KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS

K060671 · Wfr/Aquaplast Corp. · JAI · May 4, 2006 · Radiology

Device Facts

• Record ID: K060671
• Device Name: KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS
• Applicant: Wfr/Aquaplast Corp.
• Product Code: JAI · Radiology
• Decision Date: May 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5770
• Device Class: Class 2

Intended Use

The kVue IGRT Treatment Table Top, inserts, and accessories are designed to position and support patients undergoing radiation therapy. The kVue Treatment Table Top is designed to replace an original equipment manufacturer's stock table top. The Qfix kVue Patient Positioning Table Top and inserts are made using sliding beams and advanced fiber composites that contain no metal parts in the treatment area, thus allowing the devices to be used in various diagnostic and treatment modalities without fear of interference caused by metal parts. In particular these devices are designed for optimal performance when used with on board imaging and cone beam CT while simultaneously reducing beam attenuation for treatments that pass through the couch. The kVue inserts include the Cantilever Board insert, the Quest Breast Board insert, the prone breast board insert, the Ofix Pelvis/Belly Board insert, the Box Grid insert, the Solid Panel insert, the Center Spine insert, the DoseMax insert, and the removable tip extension. kVue accessories include the device adapter bar, the VacuFix Bags, the removable clamp rail, and the removable tip extension hardware.

Device Story

kVue IGRT Treatment Table Top is a patient support assembly for radiation therapy; replaces OEM stock table tops. Constructed from sliding beams and advanced fiber composites; metal-free in treatment area to prevent imaging interference. Designed for use with on-board imaging and cone-beam CT; minimizes beam attenuation for beams passing through the couch. Includes various inserts (e.g., breast boards, pelvis/belly boards, spine inserts) and accessories (e.g., VacuFix bags, adapter bars). Used in clinical radiation oncology settings; operated by radiation therapists or clinicians. Provides stable, reproducible patient positioning; facilitates high-precision imaging and treatment delivery; reduces artifacts in diagnostic images; improves dose delivery accuracy by minimizing couch attenuation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Patient support assembly constructed from advanced fiber composites and sliding beams. Metal-free design in the treatment area to minimize beam attenuation and imaging interference. Modular system including various inserts (breast, pelvis, spine) and accessories (VacuFix bags, clamp rails). Designed for integration with radiation therapy treatment couches and imaging systems (on-board imaging, cone-beam CT).

Indications for Use

Indicated for patients undergoing radiation therapy requiring positioning and support during treatment and diagnostic imaging procedures.

Regulatory Classification

Identification

A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 4 2006

Mr. J. Damon Kirk President WFR/Aquaplast Corporation, Ofix Systems 30 Lawlins Park WYCKOFF NJ 07481

Re: K060671

Trade/Device Name: kVue IGRT Treatment Table Top Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: JAI Dated: March 9, 2006 Received: March 14, 2006

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 (Premarket 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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 premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

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

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## PREMARKET NOTIFICATION INDICATION FOR USE

The kVue IGRT Treatment Table Top, inserts, and accessories are designed to position and support patients undergoing radiation therapy. The kVue Treatment Table Top is designed to replace an original equipment manufacturer's stock table top. The Qfix kVue Patient Positioning Table Top and inserts are made using sliding beams and advanced fiber composites that contain no metal parts in the treatment area, thus allowing the devices to be used in various diagnostic and treatment modalities without fear of interference caused by metal parts. In particular these devices are designed for optimal performance when used with on board imaging and cone beam CT while simultaneously reducing beam attenuation for treatments that pass through the couch. The kVue inserts include the Cantilever Board insert, the Quest Breast Board insert, the prone breast board insert, the Ofix Pelvis/Belly Board insert, the Box Grid insert, the Solid Panel insert, the Center Spine insert, the DoseMax insert, and the removable tip extension. kVue accessories include the device adapter bar, the VacuFix Bags, the removable clamp rail, and the removable tip extension hardware.

Signature

J. Damon Kirk

03/09/2006

Premarket Notification 510(k) Number K_O 6 06

*Prescription Use*

David A. Legorre

i rision Sian-O ivision of Reproductive, nd Radiological Device