(90 days)
The intended use of this device is to provide an additional aid to the fast and accurate repeat positioning of the patient for radiation or other treatment. The device forms to the back of the patient's head and eliminates the usual range of movement of ordinary head cups.
MoldCare Head & Neck Cushion Model # MT-ACL-14242. A Radiographic head holder System to be manufactured by MED-TEC, INC.
This document is a 510(k) premarket notification decision letter from the FDA regarding the Moldcare Head & Neck Cushion. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The letter explicitly states that the device is substantially equivalent to legally marketed predicate devices. This means that the FDA determined the device is as safe and effective as a device already on the market, usually without requiring new clinical studies to prove efficacy.
Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on performance criteria and validation studies.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 1998
Donald F. Riibe Vice President of Operations Med-Tec. Inc. 1401 8th Street S.E. P.O. Box 320 Orange City, IA 51041-0320 K982624
Re:
Moldcare Head & Neck Cushion Model # MT-ACL-14242 Dated: July 23, 1998 Received: July 28, 1998 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 II (Special Controls) or 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 requirements, 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. In addition, 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 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 ritro 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/cdrf/dsma/dsmamain.html".
Sincerely yours,
Lillian Yin. Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ KG82624
Device Name: MoldCare Head & Neck Cushion
Indications For Use:
MED-TEC, INC. has a Radiographic head holder System to be manufactured by MED-TEC, INC.
| Classification Name: | Head & Neck Cushion accessory for Radiographic headholder |
|---|---|
| Common/Usual Name: | Radiographic head holder |
| Proprietary Name: | MoldCare Head & Neck Cushion |
The intended use of this device is to provide an additional aid to the fast and accurate repeat positioning of the patient for radiation or other treatment. The device forms to the back of the patient's head and eliminates the usual range of movement of ordinary head cups.
Classification: Since this device The MT-ALC-14242 is used with Class I equipment, therefore we believe it is a Class I device.
(PLEASE DO NOT WRIGHT BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elvin A. Lynn
(Division Sign-Off
enrod ve, Abdominal, ENT 510
Prescription Use
Per 21 CFR 801.109)
OR
Over - The - Counter Use (Optional Format 1-2-96)
§ 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.