(59 days)
Not Found
No
The summary describes a bone graft material and its performance in animal studies, with no mention of AI or ML technology.
No
The device is a bone graft substitute and void filler, which is used to aid in the healing process by providing a scaffold for new bone growth, rather than treating a disease or condition directly.
No
The device is described as a "bone graft substitute and bone void filler" and is intended for use in the skeletal system to fill voids and gaps. Its function is to be "resorbed/ remodeled and is replaced by host bone during the healing process," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is comprised of physical components: human demineralized cortical bone fibers, non-demineralized cortical bone fibers, and an absorbable PGA mesh pouch. 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 MAGNIFUSE® Bone Graft is a "bone graft substitute and bone void filler" used in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the composition of the bone graft material and its packaging. This aligns with a medical device used for implantation or filling, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, MAGNIFUSE® Bone Graft falls under the category of a medical device used for surgical and regenerative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MAGNIFUSE® Bone Graft is intended for use as a bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. MAGNIFUSE Bone Graft is resorbed/ remodeled and is replaced by host bone during the healing process.
Product codes
MQV, MBP
Device Description
MAGNIFUSE® Bone Graft is comprised of human demineralized cortical bone fibers mixed with non-demineralized cortical bone fibers sealed in an absorbable PGA mesh pouch to form the final product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., posterolateral spine and pelvis)
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
In vivo studies of both subject and predicate MAGNIFUSE Bone Graft implants in animals showed remodeling and fusion rates comparable to each other and to autograft bone. Osteoinductivity studies in an athymic rat model also showed comparable osteoinductivity scores for the subject and predicate MAGNIFUSE Bone Grafts.
Key Metrics
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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K123691 PAGE 1 OF 3
JAN 3 1 2013
510(K) Summary - MAGNIFUSE® Bone Graft
A summary of Safety And Effectiveness Information (In accordance with the requirements of 21CFR 807.92)
November 12, 2012
- Company: Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (732)-578-6697 (732) 389-3095 Fax:
Establishment Registration: 1030489
Contact:
IV.
Muriel Ashie Principal Regulatory Affairs Specialist
II. Name of Product: Proprietary Trade Name: Common Name:
MAGNIFUSE® Bone Graft Demineralized Bone Matrix Allograft
Classification Name(s): Resorbable Bone Void Filler III. Device Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV, MBP
Description and Purpose of Application: MAGNIFUSE® Bone Graft is comprised of human demineralized cortical bone fibers mixed with non-demineralized cortical bone fibers sealed in an absorbable PGA mesh pouch to form the final product.
The purpose of this 510(k) is to request a change in formulation in MAGNIFUSE® Bone Graft. The predicate device is a combination of demineralized bone matrix in a fiber form and partially demineralized cortical chips while the subject device is a combination of demineralized bone matrix in a fiber form and non-demineralized cortical fibers.
1
V. Indications for Use:
MAGNIFUSE® Bone Graft is intended for use as a bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. MAGNIFUSE Bone Graft is resorbed/ remodeled and is replaced by host bone during the healing process.
- Identification of the Legally Marketed Predicate Devices Use to Claim VI. roomfoal - 02- 11- 02-2008 - 02-2009 - 02-2008 - 02-2008 - 10/16/2008];
| Predicate Devices: | MAGNIFUSE Bone Graft K082615, SE 10/16/200 |
|---|---|
| (Cleared as Grafton II eDBM) | |
| GRAFTON DBM [K051195, SE 12/16/2005] | |
| Regulation Number: 21 CFR 888.3045 | |
| Regulation Name: | Resorbable calcium salt bone void filler device |
| Product Code: | MQV, MBP |
The MAGNIFUSE Bone Graft that is the subject of this 510(k) is substantially equivalent to the previously cleared MAGNIFUSE Bone Graft referenced above.
Summary of Technical Characteristics of Subject Device Compared To VII. Predicate Device
The MAGNIFUSE® Bone Graft that is the subject of this 510(k) is substantially equivalent to the above mentioned predicate MAGNIFUSE Bone graft device with respect to the design features and materials. The predicate and subject MAGNIFUSE devices both consist of human cortical bone allograft tissue contained in a sealed poly(glycolic acid; PGA) mesh pouch. The allograft bone component in both the predicate and subject MAGNIFUSE consists of demineralized bone matrix (DBM) in a fiber form as an osteoinductive component, combined with an osteoconductive cortical bone allograft component, specifically, partially demineralized cortical chips in predicate MAGNIFUSE and non-demineralized cortical fibers in the subject MAGNIFUSE.
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K123691
PAGE 3 OF 3
Based on similar material composition, similar Indications for Use statement, identical operating principles, identical finished product specifications and equivalent performance in an animal model, the subject MAGNIFUSE Bone Graft, is substantially equivalent to the predicate MAGNIFUSE Bone Graft.
VIII. Performance Data
In vivo studies of both subject and predicate MAGNIFUSE Bone Graft implants in animals showed remodeling and fusion rates comparable to each other and to autograft bone. Osteoinductivity studies in an athymic rat model also showed comparable osteoinductivity scores for the subject and predicate MAGNIFUSE Bone Grafts.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract figures that are connected and appear to be in motion. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated % Ms. Muriel Ashie Principal Regulatory Affairs Associate 1800 Pyramid Place Memphis, Tennessee 38132
Letter dated: January 31, 2013
Re: K123691
Trade/Device Name: MAGNIFUSE® Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: November 26, 2012 Received: December 3, 2012
Dear Ms. Ashie:
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
4
Page 2 - Ms. Muriel Ashie
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
K123691 510(k) Number:
MAGNIFUSE® Bone Graft Device Name:
Indications for Use
MAGNIFUSE® Bone Graft (GRAFTON® II eDBM) is intended for use as a bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. MAGNIFUSE® Bone Graft is resorbed / remodeled and replaced by host bone during the healing process.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Per 21 CFR 801.109)
OR
Over-The-Counter
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Melkerson 2013.01.31 17:21:00 -05'00'
Director, DOD - K123691