ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER

K021124 · Wfr/Aquaplast Corp. · IYE · Jul 2, 2002 · Radiology

Device Facts

• Record ID: K021124
• Device Name: ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
• Applicant: Wfr/Aquaplast Corp.
• Product Code: IYE · Radiology
• Decision Date: Jul 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Acculix Tilting Radiotranslucent Headholder is designed to be used with a head rest or prone pillow and. Aquaplast RT Thermoplastic (K 935067) masks to immobilize and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Headholder attacles to the treatment table, a Silverman brand head rest (for supine treatment) or prone pillow (for prone treatment) is attached to the Headholder and a custom fit mask attaches to the Headholder. in such a way that patient head movement is minimized and the patient's head can be accurately repositioned for subsequent treatpacht sessions

Device Story

AccuFix Tilting Radiotranslucent Headholder is a mechanical positioning device used in radiation therapy. It attaches to a linear accelerator treatment table and integrates with a Silverman head rest (supine) or prone pillow (prone) and Aquaplast RT Thermoplastic masks. The device functions by securing the patient's head to minimize movement and ensure accurate repositioning for subsequent treatment sessions. It is operated by clinical staff in a radiation oncology setting. The device provides a stable platform to improve the precision of radiation delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiotranslucent headholder; mechanical assembly; designed for integration with thermoplastic masks and head rests; used in radiation therapy environments.

Indications for Use

Indicated for patients undergoing radiation therapy requiring head immobilization 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)

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or other bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 2 2002

Re: K021124

Trade/Device Name: AccuFix Tilting Radiotranslucent Headholder Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: March 29, 2002 Received: April 8, 2002

Dear Mr. Kirk:

Mr. J. Damon Kirk

30 Lawlins Park

President and Technical Director WFR/AQUAPLAST Corporation

WYCKOFF NJ 07481-1443

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,

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

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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. Snogdon

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

Enclosure

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

## 14021124

## PREMARKET NOTIFICATION INDICATION FOR USE

The Acculix Tilting Radiotranslucent Headholder is designed to be used with a head rest or prone pillow and. Aquaplast RT Thermoplastic (K 935067) masks to immobilize and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Headholder attacles to the treatment table, a Silverman brand head rest (for supine treatment) or prone pillow (for prone treatment) is attached to the Headholder and a custom fit mask attaches to the Headholder. in such a way that patient head movement is minimized and the patient's head can be accurately repositioned for subsequent treatpacht sessions

J. Damon Kirk

J. Damon Kirk

u, 26/2001

Premarket Notification 510(k) Number K

*Prescription Use*

✓

Nancy C. Hodgson
(Division Sign-Off)

Division of Reproduc and Radiological Devices 510(k) Number