(288 days)
Not Found
None
No
The description details a chemical indicator that changes visually based on temperature and time exposure, with no mention of computational analysis, algorithms, or learning.
No
The device is an emulating indicator used to verify that steam sterilization conditions were met, not to treat a medical condition or perform a medical function on a patient.
No
This device, a Dana Emulating Indicator, is used to verify that steam sterilization conditions are met, indicating the sterilizer is functioning correctly. It does not diagnose a medical condition in a patient but rather assesses the performance of a medical device (a sterilizer).
No
The device description is not found, but the intended use describes a physical indicator ("dark bar will travel along the window") that responds to steam sterilization conditions. This indicates a hardware component, not a software-only device.
Based on the provided information, the Dana Emulating Indicator is not an In Vitro Diagnostic (IVD) 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 about a person's health.
- Dana Emulating Indicator's Function: The Dana Emulating Indicator is used to monitor the effectiveness of a steam sterilization process. It does not interact with or analyze human specimens. Its purpose is to indicate whether the physical conditions (temperature and time) required for sterilization were met within a sterilizer.
Therefore, the Dana Emulating Indicator falls under the category of a sterilization process indicator, not an IVD.
N/A
Intended Use / Indications for Use
Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met.
Critical Parameters in a standard hospital pre-vacuum steam sterilizer
Temperature : 270°F (132°C) Time: 4 Minutes
Product codes
JQJ
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized caduceus symbol, which is a staff with two snakes coiled around it.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Harry Bala President Dana Products, Incorporated 7 Corey Drive South Barington, Illinois 60010
JAN 1 3 2011
Re: K100891
Trade/Device Name: Dana Emulating Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JQJ Dated: January 6, 2011 Received: January 10, 2011
Dear Mr. Bala:
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 the submit and the submit of the submit of the submit of the subject of Register.
and the comments of the comments of the comments of
1
Page 2- Mr. Bala
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/CDRHOffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
James J. Roberts
for
Anthony D. Watson, B.S., M.S., M.B.A. 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): Device Name: Dana Emulating Indicator
JAN 1 3 2011
Indications For Use:
Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met.
Critical Parameters in a standard hospital pre-vacuum steam sterilizer
Temperature : 270°F (132°C) Time: 4 Minutes
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 11
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K100891 |
| Page 1 of 1 | |
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