(195 days)
Not Found
No
The description focuses on standard incubation and fluorescence detection technology, with no mention of AI or ML algorithms for analysis or decision-making.
No.
The device is used to incubate and read biological indicators for sterilization processes, not to treat a medical condition or ailment in a patient.
No
Explanation: The device is described as an incubator and reader for biological indicators used to confirm sterilization, not to diagnose a medical condition in a patient. It is used to determine the effectiveness of a sterilization process.
No
The device description explicitly states it is an "incubator," which is a hardware device used for incubating and reading biological indicators. The performance studies also include hardware-related testing like Electromagnetic Compatibility and Electrical Safety Conformance.
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 for Steam and Vaporized Hydrogen Peroxide sterilization for a fluorescent result." Biological indicators are used to monitor the effectiveness of sterilization processes.
- Device Description: It incubates and reads fluorescent signals from biological indicators, which are used to assess the presence or absence of microbial growth after sterilization. This process is performed in vitro (outside of a living organism).
- Performance Studies: The performance studies focus on the alignment of the fluorescent read with a "7-day grow out," which is a standard method for confirming the viability of microorganisms in biological indicators. This directly relates to the diagnostic function of determining sterilization effectiveness.
While the device itself is an incubator and reader, its function is to process and interpret the results of a biological indicator, which is a key component of an in vitro diagnostic system for monitoring sterilization. The biological indicator itself is also an IVD.
N/A
Intended Use / Indications for Use
Use the Celerity 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)
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 Vaporized Hydrogen Peroxide Celerity 5 Biological Indicators
- Result: PASS
Human Factors:
- Acceptance Criteria: Typical users are capable of following the written instructions for use to correctly use the Celerity Incubators.
- Result: PASS
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
Electrical Safety Conformance:
- Acceptance Criteria: IEC 60101-1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1: General Requirements
- Result: PASS
Software Validation per IEC 62304:
- 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.)
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).
0
Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 15, 2023
STERIS Corporation Gregory Land Lead Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060
Re: K223715
Trade/Device Name: Celerity Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: May 19, 2023 Received: May 19, 2023
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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,
Christopher K. Dugard -S
for Clarence W. Murray, III, PhD Deputy 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
2
Indications for Use
Submission Number (if known)
Device Name
Celerity Incubator
Indications for Use (Describe)
Use the Celerity Incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a fluorescent result.
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 STERIS logo. The word "STERIS" is in all caps and in a serif font. Below the word is a graphic of several horizontal wavy lines in blue.
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
Lead Regulatory Affairs Specialist
Tel: 440-392-7424
greg_land@steris.com |
|------------------|-----------------------------------------------------------------------------------------------------|
| Submission Date: | June 13, 2023 |
K Number: K223715
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
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
K213881 - Celerity Incubator
3. 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.
Indications for Use 4.
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.
5. Technological Characteristics Comparison Table
A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.
| Feature | Proposed Device
Universal Biological
Indicator Incubator | Predicate Device
Celerity Indicator
(K213881) | Comparison |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications
for Use | Use the Celerity Incubator to
incubate and automatically
read STERIS Celerity
Biological Indicators for | Use the Celerity Incubator to
incubate and automatically
read STERIS Celerity
Biological Indicators for | Same |
| Feature | Proposed Device
Universal Biological
Indicator Incubator | Predicate Device
Celerity Indicator
(K213881) | Comparison |
| | Steam and Vaporized
Hydrogen Peroxide
sterilization at 55°C - 60°C
for a fluorescent result. | Steam and Vaporized
Hydrogen Peroxide
sterilization at 55°C - 60°C
for a fluorescent result. | |
| 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 | 5 minutes or 20 minutes
depending on Biological
Indicator | 20 minutes | Similar |
| 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 |
| 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 | 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 | Same |
| | Proposed Device
Universal Biological
Indicator Incubator | Predicate Device
Celerity Indicator
(K213881) | Comparison |
| Feature | 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 | 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. | 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 | 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 | |
| | for negative results. | for negative results. | |
Table 1. Technological Characteristics Comparison Table to predicate device
5
6
Summary of Non-Clinical Performance Testing 6.
Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 2.
7
| Test | Acceptance Criteria | Result |
|---|---|---|
| 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 Vaporized Hydrogen | ||
| Peroxide Celerity 5 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 60101-1 Safety Requirements for Electrical Equipment | |
| for Measurement, Control, and Laboratory Use Part 1: | ||
| General Requirements | PASS | |
| Software | ||
| Validation per | ||
| IEC 62304 | The software that controls the system was validated and | |
| determined to operate effectively and as designed. | PASS |
Table 2. Performance Testing
7. Conclusion
The Celerity Incubator has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K213881), Class II (21 CFR 880.2800), product code FRC.