(239 days)
Not Found
No
The 510(k) summary describes a demineralized bone matrix product and its testing methods. There is no mention of AI or ML in the intended use, device description, or performance studies. The testing described is standard biological and chemical analysis.
Yes
The device is intended for the treatment of surgically created osseous defects or those resulting from traumatic injury, classifying it as a therapeutic device.
No
Explanation: The device description and intended use clearly state that DBX® is a demineralized bone matrix used to fill bony voids or defects. It acts as a structural component and promotes bone growth (osteoinductive/osteoconductive), rather than diagnosing a condition or disease.
No
The device description clearly states that DBX® is a physical material (Demineralized Bone Matrix) available in Paste, Putty, and Mix forms, composed of donor bone and sodium hyaluronate. This is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that DBX® is a Demineralized Bone Matrix for filling voids or gaps in bone structures during surgery. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details the composition of the bone matrix material and its forms (Paste, Putty, Mix). This aligns with a surgical implant or bone graft substitute, not a diagnostic test.
- Performance Studies: The performance studies focus on the osteoinductive potential, biocompatibility, sterility, and viral inactivation of the bone matrix material. These are relevant to the safety and efficacy of a surgical implant, not the performance of a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing patient samples (blood, urine, tissue, etc.) to diagnose a condition, determine a patient's health status, or monitor treatment response.
While the performance studies mention an "Enzyme-Linked-ImmunoSorbent Assay (ELISA)" and "in vitro testing," these are described as methods used to test the material itself (the DBM) for its osteoinductive potential (specifically the presence of BMP-2) as a quality control measure for lot release. This is a test of the device, not a test on a patient sample for diagnostic purposes.
Therefore, DBX® is a medical device intended for surgical use, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DBX® 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 may be used in the extremities, pelvis, posterolateral spine and cranium. DBX® Mix may be used in the extremities, pelvis and spine. DBX® Paste may be used in the extremities and pelvis. DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® can be used with bone marrow. DBX® is intended for single patient use only.
Product codes
MBP, MQV, GXP
Device Description
DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of donor cortical bone; the DBX® Mix is composed of donor corticocancellous bone. The bone granules are mixed with sodium hyaluronate (Hy) in varying combinations to form the DBX® Putty, Paste, and Mix.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Extremities, Pelvis, Posterolateral Spine, Cranium, 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)
Osteoinductive potential was assessed using an athymic mouse model or an in vitro BMP-2 ELISA assay. Results from the immunoassay were correlated to the athymic mouse model for DBM alone and DBX® Putty. Biocompatibility was established through clinical use history and laboratory testing per ISO 10993. Viral inactivation potential of the DBM processing methods was evaluated using a panel of model 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
K080399 (pg. 1 of 2)
OCT 1 0 2008
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| PROPRIETARY NAME: | DBX® Demineralized Bone Matrix Putty
DBX® Demineralized Bone Matrix Paste
DBX® Demineralized Bone Matrix Mix |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 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, GXP |
| SPONSOR: | Musculoskeletal Transplant Foundation
125 May Street
Edison, NJ 08837
732-661-0202 |
INDICATIONS FOR USE:
DBX® 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 may be used in the extremities, pelvis, posterolateral spine and cranium. DBX® Mix may be used in the extremities, pelvis and spine. DBX® Paste may be used in the extremities and pelvis. DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® can be used with bone marrow. DBX® is intended for single patient use only.
DEVICE DESCRIPTION:
DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of donor cortical bone; the DBX® Mix is composed of donor corticocancellous bone. The bone granules are mixed with sodium hyaluronate (Hy) in varying combinations to form the DBX® Putty, Paste, and Mix.
1
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SAFETY AND EFFECTIVENESS INFORMATION:
This 510(k) was submitted for a change in the osteoinductivity assay for DBX® Putty. The fundamental scientific technology of the modified DBX® Putty, using BMP -2 in vitro testing as an alternative for in vivo testing for osteoinductivity, is the same as the technology for the unmodified predicate, DBX® (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 Putty is osteoconductive and has been shown to have osteoinductive potential in an athymic mouse model. DBX® Putty has been shown to contain the native, i.e., endogenous, Bone Morphogenetic Protein, BMP-2, as detected by an Enzyme-Linked-ImmunoSorbent Assay (ELISA).
Every final lot of DBX® Putty is tested in an in vivo athymic mouse model or, alternatively, each lot of DBM incorporated into DBX® Putty is assayed in vitro using the BMP-2 ELISA as a surrogate test market for osteoinductive potential. Standard testing performed in an athymic mouse model or in the BMP-2 assay must prove positive for lot release. Results from this immunoassay were correlated to the athymic mouse model for the DBM alone and the DBX® Putty. Although only one bone-derived endogenous protein is used as the test marker, i.e., BMP-2, it is the combination of various proteins that is responsible for its osteoinductive potential.
Testing each lot of DBM with this immunoassay assures that only DBM with osteoinductive potential is used in DBX®. The combination of DBM and sodium hyaluronate has not been evaluated for osteoinductivity; therefore, it is unknown to what extent the formulation components may alter the osteoinductive character of the DBM. Additionally, it is unknown how osteoinductivity of the DBM component, measured via the in vitro immunoassay, will correlate with human clinical performance of DBX®.
VIRAL CLEARANCE AND INACTIVATION:
This 510(k) was submitted for a change in the osteoinductivity assay for DBX® Putty. The fundamental scientific technology of the modified DBX® Putty, using in vitro testing as an alternative for in vivo testing for osteoinductivity, is the same as the technology for the unmodified predicate, DBX® (FDA cleared, K040262). 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo 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 logo is black and white.
OCT 1 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Musculoskeletal Transplant Foundation % Ms. Nancy Bennewitz Regulatory Affairs Submission Specialist 125 May Street, Suite 300 Edison Corporate Center Edison, New Jersey 08837
Re: K080399
Trade Name: DBX® Demineralized Bone Matrix Putty, Paste and Mix. Regulation Number: 21 CFR § 888.3045 Regulation Name: Resorbable Bone Substitute Regulatory Class: Class II Product Code: MBP Dated: September 25, 2008 Received: September 26, 2008
Dear Ms. Bennewitz:
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. Ilsting 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 such 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); 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.
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Page 2 – Ms. Nancy Bennewitz
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Indications for Use
4
IV. INDICATIONS FOR USE
510(k) Number (if known): unknown
Device Name: DBX® Demineralized Bone Matrix Putty, Paste and Mix
Indications for Use:
DBX® 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 in the:
| Putty | Mix | Paste |
|---|---|---|
| Extremities | Extremities | Extremities |
| Pelvis | Pelvis | Pelvis |
| Posterolateral Spine | Spine | |
| Cranium |
DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® can be used with bone marrow. DBX® 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)
Neil Rk Ogden forman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
CONFIDENTIAL