VERSABOARD, MODEL 7040
Device Facts
| Record ID | K030051 |
|---|---|
| Device Name | VERSABOARD, MODEL 7040 |
| Applicant | Bionix Development Corp. |
| Product Code | IYE · Radiology |
| Decision Date | Apr 4, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5050 |
| Device Class | Class 2 |
Indications for Use
The VersaBoard patient positioning system developed and manufactured by Bionix Development Corporation, Toledo, Ohio, is intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.
Device Story
VersaBoard is a patient immobilization system for radiation therapy; consists of a flat, torso-shaped board with a carbon fiber/epoxy skin and foam core. Device provides a rigid, radiolucent platform for patient positioning; features mechanical interlocks to secure the board to therapy couch tabletops and to attach low-melt thermoplastic sheets. In clinical use, patient lies supine or prone on the board; warm, pliable thermoplastic is draped over the patient's head and shoulders; as material cools, it hardens to create a custom-contoured mask, securing the patient in a reproducible position for radiation treatment. Used in clinical radiation oncology settings by trained staff; enables accurate, reproducible patient positioning to facilitate precise radiation delivery while minimizing beam attenuation.
Clinical Evidence
Bench testing only. No clinical data provided. Substantial equivalence is based on design, material properties (stiffness, radiolucency), and functional comparison to legally marketed predicate devices. Dosimetry data regarding minimal attenuation of the foam core composite is cited as widely published in medical literature.
Technological Characteristics
Composite structure: carbon fiber/epoxy skin with foam core. Mechanical interlocks for couch attachment and thermoplastic mask fixation. Radiolucent design for minimal radiation beam attenuation. Form factor: flat, torso-shaped board. Non-powered, passive device.
Indications for Use
Indicated for patients undergoing external beam radiation therapy for cancer or other diseases requiring precise positioning and immobilization.
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
Submission Summary (Full Text)
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KD30051
VersaBoard Patient Positioning System-Premarket Notification Submission
## Premarket Notification (510K) Summary
APR 0 4 2003
Date Prepared: October 14, 2002
Bionix Development Corporation Submitter: 5154 Enterprise Blvd. Toledo, Ohio 43612 419.727.8421 (phone) 419.727.4430 (fax)
Contact Person: James Huttner M.D., Ph.D. [jjhuttner(@yahoo.com (email)]
Trade Name: VersaBoard Patient Positioning System
Common Name: Carbon Fiber Patient Immobilization System
Classification Name: Medical charged-particle radiation therapy system, accessory (per CFR section 892.5050)
Intended Use: The VersaBoard from Bionix Development Corporation is designed to be used for the positioning and re-positioning of patients for receiving radiation therapy.
## Claim of Substantial Equivalence:
This product is similar in design and function to existing patient positioning devices currently in use as accessories to radiation therapy systems.
One such device is the S-Type Baseplate manufactured and legally marketed by Med-Tec. Inc. of Orange City, Iowa. This device has been classified as a Class II device by the FDA, and has been granted marketing clearance and has been assigned the document control number K933227.
The S-Type Baseplate from Med-Tec consists of a flat "board" comprised of a composite material with a carbon fiber/epoxy skin and a foam core. The device has a generally torso-shaped contour, with a specific area for the head, shoulders, and back. The head portion contains in its center a mesh-like cutout section, where the carbon fiber/epoxy skin is bonded to itself with no foam core, and then a waffle-like cutout pattern is cut into the carbon fiber to give a more open area roughly where the patient's head should be. Other important features of the device are simple mechanical interlocking systems for attaching the S-Type Baseplate to the top of the radiation therapy couch, and for the attachment of contoured low-melt thermoplastic sheets that are used to further position and hold the patient.
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## VersaBoard Patient Positioning System-Premarket Notification Submission
The carbon fiber/epoxy/foam composite structure of the board has a minimal attenuation factor. This is due primarily to the foam core of the composite, which being mostly air blocks little of the radiation. Standard dosimetry has been used to document this fact, and such results have been widely published in the medical literature. The carbon fiber/epoxy skin provides strength and stiffness; in aggregate such composite structures are ideal for producing devices that reproducibly position patients and yet do not interfere with the administration of the therapeutic radiation. Patient positioning devices with this type of composite structure are common in radiation therapy. They come in many varieties and are manufactured by several companies; examples include Med-Tec, Aktina, Arplay, and Bionix.
In practice, the Med-Tec S-Type Base-plate is secured to the therapy couch tabletop either by a lock-down mechanism, or by the patient's own weight. The patient is positioned supine on the board with his head resting on a cradle over the area of the waffle cut-out, and then a mask of his/her upper torso is made by stretching warm lowmelt thermoplastic over the patient, and then securing that mask to the board using the interlocking mechanism (in this case, custom panel-rivets) described earlier. As the lowmelt thermoplastic cools it becomes rigid, taking and holding the shape of the patient. In this fashion the patient is positioned reproducibly on the board. Radiation therapy is then administered in the usual fashion. (Copies and marketing materials from the Med-Tec, Inc. catalog and web-site are appended to this document to substantiate and clarify the above claims as to design and use of the Med-Tec S-Type Baseplate.)
The Bionix VersaBoard is substantially equivalent to the Med-Tec S-Type Baseplate in design, construction, and function. The VersaBoard is flat and has a similar, generally torso-shaped contour. with an area specifically for the head, shoulders, and back. The head portion has a central open area where a thin plate of carbon fiber/epoxy is placed. This thin plate may have a waffle-like cutout, or a more sophisticated design that allows for the prone as well as supine positioning of the patient.
The Bionix VersaBoard is manufactured according to the FDA Good Manufacturing Practice guidelines using standard methods and practices. The VersaBoard is constructed in the same manner as the S-Type Baseplate from Med-Tec, having a carbon fiber/epoxy/foam core composite structure) that is an accepted standard in radiation therapy. The carbon fiber/epoxy again provides stiffness and strength, while the foam core allows for almost no attenuation of the radiation beam during the treatment process. The VersaBoard also has simple mechanical interlocks that allow the board to be secured to the tabletop of the therapy couch. Other interlocks or clamps allow low-melt thermoplastic to be attached to the VersaBoard during the patient positioning process. (Engineering drawings and perspective views, as well as digital images of the prototype device are appended to this document to substantiate the above claims as to design and structure of the Bionix VersaBoard, as production models are not yet available.)
In clinical practice the VersaBoard again functions similarly to the Med-Tec S-Type Baseplate. The patient is positioned on the VersaBoard in either the prone or supine position, with his head resting on a foam cushion or support. Warm low-melt thermoplastic in its pliable state is then draped over the patient's head and shoulders
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where it conforms to the patient's anatomy. It is then secured to the VersaBoard using clamps or other simple mechanical interlocks. When it cools, the low-melt thermoplastic becomes rigid and retains the shape of the patient, allowing him to be positioned and repositioned securely during the radiation therapy regimen.
Based on the almost identical design and construction of the Bionix VersaBoard to the S-Type Baseplate currently manufactured and sold by Med-Tec, Inc., it is reasonable to expect that the two devices will have similar properties as regards to stiffness, support strength, and minimal attenuation of the radiotherapy beam, and should function in a substantially equivalent fashion during the patient positioning and the radiation therapy process. Both the VersaBoard and the Med-Tec S-Type Baseplate are intended for use in positioning and re-positioning patients during radiation therapy procedures, and both boards are employed in clinically identical fashions. Therefore, it is reasonable to conclude that the VersaBoard manufactured by Bionix Development Corporation is substantially equivalent in all aspects to the S-Type Baseplate manufactured by Med-Tec, Inc.
The Bionix VersaBoard is also substantially equivalent to other similar patient positioning devices constructed from carbon fiber/epoxy/foam core composites. Two such devices are the Carbon Fiber Breast Board manufactured and legally sold by Med-Tec, Inc. of Orange City, Iowa (K974703), and the Max 2 Deluxe TorsoBoard manufactured and legally sold by Bionix Development Corp., Toledo, Ohio (K905007). Both the Carbon Fiber Breast Board from Med-Tec and the Max 2 Deluxe TorsoBoard from Bionix are intended to be used to accurately position and hold patients securely during a radiation therapy treatment regimen. Both of these devices are constructed from carbon fiber/epoxy/foam core composites that produce minimal attenuation to the radiotherapy beam, similar to that exhibited by the VersaBoard. These devices also contain or use simple mechanical interlock mechanisms to secure the boards to the treatment couch tabletop, and others that secure low-melt thermoplastic to the boards themselves, allowing the low-melt thermoplastic to be formed into a mask that contours to the patient and can be used to accurately position and hold the patient during the radiation therapy procedure. In like fashion, the VersaBoard is intended to accurately position and securely hold patients undergoing radiation therapy. The VersaBoard has similar mechanical interlock mechanisms to secure the board to the therapy couch tabletop and to low-melt thermoplastic, as described above.
The almost identical design, construction, materials, properties, performance and intended use of the VersaBoard to the Carbon Fiber Breast Board from Med-Tec and the Max 2 Deluxe TorsoBoard form Bionix Development Corp., both existing legally sold devices, prove the Bionix VersaBoard to be substantially equivalent to these devices as well.
Submitted by:
pho
James Huttner M.D., Ph.D. Vice President, New Product Development Bionix Development Corporation
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## APR 0 4 2003
Re: K030051 James Huttner, M.D., Ph.D. Vice President, New Product Development Bionix Development Corporation 5154 Enterprise Blvd. TOLEDO OH 43612
Trade/Device Name: Versaboard Patient Positioning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: October 15, 2002 Received: January 6, 2003
Dear Dr. Huttner:
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 | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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ices and Radiological Heal
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Device Name: VersaBoard Patient Positioning System
Indications for Use:
The VersaBoard patient positioning system developed and manufactured by Bionix Development Corporation, Toledo, Ohio, is intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.
It is intended to be used by or under the direction of a licensed physician.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
*Prescription Use*
(Posted July 1, 1998)
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Division of Reproductive, Abdominal,
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Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030
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