(250 days)
Not Found
No
The 510(k) summary describes a ceramic bone graft substitute and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "bone void filler" and "bone graft substitute" used to fill skeletal defects, which directly addresses a physical condition (defects in bone) for the purpose of promoting bone formation.
No
The device is described as a bone void filler and bone graft substitute, intended to fill defects in the skeletal system and be replaced by new bone. It does not perform any diagnostic function.
No
The device description clearly states it 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 on the patient's body to fill a physical space.
- Device Description: The description details a "non structural bone graft substitute" made of ceramic calcium phosphate, designed to be "resorbable and able to be replaced by newly-formed bone". This further reinforces its function as a physical material used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor a disease, or screen for a health issue.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is a therapeutic device used to physically repair or augment bone.
N/A
Intended Use / Indications for Use
MBCP* ™ is intended for use as 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. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP+TM is provided sterile for single patient use.
Product codes
MQV
Device Description
MBCP+™ is a non structural bone graft substitute, which is resorbable and able to be replaced by newly-formed bone. The MBCP+™ is a ceramic constituted of two-phase of calcium phosphate 20 % hydroxyapatite and 80 % tricalcium phosphate beta. MBCP+™ is presented in a porous form. There are two types of porosity in MBCP+TM: The microporosity (pores smaller than 5μm) is constituted by all the spaces between the ceramic. The microporosity allows the biological fluids to circulate. The macroporosity (pores diameters bigger than 100µm) provides a porous scaffold upon which bone formation can occur at the expense of the ceramic.
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)
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
Not Found
Key Metrics
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.
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Image /page/0/Picture/1 description: The image shows the logo for "Biomatlante". The logo consists of a hexagon shape with a gradient fill, transitioning from light to dark. Below the hexagon, the word "Biomatlante" is written in a simple, sans-serif font.
MBCP+ ™
510(k) Summary
JUL 3 0 2007
BIOMATLANTE ZA DES IV NATIONS 5, rue Edouard Belin -F- 44360 VIGNEUX DE BRETAGNE Phone: 0033 228 020 009 Fax: 0033 228 020 010
Contact: Adeline Filliâtre Regulatory Affairs Manager
This summary was prepared on July 2007, 16th
1. DEVICE IDENTIFICATION
| Trade Name: | MBCP+™ |
|---|---|
| Common Name: | Resorbable bone substitute |
| Classification Name : | Resorbable calcium salt bone void filler |
| device | |
| Product Code : | MQV |
| Regulatory Status : | Class II |
| CFR Section : | 888.3045 |
2. PREDICATE DEVICES
| Product Code | Manufacturer | 510(k) # | Product |
|---|---|---|---|
| MQV | Orthotec | K040514 | EOVIA |
| MQV | Howmedica Osteonics | K033258 | BONESAVE |
3. DEVICE DESCRIPTION
MBCP+™ is a non structural bone graft substitute, which is resorbable and able to be replaced by newly-formed bone. The MBCP+™ is a ceramic constituted of two-phase of calcium phosphate 20 % hydroxyapatite and 80 % tricalcium phosphate beta. MBCP+™ is presented in a porous form.
There are two types of porosity in MBCP+TM:
Rev. 7/16/2007
Section 04 Page 1 of 2
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MBCP+ TM
510(k) Summary
The microporosity (pores smaller than 5μm) is constituted by all the spaces between the ceramic. The microporosity allows the biological fluids to circulate.
The macroporosity (pores diameters bigger than 100µm) provides a porous scaffold upon which bone formation can occur at the expense of the ceramic.
4. INTENDED USE
MBCP* TM is intended for use as 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. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
MBCP+TM is provided sterile for single patient use.
5. SUBSTANTIAL EQUIVALENCE INFORMATION
Documentation was provided which demonstrated the MBCP*™ to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, anatomic sites, design, material and function.
Rev. 7/16/2007
Section 04 Page 2 of 2
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2007
Biomatlante % Ms. Adeline Filliatre Regulatory Affairs Manager ZA les IV Nations 5, rue Edouard Belin Vigneux de Brentagne France 44360
Re: K063527
Trade/Device Name: MBCP+ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: May 28, 2007 Received: June 7, 2007
Dear Ms. Filliatre:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Ms. Adeline Filliatre
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Barbara Burns
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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MBCP+TM
Indications for Use
510(k) Number (if known): K063527
Device Name: MBCP+ TM
Indications for Use:
MBCP* ™ is intended for use as 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. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
MBCP+TM is provided sterile for single patient use.
MBCP+™ is provided sterile for single patient use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kaubare Breeno
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Section 03 Page 1 of 1
Rev. 5/28/2007
510(k) Number K063527