(58 days)
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.
MED-TEC, INC. has a Table, Radiographic, Stationary Top System to be manufactured by MED-TEC, INC. The MED-TEC, INC. Carbon Fiber Conformal Couch Top operates in the same manner as an ordinary couch.
This document is a 510(k) premarket notification for a "Carbon Fiber Conformal Couch Top." It is a regulatory approval letter from the FDA, and as such, it does not contain the detailed technical study information requested. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market.
Therefore, most of the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text.
Here's what can be inferred from the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as this is a regulatory approval letter rather than a technical report. However, the FDA's acceptance of substantial equivalence implies that the device met certain safety and effectiveness benchmarks comparable to predicate devices.
- Reported Device Performance: Not explicitly stated with specific metrics. The letter implies that the device operates "in the same manner as an ordinary couch" and is intended "to support and aid in positioning a patient during radiologic and other medical procedures."
Remaining information (2-9) is not available within the provided FDA letter. The letter is a formal notification of approval based on a submission, not the submission itself or a summary of its technical data.
To provide the requested details, a different type of document, such as the actual 510(k) submission summary or a scientific study report, would be necessary.
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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
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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)
§ 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.