(60 days)
No
The device description and intended use focus on the material composition and physical properties of a bone graft matrix. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies reference non-clinical testing of predicate devices, not AI/ML model validation.
Yes
The device is used to fill bony voids or gaps and facilitates bone healing, which addresses a physiological condition.
No
The device is a bone graft extender used to fill bony voids or gaps in the skeletal system, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is made from physical materials (collagen and biphasic calcium phosphate ceramic) and is supplied as a sterile strip, indicating it is a physical implant, 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 the device is a bone graft extender used to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the materials (collagen and calcium phosphate ceramic) and form (premixed strip) of the device, which are consistent with a bone graft material.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The device is applied directly to the skeletal system, which is a therapeutic intervention, not an in vitro diagnostic test.
In vitro diagnostics are devices used to perform tests on samples taken from the human body outside of the body itself. This device is implanted directly into the body for structural support and bone regeneration.
N/A
Intended Use / Indications for Use
MASTERGRAFT® Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps not intrinsic to the stability of the bony structure and can be used as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
MASTERGRAFT® Matrix EXT is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the devices, the collagen is a highly purified (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of the device is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation.
MASTERGRAFT® Matrix EXT is supplied sterile in a premixed strip form for single patient use.
The device is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the posterolateral 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)
Non-clinical testing was performed in support of substantial equivalence for MASTERGRAFT® Strip cleared under K082166 (S.E. 06/02/2009). This data is considered relevant to and supportive of the cited predicate K130335 (S.E. 04/19/2013).
The non-clinical testing was conducted in accordance with FDA Recognized Consensus Standards and FDA Guidelines, where applicable. No new non-clinical testing was performed or submitted in support of this 510(k) application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 5, 2014
Medtronic Sofamor Danek USA Inc. Ms. Courtney N. Long Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K141824
Trade/Device Name: MASTERGRAFT® Matrix EXT Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 1, 2014 Received: July 7, 2014
Dear Ms. Long:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
Laurence D/ Coyne -A
For Mark N. Melkerson
Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141824
Device Name MASTERGRAFT® Matrix EXT
Indications for Use (Describe)
MASTERGRAFT® Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| I. SUBMITTER NAME & ADDRESSS: | Medtronic Sofamor Danek USA, Inc
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133
Fax: (901) 346-9738
Establishment Registration: 1030489 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Courtney N. Long
Regulatory Affairs Specialist |
| DATE PREPARED: | July 1, 2014 |
| II. PROPOSED PROPRIETARY TRADE NAME: | MASTERGRAFT® Matrix EXT |
| DEVICE CLASSIFICATION NAME: | Resorbable Calcium Salt Bone Void
Filler |
| REGULATION NUMBER: | 21 CFR 888.3045 |
| CLASSIFICATION PRODUCT CODE: | MQV |
| CLASS: | II |
III. IDENTIFICATION OF LEGALLY MARKETED DEVICES:
| TABLE 1. Legally Marketed Devices | ||||
|---|---|---|---|---|
| Device Name | 510(k) | Substantial Equivalence Date | ||
| MASTERGRAFT® UltraMatrix | K130335 | 04/19/2013 | ||
| MASTERGRAFT® Strip and | K140375 | 04/18/2014 | ||
| MASTERGRAFT® Putty |
IV. DEVICE DESCRIPTION:
MASTERGRAFT® Matrix EXT is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the devices, the collagen is a highly purified (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of the
4
device is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation.
MASTERGRAFT® Matrix EXT is supplied sterile in a premixed strip form for single patient use.
The device is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate.
The purpose of this Traditional 510(k) application is the addition of a new contraindication to the Instructions for Use (IFU) for MASTERGRAFT® Matrix EXT.
V. INDICATIONS FOR USE:
MASTERGRAFT® Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps not intrinsic to the stability of the bony structure and can be used as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:
| Comparison Feature | Subject
MASTERGRAFT® Matrix
EXT | Predicate
MASTERGRAFT®
UltraMatrix |
|---------------------------------------------------------------------------------|---------------------------------------|------------------------------------------|
| Indication for Use | Identical | K130335 (S.E. 04/19/2013) |
| Fundamental Scientific
Technology
Operating Principle Mechanism of Action | Identical | K130335 (S.E. 04/19/2013) |
| Basic Design | Identical | K130335 (S.E. 04/19/2013) |
| Performance | Identical | K130335 (S.E. 04/19/2013) |
| Manufacturing principles | Identical | K130335 (S.E. 04/19/2013) |
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| Comparison Feature | Subject
MASTERGRAFT® Matrix
EXT | Predicate
MASTERGRAFT®
UltraMatrix |
|--------------------------------------------------|---------------------------------------|------------------------------------------|
| Sterilization | Identical | K130335 (S.E. 04/19/2013) |
| Shelf-Life | Identical | K130335 (S.E. 04/19/2013) |
| Packaging | Identical | K130335 (S.E. 04/19/2013) |
| Material Composition
• Collagen
• Granules | Identical | K130335 (S.E. 04/19/2013) |
| Use of rigid fixation | Identical | K130335 (S.E. 04/19/2013) |
| Safety and Effectiveness
profile | Identical | K130335 (S.E. 04/19/2013) |
VII. DISCUSSION OF NON-CLINICAL TESTING:
Non-clinical testing was performed in support of substantial equivalence for MASTERGRAFT® Strip cleared under K082166 (S.E. 06/02/2009). This data is considered relevant to and supportive of the cited predicate K130335 (S.E. 04/19/2013).
The non-clinical testing was conducted in accordance with FDA Recognized Consensus Standards and FDA Guidelines, where applicable. No new non-clinical testing was performed or submitted in support of this 510(k) application.
VIII. CONCLUSION:
Documentation provided in this submission demonstrates that the subject device is substantially equivalent to the previously cleared bone void filler MASTERGRAFT® UltraMatrix (K130335, SE 04/19/2013) and MASTERGRAFT® Strip and MASTERGRAFT® Putty K140375 (S.E. 04/18/2014).
The subject device is substantially equivalent to predicate MASTERGRAFT® UltraMatrix K130335 (04/19/2013) in several categories including: indication, material composition (including biphasic calcium phosphate granules and collagen), biodegradability, sterility, shelflife, need for rigid fixation, biocompatibility and the ability to resorb during the healing process. The subject device is also substantially equivalent to K140375 (S.E. 04/18/2014) MASTERGRAFT® Strip and MASTERGRAFT® Putty related to the additional contraindication identified in the labeling.