(232 days)
Not Found
No
The device description and intended use focus on the material properties and biological function of a collagen membrane, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a resorbable membrane material for use in oral surgical procedures, aiding in augmentation, reconstruction, and filling of bone/tissue defects, rather than directly treating a disease or condition itself.
No
The provided text describes Collagen Dental Membrane IV as a resorbable membrane material for use in oral surgical procedures for augmentation and regeneration. It initiates a physical process in the body and does not mention any diagnostic capabilities, such as identifying, detecting, or measuring a medical condition or disease.
No
The device description clearly states it is a physical membrane made of collagen, 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 describes a material used in oral surgical procedures to aid in tissue regeneration and augmentation. This is a therapeutic or structural function within the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a resorbable membrane matrix made of collagen, designed to be implanted. This aligns with a surgical implant or material, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Collagen Dental Membrane IV is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
Product codes
NPL
Device Description
Collagen Dental Membrane IV is a white, nonfriable, conformable, resorbable, membrane matrix consisting of highly purified type I and III collagen derived from bovine dermis. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane IV is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 results of the in vitro product characterization studies and in vivo animal studies show that Collagen Dental Membrane IV is safe and substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
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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SEP 1 8 2009
510(k) Summary of Safety and Effectiveness
Applicant Name and Address: Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417
Contact Person:
Peggy Hansen, RAC Vice President, Clinical, Regulatory, QA, and Marketing Tel: (201) 405-1477 Fax: (201) 405-1355
Date of Summary:
May 1, 2009
Device Common Name:
Device Trade Name:
Device Classification Name:
Barrier, animal source, intraoral 872.3930 NPL Class II
Resorbable Collagen Membrane
Collagen Dental Membrane IV
Predicate Device(s):
Collagen Dental Membrane - Conformable II K062881
Bio-Gide™ Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration K050446
Tutodent® Dental Membrane CopiOs™ Pericardium Membrane K073097
Description of the Device
Collagen Dental Membrane IV is a white, nonfriable, conformable, resorbable, membrane matrix consisting of highly purified type I and III collagen derived from bovine dermis. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane IV is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
Intended Use
Collagen Dental Membrane IV is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later
implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
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Summary/Comparison of Technical Characteristics
Collagen Dental Membrane IV and its predicates have similar technological characteristics. In particular, the Collagen Dental Membrane IV and its predicate are similar with respect to intended use, form, animal source, sizes, thickness, physical integrity, permeability and conformability.
Safety
Collagen Dental Membrane IV has been evaluated in a number of in vitro and in vivo tests to assess its safety/biocompatibility. The device passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.
Conclusion
The results of the in vitro product characterization studies and in vivo animal studies show that Collagen Dental Membrane IV is safe and substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows a partial view of a document or logo. On the left, there's a stylized emblem with curved lines, possibly representing an eagle or a similar symbol. To the right of the emblem, the word "DEPART" is visible, suggesting that the full text might be "DEPARTMENT" followed by additional text below a horizontal line.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring. MD 20993-0002
SEP 1 8 2009
Ms. Peggy Hansen Vice President, Clinical, Regulatory Quality Assurance Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersev 07417
Re: K090216
Trade/Device Name: Collagen Dental Membrane IV Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: September 4, 2009 Received: September 9, 2009
Dear Ms. Hansen:
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 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.
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Page 2- Ms. Hansen
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 (reporting of medical device-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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
for
Susan Runner, D.D.S., M.A. Acting 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
510(k) Number (if known): K090216
Device Name: Collagen Dental Membrane IV
Indications for Use:
Collagen Dental Membrane IV is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mulvey for MSP
Division Sign-Off) nivision of Anesthesiology, General Hospital niection Control, Dental Devices
-10(k) Number: K090216
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