(109 days)
No
The device description and performance studies focus on the material properties and biological function of a resorbable membrane, with no mention of AI or ML technologies.
No.
This device is a resorbable barrier membrane used in dental applications to aid in guided tissue and bone regeneration, functioning as a scaffold for tissue growth rather than directly treating a disease or condition as a therapeutic device would.
No
Explanation: The device is a resorbable membrane used as a barrier for guided tissue and bone regeneration in dental applications, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a physical, resorbable membrane derived from porcine pericardium, provided as a lyophilized sheet in various sizes. It is a tangible product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The DSM Biomedical Porcine Pericardium Dental Membrane is a physical barrier membrane used in surgical procedures to guide tissue and bone regeneration in the mouth. It is implanted into the body and does not analyze samples taken from the body.
The description clearly indicates it's a surgical implant used for structural support and guidance during healing, not for diagnostic testing.
N/A
Intended Use / Indications for Use
DSM Biomedical Porcine Pericardium Dental Membrane is indicated for:
- simultaneous use of GBR-membrane and implants
- augmentation around implants placed in immediate extraction sockets
- augmentation around implants placed in delayed extraction sockets
- localized ridge augmentation for later implantation
- alveolar ridge reconstruction for prosthetic treatment
- filling of bone defects after root resection, cystectomy, removal of retained teeth
- guided bone regeneration in dehiscence defects
- guided tissue regeneration procedures in periodontal defects
Product codes
NPL
Device Description
The DSM Biomedical Porcine Pericardium Dental Membrane is a resorbable porcine pericardium derived extracellular matrix barrier membrane for guided tissue and bone regeneration in dental applications. The device is manufactured using a standardized, controlled, multistage process. The origin of all animals is the United States of America. It is provided as a lyophilized sheet in sizes 15 mm x 25 mm, 20 mm x 30 mm, and 30 mm x 40 mm, which may be hydrated with saline or blood. It can be easily trimmed or shaped to the appropriate size to fit the defect to be treated. When hydrated, the membrane is easily drapeable while maintaining suture tear resistance. It is supplied sterile by ethylene oxide and is for single use only.
The DSM Biomedical Porcine Pericardium Dental Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. Animal studies have shown that DSM Biomedical Porcine Pericardium Dental Membrane is resorbed within 2 to 9 weeks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, periodontal
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
The performance of the DSM Biomedical Porcine Pericardium Dental Membrane was evaluated in a canine intrabony defect model compared to the predicate device. The study showed that coverage of dental bone defects with the subject device or predicate device results in similar new bone formation based on histopathology evaluations. The subject device degraded faster than the predicate, but based on clinical observation and extent of bone regeneration, this faster degradation does not present questions of equivalence.
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, Chronic Systemic Toxicity, and Implantation. Other testing included a viral inactivation study and residual chemical assessment. Results indicate that the device's biocompatibility profile is acceptable.
Key Metrics
Not Found
Predicate Device(s)
Bio-Gide® (K042197)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and 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
June 7, 2016
Kensey Nash Corporation Dba DSM Biomedical Brianna Schehr Regulatory Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19431
Re: K160474
Trade/Device Name: DSM Biomedical Porcine Pericardium Dental Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: May 19, 2016 Received: May 19, 2016
Dear Ms. Brianna Schehr:
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
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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 (reporting of medical devicerelated 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 yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K160474
Device Name
DSM Biomedical Porcine Pericardium Dental Membrane
Indications for Use (Describe)
DSM Biomedical Porcine Pericardium Dental Membrane is indicated for:
- simultaneous use of GBR-membrane and implants
- augmentation around implants placed in immediate extraction sockets
- augmentation around implants placed in delayed extraction sockets
- localized ridge augmentation for later implantation
- alveolar ridge reconstruction for prosthetic treatment
- filling of bone defects after root resection, cystectomy, removal of retained teeth
- guided bone regeneration in dehiscence defects
- guided tissue regeneration procedures in periodontal defects
| 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/1 description: The image shows the DSM company logo. The logo consists of a colorful abstract swirl on the left and the letters "DSM" in blue on the right. The swirl is made up of different colors, including blue, green, yellow, and pink. The letters "DSM" are in a bold, sans-serif font.
510(k) Summary
| Submitted By: | DSM Biomedical |
|---|---|
| 735 Pennsylvania Drive | |
| Exton, PA 19341 | |
| Contact Person: | Brianna Schehr |
| brianna.schehr@dsm.com | |
| (P) 484-713-2100 | |
| (F) 484-713-2806 | |
| Date Prepared: | June 5, 2016 |
| Device: | |
| Trade Name: | DSM Biomedical Porcine Pericardium Dental Membrane |
| Common/Usual Name: | Porcine Derived Collagen Dental Membrane |
| Regulation Number: | 21 CFR 872.3930 |
| Regulation Name: | Bone Grafting Material |
| Regulatory Class: | II |
| Product Code: | NPL (Barrier, Animal Source, Intraoral) |
| Advisory Panel: | Dental |
| Predicate Device: | Bio-Gide® (K042197) [Geistlich-Pharma] |
Device Description:
The DSM Biomedical Porcine Pericardium Dental Membrane is a resorbable porcine pericardium derived extracellular matrix barrier membrane for guided tissue and bone regeneration in dental applications. The device is manufactured using a standardized, controlled, multistage process. The origin of all animals is the United States of America. It is provided as a lyophilized sheet in sizes 15 mm x 25 mm, 20 mm x 30 mm, and 30 mm x 40 mm, which may be hydrated with saline or blood. It can be easily trimmed or shaped to the appropriate size to fit the defect to be treated. When hydrated, the membrane is easily drapeable while maintaining suture tear resistance. It is supplied sterile by ethylene oxide and is for single use only.
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Image /page/4/Picture/1 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo features a colorful, abstract swirl design on the left, composed of overlapping shapes in shades of blue, green, purple, and orange. To the right of the swirl is the company's name, "DSM," in bold, blue letters.
The DSM Biomedical Porcine Pericardium Dental Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. Animal studies have shown that DSM Biomedical Porcine Pericardium Dental Membrane is resorbed within 2 to 9 weeks.
Indications For Use:
DSM Biomedical Porcine Pericardium Dental Membrane is indicated for:
- simultaneous use of GBR-membrane and implants;
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment;
- filling of bone defects after root resection, cystectomy, removal of retained teeth;
- guided bone regeneration in dehiscence defects;
- quided tissue regeneration procedures in periodontal defects.
Basis for Substantial Equivalence:
The DSM Biomedical Porcine Pericardium Dental Membrane is substantially equivalent in terms of indications for use, material composition, technological characteristics, and performance characteristics to the predicate device, Bio-Gide® [Geistlich-Pharma] K042197.
A comparison of DSM Biomedical Porcine Pericardium Dental Membrane and the predicate device supports substantial equivalence based on the design, material, indications for use, technical characteristics, and performance. The technological characteristics of the DSM Biomedical Porcine Pericardium Dental Membrane are equivalent to the predicate device as shown in extensive material and physical characterization testing. The subject and predicate devices are derived from the same animal source, are provided sterile and for single use. Both devices are provided in lyophilized form in multiple size offerings. The micro-architecture is comparable as both contain a matrix of similarly sized
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Image /page/5/Picture/1 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo features a colorful, abstract swirl design on the left, with petals in shades of blue, green, orange, and purple. To the right of the swirl is the company name, "DSM," in bold, blue letters.
pores. The suture strength is also comparable, as both have suture tear resistance strength to withstand the forces of suturing to maintain positioning during implantation.
The performance of the DSM Biomedical Porcine Pericardium Dental Membrane was evaluated in a canine intrabony defect model compared to the predicate device. The study showed that coverage of dental bone defects with the subject device or predicate device results in similar new bone formation based on histopathology evaluations. The subject device degraded faster than the predicate, but based on clinical observation and extent of bone regeneration, this faster degradation does not present questions of equivalence.
| Characteristic | DSM Biomedical Porcine Pericardium
Dental Membrane
(Subject Device) | Bio-Gide®
(K042197: Predicate Device) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | DSM Biomedical Dental Bone Graft is
indicated for simultaneous use of GBR-
membrane and implants;
augmentation around implants placed
in immediate extraction sockets;
augmentation around implants placed
in delayed extraction sockets;
localized ridge augmentation for later
implantation; alveolar ridge
reconstruction for prosthetic
treatment; filling of bone defects
after root resection, cystectomy,
removal of retained teeth; guided
bone regeneration in dehiscence
defects; guided tissue regeneration
procedures in periodontal defects. | Bio-Gide® is indicated for
simultaneous use of GBR-membrane
and implants; augmentation around
implants placed in immediate
extraction sockets; augmentation
around implants placed in delayed
extraction sockets; localized ridge
augmentation for later implantation;
alveolar ridge reconstruction for
prosthetic treatment; filling of bone
defects after root resection,
cystectomy, removal of retained
teeth; guided bone regeneration in
dehiscence defects; guided tissue
regeneration procedures in
periodontal defects. |
| Target Population | Human, oral, periodontal | Human, oral, periodontal |
| Animal Origin | Porcine | Porcine |
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Image /page/6/Picture/1 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 swirl design on the left, with the letters "DSM" in bold, blue font on the right. The swirl design is made up of several overlapping shapes in different colors, including blue, green, orange, and purple. The overall design is modern and corporate.
| Characteristic | DSM Biomedical Porcine Pericardium
Dental Membrane
(Subject Device) | Bio-Gide®
(K042197: Predicate Device) |
|-------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------|
| Material
Composition | Porcine Pericardium-derived
extracellular matrix | Purified porcine collagen |
| Form | Resorbable lyophilized membrane | Resorbable lyophilized membrane |
| Sizes | 15 mm x 25 mm, 20 mm x 30 mm, 30
mm x 40 mm | 13 mm x 25 mm, 25 mm x 25 mm, 40
mm x 50 mm |
| Operating
Principles | Cell-Occlusive
Implantable
Resorbable
Biocompatible | Cell-Occlusive
Implantable
Resorbable
Biocompatible |
| Reusable | Single use only | Single use only |
| Packaging | Double pouch | Double blister |
| Non-Pyrogenic | Yes | Yes |
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 |
| Sterilization
Method | Ethylene Oxide | Gamma Irradiation |
| Shelf Life | 6 months | 36 months |
Performance Data:
The substantial equivalence of DSM Biomedical Porcine Pericardium Dental Membrane and its predicate was demonstrated based on in vitro characterization studies, biocompatibility studies, in vivo animal studies, and clinical history of the predicate device.
FDA recognized standard ISO 22803 Dentistry—Membrane Materials for Guided Tissue Regeneration in Oral and Maxillofacial Surgery—Contents of a Technical File, was used to guide the characterization of
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Image /page/7/Picture/1 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, with the letters "DSM" in bold, blue font on the right. The swirl design is made up of several overlapping shapes in different colors, including blue, green, orange, and purple. The overall design is modern and eye-catching.
the DSM Biomedical porcine Pericardium Dental Membrane as no applicable performance standards exist for this device.
In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate device. A series of device characterization and bench tests were conducted which included an evaluation of physical properties such as dimensional analysis, microarchitecture analysis including percent porosity and median pore diameter, and resorption. Evaluation of resorption was performed in a canine intrabony defect model. Material characterization testing of the DSM Biomedical Porcine Pericardium Dental Membrane was completed to evaluate the material properties of the device. Bench testing was completed to verify that the device exhibits drapeability when hydrated, adheres to tissue, and maintains sufficient suture tear resistance strength.
In addition to the in vitro characterization tests, a canine intrabony defect animal study was performed to evaluate membrane degradation and new bone formation following treatment with the DSM Biomedical Porcine Pericardium Dental Membrane 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, Chronic Systemic Toxicity, and Implantation. Other testing included a viral inactivation study and residual chemical assessment. Results indicate that the device's biocompatibility profile is acceptable.
| Biological Effect | Standard | Test | Result |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5 | L929 Neutral Red Uptake | Pass |
| Sensitization | ISO 10993-10 | Kligman Maximization Test | Pass |
| Irritation | ISO 10993-10 | Intracutaneous Injection | Pass |
| Acute Systemic | |||
| Toxicity | ISO 10993-11 | Systemic Injection Test | |
| Rabbit Pyrogen Test | Pass | ||
| Hemocompatibility | ISO 10993-4 | Hemolysis—Rabbit Blood—Indirect Contact | Pass |
| Subacute Systemic | |||
| Toxicity, Implantation | ISO 10993-6 | ||
| ISO 10993-11 | 28-Day Systemic Toxicity in Rats via | ||
| Intramuscular and Subcutaneous Implantation | Pass |
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Image /page/8/Picture/1 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo features a colorful, abstract swirl design on the left, with shades of blue, green, orange, and purple. To the right of the swirl is the company's name, "DSM," in bold, blue letters.
| Chronic Systemic
Toxicity and
Implantation | ISO 10993-6
ISO 10993-11 | 26-Week Systemic Toxicity in Rats via
Subcutaneous Implantation | Pass |
|--------------------------------------------------|-----------------------------|--------------------------------------------------------------------|------|
| Genotoxicity | ISO 10993-3 | S. Typhimurium and E. Coli Reverse Mutation
Assay | Pass |
| | | Chromosomal Aberration | Pass |
| | | Rodent Blood Micronucleus Assay | Pass |
Given the similarities between the DSM Biomedical Porcine Pericardium Dental Membrane and the predicate device, it was determined that clinical data was not necessary to demonstrate substantial equivalence.
Conclusion:
Pursuant to section 510(k), DSM Biomedical Porcine Pericardium Dental Membrane is substantially equivalent to the predicate device Bio-Gide® with regard to indication for use, material, technological characteristics, including principles of operation, and performance characteristics as shown in an anatomically relevant animal model.