(381 days)
Not Found
No
The summary describes a bone graft paste and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is intended for use in filling bony voids or gaps resulting from injury, and it is replaced by host bone during the healing process, indicating a therapeutic function.
No
The device is described as an osteoconductive human bone allograft product intended for filling bony voids or gaps, which is a therapeutic rather than a diagnostic function.
No
The device is described as a "human bone allograft product consisting of human demineralized bone matrix (DBM) to which an inert starchbased carrier has been added," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "filling bony voids or gaps of the extremities." This is a therapeutic use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a bone allograft product used for filling bone defects. This is a medical device used directly on or in the body for treatment, not for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information.
Therefore, VIAGRAF® DBM Paste is a medical device used for bone repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MBP, MQV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bony voids or gaps of the extremities
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)
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.
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.
K020078, K040755, K020895, K041186
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
§ 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.
0
2005 DEC 5
XII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
November 16, 2004
-
- Submission Applicant & Correspondent:
| Name: | Osteotech, Inc. |
|---|---|
| Address: | 51 James Way |
| Eatontown, NJ 07724 | |
| Phone No.: | (732) 542-2800 |
| Contact Person: | Chris Talbot |
-
- Name of Product:
| Trade/Proprietary/Model Name: | VIAGRAF ◊ DBM Paste |
|---|---|
| Common or Usual Name: | Demineralized Bone Matrix Allograft |
| Classification Name: | Resorbable Bone Void Filler |
-
- 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.
- Devices to Which New Product is Substantially Equivalent:
| Trade/Proprietary/Model Name | Manufacturer | 510(K) # |
|---|---|---|
| Exactech Resorbable Bone Paste | Exactech | K020078 |
| Exactech Resorbable Room | ||
| Temperature Bone Paste | Exactech | K040755 |
| Allomatrix Putty | Wright Medical | K020895 |
| Allomatrix Putty | Wright Medical | K041186 |
-
- 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.
- Device Description:
-
- 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
- Intended Use/Indications
1
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.
2
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.
3
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
4
Attachment 3
III. Indications for Use - Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K043209
Device Name: VIAGRAF® DBM Paste
Indications for Use:
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.
Prescription Use X (Per 21 CFR 801.109)
OR
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