(430 days)
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No
The summary describes a bone graft substitute material and its composition, with no mention of AI or ML technology.
Yes
The device is described as a "Bone Graft Substitute" intended to fill bony voids or gaps and is replaced with bone during the healing process, indicating a therapeutic function in aiding bone repair.
No
This device is a bone graft substitute used to fill bony voids or gaps; it is not described as diagnosing any condition or disease.
No
The device description clearly states it is a porous, resorbable scaffold composed of physical materials (PLG copolymer, calcium sulfate, PGA fibers, surfactant) intended to be packed into bony voids, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "bone graft substitute" used to "fill bony voids or gaps caused by trauma or surgery." This describes a device that is implanted into the body to aid in bone healing.
- Device Description: The description details the composition of the implant (PLG copolymer, calcium sulfate, PGA fibers, surfactant) and its function as a "porous, resorbable scaffold." This is consistent with an implantable medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition. The purpose is to physically fill a void and promote bone regeneration.
In vitro diagnostics are tests performed on samples taken from the human body to provide information about a person's health. This device is an implantable medical device used for surgical repair.
N/A
Intended Use / Indications for Use
The TRUREPAIR™ Bone Graft Substitute is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The TRUREPAIR™ Bone Graft Substitute is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
TRUREPAIR™ implants use the PolyGraft technology and are porous, resorbable scaffolds composed of polylactide-co-glycolide (PLG) copolymer and calcium sulfate. The copolymer is amorphous (noncrystalline) and resorbs in four to twelve months, depending on shape and location. The device also contains Polyglycolide (PGA) fibers and a surfactant.
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
skeletal system (i.e., the extremities, spine and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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)
Performance testing conducted includes bench and animal studies that demonstrate substantial equivalence to the PolyGraft BGS.
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.
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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§ 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.
0
NOV 0 9 2007
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as
required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
TRUREPAIR BONE GRAFT SUBSTITUTE
Date Prepared: November 7, 2007
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Deana Boushell Principal Regulatory Specialist (508)337-4036
C. Device Name
Trade Name: TRUREPAIR™ Bone Graft Substitute Common Name: Bone Graft Substitute Classification Name: Resorbable calcium salt bone void filler device
D. Predicate Devices
The Smith & Nephew TRUREPAIR Bone Graft Substitute is substantially equivalent in Intended Use and Scientific Technology to the following legally marketed device in commercial distribution: K030288 PolyGraft BGS
E. Description of Device
TRUREPAIR™ implants use the PolyGraft technology and are porous, resorbable scaffolds composed of polylactide-co-glycolide (PLG) copolymer and calcium sulfate. The copolymer is amorphous (noncrystalline) and resorbs in four to twelve months, depending on shape and location. The device also contains Polyglycolide (PGA) fibers and a surfactant . See chart below for available shapes and sizes.
| Product Name | Shape | Size Range |
|---|---|---|
| TruGraft | Granules | 3 - 30 cc |
| TruFit | Plug | 3 – 11 mm diameter |
| 18mm length | ||
| TruBlock | Block | 15 - 25 mm width |
| 15 - 25 mm height | ||
| 10 - 20 mm length | ||
| TruWedge | Wedge | 5 - 15° angle |
| 5 mm-15mm height |
1
F. Intended Use
The TRUREPAIR™ Bone Graft Substitute is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The tradina of surgery that are novels intended to be gently packed into bony voids or gaps I RONEI All