(247 days)
Not Found
Not Found
No
The device is a chemical indicator that changes color based on temperature and time exposure, which is a passive chemical reaction, not AI/ML. The summary contains no mention of AI, ML, algorithms, data processing, or any other indicators of AI/ML technology.
No.
The device is a steam sterilization emulator, indicating whether sterilization conditions were met, rather than being used for treatment or diagnosis of a disease.
No
Explanation: A diagnostic device is used to detect or measure disease, conditions, or infections in humans or animals. This device is a steam sterilization emulator, which indicates if sterilization conditions were met, a function unrelated to diagnosing medical conditions in living beings.
No
The device is a steam sterilization emulator with physical indicator bars that change color, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the effectiveness of a steam sterilization process for medical devices. It does not involve testing a sample taken from the human body to provide information about a physiological state, health, or disease.
- Device Description: While the description is "Not Found," the intended use clearly defines its function as a sterilization indicator.
- Lack of Biological Sample Testing: IVD devices are designed to test biological samples (blood, urine, tissue, etc.). This device is used within a sterilizer to assess the sterilization environment itself.
Therefore, the SteriTec Emu-Graph is a sterilization process indicator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SteriTec Emu-Graph is a steam sterilization emulator for use in a pre-vacuum steam sterilizer at 132°C (270° F) or 135° C (275° F). When exposed to a sterilization process, when the 2 MIN and 4 MIN indicator bars will turn from purple to green giving an integrated response and visible indication that accepted sterilization conditions have been met. If only the 2 MIN indicator bar turns green and the 4 MIN indicator bar displays an incomplete color change, insufficient sterilization conditions occurred.
Critical Parameters in a standard hospital pre-vacuum steam sterilizer
Temperature: 132°C (270°F), 4 MIN Indicator: 4 minutes
Temperature: 135°C (275°F), 4 MIN Indicator: 3 minutes
Product codes
JOJ
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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).
0
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 eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is depicted in a simple, abstract style, with flowing lines suggesting feathers and movement. The text is in a sans-serif font and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 30 Zuur
Ms. Linda Nelson Regulatory Affairs Manager Steritec Products Manufacturing Company, Incorporated 599 Topeka Way, Suite 400 Castle Rock, Colorado 80109
Re: K072408
Trade/Device Name: Emu-Graph Emulator, Model No .: CI 131 Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: April 10, 2008 Received: April 14, 2008
Dear Ms. Nelson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Nelson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sydite y. Micham Oms
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K072408
Device Name: Emu-Graph Emulator, Model No .: CI 131
Indications for Use:
SteriTec Emu-Graph is a steam sterilization emulator for use in a pre-vacuum steam Sterried Ema Staph is a otoan at 132°C (270° F) or 135° C (275° F). When exposed stemization proodse open the 2 MIN and 4 MIN indicator bars will turn from purple to green giving an integrated response and visible indication that from purple to groom grining an t. If only the 2 MIN indicator bar turns green and the 4 MIN indicator bar displays an incomplete color change, insufficient sterilization conditions occurred.
Critical Parameters in a standard hospital pre-vacuum steam sterilizer
| Temperature | 4 MIN Indicator |
|---|---|
| 132°C (270°F) | 4 minutes |
| 135°C (275°F) | 3 minutes |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ X (21 CFR 801 Subpart C)
..............................................................................................................................................................................
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shili A. Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K072408
Page S002-7