(203 days)
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 defects may 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.
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™ granules are packaged in vials or syringes.
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.
This document is a 510(k) Summary of Safety and Effectiveness for the MBCP™ device. It establishes the device's substantial equivalence to previously cleared devices rather than demonstrating meeting specific acceptance criteria through a new study. Therefore, the information requested regarding a new study showing the device meets acceptance criteria is largely not applicable in this context.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
This document does not present acceptance criteria and device performance in a tabular format as it's a submission for substantial equivalence, not a report on a new study with specific performance metrics against pre-defined criteria. The primary "acceptance criterion" in a 510(k) is demonstrating substantial equivalence to a predicate device.
The document states:
- "The intended use and material composition of MBCP™ Bone Graft Substitute is the same as previously cleared MBCP™ (K032268, K043005)."
- "MBCP™ Bone Graft Substitute and the predicate devices are substantially equivalent in design, materials of construction and function."
- "The safety and effectiveness of MBCP™ Bone Graft Substitute as modified in this submission is adequately supported by the substantial equivalence information, safety and performance data provided within this Premarket Notification."
2. Sample size used for the test set and the data provenance
- Not Applicable. This document does not describe a new clinical or performance study with a test set. It relies on the substantial equivalence to previously cleared devices (K032268, K043005) and "safety and performance data provided within this Premarket Notification," which typically refers to bench testing, biocompatibility, and information establishing similarity to predicates, rather than a prospective study with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As no new human subject test set is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set with expert adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. The device is a bone graft substitute, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device is not an algorithm or software; it's a physical resorbable calcium salt bone void filler.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For a substantial equivalence claim for a bone graft substitute, the "ground truth" relates to the established safety and effectiveness of the predicate devices based on their prior clearances, preclinical data (biocompatibility, resorption characteristics), and potentially historical clinical use data (though not detailed here for a new study).
8. The sample size for the training set
- Not Applicable. As no machine learning or AI algorithm is involved, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. No training set is involved.
Summary based on the document:
This 510(k) submission for MBCP™ relies on the principle of substantial equivalence to previously cleared predicate devices (K032268, K043005). The "study" proving the device meets acceptance criteria (in the context of a 510(k)) is the comparison of the new MBCP™ to these predicates, demonstrating that the design, materials, function, and intended use are the same. No new clinical efficacy studies with specific performance metrics against novel acceptance criteria are described in this summary. The safety and effectiveness are "adequately supported by the substantial equivalence information, safety and performance data provided within this Premarket Notification" – this data would typically include bench testing, biocompatibility studies, and a comparison demonstrating sameness to the predicates, rather than a new clinical human study with a test/training set, expert ground truth, or MRMC evaluation.
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K 051774
MBCPTM
-Confidential-
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 : | BIOMATLANTEZA DES IV NATIONS5, rue Edouard Belin-F- 44360 VIGNEUX DE BRETAGNEFrance |
|---|---|
| Contact : | Myriam VINCENT,Regulatory Affairs ManagerTel : +33 228 02 00 09myriamvincent@biomatlante.com |
| FDA Establishment Number : | 3002673655 |
| Trade Name: | MBCP™ |
| 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:
October 18th, 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™ granules are packaged in vials or syringes.
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.
Rev. 10/18/2005
Section 04 Page 1 of 2
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-Confidential-
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МВСРТМ
510(k) Summary of Safety and Effectiveness
4. 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 but that are not intrinsic to the stability of the bony structure. created osed with autograft as a bone graft extender. These defects may 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 ostedtomy 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.
SUBSTANTIAL EQUIVALENCE INFORMATION 5.
The intended use and material composition of MBCP™ Bone Graft Substitute is the same as previously cleared MBCP™ (K032268, K043005). MBCP™ Bone Graft Substitute and the predicate devices are substantially equivalent in design, materials of construction and function,
The safety and effectiveness of MBCP™ Bone Graft Substitute as modified in this submission is adequately supported by the substantial equivalence information, safety and performance data provided within this Premarket Notification.
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Public Health Service
JAN 2 0 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Myriam Vincent Chemical Engineer BIOMATLANTE ZA DES IV NATIONS 5, rue Edouard Belin VIGNEUX DE BRENTAGNE -F-44360 France
Re: K051774
МВСРТМ
Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: October 18, 2005 Received: October 24, 2005
Dear Ms. VINCENT:
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, listing 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. Myriam Vincent
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 your 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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Mall
Mark N. Melkerson. જ્ઞ Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K051774
Device Name: MBCP™
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 defects may 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.
| Prescription UseAND/ORPart 21 CFR 801 Subpart D) | ✓ |
|---|---|
| Over-The-Counter Use(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrantes Rif Start Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices
Page 1 of _ 1__
510(k) Number K051334
§ 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.