(96 days)
No
The summary describes a biological indicator test pack for steam sterilization, which is a physical device for monitoring sterilization cycles. There is no mention of software, data processing, or any terms related to AI or ML.
No.
The device is used for monitoring sterilization cycles, not for treating any medical condition or anatomical site.
No
Explanation: The device is intended for routine monitoring of sterilization cycles, not for diagnosing medical conditions in patients.
No
The device description clearly states it is a "disposable polypropylene sleeve assembly" and a "Reusable Biological Indicator Test Pack," indicating physical components, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "routine monitoring of 10 Minute 270° F pre-vacuum steam sterilization cycles." This is a quality control or monitoring function for a sterilization process, not a diagnostic test performed on a biological sample from a human or animal to determine a disease or condition.
- Device Description: The description is "Reusable Biological Indicator Test Pack for Steam Sterilization." This further reinforces its role in monitoring sterilization effectiveness, not diagnosing a medical condition.
- Lack of IVD Characteristics: The provided information lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnosing, monitoring, or predicting a disease or condition
- Providing information about a patient's health status
Therefore, this device falls under the category of a sterilization process indicator or monitor, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The disposable polypropylene sleeve assembly with 3M's 1292 Bl used with the Dana Reusable Test Pack can be used for routine monitoring of 10 Minute 270° F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with Dana Reusable Test Pack cleared under K 092944.
Product codes
FRC
Device Description
Reusable Biological Indicator Test Pack for Steam Sterilization.
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)
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 logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with three lines extending from its head, representing the three branches of government. The eagle is facing to the right.
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 Barrington, Illinois 60010
FEB 16 251
Re: K103321
Trade/Device Name: Reusable Biological Test Pack for Steam Sterilization Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: January 20, 2011 Received: January 28, 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 Register.
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.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersQffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony V. Water
Anthony D. Watson, M.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
2
Indications for Use
510(k) Number (if known): K103321
Device Name: Reusable Biological Indicator Test Pack for Steam Sterilization.
Indications For Use:
The disposable polypropylene sleeve assembly with 3M's 1292 Bl used with the Dana Reusable Test Pack can be used for routine monitoring of 10 Minute 270° F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with Dana Reusable Test Pack cleared under K 092944.
AND/OR Prescription Use (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
eb
(División Sign-Off) Page 1 of 1
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K103321