(88 days)
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No
The summary describes a calcium phosphate cement and its packaging, with no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No
The device is a bone cement used for repairing and restoring bone, which is a structural rather than a therapeutic function.
No
The device description indicates it is a self-setting calcium phosphate cement used for repair and augmentation of bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components (powder, solution, spatula, tray) and a sterilization method (gamma irradiation), indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that BoneSource® is a self-setting calcium phosphate cement for the repair and augmentation of bony defects in the craniofacial skeleton. This is a surgical implant/material used directly on the patient's body.
- Device Description: The description details a kit containing powder, solution, and a spatula for mixing and applying the cement. This aligns with a material used in a surgical procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
Therefore, based on the provided information, BoneSource® is a medical device used in surgery, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BoneSource® is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
Product codes (comma separated list FDA assigned to the subject device)
84GXP, 79FWP
Device Description
The packaging contains the following: BoneSource® powder in a plastic bowl with a foil lid. Sodium phosphate sterile solution in a glass syringe with a plastic cap. A polycarbonate mixing spatula, and an instruction for use card packed in a Polyethylene Terephthalate Glycol Modified (PETG) tray. The kit is terminally sterilized by gamma irradiation. Packages are being provided in sizes ranging from 5g to 50g.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
neurosurgical burr holes, contiguous craniotomy cuts, other cranial defects, craniofacial skeleton
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K991398, K953339, K964537, K970400, K990290, K012569
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
K021