(107 days)
Not Found
No
The device description and intended use focus on the biological composition and function of a demineralized bone matrix product, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as treating osseous defects and promoting bone growth (osteoconductive and osteoinductive potential), which clearly indicates a therapeutic purpose.
No
Explanation: The device is intended for treatment of osseous defects and acts as a bone matrix, indicating a therapeutic function rather than a diagnostic one. It is a medical product for bone repair and regeneration.
No
The device description clearly states that the device is composed of Demineralized Bone Matrix and sodium hyaluronate, which are physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that DBX Putty and DBX Inject are composed of demineralized bone matrix and sodium hyaluronate and are intended for use as a bone graft substitute to fill voids or gaps in bone. They are applied directly to the surgical site within the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is to physically fill bone defects and promote bone growth.
The information provided describes a medical device used for surgical implantation, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
DBX Putty is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX Putty can be used alone in the posterolateral spine. DBX Putty can also be used as an extender in the spine with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty is for single patient use only.
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. DBX Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX Inject can be used alone in the posterolateral spine. DBX Inject can also be used as . an extender in the spine with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject is for single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
MBP, MQV
Device Description
DBX Putty is composed of Demineralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Putty is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.
DBX Inject is composed of Demincralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Inject is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterolateral spine
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and Effectiveness Information:
This 510(k) was submitted for an addition to the indications for use of DBX® Putty in the posterolateral spine. Based on a recent in vivo study, DBX® Putty can be used as an extender in the spine with allograft. The fundamental scientific technology of the DBX® Putty with expanded indications for use in the posterolateral spinc is the same as the technology for the predicate DBX® Putty (FDA cleared, K040262).
Biocompatibility of DBX® materials has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. DBX® is single-donor processed using aseptic techniques and is tested for sterility per current USP .
OSTEOINDUCTIVE POTENTIAL
DBX Demineralized Bone Matrix is osteoconductive, and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final DBX Putty product is 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 DBM contained in DBX® 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:
This 510(k) was submitted for an addition to the indications for use of DBX® Inject in the posterolateral spine. Based on a recent in vivo study, DBX® Inject can be used as an extender in the spine with allograft. The fundamental scientific technology of the DBX® Inject with expanded indications for use in the posterolateral spine is the same as the technology for the predicate DBX® Putty (FDA cleared, K040262).
Biocompatibility of DBX® Inject matcrials has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. DBX® Inject is single-donor processed using aseptic techniques and is tested for sterility per current USP .
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 product is 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 DBM 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
103795 DBX® 510(k)
XII. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS
APR 1 3 2011
| PROPRIETARY NAME: | DBX® Demineralized Bone Matrix Putty |
|---|---|
| COMMON NAME: | Bone Void Filler Containing Human Demineralized |
| Bone Matrix (DBM) | |
| PROPOSED REGULATORY | |
| CLASS: | Class II |
| CLASSIFICATION | |
| IDENTIFICATION: | 21 C.F.R. §888.3045 Resorbable calcium salt bone |
| void filler device | |
| PRODUCT CODE: | MBP, MQV |
| SPONSOR: | Musculoskeletal Transplant Foundation |
| 125 May Street | |
| Edison, NJ 08837 | |
| 732-661-0202 |
INDICATIONS FOR USE:
DBX Putty is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX Putty can be used alone in the posterolateral spine. DBX Putty can also be used as an extender in the spine with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty is for single patient use only.
DEVICE DESCRIPTION:
DBX Putty is composed of Demineralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Putty is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.
1
SAFTEY AND EFFECTIVENESS INFORMATION:
This 510(k) was submitted for an addition to the indications for use of DBX® Putty in the posterolateral spine. Based on a recent in vivo study, DBX® Putty can be used as an extender in the spine with allograft. The fundamental scientific technology of the DBX® Putty with expanded indications for use in the posterolateral spinc is the same as the technology for the predicate DBX® Putty (FDA cleared, K040262).
Biocompatibility of DBX® materials has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. DBX® is single-donor processed using aseptic techniques and is tested for sterility per current USP .
OSTEOINDUCTIVE POTENTIAL
DBX Demineralized Bone Matrix is osteoconductive, and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final DBX Putty product is 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 DBM contained in DBX® 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.
2
XII. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| PROPREIETARY NAME: | DBX® Demineralized Bone Matrix Inject |
|---|---|
| COMMON NAME: | Bone Void Filler Containing Human Demineralized |
| Bone Matrix (DBM) | |
| PROPOSED REGULATORY | |
| CLASS: | Class II |
| CLASSIFICATION | |
| IDENTIFICATION: | 21 C.F.R. §888.3045 Resorable calcium salt bone |
| void filler device | |
| PRODUCT CODE: | MBP, MQV |
| SPONSOR: | Musculoskeletal Transplant Foundation |
| 125 May Street | |
| Edison, NJ 08837 | |
| 732-661-0202 |
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. DBX Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX Inject can be used alone in the posterolateral spine. DBX Inject can also be used as . an extender in the spine with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject is for single patient use only.
DEVICE DESCRIPTION:
DBX Inject is composed of Demincralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Inject is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.
3
SAFTEY AND EFFECTIVENESS INFORMATION:
This 510(k) was submitted for an addition to the indications for use of DBX® Inject in the posterolateral spine. Based on a recent in vivo study, DBX® Inject can be used as an extender in the spine with allograft. The fundamental scientific technology of the DBX® Inject with expanded indications for use in the posterolateral spine is the same as the technology for the predicate DBX® Putty (FDA cleared, K040262).
Biocompatibility of DBX® Inject matcrials has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. DBX® Inject is single-donor processed using aseptic techniques and is tested for sterility per current USP .
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 product is 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 DBM 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.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Musculoskeletal Transplant Foundation % Ms. Nancy Joy 125 May Street Edison, New Jersey 08837
APR, 1 3 2311
Re: K103795
Trade/Device Name: DBX® Demineralized Bone Matrix Putty and Inject Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV. MBP Dated: March 07, 2011 Received: March 10, 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 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
5
Page 2 - Ms. Nancy Joy
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.
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/ucm115809htm 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 vours.
Aiz B. M. he
fer
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
IV. INDICATIONS FOR USE
510(k) Number (if known): K103795
Device Name: DBX® Demineralized Bone Matrix Putty
Indications for Use:
DBX Putty is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX Putty can be used alone in the posterolateral spine. DBX Putty can also be used as an extender in the spine with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty 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.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103795
7
IV. INDICATIONS FOR USE
510(k) Number (if known): K103795
Device Name: DBX® Demineralized Bone Matrix 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. DBX Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX Inject can be used alone in the posterolateral spine. DBX Inject can also be used as an extender in the spine with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject 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.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative of Surgical, Original, Oricand Restorative Devices
510(k) Number K103795