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The TruGuard Custom Tongue and Jaw Positioner from Bionix Development Corporation is intended to be used for repeat positioning and immobilization 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.

The TruGuard Custom Tongue and Jaw Positioner consists of two dental bite trays composed of rigid plastic and connected at the base of their arcs in a bivalve fashion so as to allow the upper and lower bite trays to open and close in similar fashion as the upper and lower jaws of the patient. The two bite trays are each lined with an insert of low-temperature EVA (ethylene vinyl acetate) thermoplastic material similar to that used in commercial mouth guards. Projections on the lower and upper bite trays mate securely to a plastic indexing tab component that has holes at pre-set locations. When the plastic indexing tab is joined to the upper and lower bite trays the jaw is held open at pre-set angles, depending on the hole selected. This allows the mouth to be positioned and repositioned as needed, and ensures unrestricted air flow to the patient. An optional tongue depressor interlocks with the lower bite tray to restrict the tongue position to the lower portion of the oral cavity.

The Little Angels Swaddling Blanket developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting. It is intended to be used by or under the direction of a licensed physician.

The Little Angels Swaddling Blanket is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting. The Little Angels Swaddling Blanket is similar in composition and function to other devices used as adjuncts to current neonatal phototherapy systems used to treat neonatal hyperbilirubinemia. The Little Angels Swaddling Blanket is comprised of a sheet of spun bond polypropylene material that is die-cut and heat welded in a pattern that allows an infant undergoing phototherapy for hyperbilirubinemia to be tightly swaddled in a fashion such that only a single layer of material is ever interposed between the infant and the phototherapy source. Spun bond polypropylene is a commonly used fabric in medical products and garments. Spun bond polypropylene is non-irritating to the skin. soft, and has a good drape that allows it to easily conform to body contours. Spun bond polypropylene is available in different fabric weights, depending on the tightness of the weave and fabric density. Light-weight spun bond polypropylene fabric is used in the Little Angels Swaddling Blanket to ensure maximum light transmittance from the phototherapy source to the patient's skin. {See section on "Bench Testing".) In use, an infant undergoing phototherapy for hyperbilirubinemia is first laid atop the Little Angels Swaddling Blanket, and the blanket is then folded around the infant in a prescribed fashion that ensures the infant is tightly swaddled and that only a single layer of fabric lies between the phototherapy source and the infant's skin. When an overhead phototherapy source is used, the swaddled infant is then placed under the light source in the usual fashion in order to receive the phototherapy treatment. The Little Angels Swaddling Blanket also has a pocket formed in its rear panel (under the infant). If a light emitting pad type phototherapy source is to be used, the light emitting pad is placed in this pocket and phototherapy is administered to the swaddled infant in the usual fashion. Also, double phototherapy can be administered to an infant swaddled using the Little Angels Swaddling Blanket by combining an overhead phototherapy source together with a light emitting pad type phototherapy source, each used as described above.

Embrace Thermoplastic from Bionix Development Corporation is intended to be used for the external support and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. Silhouette Thermoplastic from Bionix Development Corporation is intended to be used for the external support and immobilization 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.

Embrace Thermoplastic from Bionix Development Corporation is a moldable lowtemperature thermoplastic comprised of polycaprolactone, a biodegradable thermoplastic polymer that has been approved by the Food and Drug Administration for other medical device applications. Embrace Thermoplastic becomes pliable and moldable by hand at temperatures of about 160 to 170 degrees Fahrenheit. This heating is most often done by immersion in hot water. To improve the ease of handling the polycaprolactone material in its heated, softened state, the Embrace Thermoplastic sheets will be bonded to a non-low temperature rigid thermoplastic frame. These frames also serve as convenient points to affix the Embrace Thermoplastic to an underlying patient support device. Embrace Thermoplastic will be supplied in a variety of configurations and sizes, depending on the size and location of the body part to be immobilized, and to enable compatibility with other radiation therapy immobilization devices already in use. The Embrace Thermoplastic sheets may be perforated to enhance an even stretch over anatomical protuberances such as the nose and chin. This improves the conformity and rigidity of the resulting mask by preventing over-stretching and thinning in these areas. Perforation patterns may be uniform (as in a sheet intended to be used over a limb) or variable (such as in a sheet intended to be used with the head), all designed to enhance the even stretch of the material and the rigidity of the resultant mask. The typical application of Embrace Thermoplastic is to create a conformal "mask" of an anatomical body part, such as the head, by stretching the pliable heated polycaprolactone sheet over the body part and allowing it to cool and become rigid. The resulting conformal "mask" can then be used to position and reposition a patient undergoing a course of external beam radiation therapy with a high degree of accuracy and reproducibility.

The Omni V SBRT Positioning System from Bionix Development Corporation is intended to be used for stereotactic localization and positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

The Bionix Omni V stereotactic body radiation therapy (SBRT) positioning system is intended to be used for stereotactic localization and positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. This device has been most likely classified as Class II by the FDA Panel on Radiology, falling under CFR 892.5050. The Omni V SBRT positioning system from Bionix Development Corporation has several component parts that are designed to work together to provide an easy to use means of reproducibly positioning a patient undergoing external beam stereotactic radiation therapy. The system includes a thermoformed base, body support vacuum cushion, upper arm support, thigh and foot bolster, breath-suppression arch, and fiducial arch. These components work together to immobilize the patient and provide an external reference system for stereotactic localization.

The Bionix T-Form Extremities Immobilizer patient positioning system, developed and manufactured by Bionix Development Corp., 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.

The Bionix T-Form Extremity Immobilizer 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. The T-Form Extremity Immobilizer from Bionix Development Corp. consists of a thermoformed patient support device with attachment areas for accessories. The T-Form Extremity Immobilizer is thermoformed from an ABS plastic material so that the resulting contoured shell is lightweight and thin-walled, providing low attenuation for unobstructed passage of the radiation therapy beam. The T-Form Extremity Immobilizer is specifically designed for immobilization of the upper and lower extremities. The T-Form Extremity Immobilizer has a generally rectangular shape, with pre-formed areas that allows,the device to be securely attached to the treatment couch tabletop. Specifically, there are pre-formed depressions with threaded holes that allow the T-Form Extremity Immobilizer to screw onto an attachment bar that can lock onto the treatment couch tabletop. These pre-formed areas can be found on both the top and side of the device, allowing the T-Form Extremity Immobilizer to be used in either a longitudinal or transverse orientation to allow greater flexibility in patient positioning. This allows the T-Form Extremity Immobilizer to be repeatedly located in the same position on the treatment couch tabletop for each therapy session. The T-Form Extremity Immobilizer has a central thermoformed depression to allow the use of optional vacuum cushions as part of the patient immobilization process. Vacuum cushions contain expanded polystyrene beads in an airtight vinyl bag, with a valve for attachment to a vacuum pump. In practice, the patient's extremity is positioned on the bag which is then evacuated using the vacuum pump. As the bag is evacuated, the polystyrene beads form a rigid cushion that accurately conforms to the contours of the patient's extremity, and also to the sides of the thermoformed depression. The latter allows the vacuum cushion to locate reproducibly onto the board, while the patient's extremity can be reproducibly located into the pocket formed into the vacuum cushion. Attachment points for standard low-melt thermoplastic (used to restrain patients undergoing radiation therapy) are provided for use in immobilizing the patient's extremities. A simple mechanical interlocking system allows the attachment of the lowmelt thermoplastic to the T-Form Extremity Immobilizer. Low-melt thermoplastic has the property of becoming soft and pliable when warm so that it can be stretched over and molded to the contoured shape of an object, in this case the patient. As it cools, it becomes rigid, and retains the object's shape. For the T-Form Extremity Immobilizer two non-adherent plastic handles are used to hold the low-melt thermoplastic. Simple screwtightened clamps mounted on the surface of the T-Form Extremity Immobilizer are used to secure the non-adherent plastic handles to the board. The low-melt thermoplastic sheet is stretched over the patient's extremity in its pliable form; once molded to the patient's anatomy, the customized low-melt thermoplastic sheet can be placed over the patient and "locked down" to the T-Form Extremity Immobilizer to ensure proper positioning for every therapy session. The Bionix T-Form Extremity Immobilizer has a thermoformed ABS shell that displays minimal attenuation of the radiotherapy beam. This is due primarily to the fact that the thermoformed shell is relatively thin. The device has an open, air filled core that is radiolucent. The resulting structure provides strength and rigidity, and is ideal for producing a device that reproducibly positions patients and yet does not interfere with the administration of therapeutic radiation. Patient positioning devices with this type of structure are common in radiation therapy. They come in many varieties and are manufactured by several companies; examples including Civco Medical Solutions. In clinical practice, the Bionix T-Form Extremity Immobilizer is secured to the therapy couch tabletop by attachment to a lock-down bar. The patient's extremity is positioned on the T-Form Extremity Immobilizer as desired, either directly onto the board or with the use of a vacuum cushion that has been evacuated to conform to the patient's anatomy. Low-melt thermoplastic is heated, and then draped in its warm, pliable state over the patient's extremity, and then secured to the T-Form Extremity Immobilizer using the screw-down clamps. When it cools, the low-melt thermoplastic becomes rigid and retains the shape of the patient's extremity, allowing it to be positioned and re-positioned securely during the radiation therapy regimen. Radiation therapy is then administered in the usual fashion.

The Bionix Thigh and Foot Positioner patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio) is intended to be used for the positioning and re-positioning of patients for receiving 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. The SuProne Plus from Bionix Development Corporation is designed to be used for the positioning and re-positioning of patients for receiving radiation therapy.

**Thigh Bolster and Foot Positioner:** The Thigh Bolster and Foot Positioner consist of two parts, a thigh support and a footrest. The thigh support portion has a generally tent-like shape, with formed contours to support the thighs and calves. The thigh support portion is designed to interface with the Bionix Secure-Bar, allowing it to be secured to the radiation therapy treatment couch in an index-able fashion. The thigh support portion also has attachment points for interlocks that allow the use of low-melt thermoplastic during the patient immobilization procedure. The Thigh Bolster and Foot Positioner are constructed of a thermoformed thermoplastic ABS shell with an air core. The Thigh Bolster and Foot Positioner also have simple mechanical interlocks that allows the individual parts to be secured to the tabletop of the therapy couch. Other interlocks or clamps allow low-melt thermoplastic to be attached to the Thigh Bolster and Foot Positioner during the patient positioning process. **SuProne Plus:** The SuProne Plus consists of a flat "headboard" comprised of a material with a carbon fiber/epoxy skin and a foam core that rests on a base-plate comprised of similar carbon fiber/epoxy composite material without the foam core. The headboard is designed to hold a patient's head in either the supine or prone position during treatment. An open area in the center of the headboard allows for prone positioning of the patient; during treatment, the patient's forehead and cheekbones rests on a foam cushion for support and comfort. For supine positioning, the patient's head rests on a thin plastic headrest for comfort. With both prone and supine positioning, low-melt thermoplastic may be used to further constrain patient movement. The headboard has clamps or other locking mechanisms that allow the low-melt thermoplastic to attach firmly to the device. The headboard rests on a base-plate made from a carbon fiber/epoxy resin composite material. This base-plate has three main elements: a base, side supports, and an upper frame that mates with the headboard. The base-plate base has simple mechanical interlocking systems that allow the device to be securely attached to the treatment couch tabletop using an attachment bar or similar device. The side supports of the base-plate provide rigidity and have semi-circular slots milled into the side support of the bas a rigid, open box-like design, and has locating pins that mate with the underside of the headboard. The sides of the upper frame have threaded pins that mate with the semi-circular slots in the side supports. These threaded pins allow the upper frame to move in an arcing fashion, following the semi-circular slots in the side supports. Tightening the threaded pins locks the upper frame at desired angle.

The Bionix Pelvis BellyBoard PLUS patient positioning system developed and manufactured by Bionix Development Corp., 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. The Bionix SecureVac patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and repositioning 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. The Bionix SecureFoam patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and repositioning 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. The Bionix SecureFit Bar patient positioning device developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and repositioning 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. The Bionix Extended Butterfly Armboard patient positioning device, developed and manufactured by Bionix Development Corp., 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.

The Pelvis BellyBoard PLUS from Bionix Development Corporation is designed to be used for the positioning and re-positioning of patients for receiving radiation therapy. The Bionix Pelvis BellyBoard PLUS is flat and has a similar, generally rounded rectangular-shaped contour, with areas specifically designed for the head, abdomen, and thighs. Specially designed cushions that fit in these areas of the Pelvis BellyBoard PLUS are used to position and support the patient. The head cushion has a contoured opening so that the patient may rest his/her head comfortably in the prone position during the treatment process. The abdominal cushion is also designed with an open, contoured cutout region. The patient is positioned over the abdominal cushion such that the belly drops into the cutout region during the radiation therapy session. Contoured thigh cushions are provided for patient comfort and support. The cushions are affixed to the thermoplastic shell of the Pelvis BellyBoard PLUS using Velcro strips in the usual fashion. The Bionix Pelvis BellyBoard PLUS is constructed in a manner similar to the Advanced Belly board System from Med-Tec, having a thermoformed thermoplastic Kydex® shell with an air core that is an accepted standard in radiation therapy. The thermoformed Kydex® shell again provides stiffness and strength, while the air core allows for almost no attenuation of the radiation beam during the treatment process. The Pelvis BellyBoard PLUS also has simple mechanical interlocks that allow the board to be secured to the tabletop of the therapy couch. Other interlocks or clamps allow lowmelt thermoplastic to be attached to the Pelvis BellyBoard PLUS during the patient positioning process. The SecureVac Immobilization System from Bionix Development Corporation is designed to be used for the positioning and repositioning of patients for receiving radiation therapy. The SecureVac bags are constructed from strong, vinyl coated nylon material that is filled with small polystyrene spheres to immobilize the patient. Each bag is double sealed airtight and fitted with a self-closing valve for ease of use. It also features a pinch clamp system for more security. Once evacuated, the Secure Vac cushion holds a rigid shape over the course of the radiation therapy treatment regimen. The Bionix SecureVac Immobilization System is constructed in a manner similar to the Vac-Lok Immobilization System from Med-Tec, having a plastic nylon/vinyl film skin and filled with small polystyrene beads. The bag is sealed to be airtight, and an integral check valve is used to deflate and re-inflate the bag, and to maintain the bag in an evacuated state. The SecureFoam from Bionix Development Corporation is designed to be used for the positioning and re-positioning of patients for receiving radiation therapy. The Bionix SecureFoam is a two-part foaming system comprised of Part B (polyol) and Part A (diisocyanate) components. The reaction of the polyol and diisocyanate components produces a water-blown polyurethane foam that hardens to rigidity as it cures. The polyurethane foam produced by this process is mostly air-filled, and thus has an air-equivalent radiolucency similar to that of the Med-Tec RediFoam. The SecureFit Bar from Bionix Development Corporation is designed to be used for the indexing of patient immobilization devices to a treatment couch top. The Bionix SecureFit Bar is comprised of either aluminum or a rigid carbon fiber/epoxy laminate material. The SecureFit Bar has an engagement pin on one end and a cam-type pivot on its other end that allows it to lock into these indentations and securely hold the bar in position on the treatment couch top. Locator pins on the SecureFit Bar engage matching openings on the underside of the immobilization device, in this case the Bionix Pelvis BellyBoard PLUS, allowing the immobilization device to be reproducibly indexed to the treatment couch top. The Extended Butterfly Armboard from Bionix Development Corporation is designed to be used for the positioning and repositioning of patients for receiving radiation therapy. The Bionix Extended Butterfly Armboard is constructed of a single piece of polycarbonate plastic material that is machined and thermoformed to achieve the final product design. The Extended Butterfly Board has elevated thermoformed "wings" on either side to support the patient's upper arms and facilitate patient positioning and comfort. An adjustable T-Bar handgrip is attached to the board. The T-Bar handgrip adjusts in both the horizontal and vertical direction to facilitate patient positioning and repositioning. Various headrests and cushions may be used to assist in patient positioning and improve patient comfort. The Bionix Extended Butterfly Armboard may be used alone or in conjunction with other patient positioning devices such as the Bionix Pelvis BellyBoard.

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.

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.