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.

Device Description

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.
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.

AI/ML Overview

This 510(k) summary describes a traditional medical device (Bone Void Filler) and not an AI/ML powered device. As such, the requested information (sample sizes, ground truth establishment, expert qualifications, HRMC studies, etc.) is not applicable and is not present in the provided document.

However, I can extract the acceptance criteria and refer to the studies mentioned in the document that were performed to demonstrate the device meets these criteria.

Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Standard	Reported Device Performance
Osteoinductive Potential	Every lot of final DBX® Inject Paste must be assayed in vivo for osteoinductive potential in an athymic mouse model and prove positive for lot release. Every lot of final DBX® Inject Putty product must be tested in an athymic mouse model or in an alkaline phosphatase assay (which has a positive correlation with the athymic mouse model) to ensure osteoinductive potential, and prove positive for lot release. Note: It is unknown how the osteoinductive potential, measured in these models, will correlate with clinical performance in human subjects.	DBX® Inject is osteoconductive and has been shown to have osteoinductive potential in an athymic mouse model. Standard testing will be performed in an athymic mouse or alkaline phosphatase assay for lot release.
Viral Clearance and Inactivation	The processing method for the demineralized bone matrix must provide significant viral inactivation potential for a wide range of potential viruses.	The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses, as evaluated with a panel of model potential human viruses representing various types, sizes, shapes, and genomes.
Donor Suitability	Donor suitability criteria used to screen donors must be in compliance with FDA regulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation.	DBX® Inject is single-donor processed, and the donor suitability criteria used are in compliance with FDA regulations 21 CFR Part 1270 and Part 1271.

Statements regarding AI/ML specific information (as it pertains to a traditional medical device):

Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are laboratory tests, not clinical trials with human patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for osteoinductivity and viral inactivation is established through standardized laboratory assays.
Adjudication method for the test set: Not applicable. Laboratory assays follow predefined protocols.
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: Not applicable. This is not an AI-powered device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
The type of ground truth used:
- Osteoinductive potential: Athymic mouse model results or alkaline phosphatase assay results.
- Viral clearance and inactivation: Results from standard viral inactivation assays using model viruses.
- Donor suitability: Compliance with FDA regulations (21 CFR Part 1270 and Part 1271).
The sample size for the training set: Not applicable. This is not an AI-powered device.
How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.

Summary

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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

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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.

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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.

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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

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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

Regulation Number and Section

§ 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.