(118 days)
MAGNIFUSE® II Bone Graft is intended for use as a bone graft substitute 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® II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.
The implant in the subject device kit for MAGNIFUSE® II Bone Graft is assembled by the clinician at the time of the procedure using the supplied human bone allograft tissue matrix mixed 1:1 with autograft tissue. The mixture is packed into a polyglycolic acid (PGA) resorbable mesh bag with the supplied accessories included in the kit that consist of disposable plastic instruments spatula, funnel, and plunger. The resorbable mesh bag provides containment of the allograft/autograft mixture to prevent migration of the grafting material. The allograft component is comprised of processed human cortical allograft bone particles consisting of demineralized bone matrix (DBM) in a fiber form and non-demineralized cortical fibers.
The provided document is a 510(k) Premarket Notification for MAGNIFUSE® II Bone Graft. This document primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the device itself against specific numerical targets.
The device is a resorbable calcium salt bone void filler that includes a human bone allograft tissue matrix. The purpose of this specific 510(k) application (K131673) is to modify the composition, ratio, and processing technique of the allograft component to improve donor utilization.
Therefore, the "acceptance criteria" discussed are largely tied to demonstrating that these modifications do not alter the substantial equivalence to the predicate devices in terms of safety and effectiveness.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the modified device's performance, as evaluated through non-clinical testing, is equivalent to that of the predicate device. Direct numerical performance targets for the final product are not explicitly stated as acceptance criteria in the document in the way one might see for a diagnostic device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Allograft Component: Equivalent composition, ratio, and processing method to predicate K123691. | "Identical" to K123691 (S.E. 01/31/2013) for Demineralized Bone Matrix (DBM) in fiber form, non-demineralized fibers, allograft ratio, and processing method of DBM fibers. |
| Bone Formation Capabilities: Equivalency in bone formation to predicate K123691. | Rabbit posterolateral lumbar spinal fusion study demonstrated "equivalency" to predicate MAGNIFUSE® Bone Graft device K123691 in manual palpation and radiographic results. |
| Osteoinductivity: Consistently produce demineralized bone matrix that is osteoinductive. | "Proprietary processing method that has been shown to consistently produce demineralized bone matrix that is osteoinductive in an athymic rat assay." Confirmed via ongoing testing utilizing a five-point linear scale (0, 1, 2, 3, 4) to score bone formation at 28 days post implantation. |
| Viral Inactivation: Validation of processing steps to inactivate target viruses. | Proprietary processing steps (demineralizing acid soaks, alcohol soaks, dehydration, supercritical CO2 for non-demineralized fibers) "have been shown and validated to inactivate viruses including: HIV-1; hepatitis B virus (duck hepatitis virus as model); hepatitis C virus (bovine diarrhea virus as model), CMV; and Polio virus." |
| Overall Equivalence: Identical Indications for Use, Fundamental Scientific Technology, Basic Design, Performance, Sterilization, Shelf-Life, Packaging, Use of Rigid Fixation, Safety and Effectiveness profile, PGA Mesh bag Closure Mechanism to predicate K122513. | All listed features are reported as "Identical" to K122513 (S.E. 03/06/2013). |
2. Sample Size Used for the Test Set and Data Provenance
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Rabbit Posterolateral Lumbar Spinal Fusion Study:
- Sample Size: Not explicitly stated how many rabbits were used.
- Data Provenance: Prospective, animal study (rabbit), conducted to evaluate the proposed allograft formulation change. Country of origin not specified, but the submission is from a US-based company, suggesting the study was likely conducted in the US or in a manner compliant with US regulations.
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Athymic Rat Assay for Osteoinductivity:
- Sample Size: Not explicitly stated for initial validation, but mentions "ongoing testing" of finished product. The reference Edwards et al; Clinical Orthopaedics, December 1998, Vol 357 typically would contain details about sample size for the original method validation.
- Data Provenance: Prospective, animal study (athymic rat). Country of origin not specified, but likely US-based due to the submitter's location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of human experts establishing "ground truth" in the context of diagnostic interpretation for this bone graft device. The studies described are animal model studies evaluating biological response (bone formation) and viral inactivation, not human diagnostic performance.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study requiring adjudication of human interpretative results. The evaluation methods for the animal studies (manual palpation, radiography, athymic rat assay scores) are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a bone graft, not a diagnostic imaging AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bone graft, not a diagnostic algorithm.
7. The Type of Ground Truth Used
- For Bone Formation: The "ground truth" for the rabbit posterolateral lumbar spinal fusion study would be the direct observation and measurement of bone formation in the animal model, likely assessed via histological analysis, micro-CT, and potentially biomechanical testing, in addition to manual palpation and radiography.
- For Osteoinductivity: The "ground truth" for the athymic rat assay is the observation and scoring (0-4 linear scale) of bone formation within the implanted material at 28 days post implantation, indicating its osteoinductive capacity.
- For Viral Inactivation: The "ground truth" is the quantitative reduction of infectious viral particles (as measured in validated lab assays) after exposure to the processing steps.
8. The Sample Size for the Training Set
Not applicable in the context of this biological device. There is no "training set" as understood for AI/machine learning models. The development of the device's formulation and processing methods would be analogous to a "training" phase, where various formulations and processes are tested to achieve desired properties. However, specific "sample sizes" for such development trials are not detailed here.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" with established ground truth in the AI/ML sense. The "ground truth" for the development of the bone graft would involve iterative laboratory and animal testing to assess performance characteristics (e.g., cell viability, mechanical properties, in vitro osteoinductivity, in vivo bone formation) of various formulations. These development phases are not detailed in a 510(k) summary, which focuses on the final validation of the modified product.
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510(K) Summary
| SUBMITTER NAME & ADDRESSS: | Medtronic Sofamor Danek USA, Inc1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738Establishment Registration: 1030489 |
|---|---|
| OCT 0 3 2013 | |
| CONTACT PERSON: | Kelly AnglinSenior Regulatory Affairs Specialist |
| DATE PREPARED: | October 02, 2013 |
II. PROPOSED PROPRIETARY TRADE NAME: MAGNIFUSE® II Bone Graft
| DEVICE CLASSIFICATION NAME: | Resorbable Calcium Salt Bone Void Filler |
|---|---|
| REGULATION NUMBER: | 21 CFR 888.3045 |
| CLASSIFICATION PRODUCT CODE: | MQV, MBP |
| CLASS: | II |
III. IDENTIFICATION OF LEGALLY MARKETED DEVICES:
| Table I. LEGALLY MARKETED DEVICES | ||||
|---|---|---|---|---|
| Device name | 510(k) number | Substantial Equivalence date | ||
| MAGNIFUSE® Bone Graft | K 123691 | 01/31/2013 | ||
| MAGNIFUSE® II Bone Graft K122513 | 03/06/2013 |
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K131673 Page 2 of 5
IV. DEVICE DESCRIPTION:
The implant in the subject device kit for MAGNIFUSE® II Bone Graft is assembled by the clinician at the time of the procedure using the supplied human bone allograft tissue matrix mixed 1:1 with autograft tissue. The mixture is packed into a polyglycolic acid (PGA) resorbable mesh bag with the supplied accessories included in the kit that consist of disposable plastic instruments spatula, funnel, and plunger. The resorbable mesh bag provides containment of the allograft/autograft mixture to prevent migration of the grafting material.
The allograft component of the predicate MAGNIFUSE® Bone Graft K123691 (S.E. 01/31/2013) and subject MAGNIFUSE® II Bone Graft is comprised of processed human cortical allograft bone particles. The particles consist of demineralized bone matrix (DBM) in a fiber form as an osteoinductive component combined with non-demineralized cortical fibers as the osteoconductive component. The allograft bone is derived from human tissue recovered in the U.S. by FDA registered tissue bank establishments. The tissue is recovered from a cadaveric donor using aseptic surgical techniques and has been microbiologically tested during recovery. Incoming donor bone tissue is subjected to various screening and testing requirements before it is released for processing in accordance with FDA requirements for donor suitability/eligibility. The final product in packaged form is tested for sterility according to the procedures in the current U.S. Pharmacopoeia USP standard <71>.
The purpose of this 510(k) application is to modify the current composition, the ratio and processing technique of the allograft component contained in the subject MAGNIFUSE® II Bone Graft device to improve donor utilization. These proposed modifications to the allograft component are identical to the predicate MAGNIFUSE® Bone Graft K123691 (S.E. 01/31/2013). Refer to Table 2 below for the summary of the technological characteristics related to the allograft component contained in the subject device. All other aspects of the subject MAGNIFUSE® II Bone Graft device are identical to the
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K131673 Page 3 of 5
predicate MAGNIFUSE® II Bone Graft K122513 (S.E. 03/06/2013) device with the exception of the changes to the allograft component mentioned above. Refer to Table 3 below for the summary of the technological characteristics. The detailed descriptions are outlined in the substantial equivalence discussion section of this 510(k).
V. INDICATIONS FOR USE:
MAGNIFUSE® II Bone Graft is intended for use as a bone graft substitute 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® II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.
| Comparison Feature | SubjectMAGNIFUSE® II BoneGraft | Predicate MAGNIFUSE®Bone Graft (K123691 S.E.01/31/2013) |
|---|---|---|
| Allograft componentDemineralized Bone Matrix (DBM) in fiber form Non-demineralized fibers | Identical | K123691 S.E. 01/31/2013 |
| Allograft Ratio | Identical | K123691 S.E. 01/31/2013 |
| Processing Method of DBMfibers | Identical | K123691 S.E. 01/31/2013 |
VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:
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| Table 3: Summary of the technological Characteristics | ||
|---|---|---|
| Comparison Feature | SubjectMAGNIFUSE® II BoneGraft | Predicate MAGNIFUSE® II BoneGraft (K122513 S.E. 03/06/2013) |
| Indication for Use | Identical | K122513 S.E. 03/06/2013 |
| FundamentalScientific Technology• OperatingPrinciple• Mechanism ofAction | Identical | K122513 S.E. 03/06/2013 |
| Basic Design | Identical | K122513 S.E. 03/06/2013 |
| Performance | Identical | K122513 S.E. 03/06/2013 |
| Sterilization | Identical | K122513 S.E. 03/06/2013 |
| Shelf-Life | Identical | K122513 S.E. 03/06/2013 |
| Packaging | Identical | K122513 S.E. 03/06/2013 |
| Use of rigid fixation | Identical | K122513 S.E. 03/06/2013 |
| Safety andEffectiveness profile | Identical | K122513 S.E. 03/06/2013 |
| PGA Mesh bagClosure Mechanism | Identical | K122513 S.E. 03/06/2013 |
VII. DISCUSSION OF NON-CLINICAL TESTING:
Non-clinical testing was performed in accordance with FDA Recognized Consensus Standards and FDA Guidelines, where applicable. A rabbit posterolateral lumbar spinal fusion study was conducted to evaluate the bone formation capabilities of the subject device related to the proposed allograft formulation change from cortical bone chips/fibers to cortical bone fiber/fiber formulation. The manual palpation and radiographic results for the subject device demonstrates equivalency to the predicate MAGNIFUSE® Bone Graft device K123691 (S.E. 01/31/2013). The complete test report and summary can be found in the Animal Performance Testing section of this application.
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The allograft component of the subject device will be processed via a proprietary processing method that has been shown to consistently produce demineralized bone matrix that is osteoinductive in an athymic rat assay. Like the predicate MAGNIFUSE® Bone Graft device K123691 (S.E. 01/31/2013), the tissue processing of the subject will be confirmed via ongoing testing of finished product for osteoinductivity in this validated athymic rat assay utilizing a five-point linear scale (0, 1, 2, 3, 4) to score bone formation at 28 days post implantation*. Bone formation in the athymic rat surrogate assay should not be interpreted as a predictor of clinical performance.
- Edwards etal; Osteoinduction of Human Demineralized Bone: Characterization in a Rat Model. Clinical Orthopaedics, December 1998, Vol 357.
Viral inactivation of the demineralized fibers in the subject MAGNIFUSE® II Bone Graft device includes proprietary processing steps of demineralizing acid soaks followed by alcohol soaks and dehydration. Viral inactivation of the non-demineralized cortical fibers in the subject device is provided by alcohol soaks and by dehydration using supercritical CO2. These processing steps that have been shown and validated to inactivate viruses including: HIV-1; hepatitis B virus (duck hepatitis virus as model); hepatitis C virus (bovine diarrhea virus as model), CMV; and Polio virus. These processes further reduce the risk of disease transmission via the use of this product beyond the protection provided by donor testing and screening procedures.
VIII. CONCLUSION:
Documentation provided in this submission demonstrates that the subject device is substantially equivalent to the previously cleared MAGNIFUSE® Bone Graft device K 123691 (S.E. 01/31/2013) for the allograft component and MAGNIFUSE® II Bone Graft K122513 (S.E. 03/06/2013) for all other aspects of the subject device.
The subject device is substantially equivalent to predicate MAGNIFUSE® II Bone Graft in several categories including: indication, material components, sterility, shelf-life, and biocompatibility.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2013
Medtronic Sofamor Danek USA, Incorporated Ms. Kelly Anglin Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re: K131673
Trade/Device Name: MAGNIFUSE® II 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: August 14, 2013 Received: August 16, 2013
Dear Ms. Anglin:
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
Image /page/5/Picture/10 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is bolded. The image is in black and white.
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Page 2 - Ms. Kelly Anglin
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.
Erin Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/7/Picture/0 description: The image shows a handwritten string of characters, seemingly a code or identifier. The characters are 'K131673', written in a cursive style with thick, dark strokes. The handwriting is clear and legible, with each character distinct and easily identifiable.
510(k) Number (if known):
Device Name: MAGNIFUSE® II Bone Graft
INDICATIONS FOR USE:
MAGNIFUSE® II Bone Graft is intended for use as a bone graft substitute 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® II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurence D. Coyne -S
Page 1 of 1
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131673
§ 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.