(58 days)
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No
The summary describes a passive device (a couch top) used for patient positioning and support, with no mention of computational or analytical functions, let alone AI/ML.
No
The device is a couch top used to support and position patients during medical procedures, not to treat a disease or condition.
No
The device is described as a "Carbon Fiber Conformal Couch Top" whose intended use is "to support and aid in positioning a patient during radiologic and other medical procedures." This indicates a supportive, rather than diagnostic, function. It operates "in the same manner as an ordinary couch."
No
The device description explicitly states it is a "Table, Radiographic, Stationary Top System" and a "Carbon Fiber Conformal Couch Top," which are physical hardware components used to support and position patients.
Based on the provided information, this device 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 physical support device used during a medical procedure, not a test performed on a sample from the body to diagnose a condition.
- Device Description: The description states it operates "in the same manner as an ordinary couch," further emphasizing its role as a physical support.
- 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 substances in samples
- Providing diagnostic information based on sample analysis
IVDs are devices used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Carbon Fiber Conformal Couch Top does not fit this description.
N/A
Intended Use / Indications for Use
The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures.
Product codes
90 IXQ
Device Description
The MED-TEC, INC. Carbon Fiber Conformal Couch Top operates in the same manner as an ordinary couch. The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures.
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)
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
§ 892.1980 Radiologic table.
(a)
Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 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 consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The bird is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 5 1997
Donald F. Riibe Medtec Corporation 1401 8th Street S.E. P.O. Box 602 Orange City, IA 51041 Re: K973842
Carbon Fiber Conformal Couch Top Dated: August 28, 1997 Received: October 8, 1997 Regulatory class: II 21 CFR 892.1980/Procode: 90 IXQ
Dear Nr. 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 II (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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements 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 Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing 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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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,
h.J.Liau 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
Carbon Fiber Conformal Couch Top Device Name:
Indications For Use:
MED-TEC, INC. has a Table, Radiographic, Stationary Top System to be manufactured by MED-TEC, INC.
| Classification Name: | Table Top |
|---|---|
| Common/Usual Name: | Table, Radiographic, Stationary Top |
| Proprietary Name: | Carbon Fiber Conformal Couch Top |
The MED-TEC, INC. Carbon Fiber Conformal Couch Top operates in the same manner as an ordinary couch. The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures.
Classification: Since this device is used with Class II equipment, we believe the Carbon Fiber Conformal Couch Top to be 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)
David C. Severson
(Division Sign-Off) of Reproductive. Abdominal, E
Prescription Use Per 21 CFR 801.109) OR
Over-the-Counter Use
(Optional Format 1-2-96)