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 pelvis and extremities. DBX Putty can also be used as an extender in the pelvis and extremities 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 pelvis and extremities. DBX Inject can also be used as an extender in the pelvis and extremities with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject 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.

DBX Inject 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 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.

AI/ML Overview

The provided text describes two medical devices, DBX® Demineralized Bone Matrix Putty and DBX® Demineralized Bone Matrix Inject. Both are bone void fillers containing human demineralized bone matrix (DBM) and sodium hyaluronate. The 510(k) submission (K103784) was for an expansion of their indications for use in the pelvis and extremities, specifically allowing their use with autograft or allograft.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (if stated)	Reported Device Performance
Safety	Biocompatibility	Established through long history of safe and effective clinical use and laboratory testing per ISO 10993.
	Sterility	Single-donor processed using aseptic techniques and tested for sterility per current USP <71>.
	Viral Clearance & Inactivation	Processing methods evaluated for viral inactivation potential against a panel of model human viruses; determined to provide significant viral inactivation potential.
Effectiveness	Osteoinductive Potential	Each lot of final product (Putty/Inject) is tested in an athymic mouse model or an alkaline phosphatase assay (which correlates with the mouse model) to ensure osteoinductive potential. Standard testing must prove positive for lot release. (Note: Correlation with human clinical performance is unknown.)
	Equivalence for expanded indications	Recent in vivo studies conducted by MTF demonstrate that the use of DBX Putty/Inject with autograft or allograft in the pelvis and extremities is equivalent to the use of DBX Putty/Inject alone.

2. Sample Size Used for the Test Set and Data Provenance

The text mentions "Recent in vivo studies conducted by MTF" for the equivalence assessment of the expanded indications. However, it does not provide the sample size for these in vivo studies.

The data provenance for these in vivo studies is not explicitly stated in terms of country of origin, nor whether they were retrospective or prospective. Given that they are described as "recent in vivo studies conducted by MTF," it implies a prospective study design primarily for this submission.

For the osteoinductive potential testing, the "test set" is described as "Every lot of final DBX Putty/Inject product." This is a continuous quality control measure rather than a single study with a fixed sample size. The testing is done in an "athymic mouse model" or an "alkaline phosphatase assay."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth for the in vivo equivalence studies. For the osteoinductive potential, the "ground truth" is defined by the outcome of the athymic mouse model or alkaline phosphatase assay, which are objective biological tests rather than expert interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the in vivo equivalency studies or for the osteoinductive potential testing. These processes appear to rely on direct measurement or observation rather than subjective review requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No MRMC comparative effectiveness study was done as this device is a bone void filler, not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, there is no discussion of human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical bone void filler, not a software algorithm or AI-based diagnostic tool. The performance evaluation focuses on its biological and physical properties in in vivo models, not on an algorithm's performance.

7. The Type of Ground Truth Used

For Equivalence for expanded indications: The ground truth is established by the outcome of the "in vivo studies" demonstrating equivalence to the predicate (DBX Putty/Inject alone). The specific metrics or "ground truth" criteria for equivalence (e.g., bone formation, histological assessment) are not detailed in the provided text.
For Osteoinductive Potential: The ground truth is the outcome of the "athymic mouse model" or the "alkaline phosphatase assay." These are biological assays that provide a quantitative or qualitative result indicative of osteoinduction.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. These devices are regulated based on their physical and biological properties and performance in in vivo models, not on machine learning algorithms that require training data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no "training set" for these types of medical devices.

Summary

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APR 1 3 2011

XII. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

PROPRIETARY NAME:	DBX® Demineralized Bone Matrix Putty
COMMON NAME:	Bone Void Filler Containing Human Demineralized BoneMatrix (DBM)
PROPOSED REGULATORYCLASS:	Class II
CLASSIFICATIONIDENTIFICATION:	21 C.F.R. §888.3045 Resorable calcium salt bone voidfiller device
PRODUCT CODE:	MBP, MQV.
SPONSOR:	Musculoskeletal Transplant Foundation

125 May Street Edison, NJ 08837 732-661-0202

INDICATIONS FOR USE:

DBX Putty can be used alone in the pelvis and extremities. DBX Putty can also be used as an extender in the pelvis and extremities with autograft. DBX 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 matcrial 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.

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SAFTEY AND EFFECTIVENESS INFORMATION:

This 510(k) was submitted for an addition to the indications for use of DBX® Putty in the pelvis and extremities. Recent in vivo studies conducted by MTF demonstrate that the use of DBX Putty with autograft or allograft in the pelvis and extremities is equivalent to the use of DBX Putty alone. The fundamental scientific technology of the DBX® Putty with the expanded indications for use in the pelvis and extremities 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 <71>>.

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.

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XII. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

PROPREIETARY NAME:	DBX® Demineralized Bone Matrix Inject
COMMON NAME:	Bone Void Filler Containing Human Demineralized BoneMatrix (DBM)
PROPOSED REGULATORYCLASS:	Class II
CLASSIFICATIONIDENTIFICATION:	21 C.F.R. §888.3045 Resorable calcium salt bone voidfiller device
PRODUCT CODE:	MBP, MQV
SPONSOR:	Musculoskeletal Transplant Foundation125 May StreetEdison, NJ 08837732-661-0202

INDICATIONS FOR USE:

DEVICE DESCRIPTION:

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SAFTEY AND EFFECTIVENESS INFORMATION:

This 510(k) was submitted for an addition to the indications for use of DBX® Inject in the pelvis and extremities. Recent in vivo studies conducted by MTF demonstrate that the use of DBX Inject with autograft or allograft in the pelvis and extremities is equivalent to the use of DBX Inject alone. The fundamental scientific technology of the DBX® Inject with the expanded indications for use in the pelvis and extremities is the same as the technology for the predicate, DBX® Putty (FDA cleared, K040262).

Biocompatibility of DBX® Inject materials 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 <71>.

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.

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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 wings and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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 2011

Re: K103784

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

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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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Alij. B. R. for

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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IV. INDICATIONS FOR USE

510(k) Number (if known): K103784

Device Name: DBX® Demineralized Bone Matrix Putty

Indications for Use:

X OR Prescription Use (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)

Yvonne L. Carey

(Division Sign 711 (Division Sign-On)
Division of Surgical, Orthopedic, Divisionative Devices

510(k) Number K103784

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IV. INDICATIONS FOR USE

510(k) Number (if known): K103784

Device Name: DBX® Demineralized Bone Matrix Inject

Indications for Use:

X OR Prescription Use _ (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)

Lawrence V. Bagby

(Division Sign-Off) (Division Sign-Sign-Sical, Orthopedic. Divisionative Devices

510(k) Number K103784

Regulation Number and Section

§ 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.