INTEGRA IMMOBILIZATION SYSTEM

K050888 · Diacor, Inc. · IYE · May 23, 2005 · Radiology

Device Facts

• Record ID: K050888
• Device Name: INTEGRA IMMOBILIZATION SYSTEM
• Applicant: Diacor, Inc.
• Product Code: IYE · Radiology
• Decision Date: May 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Integra Immobilization System is intended to immobilize the head, neck and shoulders of the patient during radiation therapy simulation or treatment.

Device Story

Integra Immobilization System provides head, neck, and shoulder immobilization for patients during radiation therapy simulation or treatment. System comprises three configurations: Integra ce Extension (attaches to Varian Exact Couch), Integra ci Insert (for CT scanner or treatment table), and Integra co Cantilever Board (stand-alone). All versions utilize carbon fiber surfaces with foam cores for high-strength, lightweight support. Device functions by securing a thermoplastic mask—heated in a water bath, molded to patient anatomy, and attached to the board—which hardens upon cooling to maintain patient position. Used in clinical radiation oncology departments; operated by radiation therapists. Output is a rigid, indexed immobilization platform ensuring reproducible patient positioning for repeated treatment fractions. Benefits include improved precision and stability during radiation delivery.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, construction, and functional comparison to the predicate device.

Technological Characteristics

Carbon fiber surfaces with foam core construction. Non-invasive thermoplastic mask immobilization. Head holder and foam wedges for positioning. Foam insert for mask attachment. Standalone mechanical device; no software or energy source.

Indications for Use

Indicated for head, neck, and shoulder immobilization of patients undergoing radiation therapy simulation or treatment.

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.

Predicate Devices

• Orfit Industries Raycast Immobilization Systems and Thermoplastics (K991319)

Submission Summary (Full Text)

{0}------------------------------------------------

K050888

DIACOR, INC., 3191 SOUTH 3300 EAST, SUITE 100A, SALT LAKE CITY, UT 84109 /801-467-0050 / FAX [phone]

Image /page/0/Picture/2 description: The image shows the word "DIACOR" in white letters against a black background. A horizontal line runs through the middle of the word, bisecting each letter. The font is bold and sans-serif, giving the word a strong and modern appearance. The overall design is simple and eye-catching.

## Premarket Notification [510(k)] Summary

April 6, 2005

MAY 2 3 2005

Trade Name: : Integra™ Immobilization System

Common Name: Head and Neck Immobilization System

Classification Name: Medical Linear Accelerator Accessory, 90 IYE (per 21 CFR section 892.5050)

| Manufacturer's Name: | DIACOR, Inc. |
|-------------------------|----------------------------------------------------|
| Address: | 3191 South 3300 East<br>Salt Lake City, Utah 84109 |
| Corresponding Official: | Glenn Waterman |
| Title: | President and CEO |
| Telephone: | 800-342-2679 |
| Fax: | 801-487-3258 |

Predicate: Orfit Industries Raycast Immobilization Systems and Thermoplastics, K991319

Device Description: The Integra Immobilization System consists of three device options which may be used as the patient simulation and treatment circumstances indicate. All three options of the System utilize the same thermoplastic, all three are designed with high strength carbon fiber, with foam core to provide a strong but light weight support base and all three provide head, neck and shoulder immobilization for patients undergoing simulation or radiation therapy using the exact same attachment of the thermoplastic to the carbon fiber board.

The "Integra ce Extension" option to the Varian Exact Couch provides a means to attach the extension securely to the end of the Exact Couch utilizing Varian's end of table design. The board provides rigid support to the head and shoulders by means of its carbon fiber and foam core construction.

The "Integra ci Insert" option to the Varian Exact Couch provides the means to provide head, neck and shoulder immobilization on a CT Scanner couch or a Varian Exact Treatment Table. This insert fits into a mating recess in the CT table overlay or a similar insert space in the Exact Treatment Table.

The "Integra co Cantilever Board" option provides head, neck and shoulder immobilization as part of a stand alone carbon fiber and foam core board. The board

{1}------------------------------------------------

is constructed utilizing carbon fiber surfaces with a foam interior. The result is an extremely stong but light weight board. The overall design of the board provides comfortable patient support and a means to index the board to the table or overlay that it rests upon.

The Integra Immobilization System utilizes the method of head, neck and shoulder fixation that is also commonly found in radiation therapy departments and has been repeatedly shown to be safe and effective in immobilizing the head, neck and shoulders. The thermoplastic from Orfit is heated in a water bath to a temperature that makes the thermoplastic moldable. The material is removed from the bath, dried and placed over the patients head, neck and shoulders. It is stretched over the head, neck and shoulders, molded to conform to the patients head, neck and shoulder contour and attached to the support board in such a way that the patient is firmly held in place and yet can be released from the position very quickly if needed. As the thermoplastic cools, it hardens and thus permanently maintains the patient contour for repeated identical immobilizations required during a course of treatment.

Intended Use: The Integra Immobilization System is intended to immobilize the head, neck and shoulders of the patient during radiation therapy simulation or treatment.

Technological Characteristics: See the attached Predicate Comparison Table

| # | Feature | Orfit Industries Thermo-plastic<br>and Hardware, K991319 | Diacor, Inc. Integra Immobilization<br>System |
|----|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Intended Use | The Raycast Immobilization<br>Systems Hardware and<br>Thermoplastic Materials are used<br>to retain and reproduce a<br>patient's position during radiation<br>therapy. | The Integra Immobilization<br>System is intended to immobilize<br>the head, neck and shoulders of<br>the patient during radiation<br>therapy simulation or treatment |
| 2. | Carbon Fiber<br>Over Foam<br>Core Board<br>Construction | HPL and Carbon Fiber Over<br>Foam Core Board Construction | Carbon Fiber Over Foam Core<br>Board Construction |
| 3. | Thermoplastic<br>Head<br>Immobilization | Yes | Yes |
| 4. | Head and<br>Neck Restraint | Non-invasive thermoplastic mask | Non-invasive thermoplastic mask |
| 5. | Head<br>Positioning | Head Holder and Foam Wedges | Head Holder and Foam Wedges |
| 6. | Thermoplastic<br>Mask Release | Foam Insert to Hold Mask in Slot | Foam Insert to Hold Mask in Slot |

## Predicate Comparison Table

{2}------------------------------------------------

The Diacor Integra Head and Neck Immobilization boards are substantially equivalent to the Orfit boards in construction, form and function.

.. |

ﺑﺮ

:

:

:

: : : : :

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird-like figure in the center. The text around the perimeter appears to be "DEPARTMENT OF HEALTH & HUMAN..." but the full text is not clear due to the image quality. The bird-like figure in the center is composed of three curved lines, suggesting movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2005

Mr. Glenn Waterman President and CEO DIACOR, Inc. 3191 South 3300 East Suite 100A SALT LAKE CITY UT 84109

Re: K050888

Trade/Device Name: Integra Immobilization System Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 6, 2005 Received: April 7, 2005

Dear Mr. Waterman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have revened your counted on substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the closed of to togally mant date of the Medical Device Amendments, or to devices that have been May 20, 1910, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not roquite approvial 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 it your device to such additional controls. Existing major regulations affecting your Apporal), It they of coole of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA are roo bail of further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FICA has made a determination that your device complies with other requirements of the Act or any FDA has made a acternination and yoursered by other Federal agencies. You must comply with all the rederal statues and regalations and limited to registration and listing (21 CFR Part 807); labeling Act S requirements, moduling, but not mixer it is in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k)
10.0 legin This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The FDA miding of saosantial oquice 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), pleased If you desire specific advice for your device on our laceming regarities (
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to prematics notification "(21 CFR Also, please note the regulation entires, "Whisonation on your responsibilities under the Act from the 180 807.97). You may obtain other general mornational and Consumer Assistance at its toll-free number (800). Drvision of Small Manufacturers, International and Collion!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Tab 3

## Indications For Use

510(k) Number: KOSO888

Device Name: Integra Immobilization System

Indications for Use:

To enable head and neck immobilization for patient placement during radiation therapy planning and treatment.

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel H. Burnham

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

Prescription Use V (per 21 CFR 801.109) OR

Over-The-Counter Use_