(213 days)
Not Found
Not Found
No
The description focuses on the material composition and intended use as a bone void filler, with no mention of AI or ML capabilities.
Yes.
The device is used to fill bony voids or gaps resulting from surgical creation or traumatic injury, providing a scaffold for bone regeneration during the healing process. This direct intervention to restore bone structure and promote healing falls under the definition of a therapeutic device.
No
Explanation: The device is described as a "Bone Void Filler" used to fill bony voids or gaps and is replaced with bone during the healing process. Its purpose is therapeutic/restorative, not diagnostic.
No
The device description explicitly states that MasterGraft™ Bone Void Filler is made of physical materials (hydroxyapatite and ß-tricalcium phosphate) and is a porous implant, indicating it is a physical medical device, 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 MasterGraft™ Void Filler is for filling bony voids or gaps in the skeletal system. This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The description details the material composition (hydroxyapatite and ß-tricalcium phosphate) and its function as an osteoconductive porous implant that resorbs and is replaced by bone. This aligns with a medical device used for surgical intervention and healing, not for analyzing samples from the body to diagnose a condition.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or treatment decisions.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. MasterGraft™ is a material implanted into the body to aid in bone healing.
N/A
Intended Use / Indications for Use
MasterGraft™ Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Bone Void Filler is to be gently packed into bony voids of the skeletal system (e.g., the spine, pelvis, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraft™ provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
MasterGraff™ Bone Void Filler is made of medical grade combination of hydroxyapatite and ßtricalcium phosphate. MasterGraft™ is provided in a 60 percent hydroxyapatite and 40 percent ßtricalcium phosphate formulation. Alternatively, MasterGraft™ may be provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MasterGraft™ is an osteoconductive porous implant.
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, 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): 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.
Not Found
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.
Not Found
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.
0
KOI2506
7 2002 MAR
Medtronic Sofamor Danek MasterGraft™ Bone Void Filler 510(K) Summary March 2002
Medtronic Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: MasterGraft™ Bone Void Filler II.
Product Description III.
MasterGraff™ Bone Void Filler is made of medical grade combination of hydroxyapatite and ßtricalcium phosphate. MasterGraft™ is provided in a 60 percent hydroxyapatite and 40 percent ßtricalcium phosphate formulation. Alternatively, MasterGraft™ may be provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MasterGraft™ is an osteoconductive porous implant.
IV. Indications
MasterGraft™ Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Bone Void Filler is to be gently packed into bony voids of the skeletal system (e.g., the spine, pelvis, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraf™ provides a bone void filler that resorbs and is replaced with bone during the healing process.
V. Substantial Equivalence
Documentation was provided which demonstrated the MasterGraft™ Bone Void Filler to be substantially equivalent to other previously cleared bone void fillers.
1
Image /page/1/Picture/1 description: The image is a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing strength and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2002 MAR
Richard W. Treharne, Ph.D. Sr. Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K012506
MasterGraft™ Bone Void Filler Regulatory Class: unclassified Product Code: MQV Dated: December 5, 2001 Received: December 7, 2001
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, 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. 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
2
Page 2 - Richard W. Treharne, Ph.D.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 N Milbersen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
for Mark N Millerson
al, Restorative
510(k) Number
3
510(k) Number (if known):
MasterGraft Bone Void Filler Device Name:
Indications for Use:
MasterGraft™ Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Bone Void Filler is to be gently packed into bony voids of the skeletal system (e.g., the spine, pelvis, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraft™ 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
(Per 21 CFR 801.109)
| (Optional 1-2-96) | |
|---|---|
| --------------------------------------------------------------- | -- |
OR
| Over-the-counter Use | ____________________ |
|---|---|
| ---------------------- | ---------------------- |
for Mark A. Mellema
Division Sign-Off
, Restorative and Neurologica
510(k) Number K012506