ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT

K032156 · Wfr/Aquaplast Corp. · IYE · Sep 2, 2003 · Radiology

Device Facts

• Record ID: K032156
• Device Name: ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT
• Applicant: Wfr/Aquaplast Corp.
• Product Code: IYE · Radiology
• Decision Date: Sep 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The AccuFix Radiolucent Patient Immobilization System is designed to be used with an Aquaplast RT Thermoplastic (K 935067) mold or mask to immobilize, position and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Immobilization Board attaches or mounts to a treatment table or to a Qfix Radiolucent Replacement Couchtop, which in turn mounts to the treatment table. The patient is then positioned on the immobilization board as deemed appropriate by the treating physician. Warm Aquaplast RT Thermoplastic, in its pliable state, is then molded over the patient where it conforms to the patient's anatomy. As the Aquaplast RT Thermoplastic cools, it becomes rigid, creating a negative mold or mask of the patient's anatomy. This mold or mask can then be used to minimize patient movement, and accurately reposition the patient for subsequent treatment sessions.

Device Story

AccuFix Radiolucent Patient Immobilization System; used in radiation therapy. Device consists of immobilization board mounting to linear accelerator treatment table or Qfix Radiolucent Replacement Couchtop. Used with Aquaplast RT Thermoplastic (K935067) to create custom patient molds/masks. Thermoplastic molded while warm; cools to rigid state to conform to patient anatomy. Minimizes patient movement; facilitates accurate repositioning for subsequent treatment sessions. Operated by clinical staff in radiation oncology settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiolucent immobilization board; mounts to linear accelerator treatment tables or Qfix Radiolucent Replacement Couchtops. Used in conjunction with thermoplastic molding materials.

Indications for Use

Indicated for patients undergoing radiation therapy requiring immobilization, positioning, and repositioning on a linear accelerator treatment table.

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.

Reference Devices

• Aquaplast RT Thermoplastic (K935067)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized bird with three curved lines representing its wings, enclosed within a circle. The text "U.S. Department of Health & Human Services" is arranged around the outer edge of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2003

Mr. J. Damon Kirk President and Technical Director WFR/Aquaplast Corp. Q-Fix Systems 30 Lawlins Park WYCKOFF NJ 07481

Re: K032156

Trade/Device Name: AccuFix Radiolucent Patient Immobilization System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE

Dated: July 8, 2003 Received: July 15, 2003

Dear Mr. Kirk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish 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 FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

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

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## PREMARKET NOTIFICATION INDICATION FOR USE

The AccuFix Radiolucent Patient Immobilization System is designed to be used with an Aquaplast RT Thermoplastic (K 935067) mold or mask to immobilize, position and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Immobilization Board attaches or mounts to a treatment table or to a Qfix Radiolucent Replacement Couchtop, which in turn mounts to the treatment table. The patient is then positioned on the immobilization board as deemed appropriate by the treating physician. Warm Aquaplast RT Thermoplastic, in its pliable state, is then molded over the patient where it conforms to the patient's anatomy. As the Aquaplast RT Thermoplastic cools, it becomes rigid, creating a negative mold or mask of the patient's anatomy. This mold or mask can then be used to minimize patient movement, and accurately reposition the patient for subsequent treatment sessions.

J. Damon Kirk

07/08/2003

Premarket Notification 510(k) Number K_U 3 こんち

Daniel H. Seymour

(Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032156

Prescription Use