(154 days)
No
The device description and performance studies focus on the biological properties and processing of demineralized bone matrix, with no mention of AI or ML.
Yes
The device, DBX® Inject, is intended for the treatment of surgically created osseous defects or defects from traumatic injury, which clearly defines a therapeutic purpose.
No
The device, DBX Inject, is a demineralized bone matrix intended for filling osseous defects. It is a therapeutic device used in surgical procedures and does not perform any diagnostic functions.
No
The device description clearly states it is composed of donated bone and sodium hyaluronate, delivered via a plastic syringe, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of DBX® Inject is for filling bone voids or gaps in the body during surgery. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a bone graft material (Demineralized Bone Matrix) delivered via a syringe. This is a surgical implant/material, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue) to diagnose a condition or provide information about a patient's health status.
- Performance Studies: The performance studies focus on the osteoinductive potential of the bone matrix and viral inactivation, which are relevant to the safety and efficacy of a bone graft material, not a diagnostic test.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. DBX® Inject is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows:
Indications for Use | Putty | Paste |
---|---|---|
Extremities | √ | √ |
Posterolateral spine | √ | |
Pelvis | √ | √ |
DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject Putty can be used as an extender in the spine with autograft. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.
Product codes
MBP, MQV
Device Description
DBX® Inject is completely resorbable and is composed of donated cortical and cancellous bone. The bone granules are mixed with sodium hyaluronate (Hy). DBX® Inject consists of DBX Putty or Paste with a separate, sterile plastic syringe for delivery directly into the operative site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Extremities, Posterolateral spine, Pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Osteoinductive Potential:
DBX® Inject is osteoconductive, and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final DBX® Inject Paste will be assayed in vivo for osteoinductive potential. Every lot of final DBX® Inject Putty product will be tested in an athymic mouse model or in an alkaline phosphatase assay, which has been shown to have a positive correlation with the athymic mouse model, to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse or alkaline phosphatase assay must prove positive for lot release. It is unknown how the osteoinductive potential, measured in the athymic mouse model or the alkaline phosphatase assay, will correlate with clinical performance in human subjects.
Viral Clearance and Inactivation:
The method for processing the demineralized bone matrix contained in DBX® Inject was evaluated for its viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
SEP 2 8 2009
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
General Company Information
Musculoskeletal Transplant Foundation Name: Nancy Bennewitz Joy Contact: Regulatory Affairs Submission Specialist
Address: | |||
---|---|---|---|
125 May Street Edison, NJ 08837 USA
Telephone: Fax: Email:
(732) 661-2381 (732) 661-2189 Nancy Joy@mtf.org
Date Prepared
August 5, 2009
General Device Information
Product Name:
DBX® Inject
Classification:
Bone Void Filler Containing Human Demineralized Bone Matrix (DBM) 21 CFR §888.3045 - Product code: MBP, MQV Class II
Predicate Devices
DBX® Demineralized Bone Matrix Musculoskeletal Transplant Foundation 510(k) K040262
Sygnal™ DBM Musculoskeletal Transplant Foundation 510(k) K080405
1
Description
DBX® Inject is completely resorbable and is composed of donated cortical and cancellous bone. The bone granules are mixed with sodium hyaluronate (Hy). DBX® Inject consists of DBX Putty or Paste with a separate, sterile plastic syringe for delivery directly into the operative site.
Intended Use (Indications)
DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows:
Indications for Use | Putty | Paste |
---|---|---|
Extremities | √ | √ |
Posterolateral spine | √ | |
Pelvis | √ | √ |
DBX® Inject is indicated for treatment of surgically created osseous defects or DBX - Info. In the matic injury. DBX® Inject Putty can be used as an extender in the spine with autograft. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.
Substantial Equivalence
This submission supports the position that DBX® Inject is substantially equivalent to a number of previously cleared devices, including:
DBX® Demineralized Bone Matrix - Musculoskeletal Transplant Foundation [K040262] Sygnal™ DBM-Musculoskeletal Transplant Foundation [K080405]
When comparing DBX® Inject to its predicate devices, there are no new types of safety and effectiveness questions. DBX® Inject has been demonstrated to be substantially equivalent to its predicate devices.
2
Osteoinductive Potential:
DBX® Inject is osteoconductive, and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final DBX® Inject Paste will be assayed in vivo for osteoinductive potential. Every lot of final DBX® Inject Putty product will be tested in an athymic mouse model or in an alkaline phosphatase assay, which has been shown to have a positive correlation with the athymic mouse model, to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse or alkaline phosphatase assay must prove positive for lot release. It is unknown how the osteoinductive potential, measured in the athymic mouse model or the alkaline phosphatase assay, will correlate with clinical performance in human subjects.
Viral Clearance and Inactivation:
The method for processing the demineralized bone matrix contained in DBX® Inject was evaluated for its viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses.
Safety and Effectiveness Information
DBX® Inject is single-donor processed. The donor suitability criteria 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.
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 DBX® Inject. The materials from which DBX® Inject is fabricated have an established history of use, and the device has been tested in accordance with applicable FDA guidelines.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the eagle.
SEP % 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Musculoskeletal Transplant Foundation % Ms. Nancy Bennewitz Joy Regulatory Affairs Submission Specialist 125 May Street Edison, NJ 08837
Re: K091218
Trade/Device Name: DBX® Inject Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV, MBP Dated: August 11, 2009 Received: August 12, 2009
Dear Ms. Bennewitz 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 individe 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 additional controls. Existing major regulations affecting your case in to rely 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 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.
4
Page 2 - Ms. Nancy Bennewitz Joy
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,
Sincerely yours,
Mark A. Millhiser
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K091218
Device Name: DBX® Inject
Indications for Use:
DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows:
Indications for Use | Putty | Paste |
---|---|---|
Extremities | √ | √ |
Posterolateral spine | √ | |
Pelvis | √ | √ |
DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject Putty can be used as an extender in the spine with autograft. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.
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------------------------------------------------------------------------------------------------------------------------------------------IF NEEDED.)
OR
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
FOR M.MELKERSON
(Division Sign-Off) Division of Surgical, Orthopedic, ad Restorative Devices
.(k) Number K091218
MTF®