DBX-H™ Hemostatic Demineralized Bone Matrix Putty is indicated for use for filling voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the extremities and pelvis.

DBX-H™ can help control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used for treatment of surgically created osseous defects and in osseous defects resulting from traumatic injury.

Device Description

DBX-H Hemostatic Demineralized Bone Matrix Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of calcium stearate (a wax-like material) and triethyl citrate (a dispersing agent). DBX-H Putty is virtually odorless, off.white in color and can be spread easily with minimal adhesion to surgical gloves.

AI/ML Overview

The provided 510(k) summary for K061131, concerning the DBX-H™ Hemostatic Demineralized Bone Matrix Putty, does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the context of device performance as would typically be seen for AI/ML devices.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting their device is as safe and effective as a legally marketed device, rather than proving performance against pre-defined numerical thresholds for a specific clinical task.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or available in this document. This is common for submissions of this era and type (medical device, not AI/ML).

Here's an analysis based on the information provided, highlighting what is present and what is not:

Acceptance Criteria and Device Performance Study (Not Applicable for this Submission Type)

The 510(k) summary for DBX-H™ Hemostatic Demineralized Bone Matrix Putty does not present acceptance criteria or a dedicated study proving performance against such criteria in the way an AI/ML device submission would. The core of this submission is to demonstrate substantial equivalence to existing predicate devices. This involves showing that the new device has the same intended use, technological characteristics, and performs comparably in terms of safety and effectiveness, leveraging existing knowledge and data for the predicate devices.

The document states: "The 510(k) Notice contains summaries of physical test results, functionality (efficacy testing) results and biocompatibility testing. The data presented demonstrate that the device is biocompatible and is suitable for its indicated use." However, specific numerical performance metrics, acceptance criteria, or detailed study designs for these tests are not provided in this summary.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Not explicitly stated/not applicable for this type of submission)	Reported Device Performance (General statements from submission)
Not specified as numerical targets for clinical performance.	Biocompatibility: "The data presented demonstrate that the device is biocompatible."
Not specified as numerical targets for clinical performance.	Functionality (Efficacy): "The data presented demonstrate that the device...is suitable for its indicated use [filling voids, controlling bleeding by mechanical barrier/tamponade]."
Not specified as numerical targets for clinical performance.	Mechanical Barrier/Tamponade: "DBX-H™ can help control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade."
Not specified as numerical targets for clinical performance.	Absorption: "The putty will be dispersed and absorbed through exposure to body temperature, body fluids and cellular transport within a period of 90 days."

Detailed Study Information (Not available/not applicable for this submission type)

Given that this 510(k) is for a physical medical device (bone void filler) and relies on substantial equivalence rather than a new performance claim validated by a clinical study with detailed statistical targets, most of the requested information regarding study methodologies for AI/ML devices is not present.

Sample size used for the test set and the data provenance: Not applicable/not provided. Performance data would typically come from physical and functional/biocompatibility testing, not a "test set" as understood in AI/ML. There is no mention of a clinical or observational study that would generate such a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. No "ground truth" establishment in the context of clinical reads or diagnostic accuracy is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.
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 device is not an AI algorithm assisting human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. "Ground truth" for biocompatibility and functionality would rely on established scientific methods and in vitro/in vivo testing results according to recognized standards, rather than expert consensus on diagnostic images or pathology.
The sample size for the training set: Not applicable/not provided. There is no "training set" in the AI/ML sense for this device.
How the ground truth for the training set was established: Not applicable/not provided.

Summary of Approach:

The submission for DBX-H™ Hemostatic Demineralized Bone Matrix Putty relies on demonstrating substantial equivalence to previously cleared predicate devices (DBX® Demineralized Bone Matrix Putty and Grafton DBM). The "study" in this context refers to standard physical, functionality, and biocompatibility testing, the results of which are summarized but not detailed in this 510(k) document. The core argument is that, because its intended use and technological characteristics are similar to already approved products, and it passes standard safety tests, it should be considered substantially equivalent.

Summary

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KOGI 21

FEB 8 2007 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

General Company Information

Name: Orthocon, Inc. Contact: Howard Schrayer Regulatory Affairs Consultant

Address: 167 Stone Hill Road Colts Neck, NJ 07722
Telephone: (732) 683 - 9304 (732) 683 - 9476 Fax:
Date Prepared February 22, 2006

General Device Information

Product Name:	DBX-H™ Hemostatic Demineralized Bone Matrix Putt
Classification:	"Bone Void Filler" and "Bone Wax",21 CFR 888.3045 - Product codes: MBP and MTJClass II

Predicate Devices

DBX® Demineralized Bone Matrix Putty Musculoskeletal Transplant Foundation 510(k) K040262

Grafton DBM Osteotech, Inc. 510(k) K051195

Description

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DBX-H is intended for use as a filler for voids or gaps that are not intrinsic to the stability of the bony structure. When applied manually to surgically incised or traumatically broken bone, DBX-H Hemostatic Demineralized Bone Matrix Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The putty will be dispersed and absorbed through exposure to body temperature, body fluids and cellular transport within a period of 90 days.

Intended Use (Indications)

Substantial Equivalence

This submission supports the position that DBX-H™ Hemostatic Demineralized Bone Matrix Putty is substantially equivalent to a number of pre-enactment and previously cleared devices, including:

DBX® Demineralized Bone Matrix Putty - Musculoskeleta! Transplant Foundation [510(k) K040262]

Grafton DBM - Osteotech, Inc. [510(k) K051195]

The 510(k) Notice contains summaries of physical test results, functionality (efficacy testing) results and biocompatibility testing.

The data presented demonstrate that the device is biocompatible and is suitable for its indicated use.

Conclusions

Orthocon, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the DBX-H™ Hemostatic Demineralized Bone Matrix Putty. The materials from which the Orthocon device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Orthocon, Inc. % Mr. Howard Schrayer Regulatory Affairs Consultant 167 Stone Hill Rd. Colts Neck, New Jersey 07722

FFB 8 2007

Re: K061131

Trade Name: DBX-H Hemostatic Demineralized Bone Matrix Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Filler, Bone Void, Demineralized Bone Matrix Regulatory Class: Class II Product Code: MBP, MTJ Dated: December 28, 2006 Received: December 29, 2006

Dear Mr. Schrayer:

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 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 - Mr. Howard Schraver

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.

Barbara Brickus

Mark N. Melkerson Division Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: DBX-H™ Hemostatic Demineralized Bone Matrix Putty

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Aabare Buchem

Division of General, Restorative. and Neurological Devices

510(k) Number k06113)

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.