(220 days)
No
The description focuses on standard incubation and fluorescence detection based on a biological process, with no mention of AI/ML terms or methodologies.
No.
The device is used to incubate and read biological indicators for sterilization, not to treat or diagnose patients.
No
This device is designed to incubate and read biological indicators to confirm the effectiveness of sterilization processes, not to diagnose a medical condition in a patient.
No
The device description clearly states it is an "incubator," which is a physical hardware device used for incubating and reading biological indicators. The performance studies also include tests related to hardware, such as "Maintenance of Incubation Temperature," "Electromagnetic Compatibility," and "Electrical Safety Conformance." While software validation is mentioned, it is part of the overall device validation, not the sole component.
Based on the provided information, the Celerity Incubator is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The device is used to "incubate and automatically read STERIS Celerity Biological Indicators". Biological indicators are used to monitor the effectiveness of sterilization processes. This falls under the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body or other sources to provide information for the diagnosis, treatment, or prevention of disease. While the biological indicator itself isn't directly from a human body, it's used to assess a process (sterilization) that directly impacts the safety of medical devices used on humans.
- Device Description: The device "incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs)." It detects a "fluorescence signal generated as a result of the production of a-glucosidase." This is a biological reaction being measured outside of the body to assess the effectiveness of a sterilization process.
- Key Metrics: The mention of "Fluorescent Read meets ≥ 97% alignment with 7-day grow out per FDA guidance on reduced incubation time for intended Biological Indicators" further supports its role in evaluating the performance of biological indicators, which are IVDs.
While the device itself doesn't directly analyze human samples, its function is to process and read biological indicators that are used to validate sterilization processes for medical devices. This places it within the scope of devices used in the context of healthcare and disease prevention, aligning with the definition of an IVD.
N/A
Intended Use / Indications for Use
Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C-60°C for a fluorescent result.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The Celerity Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The BI is incubated at 59°C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.
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)
Non-Clinical Performance Testing:
- Test: Maintenance of Incubation Temperature
- Acceptance Criteria: Temperature of BIs is maintained between 55°C - 60°C during incubation. Temperatures were observed over a 60min period and during a 1min loss of power.
- Result: PASS
- Test: Qualification Testing with intended Biological Indicators
- Acceptance Criteria: Fluorescent Read meets >= 97% alignment with 7-day grow out per FDA guidance on reduced incubation time for intended Biological Indicators for both Steam and Vaporized Hydrogen Peroxide Celerity Biological Indicators
- Result: PASS
- Test: Human Factors
- Acceptance Criteria: Typical users are capable of following the written instructions for use to correctly use the Celerity Incubators.
- Result: PASS
- Test: Electromagnetic Compatibility
- Acceptance Criteria: IEC 60601-1-2:2014 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- Result: PASS
- Test: Electrical Safety Conformance
- Acceptance Criteria: IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- Result: PASS
- Test: Software Validation
- Acceptance Criteria: The software that controls the system was validated and determined to operate effectively and as designed.
- Result: PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluorescent Read meets >= 97% alignment with 7-day grow out
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.
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 21, 2022
STERIS Corporation Gregory Land Senior Regulatory Affairs Specialist 5960 Heislev Road Mentor, Ohio 44060
Re: K213881
Trade/Device Name: Celerity Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: Class II Product Code: FRC Dated: July 5, 2022 Received: July 6, 2022
Dear Gregory Land:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213881
Device Name Celerity Incubator
Indications for Use (Describe)
Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C-60°C for a fluorescent result.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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STEI
510(k) Summary For Celerity Incubator
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Mr. Gregory Land Senior Regulatory Affairs Specialist Tel: 440-392-7424 Fax: 440-357-9198 greg land(@steris.com
Submission Date: July 21, 2022
K Number: K213881
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | Celerity Incubator |
|---|---|
| Device Class: | Class II |
| Common/usual Name: | Incubator |
| Classification Name: | Indicator, Biological Sterilization Process |
| Classification Number: | 21 CFR 880.2800 |
| Product Code: | FRC |
2. Predicate Device
K190297 – Celerity HP Incubator
3. Reference Device
K173670 - Celerity Steam Incubator
4. Device Description
The Celerity Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The BI is incubated at 59°C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.
4. Indications for Use
Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a fluorescent result.
ನ. Technological Characteristics Comparison Table
A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.
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| Feature | Subject Device
Universal Biological
Indicator Incubator
(K213881) | Predicate Device
Celerity 20 HP Indicator
(K190297) | Comparison |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications
for Use | Use the Celerity Incubator to
incubate and automatically read
STERIS Celerity Biological
Indicators for Steam and
Vaporized Hydrogen Peroxide
sterilization at 55°C - 60°C for a
fluorescent result. | Use the Celerity HP Incubator
to incubate and automatically
read Celerity 20 HP Biological
Indicators at 57°C for a
fluorescent result within 20
minutes. | Similar |
| Basis of
Readout | Photodiode detects fluorescence
produced by enzymatic activity
that results from viable
biological indicator organisms. | Photodiode detects
fluorescence produced by
enzymatic activity that results
from viable biological
indicator organisms. | Same |
| Incubation
Temperature
Range | 55 - 60 °C | 55 - 60 °C | Same |
| Voltage
Range | 100-240 VAC with 12 VDC
conversion | 100-240 VAC with 12 VDC
conversion | Same |
| Test Capacity | 8 wells | 8 wells | Same |
| Calibration | Factory calibration - no
calibration by customer | Factory calibration - no
calibration by customer | Same |
| Incubation
Time | 20 minutes | 20 minutes | Same |
| Fluorescence
Detection | UV LEDs are used to excite the
fluorescent molecule produced
by enzyme cleavage of the
fluorogenic substrate contained
in the BI's media. The emitted
light is detected by a photodiode. | UV LEDs are used to excite
the fluorescent molecule
produced by enzyme cleavage
of the fluorogenic substrate
contained in the SCBI's media.
The emitted light is detected
by a photodiode. | Same |
| Indication of
Results | Positive - audible alarm, visual
LED lights and screen Negative
- optional alarm, visual
indication with LED lights and
LCD screen
User must acknowledge results | Positive - audible alarm,
visual LED lights and screen
Negative - optional alarm,
visual indication with LED
lights and LCD screen
User must acknowledge results | Same |
| Feature | Subject Device
Universal Biological
Indicator Incubator
(K213881) | Predicate Device
Celerity 20 HP Indicator
(K190297) | Comparison |
| System
Operation | The reader/incubator wells
are arranged in 2 banks of 4
wells and preset to 59°C. The
user scans the barcode on the
label of an activated BI using
the system's barcode scanner
and places it into an open
well. The system detects the
well the BI was placed into
and begins measurement of
fluorescence; a blinking
yellow light indicates the
incubation is in process and
the read initiated. The
System uses information from
the barcode to apply the
appropriate algorithm to the
well. A "positive" reading is
interpreted as an indication of
a potential sterilization cycle
failure. A "positive" finding
is indicated to the user by red
light on the front panel
adjacent to the well, by an
audible alarm, and by text
displayed on the LCD screen.
The alarm must be muted by
the operator when a positive
result is obtained. The LCD
screen provides instructions
for the user to turn off the
alarm for that specific BI.
Should another BI become
"positive", the alarm will
sound again and the above
actions are repeated.
If the result is not positive at
the end of the incubation
time, the result is negative.
Negative results are identified
by a green light on the front
panel adjacent to the well
with the "negative" BI and by
text on the LCD. In addition, an optional alarm is available | The reader/incubator wells
are arranged in 2 banks of 4
wells and preset to 57°C. The
measurement of fluorescence
is initiated by placement of a
Celerity HP BI into any of the
incubation wells and pressing
the adjacent "ACTION”
button.
When an SCBI is placed into
a well, the auto-reader detects
its presence. Upon pressing
the button associated with
that well, a blinking yellow
light indicates that incubation
is in process and the read
initiated.
A "positive" reading is
interpreted as an indication of
a potential sterilization cycle
failure. A "positive" finding
is indicated to the user by red
| Similar |
| Feature | Subject Device
Universal Biological
Indicator Incubator
(K213881) | Predicate Device
Celerity 20 HP Indicator
(K190297) | Comparison |
| | for negative results. | for negative results. User
must acknowledge results. | |
Table 1. Technological Characteristics Comparison Table to predicate device
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6. Summary of Non-Clinical Performance Testing
Testing was performed to evaluate performance and demonstrate that device met the acceptance criteria shown in Table 2.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Maintenance of | ||
| Incubation | ||
| Temperature | Temperature of BIs is maintained between 55°C - 60°C | |
| during incubation. Temperatures were observed over a | ||
| 60min period and during a 1min loss of power. | PASS | |
| Qualification | ||
| Testing with | ||
| intended | ||
| Biological | ||
| Indicators | Fluorescent Read meets ≥ 97% alignment with 7-day grow | |
| out per FDA guidance on reduced incubation time for | ||
| intended Biological Indicators for both Steam and Vaporized | ||
| Hydrogen Peroxide Celerity Biological Indicators | PASS | |
| Human Factors | Typical users are capable of following the written | |
| instructions for use to correctly use the Celerity Incubators. | PASS | |
| Electromagnetic | ||
| Compatibility | IEC 60601-1-2:2014 General Requirements for Basic Safety | |
| and Essential Performance - Collateral Standard: | ||
| Electromagnetic Compatibility - Requirements and Tests | PASS | |
| Electrical Safety | ||
| Conformance | IEC 60601-1 Medical electrical equipment - Part 1: General | |
| requirements for basic safety and essential performance | PASS | |
| Software | ||
| Validation | The software that controls the system was validated and | |
| determined to operate effectively and as designed. | PASS |
Table 2. Performance Testing
7. Conclusion
The conclusions drawn from the non-clinical performance data demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K190297), Class II (21 CFR 880.2800), product code FRC.