(428 days)
DBX® Putty and Paste are intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral/maxillofacial and dental intraosseous defects including: Ridge augmentation, Filling of extraction sites, Craniofacial augmentation, Mandibular reconstruction, Repair of osseous defects of the jaws, Filling of cystic defect, Filling of lesions of periodontal origin, Filling of defects of endodontic origin, Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture, Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall. DBX® Mix is intended for mandibular reconstruction only. DBX® is intended for single patient use only.
DBX® is intended for single patient use only. DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of processed human cortical bone; the DBX® Mix is composed of processed human corticocancellous bone. The bone granules are mixed with sodium hyaluronate ("NaHA") in varying combinations to form the DBX® Putty, Paste and Mix. All versions of DBX® are available in five sizes. DBX® is osteoconductive and has been shown to have osteoinductivity potential in the athymic mouse model. It is unknown how the osteoinductivity potential, measured in the athymic mouse model, will correlate with clinical performance in human subjects.
This document is a 510(k) summary for the DBX® Demineralized Bone Matrix product. It describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a medical device (a 510(k) premarket notification), which typically aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than present a study against specific performance acceptance criteria.
The information you've asked for (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are commonly found in clinical study reports or performance testing documentation for devices that have undergone such evaluations. This 510(k) summary does not include that level of detail regarding device performance or formal studies as would be expected for demonstrating adherence to specific acceptance criteria.
Key takeaway from the document:
- Device: DBX® Demineralized Bone Matrix (Putty, Paste, and Mix).
- Intended Use: Augmentation of deficient maxillary and mandibular alveolar ridges and treatment of various oral/maxillofacial and dental intraosseous defects.
- Regulatory Decision: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
- Performance Claim: The device is osteoconductive and has shown osteoinductive potential in an athymic mouse model, but it is unknown how this correlates with human clinical performance. It has not been proven osteoinductive in a human model.
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Koyosol
DBX® Demineralized Bone Matrix
510(k) SUMMARY OF SAFETY & EFFECTIVENESS XI.
DBX® Demineralized Bone Matrix Putty PROPRIETARY NAME: DBX® Demineralized Bone Matrix Paste DBX® Demineralized Bone Matrix Mix COMMON NAME: Bone Grafting Material, Synthetic PROPOSED REGULATORY CLASS: Class II PRODUCT CODE: LYC PANEL CODE: 76 - Dental SPONSOR: Musculoskeletal Transplant Foundation 125 May Street Edison, NJ 08837 732-661-0202
INDICATIONS FOR USE:
DBX® Putty and Paste are intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral/maxillofacial and dental intraosseous defects including:
| Ridge augmentation | Filling of cystic defect |
|---|---|
| Filling of extraction sites | Filling of lesions of periodontal origin |
| Craniofacial augmentation | Filling of defects of endodontic origin |
| Mandibular reconstruction | |
| Repair of osseous defects of the jaws |
- Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
- Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.
DBX® Mix is intended for mandibular reconstruction only.
DBX® is intended for single patient use only.
DEVICE DESCRIPTION:
DBX® is intended for single patient use only. DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of processed human cortical bone;
MTF®
CONFIDENTIAL
Page 323 of 326
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the DBX® Mix is composed of processed human corticocancellous bone. The bone granules are mixed with sodium hyaluronate ("NaHA") in varying combinations to form the DBX® Putty, Paste and Mix. All versions of DBX® are available in five sizes.
DBX® is osteoconductive and has been shown to have osteoinductivity potential in the athymic mouse model. It is unknown how the osteoinductivity potential, measured in the athymic mouse model, will correlate with clinical performance in human subjects.
PREDICATE DEVICES:
DBX® is substantially equivalent to Geistlich-Pharma's Bio-Oss Anorganic Bovine Bone (K970321), Biomet's 3i Calcium Sodium Phosphate Bone Cement (K003493) and Xomed's Merogel (K001148).
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CONFIDENTIAL
Page 323 of 326
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Public Health Service
APR 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathleen M. Laffan Regulatory Submission Specialist Musculoskeletal Transplant Foundation 125 May Street, Suite 300 Edison Corporation Center Edison, New Jersey 08837
Re: K040501
Trade/Device Name: DBX Demineralized Bone Matrix Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: NUN Dated: March 18, 2005 Received: March 21, 2005
Dear Ms. Laffan:
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 ( var 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.
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Page 2 - Ms. Laffan
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,
Suitte H. Michau O ms
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT IV.
Page 1 of 1
| 510(kNumberknown- Comments of Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children ChildreConcess & Mich Cases Change C------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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Device Name:
Indications for Use:
DBX® Demineralized Bone Matrix is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral/maxillofacial and dental intraosseous defects including:
Filling of cystic defects Ridge augmentation Filling of extraction sites Sinus lifts Craniofacial augmentation Filling of lesions of periodontal origin Filling of defects of endodontic origin
- Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fractures
Filling resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.
For dental applications, one or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site.
DBX® is osteoconductive and has been shown to be osteoinductive in both validated animal models and a validated in vitro assay. DBX® has not been proven osteoinductive in a human model.
DBX® is intended for single patient use only.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | ||||
| Suan Pease | ||||
| Division Sign-Off) | ||||
| Division of Anesthesiology, General Hospital, | ||||
| Infection Control, Dental Devices | ||||
| MTF ® | CONFIDENTIAL | K640501 | Page 8 of 377 |
§ 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.