(89 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 can be used in the pelvis and extremities. The MTF New Bone Void Filler can be used as an extender in the pelvis and extremities with autograft or allograft. The MTF New Bone Void Filler can be used with bone marrow aspirate, blood or saline.
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 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 describes the MTF New Bone Void Filler and its substantial equivalence to predicate devices, focusing on safety and effectiveness information rather than specific acceptance criteria from a clinical study for device performance. It emphasizes the osteoinductive potential demonstrated in an athymic mouse model, but explicitly states that the correlation with clinical performance in human subjects is unknown.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be found in the provided document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Osteoinductive potential (in athymic mouse model) | Must prove positive for lot release (standard testing performed in an athymic mouse model). |
| Sterility (USP <71>) | Aseptically processed and passes USP <71> Sterility Tests. |
| Viral Clearance/Inactivation | Demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses. |
| Substantial Equivalence | Demonstrated to be substantially equivalent to predicate devices in the animal study provided within this submission. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any study mentioned.
- Data Provenance: The primary "study" mentioned for establishing osteoinductive potential is an "athymic mouse model." This indicates an animal study. No human data (retrospective or prospective) is described for device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for osteoinductive potential was based on observations in the athymic mouse model and for sterility on standard USP testing. The concept of expert consensus for ground truth as typically understood in diagnostic studies is not relevant here.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. The evaluations mentioned (e.g., osteoinductive potential in mice, sterility testing) are objective tests, not subjective interpretations requiring adjudication.
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:
- MRMC Study: No. This device is a bone void filler, not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is a medical device (bone void filler), not an algorithm. The concept of standalone algorithm performance does not apply.
7. The type of ground truth used:
- Ground Truth for Osteoinductive Potential: Positive result in an athymic mouse model (animal study observation).
- Ground Truth for Sterility: Passing USP <71> Sterility Tests (laboratory test result).
- Ground Truth for Viral Clearance: Demonstrated inactivation of model viruses (laboratory test result).
- Ground Truth for Substantial Equivalence: Comparison to predicate devices based on an "animal study" (details not provided) and material composition/intended use.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. The document describes a medical device, not a machine learning model that requires a training set. The "testing" referred to is for lot release and safety/equivalence rather than machine learning model development.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set mentioned for a machine learning model.
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JAN 2 4 2012
MTF New Bone Void Filler 510(k) Premarket Notification
KII367
PAGE 1 OF 3
VII. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
Name: Musculoskeletal Transplant Foundation Contact: Nancy Joy Senior Regulatory Affairs Submission Specialist
Address:
125 May Street Edison, NJ 08837 USA
Telephone: Fax:
(732) 661-2381 (732) 661-2189
Date Prepared
October 19, 2011
General Device Information
Product Name:
The MTF New Bone Void Filler
Classification:
Bone Void Filler Containing Human Bone 21 CFR §888.3045 - Product code: MBP, MOV Class II
· Predicate Devices
DBX® Demineralized Bone Matrix Musculoskeletal Transplant Foundation 510(k) K040262, K103784, K103795
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 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 can be used in the pelvis and extremities. The MTF New Bone Void Filler can be used as an extender in the pelvis and extremities with autograft or allograft. The MTF New Bone Void Filler can be used with bone marrow aspirate, blood or saline.
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 MTF New Bone Void Filler 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 [K040262, K103784, K103795] 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 animal study provided within this submission.
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K113167 PAGE 3 OF 3 MTF New Bone Void Filler 510(k) Premarket Notification
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 donor suitability criteria used to screen this donor are in compliance with the FDA regulations published in 21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue Based Products.
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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
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
JAN 2 4 2012
Re: K113167
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: Class II Product Code: MQV, MBP Dated: October 25, 2011 Received: October 27, 2011
Dear Ms. Joy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your co determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfall 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 r ou may) ateresy majors 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 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 1 tease be day isou may 1 Dr wintian that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I oderal states and securements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Or ice rated 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
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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V. INDICATIONS FOR USE
510(k) Number (if known): not known
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 traumatic injury. It can be used in the pelvis and extremities. The MTF New Bone Void Filler can be used as an extender in the pelvis and extremities with autograft or allograft. The MTF New Bone Void Filler can be used with bone marrow aspirate, blood or saline.
The MTF New Bone Void Filler is for single patient use only.
OR Prescription Use X (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.) ﺘ
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113167
§ 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.