(232 days)
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No
The description focuses on electronic recognition, color detection (purple/yellow), and printing capabilities, which are standard electronic and mechanical functions, not indicative of AI/ML. There is no mention of learning, adaptation, or complex pattern recognition beyond simple color sensing.
No
The device is an incubator for biological indicators used to assess the efficacy of sterilization processes, not to treat a medical condition or perform a therapeutic function on a patient.
No
The device is an incubator for biological indicators and an electronic monitoring system that detects color changes in the biological indicators. While it monitors and reports the results (positive/negative), its primary function is to facilitate the incubation and reading of biological indicators used to determine the efficacy of sterilization processes, rather than directly diagnosing a patient's condition or disease or providing information to that effect to the user. The "diagnostic device" traditionally refers to devices that diagnose a patient condition or disease.
No
The device description clearly describes a physical incubator with incubation cavities, LEDs, and an electronic monitoring system, indicating it is a hardware device with integrated software.
Based on the provided text, the Smart-Well Model 1710 EZTest Incubator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Smart-Well Function: The Smart-Well Model 1710 EZTest Incubator is designed to incubate and monitor a biological indicator (BI), which is a device used to assess the effectiveness of a sterilization process. The BI itself contains bacterial spores, but the incubator is not analyzing a human specimen.
- Purpose: The purpose of the Smart-Well is to facilitate the growth and detection of bacterial spores in the BI after it has been exposed to a sterilization cycle. This is a quality control measure for the sterilization process, not a diagnostic test performed on a patient sample.
Therefore, the Smart-Well Model 1710 EZTest Incubator falls under the category of a device used in the sterilization process quality control, not as an IVD for patient diagnosis.
N/A
Intended Use / Indications for Use
The Smart-Well Model 1710 EZTest Incubator is intended for use with the Smart-Read EZTest Steam self-contained biological indicator (SCBI).
When an activated Smart-Read EZTest Steam SCBI is placed into one of the incubation cavilies the LED in front of the cavity will illuminate amber, which indicates that the incubator electronically recognizes the Smart-Read EZTest Steam SCBI unit for incubation.
Smart-Read EZTest is a Self-contained Biological Indicator (SCBI) intended for use in determining the efficacy of steam sterilization processes. The SCBI may be used in the following steam sterilization cycles:
| Cycle Type | Cycle Temperature | Cycle Exposure Time |
|---|---|---|
| Gravity | 121°C | 30 minutes |
| Gravity | 132°C | 10 minutes |
| Flash Gravity | 132°C | 3 minutes* |
| Pre-Vac | 132°C | 4 minutes |
| Pre-Vac | 135°C | 3 minutes |
*Unwrapped nonporous devices only.
Each incubation cavily also has an electronic monitoring system that detects if the Bl is either purple or yellow.
The Smart-Well Model 1710 EZTest Incubator can also be supplied with a printer which documents each individual Smart-Read EZTest Steam SCBI tested. The printer can also display information that is normally entered into a log book. The printer can also be configured to display Bl exposure information that includes Bl Lot number, Sterilizer number, User identification and Cycle ID. If no selection is made for these options during the BI Wizard set up, the printed report will print a "?" mark indicating no selection was made.
The printed record will always indicate incubation cavity being reported. Bl results (status), incubation start date and time when the SCB! was placed into the incubation cavity and the total time of incubation. The result options are 1) NEGATIVE (purple)-incubation time completed with no detectable color change in the Smart-Read EZTest unit, 2) POSITIVE (yellow)—time that a yellow color was detected in the Smart-Read EZTest unit, or 3) TESTING-when a printout is requested and event 1) or 2) have not happened. These results are easily verified by the user as performed in all conventional incubators without printers.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The Smart-Well Model 1710 EZTest Incubator is intended for use with the Smart-Read EZTest Steam self-contained biological indicator (SCBI). When an activated Smart-Read EZTest Steam SCBI is placed into one of the incubation cavities the LED in front of the cavity will illuminate amber, which indicates that the incubator electronically recognizes the Smart-Read EZTest Steam SCBI unit for incubation. Each incubation cavity also has an electronic monitoring system that detects if the BI is either purple or yellow. The Smart-Well Model 1710 EZTest Incubator can also be supplied with a printer which documents each individual Smart-Read EZTest Steam SCBI tested. The printer can also display information that is normally entered into a log book and can be configured to display BI exposure information including BI Lot number, Sterilizer number, User identification and Cycle ID. The printed record will indicate the incubation cavity, BI results (status: NEGATIVE (purple), POSITIVE (yellow), or TESTING), incubation start date and time, and total incubation time.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2013
Ms. Jole Wilson Quality Assurance Manager Bozeman Manufactiring Facility 10 Evergreen Drive BOZEMAN, MONTANA 59715
Re: K122362
Trade/Device Name: Smart-Well Model 1710 EZTest Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: FRC Product Code: II Dated: February 25, 2013 Received: February 26, 2013
Dear Ms. Wilson:
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.
1
· Page 2 - Ms. Wilson
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/7 description: The image contains text that appears to be extracted from a document or record. The text includes the names "Anthony D. Watson" repeated twice, along with the abbreviation "S". There is also a date, "2013.03.26", and a timestamp, "17:02:22-04'00'" present in the image.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
· Radiological Health
Enclosure
2
002 Indications for Use Statement
K122362 510(k) Number
. Smart-Well Model 1710 EZTest Incubator Device Name
Indications for Use
The Smart-Well Model 1710 EZTest Incubator is intended for use with the Smart-Read EZTest Steam self-contained biological indicator (SCBI).
When an activated Smart-Read EZTest Steam SCBI is placed into one of the incubation cavilies the LED in front of the cavity will illuminate amber, which indicates that the incubator electronically recognizes the Smart-Read EZTest Steam SCBI unit for incubation.
Smart-Read EZTest is a Self-contained Biological Indicator (SCBI) intended for use in determining the efficacy of steam sterilization processes. The SCBI may be used in the following steam sterilization cycles:
| Cycle Type | Cycle Temperature | Cycle Exposure Time |
|---|---|---|
| Gravity | 121°C | 30 minutes |
| Gravity | 132°C | 10 minutes |
| Flash Gravity | 132°C | 3 minutes* |
| Pre-Vac | 132°C | 4 minutes |
| Pre-Vac | 135°C | 3 minutes |
*Unwrapped nonporous devices only.
Each incubation cavily also has an electronic monitoring system that detects if the Bl is either purple or yellow.
The Smart-Well Model 1710 EZTest Incubator can also be supplied with a printer which documents each individual Smart-Read EZTest Steam SCBI tested. The printer can also display information that is normally entered into a log book. The printer can also be configured to display Bl exposure information that includes Bl Lot number, Sterilizer number, User identification and Cycle ID. If no selection is made for these options during the BI Wizard set up, the printed report will print a "?" mark indicating no selection was made.
The printed record will always indicate incubation cavity being reported. Bl results (status), incubation start date and time when the SCB! was placed into the incubation cavity and the total time of incubation. The result options are 1) NEGATIVE (purple)-incubation time completed with no detectable color change in the Smart-Read EZTest unit, 2) POSITIVE (yellow)—time that a yellow color was detected in the Smart-Read EZTest unit, or 3) TESTING-when a printout is requested and event 1) or 2) have not happened. These results are easily verified by the user as performed in all conventional incubators without printers.
Prescription Use ___________ or Over-the-Counter Use X
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of ( 2013.03.26 11:18:19 -04 000
(Division Sign-Off)
ൗivision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number:
Original Date: August 3, 2012 Revision Date: February 5, 2013
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