(283 days)
The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. It is for use in the posterolateral spine only, for posterolateral spine fusions. The MTF New Bone Void Filler must be used in the spine with bone marrow aspirate.
The MTF New Bone Void Filler is for single patient use only.
The MTF New Bone Void Filler is processed human bone that has been demineralized and combined with gelatin and sodium hyaluronate, which are naturally derived materials that are biocompatible and biodegradable. The sodium hyaluronate used in the manufacturing of the MTF New Bone Void Filler is not of animal origin. The MTF New Bone Void Filler comes in the form of a mixture of demineralized bone with gelatin and sodium hyaluronate, and a spatula that is necessary to mix the components. A hydrating agent can be used with the MTF New Bone Void Filler. Upon addition of a hydrating agent, the MTF New Bone Void Filler will achieve a flowable or moldable consistency. The resultant putty can then be manipulated by a surgeon into various shapes for ease and flexibility of use during surgical application.
The provided text does not contain detailed acceptance criteria, device performance data in a quantitative format, or descriptions of a study that would specifically prove the device meets such criteria in the manner typical of AI/medical imaging device submissions. The submission is for a "Bone Void Filler" and focuses on demonstrating substantial equivalence to predicate devices through material properties and in vitro or animal model testing, rather than human clinical trials with strict performance metrics.
Specifically, there is no mention of:
- A table of acceptance criteria with reported device performance for metrics like sensitivity, specificity, AUC, etc.
- Sample sizes for test sets (as there isn't a human clinical test set described in the context of device performance metrics).
- Data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Sample size or ground truth establishment for a training set (as this is not an AI/machine learning device).
However, I can extract the information that is present and frame it in a way that aligns with the spirit of your request, interpreting "acceptance criteria" as implicitly tied to the demonstration of substantial equivalence and safety/effectiveness for this type of device.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Given that K110003 is a 510(k) premarket notification for a Bone Void Filler, the primary "acceptance criterion" is demonstrating substantial equivalence to legally marketed predicate devices, along with evidence of safety and effectiveness. This is achieved by comparing the new device's technological characteristics, intended use, and performance to those of the predicate.
The key study mentioned is an animal model study, and lot release testing, to support the substantial equivalence claim.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence and Safety/Effectiveness) | Reported Device Performance/Evidence |
|---|---|
| Material Composition comparable to predicates | The device is processed human bone demineralized and combined with gelatin and sodium hyaluronate, which are naturally derived, biocompatible, and biodegradable. The sodium hyaluronate is not of animal origin. This composition is compared to DBX and DBX Strip. |
| Intended Use comparable to predicates | Intended for use as a Demineralized Bone Matrix for voids or gaps not intrinsic to bony structure stability, for surgically created or traumatic osseous defects. Indicated for posterolateral spine only, in posterolateral spine fusions, and must be used with bone marrow aspirate. This matches the indication claims of the predicate devices. |
| Osteoconductivity | The MTF New Bone Void Filler is stated to be osteoconductive. |
| Osteoinductive Potential (as demonstrated in an in vivo model) | Demonstrated osteoinductive potential in an athymic mouse model. Every lot of final product is tested to ensure this potential; standard testing in an athymic mouse model must prove positive for lot release. |
| Sterility | Aseptically processed and passes USP <71> Sterility Tests. |
| Viral Clearance/Inactivation | Viral inactivation testing demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses. The BVF process further reduces risk beyond donor testing and screening. |
| Biocompatibility | Materials (gelatin, sodium hyaluronate) are naturally derived, biocompatible, and biodegradable with an established history of use. |
| Performance in an in vivo model (comparative) | The study "New Generation DBX Putty (DBM Putty III) Tested in a Rabbit Model of Posterolateral Lumbar Fusion" demonstrated the new device to be substantially equivalent to its predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The primary "test set" in the context of demonstrating equivalence for this non-AI bone graft device is an in vivo animal study combined with in vitro testing.
- Sample Size: The specific sample size for the "Rabbit Model of Posterolateral Lumbar Fusion" study is not provided in the given text.
- Data Provenance: The study was conducted in a rabbit model, implying an animal study rather than human data. The geographical origin of the study is not specified, but it's presented by a US-based foundation (Musculoskeletal Transplant Foundation). It is inherently a prospective study if referring to the animal experimentation conducted to compare the new device to predicates.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts & Qualifications: This section is not applicable as the ground truth for an animal model study (e.g., fusion success, bone formation) would typically be established by veterinary pathologists, histologists, and/or radiologists specializing in animal models, not human medical experts in the context of clinical interpretation. The text does not provide these details.
4. Adjudication Method for the Test Set
- Adjudication Method: This is not applicable as the data presented is not based on expert interpretation of images or clinical outcomes in human subjects requiring an adjudication panel. Outcomes in an animal fusion model would typically be assessed objectively (e.g., imaging, histology, biomechanical testing).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret patient cases with and without AI assistance to measure reader performance improvement. This device is a bone void filler, not a diagnostic imaging AI.
6. Standalone Performance Study (Algorithm Only)
- Standalone Study: No, a standalone performance study (algorithm only) was not done. This is also relevant for AI/machine learning algorithms. The device is a physical bone void filler.
7. Type of Ground Truth Used
- Ground Truth Type:
- For Osteoinductive Potential: The ground truth is established by positive results in an athymic mouse model (likely histological evidence of ectopic bone formation).
- For the Rabbit Model of Posterolateral Lumbar Fusion: The ground truth for fusion outcomes would typically be based on a combination of radiographic evidence, CT imaging, and potentially histopathological analysis of explanted spines after a defined healing period. The specific details are not provided in the summary.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical medical device, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. As there is no AI/machine learning component, there is no training set or ground truth establishment for such a set.
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OCT 1 3 2011
VII. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
| Name: | Musculoskeletal Transplant Foundation |
|---|---|
| Contact: | Nancy JoySenior Regulatory Affairs Submission Specialist |
| Address: | 125 May StreetEdison, NJ 08837 USA |
| Telephone: | (732) 661-2381 |
| Fax: | (732) 661-2189 |
| Date Prepared | December 23, 2010 |
| General Device Information | |
| Product Name: | The MTF New Bone Void Filler |
| Classification: | Bone Void Filler Containing Human Bone21 CFR §888.3045 – Product code: MBP, MQVClass II |
| Predicate Devices |
DBX® Demineralized Bone Matrix Musculoskeletal Transplant Foundation 510(k) K080399
DBX Strip® Musculoskeletal Transplant Foundation 510(k) K042829, K062205
Osteoinductive Potential
The MTF New Bone Void Filler is osteoconductive and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final product is tested to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse model must prove positive for lot release. It is unknown how the osteoinductive potential, measured in the athymic mouse model, will correlate with clinical performance in human subjects.
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Description
The MTF New Bone Void Filler is processed human bone that has been demineralized and combined with gelatin and sodium hyaluronate, which are naturally derived materials that are biocompatible and biodegradable. The sodium hyaluronate used in the manufacturing of the MTF New Bone Void Filler is not of animal origin. The MTF New Bone Void Filler comes in the form of a mixture of demineralized bone with gelatin and sodium hyaluronate, and a spatula that is necessary to mix the components. A hydrating agent can be used with the MTF New Bone Void Filler. Upon addition of a hydrating agent, the MTF New Bone Void Filler will achieve a flowable or moldable consistency. The resultant putty can then be manipulated by a surgeon into various shapes for ease and flexibility of use during surgical application.
Intended Use (Indications)
The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. It is for use in the posterolateral spine only, for posterolateral spine fusions. The MTF New Bone Void Filler must be used in the spine with bone marrow aspirate.
The MTF New Bone Void Filler is for single patient use only.
Viral Clearance and Inactivation
A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The viral inactivation testing demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses. The BVF process further reduces the risk of viral contamination beyond donor testing and screening procedures.
Substantial Equivalence .
This submission supports the position that the MTF New Bone Void Filler is substantially equivalent to a number of previously cleared devices, including:
DBX® Demineralized Bone Matrix - Musculoskeletal Transplant Foundation [K080399] DBX Strip® - Musculoskeletal Transplant Foundation [K042829, K062205]
When comparing the MTF New Bone Void Filler to its predicate devices, there are no new types of safety and effectiveness questions. The MTF New Bone Void Filler has been demonstrated to be substantially equivalent to its predicate devices in the study "New Generation DBX Putty (DBM Putty III) Tested in a Rabbit Model of Posterolateral Lumbar Fusion "
Safety and Effectiveness Information
The MTF New Bone Void Filler is single-donor processed. The MTF New Bone Void Filler is aseptically processed and passes USP <71> Sterility Tests. The MTP Trieria used to screen this donor are in compliance with the FDA regulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation.
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Conclusion
Musculoskeletal Transplant Foundation believes that the information provided in this 510(k) submission establishes that similar legally marketed devices have been used for the same clinical applications as the MTF New Bone Void Filler. The materials from which the MTF New Bone Void Filler is fabricated have an established history of use, and the device has been tested in accordance with applicable FDA guidelines.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Nancy Joy Musculoskeletal Transplant Foundation 125 May Street Edison, New Jersey 08837
OCT 1 3 2011
Re: K110003
Trade/Device Name: MTF New Bone Void Filler (BVF) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device
Regulatory Class: Close U Regulatory Class: Class II Product Code: MQV, MBP Dated: October 5, 2011 Received: October 6, 2011
Dear Ms. Joy:
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 Devices marketed in interstate
devices that have been reclassified in accordance with the Medical Device Ame devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, Inc.
and Cosmetic Act (Act) that do not require approvisions of the Federal F and Cosmetic Act (Act (Act that do not require approval of the Federal Food, Drug,
You may, therefore, market the device, subject to the seems You may, therefore, market the device, subject to the general oontrols provisions of PMA).
general controls provisions of the Act include requirements provisions of the Act. general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misting and adulteration.
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 resultations of may be subject to additional controls. Existing major regulations affectives your device care in (PMA)
found in the Code of Federal Repulations Title 2 , Regulations affect 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 ather requirements of t or any Federal statute and regulations administered by other requirements of f
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 do: registration and l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting and listing);
device-related adverse events) (21 CFR Part 801); medical device reporting of med device-related adverse events) (21 CFR 803); good manufacturing of medical (2006)
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Ms. Nancy Joy
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/CDRH0ffices/ucm115809.html for the Center for Devices and Badiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misblanding 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.fdagov/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 the many of School the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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MTF New Bone Void Filler 510(k) Premarket Notification
V. INDICATIONS FOR USE
510(k) Number (if known): K110003
Device Name: MTF New Bone Void Filler
Indications for Use:
The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from the traumatic injury. It is for use in the posterolateral or osserolateral spine first of control from thisions. The MTF New Bone Void Filler must be used in the spine with bone marrow aspirate.
The MTF New Bone Void Filler is for single patient use only.
Prescription Use x OR (Per 21 CFR 801 Subpart D)
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF
NEEDED \ NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110003
§ 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.