VIAGRAF® DBM Paste is intended for use in filling bony voids or gaps of the extremities that are not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. VIAGRAF® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.

Device Description

VIAGRAF DBM Paste is an osteoconductive human bone allograft product consisting of human demineralized bone matrix (DBM) to which an inert starchbased carrier has been added. It is intended for use in filling bony voids or gaps of the extremities not intrinsic to the stability of the bony structure. VIAGRAF® DBM Paste is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes. It is provided in various package sizes by volume.

AI/ML Overview

The provided document, K043209, does not contain detailed acceptance criteria or a comprehensive study with specific numerical performance metrics typically found for medical devices with algorithmic components. This 510(k) pertains to a demineralized bone matrix paste (VIAGRAF® DBM Paste), which is a biological product, not a software or AI-driven device. Therefore, the requested information, which is more relevant to AI/ML or diagnostic devices, is not explicitly available in this document.

However, based on the information provided, I can infer the general nature of the performance data and its purpose:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Inferred)	Reported Device Performance
Acceptable bone formation in animal models	"The results of bone formation studies in animal models demonstrated acceptable bone formation with VIAGRAF® DBM Paste."
Relevant clinical data supporting performance	"In addition, relevant clinical data exists that supports the performance of VIAGRAF® DBM Paste."
Validation of viral inactivation process	"VIAGRAF® DBM Paste is produced by a proprietary production process that has been validated to inactivate viruses including: HIV-1; hepatitis B virus (...); hepatitis C virus (...), CMV; and Polio virus."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified.
Data Provenance: The document mentions "animal models" for bone formation studies and "relevant clinical data." No specific country of origin or whether the clinical data was retrospective or prospective is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. The performance evaluation for this product relies on biological outcomes (bone formation) and viral inactivation, not expert interpretation of outputs like images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This concept is typically relevant for studies where human expert consensus is used to establish ground truth for a diagnostic device.

5. 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/ML or diagnostic device that involves human readers interpreting results.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For bone formation: Biological outcomes in animal models.
For viral inactivation: Validation of the proprietary process against specific viruses.
For clinical performance: "Relevant clinical data" (assumed to be patient outcomes/follow-up data).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that uses a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K043209

2005 DEC 5

XII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

November 16, 2004

1. Submission Applicant & Correspondent:

Name:	Osteotech, Inc.
Address:	51 James Way
	Eatontown, NJ 07724
Phone No.:	(732) 542-2800
Contact Person:	Chris Talbot

1. Name of Product:

Trade/Proprietary/Model Name:	VIAGRAF ◊ DBM Paste
Common or Usual Name:	Demineralized Bone Matrix Allograft
Classification Name:	Resorbable Bone Void Filler

1. Devices to Which New Product is Substantially Equivalent:
  VIAGRAF DBM Paste is substantially equivalent, for the purpose of this 510(k), to the following predicate devices.

Trade/Proprietary/Model Name	Manufacturer	510(K) #
Exactech Resorbable Bone Paste	Exactech	K020078
Exactech Resorbable RoomTemperature Bone Paste	Exactech	K040755
Allomatrix Putty	Wright Medical	K020895
Allomatrix Putty	Wright Medical	K041186

1. Device Description:
  VIAGRAF DBM Paste is an osteoconductive human bone allograft product consisting of human demineralized bone matrix (DBM) to which an inert starchbased carrier has been added. It is intended for use in filling bony voids or gaps of the extremities not intrinsic to the stability of the bony structure. VIAGRAF® DBM Paste is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes. It is provided in various package sizes by volume.
1. Intended Use/Indications
  VIAGRAF DBM Paste is intended for use in filling bony voids or gaps of the extremities that are not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury

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to the bone. VIAGRAF® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.

6. Technical Comparison

VIAGRAF® DBM Paste is substantially equivalent to one or more of the predicate devices with respect to materials in that it consists of human demineralized bone matrix (DBM) and an inert resorbable non-tissue additive or carrier. It is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes.

7. Performance Data

The results of bone formation studies in animal models demonstrated acceptable bone formation with VIAGRAF® DBM Paste. In addition, relevant clinical data exists that supports the performance of VIAGRAF® DBM Paste.

8. Viral Inactivation

VIAGRAF® DBM Paste is produced by a proprietary production process that has been validated to inactivate viruses including: HIV-1; hepatitis B virus (duck hepatitis virus as model); hepatitis C virus (bovine diarrhea virus as model), CMV; and Polio virus. This process is used to further reduce the risk of disease transmission via the use of this product beyond the protection provided by donor testing and screening procedures.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them.

Public Health Service

DEC 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Christopher Talbot Director, Regulatory Affairs Osteotech, Inc. 51 James Way Eatontown, NJ 07724

Re: K043209

VIAGRAF® DBM Paste Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MBP, MQV Dated: October 27, 2005 Received: October 28, 2005

Dear Mr. Talbot:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beener been 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 Interstate conmiseree prior to ria) 20, 2011 reclassified in accordance with the provisions of Amendinents, or to de rouses 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 approval application (114) in the general controls provisions of the Act include controls provisions of the engistration, 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 (FMA), it may of subject to back adalaf Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundsh further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be acrisod that 1 Da determination that your device complies with other requirements mean that + D7 mas mass statutes and regulations administered by other Federal agencies.

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Page 2 – Mr. Christopher Talbot

You must comply with all the Act's requirements, including, but not limited to: registration 1 our intest comply William (21 CFR Part 801); good manufacturing practice alle houng (21 CF ref art of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualify ijon control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section This letter inn and in Justication. The FDA finding of substantial equivalence of your device s ro 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), 11 you desire specifice 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 may overni of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mellon

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

Enclosure

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Attachment 3

III. Indications for Use - Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K043209

Device Name: VIAGRAF® DBM Paste

Indications for Use:

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

vision Sign-Off

Division of General, Restorative, and Neurological Devices

510(k) Number_ K043 209

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.