(158 days)
Not Found
No
The document describes a demineralized bone matrix product and its intended uses and testing methods. There is no mention of AI or ML technology in the device description, intended use, or any other section.
Yes
The device is intended for the treatment of surgically created or traumatically induced osseous defects, functioning as a demineralized bone matrix to aid in the healing and reconstruction of bone, which aligns with the definition of a therapeutic device.
No
The device is a Demineralized Bone Matrix for filling voids or gaps and repairing defects, not for diagnosing conditions.
No
The device description clearly indicates that DBX® Inject is a physical demineralized bone matrix product, not a software application. It describes the material composition, testing methods (in vivo and alkaline phosphatase assay), and donor processing, all of which relate to a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a material for filling bone voids and defects in the body (in vivo use). IVDs are used to examine specimens taken from the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the material properties (osteoconductive, osteoinductive potential) and processing of the bone matrix, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing patient samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
The testing described (athymic mouse model, alkaline phosphatase assay) is for quality control of the product itself to ensure its biological activity, not for diagnosing a patient's condition.
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:
Ridge augmentation
Filling of extraction sites
Craniofacial augmentation
Mandibular reconstruction
Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
Filling resection defects in benign tumors, benign cysts, or other osseous defects in the alveolar ridge wall
Filling of cystic defect
Filling of lesions of periodontal origin
Filling of defects of endodontic origin
DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. 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)
NUN
Device Description
Bone Void Filler Containing Human Demineralized Bone Matrix (DBM). DBX® Iniect 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® Iniect 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge
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)
Not Found
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
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K09 1217
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
General Company Information
OCT - 2 2009
・・・
| Name: | Musculoskeletal Transplant Foundation |
|---|---|
| Contact: | Nancy Bennewitz Joy |
| Regulatory Affairs Submission Specialist |
| Address: | 125 May Street Edison, NJ 08837 USA |
|---|---|
| ---------- | ------------------------------------- |
Telephone: (732) 661-2381 Fax: (732) 661-2189 Email: 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 §872.3930 - Product code: NUN Class II
Predicate Devices
DBX® Demineralized Bone Matrix Musculoskeletal Transplant Foundation 510(k) K040262
Sygnal™ DBM Musculoskeletal Transplant Foundation 510(k) K080405
1
Osteoinductive Potential:
DBX® Iniect 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® Iniect 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.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or other bird-like figure. The image is somewhat grainy and the details are not perfectly clear.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring. MD 20993-0002
Ms. Nancy Bennewitz Joy Regulatory Affairs Submission Specialist Musculoskeletal Transplant Foundation 125 May Street Edison, New Jersey 08837
OCT - 2 2009
Re: K091217
Trade/Device Name: DBX® Inject Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: September 29, 2009 Received: September 29, 2009
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.
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.
3
Page 2- Ms. Joy
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.
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/cdrh/mdr/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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
INDICATIONS FOR USE
510(k) Number (if known): K091217
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 |
|---|---|---|
| Ridge augmentation | √ | √ |
| Filling of extraction sites | √ | √ |
| Craniofacial augmentation | √ | √ |
| Mandibular reconstruction | √ | √ |
| Repair of traumatic defects of the alveolar ridge, | ||
| excluding maxillary and mandibular fracture | √ | √ |
| Filling resection defects in benign tumors, benign cysts, | ||
| or other osseous defects in the alveolar ridge wall | √ | √ |
| Filling of cystic defect | √ | √ |
| Filling of lesions of periodontal origin | √ | √ |
| Filling of defects of endodontic origin | √ | √ |
DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. 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) Tre ========================================================================================================================================================================== ાપ્ C (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K09121
Confidential