(74 days)
Not Found
No
The document describes a bone void filler material and its physical properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
Biofill is a bone void filler intended for use in the treatment of osseous defects, which directly contributes to the healing process of bone, thus serving a therapeutic function.
No
Explanation: The device, Biofill, is described as a "bone void filler" intended for surgical implantation and replacement by new bone during healing. Its function is therapeutic, not diagnostic.
No
The device description clearly states that Biofill Bone Void Filler is a tricalcium phosphate bone void filler supplied in the form of granules, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Biofill's Intended Use: Biofill is intended to be implanted into the body to fill bone voids. It is a bone void filler that is placed directly into the skeletal system.
- Device Description: The description details a physical material (tricalcium phosphate granules) designed for implantation, not for testing biological samples.
Biofill is a medical device, but it falls under the category of an implantable device or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Biofill Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure, Biofill Bone Void Filler is indicated for use in the treatment of surgically created osscous defects or osseous defects created from traumatic injury to bone. Biofill Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Biofill Bone Void Filler is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Product codes
MOV
Device Description
Biofill Bone Void Filler is a tricalcium phosphate bone void filler.
It is supplied in the form of parallelevined granules measuring 1mm-4mm on each side. It is marketed in quantities of Scc, 10cc and 15cc dosages.
The Biofill structure is made up of intercomected macroporcs occupying 60-80% of the granule. Pore size is 200-700um with an average of 400μm. Microporosity is also present with pore size
§ 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
KD40454
510(k) Summary - Revised
Date April 28, 2004
Submitter Scient'x Batiment Calypso Parc Ariane 3 78284 Guyancourt FRANCE
Contact person J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name
Bone void filler
Classification name
Filler, calcium sulfate, preformed pellets
Equivalent Device
Biofill is equivalent in material, indications and use as BIOSORB (K021963) (Sciences et Bio Materiaux, Lourdes, France) and Vitoss™ Scaffold (K994337) (Orthovita, Inc. (Malvern PA).
Device Description
Biofill Bone Void Filler is a tricalcium phosphate bone void filler.
It is supplied in the form of parallelevined granules measuring 1mm-4mm on each side. It is marketed in quantities of Scc, 10cc and 15cc dosages.
The Biofill structure is made up of intercomected macroporcs occupying 60-80% of the granule. Pore size is 200-700um with an average of 400μm. Microporosity is also present with pore size