(224 days)
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No
The description focuses on the material properties and delivery system of a bone cement, with no mention of AI or ML capabilities.
No.
A therapeutic device is typically involved in the treatment or prevention of a disease or condition. This device, Norian CRS, is intended for "filling craniofacial defects in the restoration or augmentation of bony contours," which is a structural repair rather than a therapeutic treatment. While it aids in the restoration of bone, it does not directly treat the underlying cause of a disease or provide therapy to a physiological function.
No
The device is described as a "paste-like bone cement" intended for "filling craniofacial defects in the restoration or augmentation of bony contours," not for diagnosis. Its function is to provide structural support and eventually be resorbed, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states that the device is a "paste-like bone cement" and includes physical components like a "Reactants Pack," "Norian Mixer," "Delivery Device," and "Delivery Needles." These are all hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Norian CRS is for "filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton". This is a direct therapeutic intervention on the patient's body.
- Device Description: The device is a "paste-like bone cement" that is "applied directly to the operative site". This is a material implanted or applied to the patient during surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. Norian CRS does not perform any such testing on specimens.
The information provided clearly describes a surgical implant/material used for bone repair and augmentation, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
Norian CRS is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm2.
Product codes (comma separated list FDA assigned to the subject device)
GXP
Device Description
Norian Craniofacial Repair System (Norian CRS) is a paste-like bone cement which is intended for the restoration or augmentation of bony contours in the craniofacial skeleton, such as burr hole voids and other cranial defects. Norian CRS is an injectable and moldable, biocompatible, bone coment. The Norian CRS Reactants Pack contains the two sterile components used in Norian CRS: Calcium Phosphate Powder and Sodium Phosphate Solution.
When the Reactants Pack is mixed, a smooth, viscous paste is applied directly to the opcrative site, where it hardens in about 10 minutes to provide initial structural support. Within 24 hours, Norian CRS cures into a carbonated apatie that is similar to the mincral component of bone. The compresssive strength of Norian CRS is approximately 50MPa. Over time, Norian CRS is gradually resorbed.
The Norian Mixer. Delivery Device, and Delivery Needles are used to mix and deliver the Norjan CRS to the operative site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
craniofacial skeleton (including fronto-orbital, malar, and mental areas)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following summaries present the results of Norian CRS in vitro testing:
X-ray Diffraction: The x-ray diffraction data demonstrates that sct (initial hardening) occurs at about 10 minutes, and the reaction is greater than 90% complete by 24 hours. In addition, the x-ray diffraction patterns demonstrate that Norian CRS cures to become an apatite of low crystalline order with no by-products present.
DH Value Determination: Laboratory testing showed that the pH range of Norian SRS is 6.0-8.0. The testing measured the pH values both during and after setting.
Dimensional Verification: Norian SRS hardens in approximately 10 minutes at body temperature (37°C) with no significant dimensional changes (
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).
0
MAY 1 5 1998 510(k) Summary
General Information
Bone Cement Classification Name:
Hydroxyapatite Cement (HAC) Common Name:
Norian CRSTM Device Trade Name:
Classification Code:
Submitter's Name & Address: Norian Corporation
10260 Bubb Road
Cuperino, CA 95014-4166
(408)252-6800
Establishment Registration:
Contact Person: Susan G. Marques, Manager, Regulatory Affairs Summary Preparation Date: May 14, 1998
Predicate Device
Norian CRSTM is substantially equivalent to Osteogenics BoneSource® Hydroxyapatite Cement (K933339, K964537. K970400).
Device Description
Norian Craniofacial Repair System (Norian CRS) is a paste-like bone cement which is intended for the restoration or augmentation of bony contours in the craniofacial skeleton, such as burr hole voids and other cranial defects. Norian CRS is an injectable and moldable, biocompatible, bone coment. The Norian CRS Reactants Pack contains the two sterile components used in Norian CRS: Calcium Phosphate Powder and Sodium Phosphate Solution.
When the Reactants Pack is mixed, a smooth, viscous paste is applied directly to the opcrative site, where it hardens in about 10 minutes to provide initial structural support. Within 24 hours, Norian CRS cures into a carbonated apatie that is similar to the mincral component of bone. The compresssive strength of Norian CRS is approximately 50MPa. Over time, Norian CRS is gradually resorbed.
The Norian Mixer. Delivery Device, and Delivery Needles are used to mix and deliver the Norjan CRS to the operative site.
Indications for Use
Norian CRS is intended for filling craniofacial defects in the restoration of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm2.
1
Technological Characteristics
Norian CRS is comprised of monocalcium phosphate, inonohydrate (MCPM, Ca(H,PO2)x+H2O], & - iricalcium phosphate (TCP, Ca3(PO2)}], and calcium carbonate (CC,CaCO,) to which a sodium phosphate solution is added to form a paste. The paste cures in situ at 37°C for approximately 12 hours, Norian CRS cures into a carbonated aparite that is similar to the mineral component of bone.
Performance Data
The following summaries present the results of Norian CRS in vitro testing:
X-ray Diffraction
The x-ray diffraction data demonstrates that sct (initial hardening) occurs at about 10 minutes, and the reaction is greater than 90% complete by 24 hours. In addition, the x-ray diffraction patterns demonstrate that Norian CRS cures to become an apatite of low crystalline order with no by-products present.
DH Value Determination
Laboratory testing showed that the pH range of Norian SRS is 6.0-8.0. The testing measured the pH values both during and after setting.
Dimensional Verification
Norian SRS hardens in approximately 10 minutes at body temperature (37°C) with no significant dimensional changes (