RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS

K991319 · Orfit Industries · IYE · Sep 21, 1999 · Radiology

Device Facts

• Record ID: K991319
• Device Name: RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS
• Applicant: Orfit Industries
• Product Code: IYE · Radiology
• Decision Date: Sep 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials are used to retain and reproduce a patient's position during radiation therapy.

Device Story

RAYCAST® Immobilization Systems consist of hardware components and thermoplastic materials used in radiation therapy. Thermoplastic sheets are heated to become pliable, molded to the patient's anatomy, and then cooled to form a rigid, custom-fit immobilization mask or support. Hardware components provide the structural framework to secure these molds to the treatment table. Used in clinical radiation oncology settings by radiation therapists and oncologists. The device ensures precise, reproducible patient positioning for each treatment fraction, minimizing movement to improve the accuracy of radiation dose delivery to the target area while sparing surrounding healthy tissue.

Clinical Evidence

Bench testing only.

Technological Characteristics

System comprises thermoplastic materials and mechanical hardware for patient positioning. Thermoplastic material becomes pliable when heated and rigid upon cooling. Hardware provides mechanical fixation to treatment tables. Non-electronic, non-software, non-sterile.

Indications for Use

Indicated for patients undergoing radiation therapy requiring immobilization to retain and reproduce 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

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SEP 2 1 1999

ORFIT Industries C/O Cynthia J.M. Nolte, Ph.D., RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re:

K991319 RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials Dated: July 30, 1999 Received: August 2, 1999 Requiatory Class: II (TWO) Product Code: 90 IYE 21 CFR 892.5050

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 legally marketed predicate 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 Requlations, 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 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel S. Scheidt, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Dear Dr. Nolte:

Enclosure

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991819 510(k) Number (if known):

## Immobilization Systems_Hardware_and_Thermoplastic Device Name: RAYCAST® Materials

Indications For Use:

The RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials are used to retain and reproduce a patient's position during radiation therapy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991319

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)