(126 days)
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No
The summary describes a biological and chemical indicator for steam sterilization, which relies on physical and biological changes, not AI/ML. There are no mentions of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
This device is a biological test pack designed to verify the effectiveness of steam sterilizers, not to treat or cure any medical condition.
No
This device is a biological indicator used to test the effectiveness of steam sterilizers, not to diagnose a medical condition in a patient. It indicates whether sterilizing conditions were met.
No
The device description explicitly states it consists of a biological indicator inside a package of porous and nonporous materials, which are physical components, 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 test the effectiveness of steam sterilizers, specifically for sterilization cycles. This is a quality control measure for a medical device (the sterilizer), not a test performed on a biological sample from a human or animal to diagnose a condition, monitor treatment, or screen for disease.
- Device Description: The device contains a biological indicator (bacteria) and a chemical integrator. These components are used to assess the sterilization process, not to analyze a biological specimen.
- Lack of IVD Characteristics: The description does not mention analyzing blood, urine, tissue, or any other biological sample. It doesn't involve diagnosing, monitoring, or screening for any medical condition.
Therefore, the SteriTec Smart-Read® Biological Test Pack with Instant Readout Integrator falls under the category of a sterilization process indicator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SteriTec Smart-Read® Biological Test Pack with Instant Readout Integrator is designed specifically for testing of 3 minutes or longer at 132°C (270°F) in pre-vacuum steam sterilizers. The test pack consists of a self-contained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by ANSI/AAMI ST79. When used as directed, the Chemical Integrator Record Card gives visible indication that sterilizing conditions were met.
Product codes
JOJ
Device Description
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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
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Suzanne Dennis Director Regulatory Affairs/Quality Assurance SteriTec Products Manufacturing Company, Incorporated 74 Inverness Drive East Englewood, Colorado 80112
FEB 1 1 200
Re: K103000
Trade/Device Name: SteriTec Biological Test Pack with Instant Readout Integrator Model No.: BI 108 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: January 26, 2011 Received: January 28, 2011
Dear Ms. Dennis:
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. Dennis
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 (OS) 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/Resourcesfor You/Industrv/default.htm.
Sincerely yours,
Jams 2. Kistoch
faz
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
K103000 510(k) Number (if known):
Device Name: SteriTec Biological Test Pack with Instant Readout Integrator, Model No.: Bl 108
INDICATIONS FOR USE
SteriTec Smart-Read® Biological Test Pack with Instant Readout Integrator is designed specifically for testing of 3 minutes or longer at 132°C (270°F) in pre-vacuum steam sterilizers. The test pack consists of a self-contained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by ANSI/AAMI ST79. When used as directed, the Chemical Integrator Record Card gives visible indication that sterilizing conditions were met.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (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)
Elizabeth F. Clavine-Wilson
(Division Sign-Off)
Division of Anesthessology, General Hospital
Division of Anesthesiology, General Devices Division of Ancolinal Devices
510(k) Number: K103000