(84 days)
Not Found
Not Found
No
The summary describes a physical positioning device and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is used to support and position a patient during radiologic procedures, which is a supportive function and not a direct therapeutic intervention.
No
Explanation: The device is a patient positioning board for medical procedures, not for disease detection or diagnosis.
No
The device description clearly states "Carbon Fiber Breast Board," which is a physical hardware component used for patient positioning.
Based on the provided information, the MED-TEC, INC. Carbon Fiber Breast Board is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "support and aid in positioning a patient during radiologic and other medical procedures." This describes a device used on a patient for positioning during imaging or treatment, not a device used to test samples from a patient (which is the core function of an IVD).
- Device Description: "Carbon Fiber Breast Board" describes a physical support structure.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.), which is characteristic of IVDs.
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Carbon Fiber Breast Board's function is purely for patient positioning during procedures.
N/A
Intended Use / Indications for Use
The intended use of the MED-TEC, INC. Carbon Fiber Breast Board is to support and aid in positioning a patient during radiologic and other medical procedures.
Product codes
90 IYE
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized bird or a series of interconnected human profiles. The symbol is composed of three curved lines that create a sense of movement and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 1998
Donald F. Riibe Medtec Corporation 1401 8th Street S.E. P.O. Box 602 Orange City, IA 51041 Re:
K974703 Carbon Fiber Breast Board Dated: December 12, 1997 Received: December 16, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Riibe:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further amouncements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally. for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
W. Liao Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (if known): Not assigned yet
Device Name: Carbon Fiber Breast Board
Indications For Use:
MED-TEC, INC. has a Table, Radiographic, Stationary Top System to be manufactured by MED-TEC, INC.
Classification Name: Breast Board Common/Usual Name: Table, Radiographic, Stationary Top Proprietary Name: Carbon Fiber Breast Board
The intended use of this device is to The MED-TEC, INC. Carbon Fiber Breast Board operates in the same manner as ordinary breast boards. or The intended use of the MED-TEC, INC. Carbon Fiber Breast Board is to support and aid in positioning a patient during radiologic and other medical procedures. .
Classification: Since this device, The MT-350, is used with Class II equipment, we believe the Carbon Fiber Breast Board is a Class II device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Gamil A. Seymore
Division Sign-Off) n of Reproductive. Abdominal.
Prescription Use ✓
OR
Over - The - Counter Use
Per 21 CFR 801.109)
1-2-96)
(Optional Format