices are specifically intended for use in the examination of specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Celerity 20 Steam Incubator does not fit this definition. It is a device used in the quality control of sterilization processes.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
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.
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)
Nonclinical Tests:
-
Maintenance of Incubation Temperature:
- Acceptance Criteria: Maintain 55-60 °C for a minimum of 20 minutes (incubation time of Celerity 20 Steam BI).
- Conclusion: PASS
-
Qualification testing with Celerity 20 Steam BI:
- Acceptance Criteria: 20-minute fluorescent read meets >97% alignment with 7-day growth results per FDA guidance on reduced incubation time.
- Conclusion: PASS
-
Qualification testing with Celerity 20 Steam BI:
- Acceptance Criteria:
- Pass testing with BI exposed to full cycle exposure and negative growth result in incubator.
- Fail testing with BI exposed in abbreviated cycle exposure and positive result in incubator.
- Conclusion: PASS, PASS
- Acceptance Criteria:
-
Alarm, LED and Print function Test:
- Acceptance Criteria: Demonstrate proper function of alarms, LED and print outputs.
- Conclusion: PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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);
1
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 (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) 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: (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
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tony_piotrkowski@steris.com
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 |
| (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.
5
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173670 Celerity 20 Steam Incubator
| Feature | Celerity Steam Incubator
(proposed) | VERIFY Incubator
(K71587) Predicate | Comparison |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Use the VERIFY
Incubator for Assert
VH2O2 Self
Contained Biological
Indicators (Incubator)
to incubate and
automatically read
VERIFY Assert
VH2O2 Self-
Contained Biological
Indicators at 57 °C for
a fluorescent result | Identical except for
the BI they are meant
to read.
Testing with the
Celerity 20 Steam BI,
included in the
submission,
demonstrates proper
performance. |
| Basis of
Readout | Photodiode detects
fluorescence produced
by enzymatic activity
that results from
growing biological
indicator organisms | within 20 minutes.
Photodiode detects
fluorescence produced
by enzymatic activity
that results from
growing biological
indicator organisms | Same |
| Incubation
Temperature
Range | 55 - 60 °C | 55 - 60 °C | Same |
| Voltage
Range | 90 to 264 VAC with
12 VDC conversion. | 90 to 264 VAC with
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 | ||
| Incubation | ||
| Temperature | Maintain 55-60 °C for a minimum of 20 minutes | |
| (incubation time of Celerity 20 Steam BI) | PASS | |
| Qualification testing | ||
| with Celerity 20 | ||
| Steam BI | 20-minute fluorescent read meets >97% | |
| alignment with 7-day growth results per FDA | ||
| guidance on reduced incubation time. | PASS |
6
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173670 Celerity 20 Steam Incubator
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Qualification testing | ||
| with Celerity 20 | ||
| Steam BI | • Pass testing with BI exposed to full cycle | |
| exposure and negative growth result in | ||
| incubator | ||
| • Fail testing with BI exposed in abbreviated | ||
| cycle exposure and positive result in incubator | PASS | |
| PASS | ||
| Alarm, LED and | ||
| Print function Test | Demonstrate proper function of alarms, LED and | |
| 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).