(29 days)
No
The description focuses on a standard incubator and fluorescent reading technology, with no mention of AI or ML terms or concepts.
No
The ConFirm 20 Minute Incubator is used to incubate and read biological indicators for sterilization processes, not to treat or diagnose patients.
No
Explanation: This device is an incubator and reader for biological indicators used to assess the effectiveness of sterilization processes, not to diagnose a medical condition in a patient.
No
The device description explicitly states it is an "incubator," which is a physical hardware device used for incubation and reading of biological indicators.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to incubate and read biological indicators used to monitor the effectiveness of sterilization processes (steam and vaporized hydrogen peroxide). This is a quality control function for sterilization equipment, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device incubates and reads biological indicators based on the production of an enzyme (a-glucosidase) by microorganisms. This is a test of the sterilization process, not a test on a human sample.
- Lack of Patient Information: The description explicitly states "Anatomical Site: Not Applicable" and "Indicated Patient Age Range: Not Applicable," which are key characteristics of devices used for patient diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function.
N/A
Intended Use / Indications for Use
Use the ConFirm 20 Minute Incubate and automatically read ConFirm Rapid 20 Minute Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C-60°C for a fluorescent result.
Product codes
FRC
Device Description
The ConFirm 20 Minute Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The Bl 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 Testing:
- Study Type: Regression Testing
- Sample Size: Not specified
- AUC: Not specified
- MRMC: Not specified
- Standalone performance: Not specified
- Key Results: "No unresolved anomalies" with a result of PASS.
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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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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
December 15, 2023
Steris Corporation Logan Persons Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060
Re: K233681
Trade/Device Name: ConFirm 20 Minute Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 16, 2023 Received: November 16, 2023
Dear Logan Persons:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Christopher K. Dugard -S
Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical
2
and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233681
Device Name ConFirm 20 Minute Incubator
Indications for Use (Describe)
Use the ConFirm 20 Minute Incubate and automatically read ConFirm Rapid 20 Minute 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)
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Image /page/4/Picture/0 description: The image shows the STERIS logo. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue.
510(k) Summary For ConFirm 20 Minute Incubator K233681
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Mr. Logan Persons Regulatory Affairs Specialist Tel: 440-392-7325 Fax: 440-357-9198 Logan persons@steris.com
Summary Date: December 15, 2023
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1. Device Name
| Trade Name: | ConFirm 20 Minute Incubator |
|---|---|
| Device Classification: | II |
| Common Name: | Incubator |
| Classification Name: | Indicator, Biological Sterilization Process |
| Classification Panel: | General Hospital and Personal Use Devices Panel |
| Classification Number: | 21 CFR 880.2800 |
| Product Code | FRC |
2. Predicate Device
K223715 - Celerity Incubator
Reference Device K173634 - ConFirm Biological Indicator (cleared as CELERITY 20 Steam Biological Indicator)
3. Device Description
The ConFirm 20 Minute Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The Bl 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 ConFirm 20 Minute Incubator to incubate and automatically read ConFirm Rapid 20 Minute Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C-60°C for a fluorescent result.
ડ. Technological Characteristics Comparison Table
A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.
| Feature | Modified Device
ConFirm 20 Minute
Incubator | Predicate Device
Celerity Indicator
(K223715) | Comparison |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Indications
for Use | Use the ConFirm 20 | Use the Celerity Incubator | Same, only |
| Feature | Modified Device
ConFirm 20 Minute
Incubator | Predicate Device
Celerity Indicator
(K223715) | Comparison |
| | Minute Incubator to
incubate and automatically
read ConFirm Rapid 20
Minute Biological
| 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. | change is
branding of
incubator and
BI with which
it is used |
| 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 | 5 minutes or 20 minutes
depending on Biological
Indicator | Similar, the 5-
minute BI is
not being
rebranded. |
| 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 BI's
media. The emitted light is
detected by a photodiode. | Same |
| Indication of
Results | Positive – audible alarm,
visual LED lights and | Positive – audible alarm,
visual LED lights and | Same |
| Feature | Modified Device
ConFirm 20 Minute
Incubator | Predicate Device
Celerity Indicator
(K223715) | Comparison |
| | screen
Negative - optional alarm,
visual indication with LED
lights and LCD screen
User must acknowledge
results | screen
Negative - optional alarm,
visual indication with LED
lights and LCD screen
User must acknowledge
results | |
| 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. | 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. | Same |
| Feature | Modified Device
ConFirm 20 Minute
Incubator | Predicate Device
Celerity Indicator
(K223715) | Comparison |
| | 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
for negative results. | 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
for negative results. | |
Table 1. Technological Characteristics Comparison Table to predicate device
6
7
8
6. Summary of Non-Clinical Testing
Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 2.
Table 2. Performance Testing
| Test | Acceptance Criteria | Result |
|---|---|---|
| Regression | ||
| Testing | No unresolved anomalies | PASS |
7. Conclusion
The ConFirm 20 Minute 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 (K223715), Class II (21 CFR 880.2800), product code FRC.