(183 days)
Not Found
No
The summary describes a bone graft substitute material and its intended use, with no mention of AI or ML technology.
Yes
The device is a bone void filler intended to facilitate the healing process of bony structures, indicating a therapeutic purpose.
No
Explanation: The device, MBCP™, is described as a bone void filler and bone graft substitute. Its intended use is to fill bony voids or gaps and gradually resorb, being replaced by bone during healing. This function is therapeutic/restorative, not diagnostic.
No
The device description clearly states that MBCP™ is a ceramic bone graft substitute, which is a physical material, 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 MBCP™ is a "bone void filler for bony voids or gaps of the skeletal system". This describes a device that is implanted or used directly within the body to facilitate bone healing.
- Device Description: The description details the material composition (calcium phosphate ceramic) and how it is used (packed into a bony site, resorbs and is replaced by bone). This aligns with a medical device used for surgical procedures.
- Lack of IVD Characteristics: 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 physiological state, disease, or condition. IVDs are typically used in laboratories or point-of-care settings for diagnostic purposes.
Therefore, MBCP™ is a medical device used for bone repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MBCP™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. MBCP™ can be used with autograft as a bone graft extender. These bony be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
MBCP™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
When packed into a bony site, MBCP™ gradually resorbs and is replaced with bone during the healing process.
In addition, when used with appropriate opening osteotomy system devices, plates and screws. MBCP™ is intended to be used as a bone void filler in femoral or tibial osteotomies. MBCP™ is to be used in association with adequate post-operative immobilization.
Product codes
MQV
Device Description
MBCP™ is a bone graft substitute. MBCP™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). MBCP™ is available in various shapes and sizes.
MBCP™ may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA).
MBCP™ is provided sterile for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (e.g. extremities, spine and pelvis), femoral or tibial osteotomies
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
-Confidential-
MAY - 3 2005 МВСРТМ
510(k) Summary of Safety and Effectiveness
This 510(k) Summary for MBCP™ is provided as required per Section 513(1)(3) of the Food. Drug and Cosmetic Act.
1. GENERAL INFORMATION
| Submitter's name and adress : | BIOMATLANTE
ZA DES IV NATIONS
5, rue Edouard Belin
-F- 44360 VIGNEUX DE BRETAGNE
France |
|-------------------------------|----------------------------------------------------------------------------------------------------------|
| Contact : | Myriam VINCENT,
Regulatory Affairs Manager
Tel : +33 228 02 00 09
myriamvincent@biomatlante.com |
| FDA Establishment Number : | 3002673655 |
| Trade Name: | MBCPTM |
| Common Name: | Resorbable Calcium Salt Bone Void Filler |
| Classification Name : | Resorbable Calcium Salt Bone Void Filler |
| Product Code : | MQV |
| CFR Section : | 888.3045 |
| Device Panel : | Orthopedic |
Summary preparation date:
April 12th, 2005
2. PREDICATE DEVICES
The subject device is substantially equivalent to similar previously cleared devices.
3. DEVICE DESCRIPTION
MBCP™ is a bone graft substitute. MBCP™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). MBCP™ is available in various shapes and sizes.
MBCP™ may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA).
MBCP™ is provided sterile for single patient use.
1