(181 days)
Not Found
No
The description focuses on the material composition and physical properties of the bone void filler, with no mention of AI or ML capabilities.
Yes.
The device is used to fill bony voids or gaps and provides a bone void filler that resorbs and is replaced with bone during the healing process, indicating a therapeutic purpose to aid in bone healing and regeneration.
No
MasterGraft™ Matrix is a bone void filler designed to resorb and be replaced by bone during the healing process. Its function is to facilitate bone growth in voids or gaps, rather than to diagnose medical conditions or analyze patient health.
No
The device description clearly states that MasterGraft™ Matrix is made of physical materials (collagen, hydroxyapatite, and B-tricalcium phosphate ceramic) and is supplied as a physical product (premixed strip form). This indicates it is a physical medical device, not software-only.
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 MasterGraft™ Matrix is a bone void filler used to treat bony voids or gaps in the skeletal system. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the materials and physical properties of the implant, which is designed to be surgically placed within the body. IVD devices are typically used to examine samples taken from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, MasterGraft™ Matrix is a medical device used for surgical intervention and bone repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MasterGraft™ Matrix combined with autogenous bone marrow is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Matrix is to be gently packed into bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraff™ Matrix provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
MasterGraft™ Matrix is made of medical grade combination of purified collagen and hydroxyapatite and B-tricalcium phosphate ceramic. The collagen is a highly purified bioresorbable lyophilized bovine tendon that is primarily Type I collagen. The ceramic portion of MasterGraft™ Matrix is provided in a 15 percent hydroxyapatite and 85 percent B-tricalcium phosphate formulation. The product is supplied sterile in a premixed strip form for single patient use. MasterGraft™ Matrix is a 3-dimensional, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is biocompatible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (e.g., the spine, pelvis, ilium, and/or extremities)
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.
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Medtronic Sofamor Danek MasterGraft™ Matrix 510(K) Summary (K023553) April 2003
Medtronic Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
II. Proposed Proprietary Trade Name: MasterGraft™ Matrix
III. Product Description
MasterGraft™ Matrix is made of medical grade combination of purified collagen and hydroxyapatite and B-tricalcium phosphate ceramic. The collagen is a highly purified bioresorbable lyophilized bovine tendon that is primarily Type I collagen. The ceramic portion of MasterGraft™ Matrix is provided in a 15 percent hydroxyapatite and 85 percent B-tricalcium phosphate formulation. The product is supplied sterile in a premixed strip form for single patient use. MasterGraft™ Matrix is a 3-dimensional, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is biocompatible.
IV. Indications
MasterGraff™ Matrix combined with autogenous bone manow is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Matrix is to be gently packed into bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraft™ Matrix provides a bone void filler that resorbs and is replaced with bone during the healing process.
V. Substantial Equivalence
Documentation was provided which demonstrated MasterGraft™ Matrix to be substantially equivalent to the previously cleared Master Graft™ Resorbable Ccramic (K020986 and K012506).
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2003
Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 31832
Re: K023553
Trade/Device Name: MasterGraft™ Matrix Regulatory Class: Unclassified Product Code: MQV Dated: February 11, 2003 Received: February 12, 2003
Dear Dr. Treharne:
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. 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.
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Page 2 - Richard W. Treharne, Ph.D.
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 (301) 594- . 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/dsma/dsmamain.html
Sincerely yours,
Mark A Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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:510(k) Number (if known): K023553
MasterGraft™ Matrix Device Name:
Indications for Use:
MasterGraft™ Matrix combined with autogenous bone marrow is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Matrix is to be gently packed into bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraff™ Matrix provides a bone void filler that resorbs and is replaced with bone during the healing process.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use
(F'er 21 CFR 801.109)
(Optional 1-2-96)
OR
Over-the-counter Use