(68 days)
Not Found
No
The 510(k) summary describes a physical collagen membrane used for wound healing and bone regeneration, with no mention of software, algorithms, or any AI/ML related terms. The performance studies focus on biocompatibility and resorption time, not algorithmic performance.
Yes.
The device is intended for use in oral surgical procedures to aid in wound healing and bone repair, which are therapeutic applications.
No
The device is a resorbable material used in oral surgical procedures to aid in wound healing, not to diagnose a condition.
No
The device description clearly states it is a "resorbable, type I collagen matrix of defined geometry," which is a physical material, not software. The summary also details biocompatibility and resorption studies, which are relevant to a physical implantable device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for use in oral surgical procedures as a resorbable material to aid in wound healing. This is a therapeutic or surgical aid, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a physical matrix implanted during surgery. It doesn't analyze biological samples to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, measure a substance in a sample, or provide information about a patient's health status based on in vitro analysis.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to support healing.
N/A
Intended Use / Indications for Use
Collagen Dental Membrane is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect or ridge augmentation to aid in wound healing post surgery.
Product codes (comma separated list FDA assigned to the subject device)
NPL
Device Description
The Collagen Dental Membrane is a resorbable, type I collagen matrix of defined geometry, in vivo stability, permeability and mechanical strength for use as a material to aid in wound healing in bone repair, ridge augmentation and dental implant procedures.
The device is provided in two sizes 20 mm x 30 mm x 40 mm. The device can be easily trimmed for a final fit during surgery to the appropriate size and shape required for the defect to be treated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral surgical procedures, dental implant, bone defect, ridge augmentation
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)
Summary of Biocompatibility Studies: The Collagen Dental Membrane is biocompatible based on the tests recommended by the FDA.
Summary of In Vivo Resorption Studies: In vivo resorption time for the Collagen Dental Membrane was evaluated in a rat subcutaneous implantation model. The results of the studies showed that Collagen Dental Membrane has an in vivo resorption time from 26 to 38 weeks.
Summary of Effectiveness Data - Animal Data: The concept of "Guided Bone Regeneration (GBR)" in bone repair, ridge augmentation and dental implant surgeries has been proven from animal model studies. A comprehensive literature search confirmed that numerous materials studied as a barrier in GBR studies in various animal models showed that the concept of GBR using membranes as a barrier to aid in wound healing is a valid approach.
Summary of Effectiveness Data - Clinical Data: Results from human studies from the literature are consistent with animal studies. Both resorbable and non-resorbable materials studied are effective as a barrier to aid in wound healing in dental implant, ridge augmentation and bone repair procedures.
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.
BioGide®, [510(k) #K960724]
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.
0
AUG - 7 2001
510 (k) Summary of Safety And Effectiveness
| Applicant name and address: | Collagen Matrix, Inc.
509 Commerce Street
Franklin Lakes, NJ 07417 |
|--------------------------------------|--------------------------------------------------------------------------|
| Contact person and telephone number: | Shu-Tung Li, Ph.D.
President & CEO
Tel: (201) 405-1477 |
| Date of summary: | May 24, 2001 |
| Device generic name: | Collagen Dental Membrane |
| Device trade name: | None |
| Predicate device: | BioGide®,[510(k) #K960724] |
Description of the device:
The Collagen Dental Membrane is a resorbable, type I collagen matrix of defined geometry, in vivo stability, permeability and mechanical strength for use as a material to aid in wound healing in bone repair, ridge augmentation and dental implant procedures.
The device is provided in two sizes 20 mm x 30 mm x 40 mm. The device can be easily trimmed for a final fit during surgery to the appropriate size and shape required for the defect to be treated.
Intended Use of the Device
Collagen Dental Membrane is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect or ridge augmentation to aid in wound healing post surgery.
Technical Characteristics
Collagen Dental Membrane has been designed in accordance with the accepted principles of guided bone regeneration (GBR) as a wound healing material post surgery.
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Specifically, the device is designed to be resorbable, biocompatible, cell occlusive, clinically manageable, and suturable.
Summary of Biocompatibility Studies
The Collagen Dental Membrane is biocompatible based on the tests recommended by the FDA.
Summary of In Vivo Resorption Studies
In vivo resorption time for the Collagen Dental Membrane was evaluated in a rat subcutaneous implantation model. The results of the studies showed that Collagen Dental Membrane has an in vivo resorption time from 26 to 38 weeks.
Summary of Effectiveness Data
Animal Data
The concept of "Guided Bone Regeneration (GBR)" in bone repair, ridge augmentation and dental implant surgeries has been proven from animal model studies. That is, during the surgery, a barrier membrane is placed over the bone, ridge or dental implant to retard and/or prevent the down growth of epithelium, and to prevent the contact of gingival connective tissue with the implant and bony surface. Thereby, bone cells can grow into the defect site to fill the defect space or integrate with the dental implant for a firm anchor of the implant within the bone socket.
A comprehensive literature search showed that numerous materials have been studied as a barrier in the GBR studies in various animal models. The animal data provided evidence that the concept of GBR using membranes as a barrier to aid in wound healing has been verified using either resorbable or non-resorbable membranes is a valid approach.
b. Summary of Clinical Data
Results from human studies from the literature are consistent with animal studies. Similar to animal studies, the materials studied thus far, resorbable and nonresorbable,
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are both effective as a barrier to aid in wound healing in dental implant, ridge augmentation and bone repair procedures.
Conclusion
Thus, based on the biocompatibility testing conducted on the Collagen Dental Membrane and literature research on the various membranes, we conclude that the Collagen Dental Membrane is safe for implantation and is effective as a resorbable membrane to aid in wound healing post dental implant, bone repair and ridge augmentation surgeries. The Collagen Dental Membrane is substantially equivalent to BioGide®
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
OCT 1 0 2007
Mr. Shu-Tung Li President Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417
Re: K011695 Trade Name: Collagen Dental Membrane Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPL Dated: May 30, 2001 Received: May 31, 2001
Dear Mr. Li:
This letter corrects our substantially equivalent letter of August 7, 2001.
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 (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 -
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 continue 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sujette y Michie On.D.
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
Image /page/4/Picture/7 description: The image is a black and white circular logo. The logo has the letters "FDA" in large bold font in the center. Above the letters are the numbers "1906 - 2006". The word "Centennial" is written in cursive font below the letters. The text "FOOD AND DRUG ADMINISTRATION" is written around the top of the circle, and the text "IN YOUR SERVICE OF PUBLIC HEALTH" is written around the bottom of the circle.
Protecting and Promoting Public Health
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510(k) Number (if known):
Collagen Dental Membrane Device Name:
Indications for Use:
Collagen Dental Membrane is intended for use in oral surgical procedures as a resorbable Conagon Dontal Monttin the area of dental implant, bone defect or ridge augmentation to aid in wound healing post surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ V (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Muald W. Sherman for MSR
(Division Sign-Off) Division of Dental, Infection Contr and General Hospital Devic 510(k) Number _
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