(30 days)
The IlluminOss Photodynamic Bone Stabilization System is in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, pelvis, fibula, metacarpals, metatarsals, and phalanges. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with FDA-cleared fracture fixation systems to provide supplemental fixation in these anatomic sites.
The IlluminOss Photodynamic Bone Stabilization System provides an important treatment option in the fixation and stabilization of fractures through a minimally invasive procedure. The system uses a catheter to deploy an inflatable, noncompliant, thin wall PET balloon into the medullary canal of the bone across the fracture site. The balloon is infused using a syringe with a photodynamic (light cured) monomer that causes the balloon to slowly expand and fill the intramedullary canal of the fractured bone. Activation of the light system allows for visible spectrum light to be delivered through a radially emitting light fiber that is temporarily positioned into a central lumen of the catheter that runs the length of the balloon. With this design, the liquid monomer within the balloon is exposed to light along the entire length of the balloon during the curing process. The system is currently indicated for use in the humerus, radius, ulna, clavicle, metacarpal, metatarsal, phalanges, ulna, and anterior ring of the pelvic. The purpose of this Special 510(k) is to expand the indications for use to include the fibula.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the IlluminOss Photodynamic Bone Stabilization System.
It includes:
- Device Name and Regulation Information: IlluminOss Photodynamic Bone Stabilization System, regulated as an in vivo cured intramedullary fixation rod (21 CFR 888.3023).
- Clearance Date and Reference Number: August 13, 2020, K201961.
- Indications for Use: Treatment of traumatic, fragility, pathological, and impending pathological fractures of humerus, radius, pelvis, fibula, metacarpals, metatarsals, and phalanges, and as supplemental fixation.
- Predicate Device Information: The device is deemed substantially equivalent to the Synthes Elastic Intramedullary Nail System (K081452). A previously cleared IlluminOss system (K200295) is also referenced for expanding indications to the fibula.
- Device Description: Details on how the system works (inflatable PET balloon, photodynamic monomer, light curing).
- Performance Testing Summary (brief): States that testing demonstrates "sufficient strength upon curing for the fibular indications."
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample size, data provenance, number/qualifications of experts, or adjudication methods for any test set or ground truth establishment.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Specific types of ground truth used (e.g., pathology, outcomes data).
- Training set size or how its ground truth was established.
Therefore, I cannot fulfill your request for this specific information based on the provided text.
§ 888.3023 In vivo cured intramedullary fixation rod.
(a)
Identification. An in vivo cured intramedullary fixation rod is a prescription implanted device consisting of a balloon that is inserted into the medullary canal of long bones for the fixation of fractures. The balloon is infused with, and completely encapsulates, a liquid monomer that is exposed to a curing agent which polymerizes the monomer within the balloon creating a hardened rigid structure.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Mechanical testing must be conducted on the final device to assess burst, abrasion, bending, and torsion in static and dynamic conditions.
(ii) Mechanical testing must demonstrate the integrity of the balloon including testing for leaks, ruptures, and release of cured/uncured material.
(iii) Performance testing must demonstrate that the device can be inserted and removed.
(iv) Performance testing must demonstrate the ability, in the event of a leak, to remove the uncured material from its in vivo location.
(v) Performance testing must demonstrate the reliability and accuracy of the curing method used.
(vi) Thermal safety testing must be conducted to evaluate the temperature rise during curing.
(2) Electrical safety, electromagnetic compatibility (EMC) testing, and electromagnetic interference (EMI) testing must be conducted for all electrical components.
(3) All patient-contacting components must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility and pyrogenicity of patient contacting components of the device that are provided sterile.
(5) Performance data must validate the reprocessing instructions for any reusable components or instruments.
(6) Performance data must support the shelf life of the system by demonstrating continued sterility, package integrity, and system functionality over the established shelf life.
(7) Technological characterization of the device must include materials, curing agents, and a description of the operating principles of the device, including the delivery system and devices which initiate the curing process.
(8) Labeling must include the following:
(i) A detailed summary of the device technical parameters.
(ii) Information describing all materials of the device.
(iii) Information describing how to perform the procedure and use the device, including the delivery system and devices which initiate the curing process, as well as how to remove the device and any uncured materials.
(iv) A shelf life.
(v) Validated methods and instructions for reprocessing any reusable components or instruments.