(71 days)
Not Found
No
The device description focuses on the material properties and physical structure of the bone void filler, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for use in the treatment of osseous defects caused by trauma or surgery, to assist in the healing process by acting as a bone void filler and being replaced with bone, which aligns with the definition of a therapeutic device.
No
Explanation: This device is a bone void filler intended for use as a scaffold for bone regeneration, not for diagnosing conditions.
No
The device description clearly states it is a porous, resorbable osteoconductive scaffold constructed of ß tri-calcium phosphate, which is a physical material intended for implantation. It is supplied as granules, indicating a physical product, 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 void filler" for surgically created or traumatic osseous defects. It is implanted into the body to aid in bone healing.
- Device Description: The description details a porous, resorbable scaffold made of calcium phosphate, designed to be implanted and replaced by bone.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health, disease, or condition. IVDs are used for diagnostic purposes outside of the body.
This device falls under the category of a medical device used for surgical implantation and bone repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ßGran Synthetic Osteoconductive Scaffold Bone Void Filler is intended for use as a bone void filler IfGran Synthelic Osteoconductive bandra Bone FBC of the bony structure. If cransage defects co for volds or gaps that are not insic to the basility or sheous defects or osseous defects created indicated for use in the treatment of surgically created osseous defects cr indicated for use in the treathent of surgically of saiffeld should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
ßGron Scaffold is intended to be packed into bony voids or gaps of the sketal system (ite., the BGron Scaroid is intended to be packed this bony folse of golf extremittes, spine and pelvis) and may be combined with autogenous blood and is some is sopher extremittes, spine and peris) and that be combines that about of the same and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
BGran is a porous, resorbable osteoconductive scaffold constructed of highly pure ß tri-calcium phosphate for use in the repair of bony defects. The material is designed and manufactured to achieve the specification set out in the standard ASTM F 1088-87 (1992) e-1.
The interconnected pores provide a three-dimensional scaffold that mimics the geometry of human cancellous bone matrix. The three-dimensional platform provided by BGran's osteoconductive scaffold guides the regenerating bone throughout the defect into which it has been implanted. Pore diameters ranging from 1 pm to 700 m support re-vascularisation and cellular invasion throughout the matrix
Studies have shown that when ß tri-calcium phosphate is implanted in direct contact with host bone, which has a viable blood supply, that it responds physiologically. Throughout the healing process the matrix resorbs and is replaced by bone and connective tissue. Complete resobption takes between 3 to 12 months
BGran is supplied as granules, available in three sieve sizes, sterile for single patient use
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bony voids or gaps of the skeletal system (i.e., long bones, extremities, spine and pelvis, mandible or maxilla).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
suitable trained surgical personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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
| AUG | 2 5 2004 |
|---|---|
| ----- | ---------- |
510(k) Summary ßGran synthetic osteoconductive scaffold
| Prepared & Submitted by: | Orthos (UK) Limited | ||
|---|---|---|---|
| Contact Person: | Mr Alan Rorke | ||
| Address: | The Stables, Leigh Court, | ||
| Abbots Leigh | |||
| Bristol | |||
| North Somerset | |||
| BS8 3RA | |||
| United Kingdom | Tel: | ||
| Fax: | |||
| Email: | +44 1275 376 377 | ||
| +44 1275 376 378 | |||
| post@orthos.com |
| Trade Name | βGran™ synthetic
osteoconductive scaffold | Vitoss™ Scaffold Synthetic
Cancellous Bone Void Filler | CerasorbORTHO |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Registration No: | | K032409 | K014156 |
| Common Name | Resorbable Synthetic Bone Void Filler/Bone Graft Substitute | | |
| Classification Name | Resorbable Calcium Salt Bone Void Filler Device | | |
| | | | |
| Trade Name | BGran™ synthetic
osteoconductive scaffold | Vitoss™ Scaffold Synthetic
Cancellous Bone Void Filler | CerasorbORTHO |
| 510(k) Registration No: | | K032409 | K014156 |
| Intended Use | The devices intended use is
the same as for the
Predicate devices. i.e. the
treatment of osseous
defects, which are not
intrinsic to the stability or
integrity of the skeleton.
For complete details please
refer to the Intend Use
Statement | As a bone void filler for
voids or gaps that are not
intrinsic to the stability of
bone structures. It is
indicated for use in the
treatment of surgically
created osseous defects or
osseous defects cause by
traumatic injury to the bone. | As a bone void filler for
voids or gaps that are not
intrinsic to the stability of
bone structures. It is
indicated for filling of bone
defects, caused by surgery,
trauma or degenerative
process. |
| Target Population | Individuals with bony defects
resulting from surgery or
trauma | Individuals with bony defects
resulting from surgery or
trauma | Patients with bone voids or
gaps, caused by surgery,
trauma or degeneration |
| Anatomical Locations | Bony voids or gaps of the
skeletal system, i.e., the
extremities, spine and pelvis | Bony voids or gaps of the
skeletal system, i.e., the
extremities, spine and pelvis | skeletal system,
(extremities, spine, pelvis) |
| Labeling | Labeling contains same
intended use,
contraindications and
adverse events as predicate
devices | Labeling contains same
intended use,
contraindications and
adverse events as ßGran
synthetic osteoconductive
scaffold | Labeling contains same
intended use,
contraindications and
adverse events as ßGran
synthetic osteoconductive
scaffold |
| Materials | ß-Tricalcium Phosphate
Ca3(PO4)2 satisfies ASTM F
1088 | ß-Tricalcium Phosphate
Ca3(PO4)2 satisfies ASTM F
1088 | ß-Tricalcium Phosphate
Ca3(PO4)2 |
| Design | | | |
| Physical Structure | Interconnective porosity | Trabecular structure similar
to cancellous bone | Interconnective porosity |
| Porosity | Approximately 70% | Approximately 90% | Approximately 60% to 70% |
| Pore Size (range) | 0