(34 days)
No
The device description focuses on the material composition and physical properties of a collagen membrane for guided tissue and bone regeneration. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device, MUCOGRAFT®, is a resorbable bilayer membrane used for guided tissue and bone regeneration. While it aids in the healing and reconstruction of tissues, its primary function is to serve as a physical barrier and scaffold to promote natural biological processes, not to directly treat a disease or condition with a therapeutic substance or energy.
No
The device, MUCOGRAFT®, is described as a resorbable bilayer membrane used for guided tissue and bone regeneration. Its intended uses involve supporting biological processes like tissue and bone growth, not diagnosing medical conditions.
No
The device description clearly describes a physical, resorbable bilayer membrane made of collagen, which is a hardware component. It is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly indicate that this device is a resorbable bilayer membrane used for guided tissue and bone regeneration within the body during surgical procedures. It is a physical barrier and scaffold for tissue growth, not a test performed on a sample outside the body.
The device is a surgical implant/material used for regenerative procedures, not a diagnostic tool.
N/A
Intended Use / Indications for Use
MUCOGRAFT® is recommended for:
- Simultaneous use of GBR-membrane (MUCOGRAFT) 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; and
- -Guided tissue regeneration procedures in periodontal defects.
Indications for Use: Simultaneous use of GBR-membrane (MUCOGRAFT) 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
MUCOGRAFT® resorbable bilayer membrane for guided tissue and bone regeneration is physically identical to MUCOGRAFT® resorbable bilayer membrane (K012423), but labeled with an additional indication: guided tissue regeneration in periodontal defects. MUCOGRAFT® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. MUCOGRAFT® is sterilized in double blisters by gamma irradiation. MUCOGRAFT® has a bilayer structure with one smooth, non-permeable layer and one porous. The "outer," smooth side has a smooth surface which is cell occlusive and prevents cell adhesion and acts as a barrier. It allows tissue adherence favoring wound healing. It is made from the peritoneum of pigs. This side is turned towards the soft tissue. The smooth texture has appropriate elastic properties to accommodate suturing to the host mucosal margins and to protect the graft material from oral trauma during biodegradation and healing. The "inner" porous layer consists of collagen fibers in a loose, porous arrangement to enable cell invasion. This porous layer is made from pig skin. This side is turned toward the bone defect and/or soft tissue to encourage bone-forming cells and tissue growth and to stabilize the blood clot.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K960724, K042197, K050446, K012423
Reference Device(s)
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
MUCOGRAFT®
JUN -6 2006
1. SPONSOR
Ed. Geistlich Soehne Ag für Chemische Industrie · Geistlich Pharma Ag Bahnhofstrasse 40 CH-6110 Wolhusen SWITZERLAND
Contact Person: Peter S. Reichertz, (202) 772-5333 Date Prepared: April 21, 2006
2. DEVICE NAME
| Proprietary Name | MUCOGRAFT® |
|---|---|
| Common/Usual Name: | Resorbable Bilayer Membrane for Guided Tissue and Bone |
| Regeneration | |
| Classification Name: | Barrier, Animal Source, Dental |
3. PREDICATE DEVICES
BIO-GIDE® (K960724; K042197; and K050446) MUCOGRAFT® (K012423)
INTENDED USE 4.
MUCOGRAFT® is recommended for:
- Simultaneous use of GBR-membrane (MUCOGRAFT) 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; and
- -Guided tissue regeneration procedures in periodontal defects.
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నే. DEVICE DESCRIPTION
MUCOGRAFT® resorbable bilayer membrane for guided tissue and bone regeneration is physically identical to MUCOGRAFT® resorbable bilayer membrane (K012423), but labeled with an additional indication: guided tissue regeneration in periodontal defects. MUCOGRAFT® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. MUCOGRAFT® is sterilized in double blisters by gamma irradiation. MUCOGRAFT® has a bilayer structure with one smooth, non-permeable layer and one porous. The "outer," smooth side has a smooth surface which is cell occlusive and prevents cell adhesion and acts as a barrier. It allows tissue adherence favoring wound healing. It is made from the peritoneum of pigs. This side is turned towards the soft tissue. The smooth texture has appropriate elastic properties to accommodate suturing to the host mucosal margins and to protect the graft material from oral trauma during biodegradation and healing. The "inner" porous layer consists of collagen fibers in a loose, porous arrangement to enable cell invasion. This porous layer is made from pig skin. This side is turned toward the bone defect and/or soft tissue to encourage bone-forming cells and tissue growth and to stabilize the blood clot.
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
MUCOGRAFT® resorbable bilayer membrane for guided tissue and bone regeneration is substantially equivalent to Geistlich's existing products BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration (subject to K960724; K042197; and K050446) and MUCOGRAFT® resorbable bilayer membrane (K012423). The only difference between the new product and the BIO-GIDE and MUCOGRAFT® products cleared previously via K042197 and K012423, respectively, is the proposed additional indication for "guided tissue regeneration procedures in periodontal defects." Included by reference are all data submitted in the previous notification and clearance of BIO-GIDE® (K042197) and MUCOGRAFT® (K012423).
MUCOGRAFT®, like BIO-GIDE®, is a collagen membrane used in dental grafting procedures. MUCOGRAFT® was previously determined to be substantially equivalent to BIO-GIDE® and was cleared for all of the indications for which BIO-GIDE® had been cleared at that time (pursuant to K960724). Per K042197, BIO-GIDE® was subsequently cleared for, among other uses, "guided tissue regeneration procedures in periodontal defects."
The following is a table comparing MUCOGRAFT® resorbable bilayer membrane to BIO-GIDE resorbable bilayer membrane for guided tissue and bone regeneration.
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Table 1: BIO-GIDE® Resorbable Bilayer Membrane (Predicate Device) vs. MUCOGRAFT® Resorbable Bilayer Membrane Comparison Chart
| | BIO-GIDE® Resorbable
Bilayer Membrane | MUCOGRAFT®
Resorbable Bilayer Membrane |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used for guided tissue
regeneration procedures in
periodontal defects to enhance
regeneration of the periodontal
apparatus. | Used for guided tissue
regeneration procedures in
periodontal defects to enhance
regeneration of the periodontal
apparatus. |
| Incorporates Same Basic
Design | Yes | Yes |
| Utilizes Same Operating
Principle | Cell occlusive
Implantable
Resorbable
Hemostatic | Cell occlusive
Implantable
Resorbable
Hemostatic |
| Incorporates Same Materials? | Yes, Type I and Type III
Collagen | Yes, Type I and Type III
Collagen |
| Sterilization Process | Gamma Irradiation | Gamma Irradiation |
| Biocompatible | Yes | Yes |
| Non-pyrogenic | Yes | Yes |
| Shelf Life | 36 Months | 36 Months |
:
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle and profiles are encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Public Health Service
OCT 1 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
Ed. Geistlich Soehne Ag Fur Chemische Industrie C/O Mr. Peter S. Reichertz Official Correspondent/U.S. Agent Sheppard Mullin Richter & Hampton LLP 1300 I Street N.W. 11th Floor East Washington, D.C. 20005-3314
Re: K061244
Trade Name: MUCOGRAFT® Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPL Dated: May 2, 2006 Received: May 3. 2006
Dear Mr. Reichertz:
This letter corrects our substantially equivalent letter of June 6, 2006.
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 vour 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 vours.
Syndite Y. Michie Ows.
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 circular logo or seal. It features the text "1906-2006" at the top, indicating a centennial celebration. The letters "FDA" are prominently displayed in the center, with the word "Centennial" written below. The text around the circle reads "California Processing Tomato Industry".
Protecting and Promoting Public Health
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Indications for Use
510(k) Number (if known):
MUCOGRAFT® Resorbable Bilayer Membrane for Guided Tissue and Device Name: Bone Regeneration.
Indications for Use: Simultaneous use of GBR-membrane (MUCOGRAFT) 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.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Y (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
Suser Runne
(1) Jign-Cit) an of Anesthesiology, General Hospital, Jon Control, Dental Devices
861244