(110 days)
Not Found
No
The summary describes a bone graft material and its testing, with no mention of AI or ML technology.
Yes.
The device is a bone mineral matrix used for augmentation and reconstructive treatment in various dental and oral surgeries, which clearly falls under therapeutic intervention.
No
This device is a bone graft material used for reconstructive treatments and filling defects, not for diagnosing medical conditions.
No
The device description clearly states it is a "non-pyrogenic porous bone mineral matrix" and describes its physical form (cancellous granules) and composition (porcine bone). This indicates a physical, implantable material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures for bone grafting and regeneration in the oral and maxillofacial area. These are therapeutic and reconstructive applications performed directly on the patient.
- Device Description: The device is described as a porous bone mineral matrix for surgical use. This aligns with a device used in vivo (within the body) during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples in vitro (outside the body), such as blood, urine, or tissue, to diagnose a condition or provide information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically augment or reconstruct bone tissue during surgery.
N/A
Intended Use / Indications for Use
DSM Biomedical Dental Bone Graft is indicated for:
- Augmentation or reconstructive treatment of the alveolar ridge
- Filling of infrabony periodontal defects
- Filling of defects after root resection, apicoectomy, and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of the maxillary sinus floor
- Filling of periodontal defects in conjuncts intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
Product codes (comma separated list FDA assigned to the subject device)
NPM
Device Description
The DSM Biomedical Dental Bone Graft is a non-pyrogenic porous bone mineral matrix for use in periodontal, oral, and maxillofacial surgery. It is produced by removing organic components from porcine bone. The composition of DSM Biomedical Dental Bone Graft meets the requirements of ASTM F 1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is provided as cancellous granules approximately 0.25 - 1.0mm in size. It is supplied sterile by gamma irradiation and is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, periodontal, oral, maxillofacial, maxillary sinus
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)
Material characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study have been conducted to evaluate the performance characteristics and biological safety of DSM Biomedical Dental Bone Graft.
Material characterization of the DSM Biomedical Dental Bone Graft was completed in accordance with the FDA Guidance Document, Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices and ASTM F 1581, Standard Specifications for Composition or Anorganic Bone for Surgical Implants. Bench testing was completed to verify that the device can be hydrated and mixed in the provided packaging.
A canine intrabony defect animal study was performed to evaluate bone healing following treatment with the DSM Biomedical Dental Bone Graft compared to the predicate device.
Biocompatibility testing was completed in accordance with the requirements of ISO 10993-1: 2009, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process for a permanent implant device with tissue/bone contact. Testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Genotoxicity, Hemocompatibility, Subacute Systemic Toxicity, and Chronic Systemic Toxicity, and Implantation. Other safety testing included a viral inactivation study and residual chemical assessment. Results indicate that the device's biocompatibility profile is acceptable.
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.
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
§ 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.
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Image /page/0/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2017
Kensey Nash Corporation Dba DSM Biomedical Susan Pileggi Senior Regulatory Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341
Re: K170245
Trade/Device Name: DSM Biomedical Dental Bone Graft Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: April 12, 2017 Received: April 13, 2017
Dear Susan Pileggi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name DSM Biomedical Dental Bone Graft
Indications for Use (Describe)
DSM Biomedical Dental Bone Graft is indicated for:
-
Augmentation or reconstructive treatment of the alveolar ridge
-
Filling of infrabony periodontal defects
-
Filling of defects after root resection, apicoectomy, and cystectomy
-
Filling of extraction sockets to enhance preservation of the alveolar ridge
-
Elevation of the maxillary sinus floor
-
Filling of periodontal defects in conjuncts intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
-
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo consists of a colorful abstract graphic on the left and the letters "DSM" in bold blue font on the right. The graphic is composed of overlapping curved shapes in various colors, including blue, green, orange, and purple, forming a circular design with a hexagonal shape in the center.
510(k) Summary
| Submitted By: | DSM Biomedical
735 Pennsylvania Drive
Exton, PA 19341 |
|-----------------|--------------------------------------------------------------------------------|
| Contact Person: | Susan Pileggi
susan.pileggi@dsm.com
(P) 484-713-2100
(F) 484-713-2903 |
| Date Prepared: | April 11, 2017 |
Date Prepared:
Device:
| Trade Name: | DSM Biomedical Dental Bone Graft |
|---|---|
| Common/Usual Name: | Bone Grafting Material |
| Classification Name: | Bone Grafting Material |
| Classification Regulation: | 21 CFR 872.3930 |
| Device Class: | II |
| Device Code: | NPM |
| Advisory Panel: | Dental |
Predicate Device:
Bio-OSS® (K033815) [Geistlich-Pharma]
Device Description
The DSM Biomedical Dental Bone Graft is a non-pyrogenic porous bone mineral matrix for use in periodontal, oral, and maxillofacial surgery. It is produced by removing organic components from porcine bone. The composition of DSM Biomedical Dental Bone Graft meets the requirements of ASTM F 1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is provided as cancellous granules approximately 0.25 - 1.0mm in size. It is supplied sterile by gamma irradiation and is for single use only.
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Image /page/4/Picture/0 description: The image shows the logo for DSM, a global science-based company. The logo consists of a colorful, abstract swirl design on the left and the letters "DSM" in bold, blue font on the right. The swirl design is made up of overlapping shapes in various colors, including blue, green, yellow, and purple. The overall design is modern and eye-catching.
Indications For Use:
DSM Biomedical Dental Bone Graft is indicated for:
- Augmentation or reconstructive treatment of the alveolar ridge
- Filling of infrabony periodontal defects
- Filling of defects after root resection, apicoectomy, and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of the maxillary sinus floor
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
Basis for Substantial Equivalence
The DSM Biomedical Dental Bone Graft is substantially equivalent in terms of indications for use, material composition, technological characteristics and performance characteristics to the predicate device, Bio-OSS® [Geistlich-Pharma] K033815.
DSM Biomedical Dental Bone Graft and the predicate device have identical indications for use. Both are for use in the same target population. They are similar in sizes offered with the subject device sizes falling within the range of the predicate sizes. Both are sterilized by gamma irradation and supplied in a single use vial. The materials are shown to be an osteoconductive hydroxyapatite bone mineral to aid in bone formation. The devices are both trabecular and contain interconnecting macro and micro pores. The devices are both biocompatible. The subject device is derived from porcine bone while the predicate is derived from bovine bone. This does not raise questions of substantial equivalence as both types of bone are subjected to manufacturing processes which remove organic content from the source bone. Chemical and physical characteristics have been shown to be substantially equivalent in benchtop and animal testing.
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Image /page/5/Picture/0 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo consists of a colorful abstract graphic to the left of the company name, "DSM," which is written in a bold, blue sans-serif font. The graphic is composed of overlapping, curved shapes in various colors, including blue, green, purple, and orange, creating a sense of dynamism and innovation. The overall design is modern and corporate, reflecting the company's focus on scientific solutions.
| Characteristic | DSM Biomedical Dental Bone Graft
( Subject Device ) | Bio-OSS®
( K033815: Predicate Device ) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | DSM Biomedical Dental Bone Graft is
indicated for augmentation or
reconstructive treatment of the alveolar
ridge; filling of infrabony periodontal
defects; filling of defects after root
resection, apicoectomy, and cystectomy;
filling of extraction sockets to enhance
preservation of the alveolar ridge;
elevation of the maxillary sinus floor;
filling of periodontal defects in
conjunction with products intended for
Guided Tissue Regeneration (GTR) and
Guided Bone Regeneration (GBR); filling
of peri-implant defects in conjunction
with products intended for Guided Bone
Regeneration (GBR). | Bio-OSS® is indicated for augmentation
or reconstructive treatment of the
alveolar ridge; filling of infrabony
periodontal defects; filling of defects
after root resection, apicoectomy, and
cystectomy; filling of extraction sockets
to enhance preservation of the alveolar
ridge; elevation of the maxillary sinus
floor; filling of periodontal defects in
conjunction with products intended for
Guided Tissue Regeneration (GTR) and
Guided Bone Regeneration (GBR); filling
of peri-implant defects in conjunction
with products intended for Guided Bone
Regeneration (GBR). |
| Target Population | Human, oral, periodontal | Human, oral, periodontal |
| Source Bone | Porcine bone | Bovine bone |
| Form | 0.25 - 1.0mm granules | 0.25mm - 1.0mm or 1.00mm - 2.0mm
granules |
| Supplied As | Granules supplied in a single use
sterilized vial | Granules supplied in a single use
sterilized vial |
| Material | Porcine-derived osteoconductive
hydroxyapatite bone mineral | Bovine-derived osteoconductive
hydroxyapatite bone mineral |
| Physical
Morphology | Trabecular, interconnecting macro and
micro pores | Trabecular, interconnecting macro and
micro pores |
| Performance | Bone formation | Bone formation |
| Biocompatible | Yes | Yes |
| Characteristic | DSM Biomedical Dental Bone Graft
( Subject Device ) | Bio-OSS®
( K033815: Predicate Device ) |
| Reusable | Single Use Device | Single Use Device |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation |
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Image /page/6/Picture/0 description: The image shows the logo for DSM, a global science-based company. The logo consists of a colorful abstract graphic on the left and the letters "DSM" in bold blue font on the right. The graphic is composed of swirling shapes in shades of blue, green, yellow, and pink, creating a sense of movement and dynamism. The overall design is modern and corporate, reflecting the company's focus on innovation and technology.
Biocompatibility and Performance Data:
Material characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study have been conducted to evaluate the performance characteristics and biological safety of DSM Biomedical Dental Bone Graft.
Material characterization of the DSM Biomedical Dental Bone Graft was completed in accordance with the FDA Guidance Document, Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices and ASTM F 1581, Standard Specifications for Composition or Anorganic Bone for Surgical Implants. Bench testing was completed to verify that the device can be hydrated and mixed in the provided packaging.
A canine intrabony defect animal study was performed to evaluate bone healing following treatment with the DSM Biomedical Dental Bone Graft compared to the predicate device.
Biocompatibility testing was completed in accordance with the requirements of ISO 10993-1: 2009, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process for a permanent implant device with tissue/bone contact. Testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Genotoxicity, Hemocompatibility, Subacute Systemic Toxicity, and Chronic Systemic Toxicity, and Implantation. Other safety testing included a viral inactivation study and residual chemical assessment. Results indicate that the device's biocompatibility profile is acceptable.
Conclusion:
Pursuant to section 510(k), DSM Biomedical Dental Bone Graft is substantially equivalent to the predicate device Bio-OSS® with regard to indication for use, material, technological characteristics, including principles of operation, and performance characteristics as shown in an anatomically relevant animal model.