MATRIX MT-MX3

K974700 · Medtec, Inc. · IYE · Mar 4, 1998 · Radiology

Device Facts

• Record ID: K974700
• Device Name: MATRIX MT-MX3
• Applicant: Medtec, Inc.
• Product Code: IYE · Radiology
• Decision Date: Mar 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Indications for Use

The intended use of the MED-TEC, INC. MT-MX3 MATRIX thermoplastic shield is to shield healthy tissue from radiation.

Device Story

The MATRIX MT-MX3 is a thermoplastic personnel protective shield. It is used in clinical settings to protect healthy patient tissue from radiation exposure during radiological procedures. The device functions as a physical barrier, operating in the same manner as other standard personnel protective shields. It is intended for prescription use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Thermoplastic material; physical radiation shielding barrier; passive device; no energy source or software components.

Indications for Use

Indicated for shielding healthy tissue from radiation during medical procedures.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Donald F. Riibe Vice President of Operations Med-Tec Corporation 1401 8th Street S.E. P.O. Box 602 Orange City, IA 51041

Re:

MAR - 4 1998 K974700 · Matrix MT-MX3 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 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 (Fremarket 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 (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 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 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 [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/cdrl/dsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4974700 510(k) Number (if known): _Not assigned yet_

Device Name: MATRIX

Indications For Use:

MED-TEC, INC. has a Personnel Protective Shield System to be manufactured by MED-TEC, INC.

Classification Name: Common/Usual Name: Proprietary Name:

Thermoplastic Shield Personnel Protective Shield MATRIX

The intended use of this device is to sheild healthy tissue from radiation. The MED-TEC, INC. MT-MX3 thermoplastic shield MATRIX operates in the same manner as other personnel protective shields. or The intended use of the MED-TEC, INC. MT-MX3 MATRIX thermoplastic shield is to shield healthy tissue from radiation.

Classification: Since this device, "the MT-MX3" is a personnel protective shield 892.6500, we believe the MATRIX is a Class I device.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Seymore
(Division Sign-Off)

on of Reproductive, Abdominal

OR

Prescription Use X

Per 21 CFR 801.109)

Over - The - Counter Use

(Optional Format 1-2-96)