MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242

K982624 · Med-Tec,Inc. · IYE · Oct 26, 1998 · Radiology

Device Facts

• Record ID: K982624
• Device Name: MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242
• Applicant: Med-Tec,Inc.
• Product Code: IYE · Radiology
• Decision Date: Oct 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

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.

Device Story

MoldCare Head & Neck Cushion is a patient positioning accessory; designed to conform to the back of a patient's head; used in conjunction with radiographic head holder systems. Device provides stabilization; limits movement beyond that of standard head cups; facilitates accurate, repeatable patient positioning for radiation therapy or other clinical treatments. Operated by clinical staff in radiation oncology or imaging settings. Benefits include improved immobilization and treatment precision.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Passive positioning cushion; form-fitting material; designed for use with radiographic head holder systems. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring head and neck immobilization for radiation therapy or other clinical treatments to ensure accurate, repeatable positioning.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 head<br>holder |
|----------------------|---------------------------------------------------------------|
| 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)