(183 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™ 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.
The provided 510(k) summary for MBCP™ (K043005) does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics.
Instead, this submission is a Premarket Notification (510(k)) which focuses on demonstrating substantial equivalence to a predicate device, rather than performing clinical trials to establish device performance against predefined acceptance criteria. The document explicitly states:
"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." (Page 2)
And also, regarding predicate devices:
"The intended use and material composition of MBCP™ Bone Graft Substitute is the same as previously cleared MBCP™ (K032268). MBCP™ Bone Graft Substitute and the predicate devices are substantially equivalent in design, materials of construction and function." (Page 2)
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for proving device performance against specific metrics is not available in this document. The focus of a 510(k) is to show that the new device is as safe and effective as another legally marketed device, not to prove novel performance through a new clinical study with acceptance criteria.
However, based on the provided text, I can infer some points related to the equivalence claim:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for 510(k) (Inferred): Substantial equivalence in intended use, material composition, design, materials of construction, and function to the predicate device (K032268).
- Reported Device Performance: The document claims the device "is adequately supported by the substantial equivalence information, safety and performance data provided within this Premarket Notification." (Page 2). Specific quantitative performance metrics (e.g., bone growth rate, resorption rate) that would typically be evaluated against acceptance criteria are not detailed as part of a new study in this summary.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document does not describe a clinical study with a "test set" in the context of new device performance assessment. The "data" refers to the information supporting substantial equivalence, likely from existing data on the predicate device or bench/animal testing if new non-clinical data was submitted.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth establishment for a test set of data is not described as part of this 510(k) submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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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. This device is a bone void filler, not an AI-assisted diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a bone void filler, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable directly to a new performance study. For a 510(k), the "ground truth" for demonstrating equivalence would be the established safety and effectiveness profile of the predicate device (K032268), which would have been based on clinical data, material testing, and other evidence at the time of its clearance.
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The sample size for the training set:
- Not applicable / Not provided. No training set for an algorithm is mentioned.
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How the ground truth for the training set was established:
- Not applicable / Not provided.
In summary: This 510(k) submission for MBCP™ is a substantial equivalence submission. It does not present a new study with explicit acceptance criteria for device performance. Instead, it leverages the established safety and effectiveness of a predicate device (K032268) to demonstrate that the current device is equally safe and effective.
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-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 : | 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: | 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.
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МВСР™
-Confidential-
510(k) Summary of Safety and Effectiveness
4. INTENDED 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.
5. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use and material composition of MBCP™ Bone Graft Substitute is the same as previously cleared MBCP™ (K032268). 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.
Rev. 04/12/2005
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
MAY - 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Myriam VINCENT Regulatory Affairs Manager BIOMATLANTE ZA DES IV NATIONS 5, rue Edouard Belin -F-44360 VIGNEUX DE BRENTAGNE France
Re: K043005
МВСРТМ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: January 28, 2005 Received: February 2, 2005
Dear Ms. VINCENT:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your ever 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, of to act roomstic Act (Act) that do not require approval of a premarket the Federal 1 00d, Drug, dAS You may, therefore, market the device, subject to the general approvin apprevisions of the Act. The general controls provisions of the Act include controls provisions of an 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 If your device is classified (see ass 10) in a controls. Existing major regulations affecting (1 Mrc), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not I least be advisod that i Dr. o losains on that your device complies with other requirements modi that I DA mas mad regulations administered by other Federal agencies.
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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 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,
Hugh Purvis
Miriam C. Provost, Ph.D. 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): K043005
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 autograff as a bone graft extender. These bony be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
tradinato mjary to the 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 in addition, which 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 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 IF NEEDED)
C
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K043005
§ 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.