(314 days)
Not Found
Not Found
No
The provided text describes biological and chemical indicators for sterilization processes and an incubator/reader for these indicators. There is no mention of AI or ML technology in the intended use or any other section.
No
The device is described as a biological indicator and a process challenge device used for monitoring sterilization processes, not for treating patients.
No.
The device is a biological indicator and reader system for monitoring sterilization processes, not for diagnosing medical conditions in patients.
No
The device description is not provided, but the intended use and description of the Terragene Bionova® IC10/20FR Reader clearly indicate the device includes hardware components (biological indicators, chemical indicators, and an incubator/reader).
Based on the provided information, the Terragene Bionova® SCBI, PCD, and IC10/20FR Reader are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is clearly stated as "monitoring the effication processes" and "routine monitoring and sterilizer qualification testing steam sterilization processes." This relates to the effectiveness of sterilization equipment, not to diagnosing a disease or condition in a patient using a sample from the human body.
- Device Description: While a detailed device description is "Not Found," the description of the components (biological indicator with spores, chemical indicator, reader/incubator) aligns with devices used for sterilization monitoring, not for analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition in a patient.
These devices are designed to assess the performance of sterilization equipment, which is a quality control process for medical devices or other items, not a diagnostic test performed on a patient.
N/A
Intended Use / Indications for Use
Terragene Bionova® SCBI (BT220, BT221, BT222, BT223) is a self-contained biological indicator inoculated with viable 10f Geobacillus stearothermophilus bacterial spores and is intended for monitoring the effication processes. Oneach Terragene Bionova® SCB is a chemical process indicator that changes color from pink to brown when exposed to steam.
Terragene Bionova® PCD (PCD220-C. PCD222-C. PCD222-C. PCD222-2) provides a defined challenge resistance against the claimed cycles shown below and also demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification testing steam sterilization processes.
Terragene Bionova® IC10/20FR Reader Incubates at 60 ℃ and reads the Terragene Bionova® SCBI (BT220, BT221, BT222, and BT223) for fluorescent results at 30 minutes (BT221, BT222), and 3 hours (BT220)
Product codes (comma separated list FDA assigned to the subject device)
FRC
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): 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
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 pattern around the symbol. The caduceus symbol is composed of three abstract human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2017
Terragene Sa % Raymond Kelly Consultant Licensale Inc 68 Southwoods Ter Southbury, Connecticut 06488
Re: K163646
Trade/Device Name: Terragene Bionova® SCBI (BT220, BT221, BT222, BT223), Terragene Bionova® PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova ® IC10/20FR Reader Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: October 26, 2017 Received: October 31, 2017
Dear Raymond Kelly:
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.
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
1
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 devicerelated 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 and Part 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tara A. Ryan -S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications forUse
510(k) Number (if known) K163646
Device Name
Terragene Bionova® SCBI (BT220, BT221, BT222, BT223), Terragene Bionova® PCD (PCD220-C, PCD222-C, PCD222-2), and Terragene Bionova ® IC10/20FR Reader Incubator
Indications for Use (Describe)
Terragene Bionova® SCBI (BT220, BT221, BT222, BT223) is a self-contained biological indicator inoculated with viable 10f Geobacillus stearothermophilus bacterial spores and is intended for monitoring the effication processes. Oneach Terragene Bionova® SCB is a chemical process indicator that changes color from pink to brown when exposed to steam.
Terragene Bionova® PCD (PCD220-C. PCD222-C. PCD222-C. PCD222-2) provides a defined challenge resistance against the claimed cycles shown below and also demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification testing steam sterilization processes.
Terragene Bionova® IC10/20FR Reader Incubates at 60 ℃ and reads the Terragene Bionova® SCBI (BT220, BT221, BT222, and BT223) for fluorescent results at 30 minutes (BT221, BT222), and 3 hours (BT220)
| Models | 121°C | 132°C | 135°C |
|---|---|---|---|
| Gravity Displacement | |||
| BT220, BT222, PCD220-C, PCD220-2, PCD222-C, | |||
| PCD222-2 | 30 minutes | 15 minutes, | |
| 25 minutes | 10 minutes | ||
| BT221, BT223 | NA | 3 minutes, | |
| 10 minutes | 3 minutes, | ||
| 10 minutes | |||
| Dynamic Air Removal (Vacuum Assist) | |||
| BT220, BT222, PCD220-C, PCD220-2, PCD222-C, | |||
| PCD222-2 | NA | 4 minutes | 3 minutes |
| Models | Fluorescence Read Time | pH Color Change | |
| BT221, BT222, PCD222-C, PCD222-2 | 1 hour | 48 Hours | |
| BT223 | 30 minutes | 48 Hours | |
| BT220, PCD220-C, PCD220-2 | 3 hours | 48 Hours |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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