(84 days)
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.
Carbon Fiber Breast Board
I am sorry, but based on the provided documents, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The documents are a 510(k) clearance letter and an Indications for Use statement for a "Carbon Fiber Breast Board." These documents confirm the regulatory clearance of the device but do not contain detailed study information such as:
- Acceptance criteria: There's no mention of specific performance metrics or thresholds the device needed to meet.
- Reported device performance: No data on the device's performance is provided.
- Study details: Information regarding sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth establishment, or training set sizes is absent.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against predefined acceptance criteria for a novel device.
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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
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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
§ 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.