(426 days)
None
No
The summary describes a bone graft material and its intended use, with no mention of AI or ML technology.
Yes
GRAFTON PLUS® DBM Paste is a bone graft product intended to fill and augment bony voids or gaps, which directly pertains to the repair and healing of tissues, aligning with the definition of a therapeutic device.
No
Explanation: The device, GRAFTON PLUS® DBM Paste, is an allograft product intended to fill and augment bony defects, not to diagnose medical conditions. Its function is therapeutic, assisting in bone regeneration.
No
The device description clearly states that GRAFTON PLUS® DBM Paste is a human bone allograft product consisting of human demineralized bone matrix (DBM) mixed with an inert starch-based additive. This is a physical material, 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 GRAFTON PLUS® DBM Paste is for filling and/or augmenting bony voids or gaps in the body (dental, oral, cranio-/maxillofacial). This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The description details a human bone allograft product used for bone grafting. It describes its physical form and properties related to bone formation, not diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue) to provide information about a patient's health status, disease, or condition. IVDs are designed for this type of analysis.
- Performance Studies: The performance studies mentioned focus on bone formation in an animal model, which is relevant to its function as a bone graft, not a diagnostic test.
In summary, GRAFTON PLUS® DBM Paste is a medical device used for surgical reconstruction and repair of bone defects, not for performing diagnostic tests on in vitro samples.
N/A
Intended Use / Indications for Use
GRAFTON PLUS® DBM Paste is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON PLUS® DBM Paste may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON PLUS® DBM Paste is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.
Product codes
NUN
Device Description
GRAFTON PLUS® DBM Paste is a human bone allograft product consisting of human demineralized bone matrix (DBM) mixed with an inert starch-based additive. It is intended to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. GRAFTON PLUS® 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.
GRAFTON PLUS® DBM Paste is an osteoinductive bone graft product in that it forms ossicles of bone when implanted ectopically in an athymic rat model. It is produced using a process that has been validated to consistently produce osteoinductive DBM as measured in the athymic rat test model.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental intraosseous, oral and cranio-/maxillofacial defects, bony voids or gaps, periodontal/infrabony defects; alveolar ridge, dental extraction sites, cystic defects
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
Studies of bone formation with GRAFTON PLUS® DBM Paste were conducted using an animal model. These studies demonstrated consistent bone formation with GRAFTON PLUS® DBM Paste.
Key Metrics
Not Found
Predicate Device(s)
K960267, K040278, K030682, K031073
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV 3 0 2005
XII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
September 29, 2004
-
- Submission Applicant & Correspondent:
Name: Address:
- Submission Applicant & Correspondent:
Phone No.: Contact Person:
Osteotech. Inc. 51 James Way Eatontown, NJ 07724 (732) 542-2800 Chris Talbot
-
- Name of Product:
| Trade/Proprietary/Model Name: | GRAFTON PLUS® DBM Paste |
|---|---|
| Common or Usual Name: | Demineralized Bone Matrix Allograft |
| Classification Name: | Bone Grafting Material |
-
- Devices to Which New Product is Substantially Equivalent:
Grafton Plus 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) # |
|---|---|---|
| TBM Sponge | Biocoll Laboratories | K960267 |
| PerioGlass-BioGlass Bone | ||
| Graft Particulate | NovaBone Products, Inc. | K040278 |
| Calcium Hydroxylapatite Implant | BioForm, Inc. | K030682 |
| PerioGlass Plus-Settable Bone | ||
| Graft Substitute | NovaBone Products, Inc. | K031073 |
In addition, GRAFTON PLUS® DBM Paste is substantially equivalent to human freeze dried bone, such as demineralized bone matrix, to which one or more predicate devices in this device category have claimed substantial equivalence.
-
- Device Description:
GRAFTON PLUS® DBM Paste is a human bone allograft product consisting of human demineralized bone matrix (DBM) mixed with an inert starch-based additive. It is intended to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. GRAFTON PLUS® 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:
1
GRAFTON PLUS® DBM Paste is an osteoinductive bone graft product in that it forms ossicles of bone when implanted ectopically in an athymic rat model. It is produced using a process that has been validated to consistently produce osteoinductive DBM as measured in the athymic rat test model.
5. Intended Use/Indications
GRAFTON PLUS® DBM Paste is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON PLUS® DBM Paste may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON PLUS® DBM Paste is indicated only for bony voids or gans that are . not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.
-
- Technical Comparison
GRAFTON PLUS® DBM Paste is substantially equivalent to one or more predicate devices with respect to materials in that it consists of human demineralized bone matrix and an inert non-tissue additive. It 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 implanted in this malleable state and does not set or harden prior to or after implantation.
- Technical Comparison
7. Performance Data
Studies of bone formation with GRAFTON PLUS® DBM Paste were conducted using an animal model. These studies demonstrated consistent bone formation with GRAFTON PLUS® DBM Paste.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2005
Mr. Christopher Talbot Director of Regulatory Affairs Osteotech, Incorporated 51 James Way Eatontown, New Jersey 07724
Re: K042707
Trade/Device Name: GRAFTON PLUS® DBM Paste Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: November 21, 2005 Received: November 22, 2005
Dear Mr. Talbot:
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.
3
Page 2 - Mr. Talbot
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.
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) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu-Lin, Ph.D.
Chiu Lin, Ph.Ď. 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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III. Indications for Use - Statement
510(k) Number (if known):
Device Name: GRAFTON PLUS® DBM Paste
Indications for Use:
GRAFTON PLUS®DBM Paste is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON PLUS® DBM Paste may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON PLUS® DBM Paste is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is absorbed/remodeled and replaced by host bone during the healing process.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russoe
on of Anesthesiology, G Control, Control, Dental D
Number: K042707
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)