(124 days)
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No
The 510(k) summary describes a bone graft substitute material and its physical and biological properties. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material properties and biological integration, not algorithmic performance.
Yes
The device is described as a "bone graft substitute" intended for use in "bony voids or gaps of the skeletal system" to facilitate healing by providing an osteoconductive scaffold that resorbs and is replaced by host bone. This indicates a direct therapeutic action in aiding the body's natural healing process for bone defects.
No
Explanation: This device is described as a bone graft substitute that is implanted to aid in bone regeneration, not to diagnose a condition.
No
The device description clearly states it is a bone graft substitute comprising physical materials (mineral granules and collagen matrix) and is provided in a strip form, indicating a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- MCS Bone Graft Function: The provided description clearly states that MCS Bone Graft is a bone graft substitute intended for implantation into bony voids or gaps within the skeletal system. It is used in vivo (within the body) to help with bone regeneration.
- Lack of Diagnostic Testing: The description does not mention any testing of samples from the body or providing diagnostic information. Its purpose is therapeutic (to aid in bone healing), not diagnostic.
Therefore, based on the intended use and device description, MCS Bone Graft is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MCS Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCS Bone Graft is indicated to be hydrated with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCS Bone Graft is to be used as an autograft extender. Following implantation, the graft resorbs and is replaced by host bone during process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
MCS Bone Graft is a bone graft substitute comprising biphasic mineral granules suspended in a porous, bovine type I collagen matrix. The biphasic granules are 60% hydroxyapatite (HA) and 40% beta tri-calcium phosphate (βTCP). The device is provided in a strip form and is supplied terminally sterile for single patent use. The device is designed to be combined with autologous bone marrow aspirate prior to facilitate packing into bony defects and is used with autologous bone in the posterolateral spine. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
extremities, pelvis and posterolateral spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed in accordance with FDA guidance documents and recognized consensus standards as applicable. Physical and chemical characterization of the implant raw materials and finished device was conducted as recommended in the FDA class II bone void filler guidance document and meet relevant requirements of ASTM F1185-03, F1088-04a and F2212-11. The collagen raw materials meet essential safety requirements for medical devices utilizing animal tissues according to ISO 22442. The device has met biocompatibility requirements for permanent tissue/bone implants according to FDA's Guidance for Industry and Food and Drug Administration Staff: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Viral inactivation, sterilization, packaging and shelf life stability evaluations have been performed with passing results.
Animal performance testing was conducted to demonstrate the safety and performance of the MCS Bone Graft as directly compared to the predicate devices. In the prior 510(k) submission (K142276), the MCS Bone Graft was evaluated in a critical-size rabbit femoral defect study and deemed substantially equivalent to Vitoss Scaffold Foam. In the current submission, the MCS Bone Graft was evaluated in a rabbit posterolateral spine fusion study, which demonstrates substantially equivalent spine fusion performance compared to the predicate device and control group (iliac crest bone graft). Outcomes were determined using radiographic, microCT, biomechanical and histological endpoints, measured at 4, 8 and 12 weeks after surgery.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2017
Bioventus, LLC % Patsy Trisler, J.D., R.A.C. Regulatory Consultant Trisler Consulting 5600 Wisconsin Avenue Chevy Chase, Maryland 20815
Re: K162860
Trade/Device Name: MCS Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: December 28, 2016 Received: December 28, 2016
Dear Ms. Trisler:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162860
Device Name
MCS Bone Graft
Indications for Use (Describe)
MCS Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCS Bone Graft is indicated to be hydrated with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCS Bone Graft is to be used as an autograft extender. Following implantation, the graft resorbs and is replaced by host bone during process.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Submitter Information:
| Name: | Bioventus, LLC |
|---|---|
| Address: | 4721 Emperor Boulevard, Suite 100 |
| Durham, NC 27703 | |
| Contact Person: | John Brunelle, PhD |
| Chief Technology Officer – Surgical | |
| Telephone: | (949) 553-1717 |
| Date Prepared: | February 6, 2017 |
Device Information:
Trade Name: MCS Bone Graft Common Name: Bone graft substitute Classification: Class 2 Regulation: 888.3045, Resorbable calcium salt bone void filler device Product Code: MQV
Predicate Device(s):
K142276: MCS Bone Graft (BioStructures, LLC) K071813: Mastergraft® Putty (Medtronic Sofamor Danek)
Background:
MSC Bone Graft has been previously cleared as a bone filler device under 510(k) submission K142276 with indications for use in osseous defects of the extremities and pelvis when mixed with bone marrow aspirate. The purpose of the current submission is to obtain clearance for an additional indication for use in the posterolateral spine when mixed with bone marrow aspirate and combined with autologous bone.
Indications for Use:
MCS Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCS Bone Graft is indicated to be hydrated with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCS Bone Graft is to be used as an autograft extender. Following implantation, the graft resorbs and is replaced by host bone during the healing process.
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Device Description:
MCS Bone Graft is a bone graft substitute comprising biphasic mineral granules suspended in a porous, bovine type I collagen matrix. The biphasic granules are 60% hydroxyapatite (HA) and 40% beta tri-calcium phosphate (βTCP). The device is provided in a strip form and is supplied terminally sterile for single patent use. The device is designed to be combined with autologous bone marrow aspirate prior to facilitate packing into bony defects and is used with autologous bone in the posterolateral spine. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
Performance Testing:
Non-Clinical Testing:
Non-clinical testing was performed in accordance with FDA guidance documents and recognized consensus standards as applicable. Physical and chemical characterization of the implant raw materials and finished device was conducted as recommended in the FDA class II bone void filler guidance document and meet relevant requirements of ASTM F1185-03, F1088-04a and F2212-11. The collagen raw materials meet essential safety requirements for medical devices utilizing animal tissues according to ISO 22442. The device has met biocompatibility requirements for permanent tissue/bone implants according to FDA's Guidance for Industry and Food and Drug Administration Staff: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Viral inactivation, sterilization, packaging and shelf life stability evaluations have been performed with passing results.
In Vivo Performance Testing:
Animal performance testing was conducted to demonstrate the safety and performance of the MCS Bone Graft as directly compared to the predicate devices. In the prior 510(k) submission (K142276), the MCS Bone Graft was evaluated in a critical-size rabbit femoral defect study and deemed substantially equivalent to Vitoss Scaffold Foam. In the current submission, the MCS Bone Graft was evaluated in a rabbit posterolateral spine fusion study, which demonstrates substantially equivalent spine fusion performance compared to the predicate device and control group (iliac crest bone graft). Outcomes were determined using radiographic, microCT, biomechanical and histological endpoints, measured at 4, 8 and 12 weeks after surgery.
Substantial Equivalence:
MCS Bone Graft has the same intended use, and the same or similar technological characteristics, principles of operation and indications as the predicate devices. The material composition of the MCS Bone Graft is identical to the previously cleared MCS Bone Graft and similar to the Mastergraft Putty. All devices comprise biphasic granules (mixture of hydroxyapatite and beta-tricalcium phosphate) and bovine type I collagen. MCS Bone Graft is provided in strip form and has >90% implant porosity, same as the previously cleared MCS Bone Graft. MCS Bone Graft is supplied sterile and is combined with bone marrow aspirate prior to use, same as both predicates. MCS Bone Graff is to be used with autologous bone in the posterolateral spine, same as Mastergraft Putty. Any technological differences presented by the MCS Bone Graft do not raise new issues of safety or effectiveness.
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Conclusion:
Performance testing and technological comparisons presented in this 510(k) indicate MCS Bone Graft is substantially equivalent to the predicate devices.