(77 days)
Cerasorb" ORTHO (granular or block forms) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (extremities, spinc, pelvis) that arc not intrinsic to the stability of the bony structure. Following placement in the bony vold or gap, the B-TCP ceramic material is gradually resorbed and replaced with bonc. The placement of Cerasorb ORTHO should not be in dry form, the material should be mixed with autologous blood.
The predicate device Cerasorb™ ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity. This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as block forms of different geometry (for example wadge, cylinder, cube, parallelepiped) and in different sizes up to 30cc. The basic pure phase Beta-Tricalcium Phosphate material is also of interconnecting microporosity. Straight through macropores of different size (500-2000um) are mechanically introduced by drilling.
This document is a 510(k) summary for a line extension to Cerasorb™ ORTHO, a bone void filler. It describes a modification to the device, changing its form from granular to additional block shapes. The document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The 510(k) process is primarily a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria through a clinical study in the way one might typically describe for a software-as-a-medical-device (SaMD) or diagnostic device.
The provided text focuses on:
- Device Identification: Cerasorb™ ORTHO Bone Void Filler.
- Predicate Devices: Cerasorb™ ORTHO (granular form), ChronOs, Viitoss Scaffold Synthetic.
- Device Modification: Change in size/geometry from granular forms to additional block forms (wadge, cylinder, cube, parallelepiped) up to 30cc, while maintaining the same Beta-Tricalcium Phosphate material with interconnecting porosity and introducing macropores mechanically.
- Intended Use: As a bone void filler in the skeletal system for voids/gaps not intrinsic to bony structure stability, to be gradually resorbed and replaced with bone, and mixed with autologous blood (same intended use as the predicate).
- Technological Comparison: Stating that all design modifications consist of the same pure phase Beta-Tricalcium Phosphate ceramic material (ASTM F 1088-87), porous, osteoconductive, and resorbable.
- FDA Substantial Equivalence Determination: The FDA letter confirms the device is substantially equivalent to the predicate, allowing it to be marketed.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving those criteria are met, as this information is not present in the provided document. The 510(k) process for this type of device (a material-based implant with a geometry change) typically relies on demonstrating material equivalence, manufacturing controls, and potentially biocompatibility, rather than a clinical performance study with defined acceptance criteria and statistical endpoints in the manner described by the prompt's questions.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.