(203 days)
No
The device description and performance studies focus on the material properties and biocompatibility of a collagen membrane, with no mention of AI or ML technology.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is used as a resorbable membrane material in oral surgical procedures, aiding in tissue regeneration and augmentation, but it does not directly treat a disease or condition itself.
No
Explanation: The device description and intended use clearly state that Collagen Dental Membrane V is a resorbable membrane for use in oral surgical procedures to augment tissue and bone. It does not mention any function related to diagnosing medical conditions.
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 vivo (within the body) during oral surgical procedures to aid in tissue and bone regeneration. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a resorbable membrane matrix made of collagen, designed to be implanted in the body. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, Collagen Dental Membrane V is a medical device used in surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Collagen Dental Membrane V is intended for use in oral surgical procedures as a resorbable 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 V is a white, nonfriable, conformable, resorbable, membrane matrix consisting of highly purified type I and III collagen derived from porcine dermis. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane V 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Collagen Dental Membrane V 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.
The results of the in vitro product characterization studies and in vivo animal studies show that Collagen Dental Membrane V is safe and substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
510(k) Summary of Safety and Effectiveness
| Applicant Name and Address: | Collagen Matrix, Inc.
509 Commerce Street
Franklin Lakes, New Jersey 07417 | AUG 11 2010 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Peggy Hansen, RAC
Vice President, Clinical, Regulatory, QA, and Marketing
Tel: (201) 405-1477
Fax: (201) 405-1355 | |
| Date of Summary: | January 14, 2010 | |
| Device Common Name: | Resorbable Collagen Membrane | |
| Device Trade Name: | Collagen Dental Membrane V | |
| Device Classification Name: | Barrier, animal source, intraoral
872.3930
NPL
Class II | |
| Predicate Device(s): | Collagen Dental Membrane IV
K090216
Bio-Gide™ Resorbable Bilayer Membrane for Guided
Tissue and Bone Regeneration
K050446 | |
Description of the Device
Collagen Dental Membrane V is a white, nonfriable, conformable, resorbable, membrane matrix consisting of highly purified type I and III collagen derived from porcine dermis. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane V is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
Intended Use
Collagen Dental Membrane V is intended for use in oral surgical procedures as a resorbable 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.
Summary/Comparison of Technical Characteristics
Collagen Dental Membrane V and its predicates have similar technological characteristics. In particular, the Collagen Dental Membrane V and its predicate are
1
Collagen Matrix, Inc. 510(k) Summary of Safety and Effectiveness Collagen Dental Membrane V
similar with respect to intended use, form, animal source, sizes, thickness, physical integrity, permeability and conformability.
Safety
Collagen Dental Membrane V 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 V is safe and substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Peggy Hansen Vice President, Clinical, Regulatory, Quality Assurance and Marketing Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417
Re: K100156
Trade/Device Name: Collagen Dental Membrane V Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: July 22, 2010 Received: July 23, 2010
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 provise vet 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
AUG 1 1 2010
3
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 its its accidention 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.
lf 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/ucm1115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K 100156
Indications for Use
510(k) Number (if known):
AUG 1 1 2010
Device Name: _Collagen Dental Membrane V
Indications for Use:
Collagen Dental Membrane V 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 Deffice Evaluation a
Kevin Mulvey for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices
510(k) Nur
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