FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification submission for the Pelvis BellyBoard PLUS and accessory products. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than providing a study proving the device meets specific performance acceptance criteria.

The document does not contain information about:

A table of acceptance criteria and reported device performance.
Sample sizes for a test set, data provenance, or ground truth establishment for a test set.
Number of experts or their qualifications, or adjudication methods for a test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone (algorithm-only) performance studies.
Sample size for a training set or how ground truth for a training set was established.

Instead, the submission relies on the concept of substantial equivalence. It argues that the Bionix devices (Pelvis BellyBoard PLUS, SecureVac System, SecureFoam System, SecureFit Bar, Extended Butterfly Armboard) are so similar in design, construction, function, and intended use to existing, legally marketed predicate devices that they should be considered substantially equivalent.

The "study" that proves the device meets the acceptance criteria (interpreted here as demonstrating substantial equivalence) is the comparison presented in the 510(k) submission itself.

Here's a breakdown of the claims of substantial equivalence for each product:

1. Pelvis BellyBoard PLUS

Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties in terms of stiffness, support strength, and minimal attenuation of the radiotherapy beam as the predicate devices, and function in a clinically identical fashion.
Reported Device Performance (as demonstrated by comparison):
- Predicate Devices:
  - Med-Tec Advanced Belly board System (K023293): Thermoformed plastic shell with a foam core, generally rectangular, specific areas for head, abdominal, and leg cushions (Velcro affixed), mechanical interlocking for couch attachment and low-melt thermoplastic masks. Minimal attenuation due to foam core (mostly air).
  - AccuFix IMRT Quick-fix Carbon Fiber Pelvis System (WFR/Aquaplast Corp.): Carbon fiber/epoxy skin with a foam core, provides strength, stiffness, and minimal attenuation. Can be indexed to treatment tabletops, used with low-melt thermoplastic for positioning.
- Bionix Pelvis BellyBoard PLUS: Flat, similar rounded rectangular contour, areas for head, abdomen, thighs. Specially designed cushions (Velcro affixed), head cushion with contoured opening, abdominal cushion with open contoured cutout. Constructed with thermoformed Kydex® shell with an air core, providing stiffness, strength, and almost no radiation beam attenuation. Simple mechanical interlocks for couch attachment and low-melt thermoplastic. Can be used prone (with belly falling into cutout) or supine (with standard or custom SecureVac/SecureFoam cushions).
Conclusion of Substantial Equivalence: Based on almost identical design, construction, and function to the Med-Tec Advanced Belly board System and similar design and intended use to the AccuFix IMRT Quick-fix Carbon Fiber Pelvis System, it is "reasonable to expect" similar properties (stiffness, support strength, minimal attenuation) and clinically identical function.

2. SecureVac System

Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties and attenuation factors as the predicate devices, and function in a clinically identical fashion for patient positioning and repositioning.
Reported Device Performance (as demonstrated by comparison):
- Predicate Devices:
  - Med-Tec Vac-Lok System (K935300): Nylon-reinforced blue urethane bags filled with tiny polystyrene beads, airtight, closeable check valve. Air-equivalent radiolucency. Bags are evacuated to conform to anatomy, forming a rigid, re-positionable mold.
  - S&S Par Scientific Vac Fix System (K895697): Urethane film bag filled with polystyrene beads, check valve, airtight. Functions by evacuation to conform to patient anatomy.
- Bionix SecureVac Immobilization System: Constructed from strong, vinyl-coated nylon material filled with small polystyrene spheres. Double-sealed airtight, self-closing valve, pinch clamp system for security. Evacuated bags form a rigid shape conforming to patient anatomy for re-positioning.
Conclusion of Substantial Equivalence: Based on almost identical design, construction, and function to the Med-Tec Vac-Lok Immobilization System and the S&S Par Scientific Vac Fix System, it is "reasonable to expect" similar properties and attenuation factors, and clinically identical function.

3. SecureFoam System

Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties and attenuation factors as the predicate devices, and function in a clinically identical fashion for patient positioning and repositioning.
Reported Device Performance (as demonstrated by comparison):
- Predicate Devices:
  - Med-Tec RediFoam (K951808): Two-part foaming agent (diisocyanate and polyol) reacting to form water-blown polyurethane foam. Mostly air-filled, effectively air-equivalent for minimal attenuation. Poured into a plastic bag, placed on immobilization device, expands around patient, cures to rigid, re-positionable mold.
  - Soule, Inc. Rapid-Foam (K952457): Two-part foaming agent (diisocyanate and polyol) reacting to form water-blown rigid polyurethane foam. Mostly air-filled, air-equivalent radiolucency. Functions by expanding around patient and curing to a rigid, re-positionable mold conforming to patient and immobilization device.
- Bionix SecureFoam: Two-part foaming system (Part B polyol, Part A diisocyanate) reacting to produce water-blown polyurethane foam. Hardens to rigidity, mostly air-filled, air-equivalent radiolucency similar to Med-Tec RediFoam. Used in the same fashion as predicate devices: reacted components poured into a plastic bag, placed over patient immobilization device (e.g., Pelvis BellyBoard PLUS), expands around patient, rapidly cures to rigidity, forming a custom, re-positionable mold.
Conclusion of Substantial Equivalence: Based on almost identical composition and mixing process to the Med-Tec RediFoam and Soule, Inc. Rapid-Foam, it is "reasonable to expect" similar properties and attenuation factors, and clinically identical function.

4. SecureFit Bar

Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties in terms of stiffness and support strength as the predicate devices, and function in a clinically identical fashion for indexing patient immobilization devices.
Reported Device Performance (as demonstrated by comparison):
- Predicate Device:
  - Med-Tec Exact Lok-Bar (K973842): Rigid aluminum bar machined to couch width, engagement pins on underside for couch indentations. Cam-like pivot for tightening to couch. Locator pins on surface for corresponding holes on immobilization device. Not intended to be radiolucent as it's outside the treatment field.
- Bionix SecureFit Bar: Comprised of either aluminum or rigid carbon fiber/epoxy laminate material. Engagement pin on one end and cam-type pivot on other end for locking into couch indentations. Locator pins engage matching openings on the underside of immobilization devices (e.g., Pelvis BellyBoard PLUS) for reproducible indexing.
Conclusion of Substantial Equivalence: Based on almost identical design and construction to the Med-Tec Exact Lok-Bar, it is "reasonable to expect" similar properties (stiffness, support strength) and clinically identical function for reproductively indexing immobilization devices.

5. Extended Butterfly Armboard

Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties in terms of stiffness, support strength, and minimal attenuation of the radiotherapy beam as the predicate device (when positioned flat), and function in a clinically identical fashion.
Reported Device Performance (as demonstrated by comparison):
- Predicate Device:
  - Med-Tec MT-200 Acrylic Breastboard (K935412): Two pieces of machined acrylic plastic hinged to form a device. Upper piece for patient support (can be angled), lower piece as base. Notched rod for angle adjustment. Threaded rods serve as adjustable handgrips to elevate arms out of the treatment field. Used with cushions/headrests for comfort.
- Bionix Extended Butterfly Armboard: Single piece of machined and thermoformed polycarbonate plastic. Elevated thermoformed "wings" to support upper arms. Adjustable T-Bar handgrip (horizontal and vertical adjustment) for patient positioning and repositioning, to keep arms elevated. Can use various headrests/cushions. Mounting holes for use with other devices.
Conclusion of Substantial Equivalence: Based on similar design, composition, and construction to the Med-Tec MT-200 Acrylic Breastboard (specifically when the predicate is in the flat, true supine position), it is "reasonable to expect" similar properties (stiffness, support strength, minimal attenuation) and clinically identical function.

In summary, the "study" for these devices is the detailed comparison to predicate devices, asserting that the new devices share fundamental technological characteristics and intended use, and therefore can be expected to perform equivalently. No experimental studies with specific acceptance criteria, sample sizes, expert ground truth, or MRMC/standalone performance data are presented in this 510(k) submission.

Summary

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.