(151 days)
No
The device description focuses on the material composition and physical properties of a collagen membrane, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a pure collagen membrane used for guided bone regeneration and tissue regeneration procedures, which are therapeutic interventions. Its intended uses include treating various dental and periodontal defects, and it's compared to predicate devices with similar therapeutic applications.
No
Explanation: The device description clearly states that MUCOGRAFT® is a "pure collagen membrane" used for "guided bone regeneration" and "guided tissue regeneration procedures." Its function is to cover defects and reconstruct tissue, not to diagnose medical conditions.
No
The device description clearly describes a physical collagen membrane made from animal tissue, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description and intended use of MUCOGRAFT® clearly indicate it is a collagen membrane used for surgical procedures related to bone and tissue regeneration in the mouth. It is implanted directly into the body to act as a barrier and scaffold for healing.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any specimens from the human body. The device itself is the therapeutic/regenerative material.
Therefore, MUCOGRAFT® falls under the category of a surgical implant or regenerative device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MUCOGRAFT® Collagen Matrix is recommended for:
- Simultaneous use of GBR-membrane (MUCOGRAFT) and implants; ー
- ﺴﺘ Covering of implants placed in immediate extraction sockets;
- -Covering of implants placed in delayed extraction sockets:
- ー Localized ridge augmentation for later implantation:
- -Alveolar ridge reconstruction for prosthetic treatment;
- -Covering of bone defects after root resection, cystectomy, removal of retained teeth;
- . Guided bone regeneration in dehiscence defects; and
- Guided tissue regeneration procedures in periodontal and recession defects.
Product codes (comma separated list FDA assigned to the subject device)
NPL
Device Description
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): 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.
K012423, K061244, K960724, K042197, K050446
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.
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.
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510(k) Summary
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MUCOGRAFT®
MAY 3 0 2008
SPONSOR 1.
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: May 22, 2008
2. · DEVICE NAME
| Proprietary Name | MUCOGRAFT® Collagen Matrix |
|---|---|
| Common/Usual Name: | Resorbable Bilayer Membrane for Guided Tissue and Bone |
| Regeneration | |
| Classification Name: | Barrier, Animal Source, Dental |
3. PREDICATE DEVICES
MUCOGRAFT® (K012423 and K061244) BIO-GIDE® (K960724; K042197; and K050446)
4. INTENDED USE
MUCOGRAFT® Collagen Matrix is recommended for:
- Simultaneous use of GBR-membrane (MUCOGRAFT) and implants; ー
- ﺴﺘ Covering of implants placed in immediate extraction sockets;
- -Covering of implants placed in delayed extraction sockets:
- ー Localized ridge augmentation for later implantation:
- -Alveolar ridge reconstruction for prosthetic treatment;
- -Covering of bone defects after root resection, cystectomy, removal of retained teeth;
- . Guided bone regeneration in dehiscence defects; and
- Guided tissue regeneration procedures in periodontal and recession defects. -
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DEVICE DESCRIPTION 5.
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® collagen matrix is substantially equivalent to Geistlich's existing products MUCOGRAFT® resorbable bilayer membrane (K012423 and K061244) and BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration (subject to K960724; K042197; and K050446). The differences between the new product and the BIO-GIDE and MUCOGRAFT® products cleared previously via K061244 and K042197, respectively, are the following: (1) changes to the manufacturing process, including a change in the concentration and duration of the alkaline treatment step, a new freeze-dryer, and the solvent cleaning phase being performed earlier in the process; (2) a change in the blister material from polystyrene (PS) to amorphic polyethylene terephtalate (A-PET); (3) changes to the product specifications, including a parametric release for the Gamma-Sterilization, and the omission of certain release controls; (4) expanded indication for use in Guided Tissue Regeneration; (5) a new-layout for the product label and packaging; and (6) the thickness of membrane when dry is 2.5 mm to 5 mm as opposed to 2 mm with MUCOGRAFT® Resorbable Bilayer Membrane, but when wet and placed into a defect, both are approximate 1 mm. The proposed additional indication is 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® Resorbable Bilayer Membrane (K061244).
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 is cleared for all of the indications for which BIO-GIDE® is cleared.
The following is a table comparing MUCOGRAFT® Collagen Matrix to MUCOGRAFT® Resorbable Bilayer Membrane for guided tissue and bone regeneration.
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Table 1: MUCOGRAFT® Resorbable Bilayer Membrane (Predicate Device) vs. MUCOGRAFT® Collagen Matrix Comparison Chart
| | MUCOGRAFT® Resorbable
Bilayer Membrane | MUCOGRAFT®
Collagen Matrix |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 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
Same Amount | Yes, Type I and Type III
Collagen
Same Amount |
| Sterilization Process | Gamma Irradiation | Gamma Irradiation |
| Biocompatible | Yes | Yes |
| Non-pyrogenic | Yes | Yes |
| Shelf Life | 36 Months | 36 Months |
| Thickness (dry) | Approx. 2 mm | Approx. 2.5-5 mm |
| Thickness (when placed over
defect) | Approx. 1 mm | Approx. 1 mm |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
MAY 3 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ed. Geistlich Soehne Ag Für Chemische Industrie C/O Mr. Peter S. Reichertz Sheppard, Mullin, Richter & Hampton LLP 1300 I Strect, N.W., 11th Floor East Washington, DC 20005
Re: K073711
Trade/Device Name: MUCOGRAFT® Collagen Matrix Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: May 22, 2008 Received: May 23, 2008
Dear Mr. Reichertz:
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 such 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 -- Mr. Reichertz
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 begin 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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
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K073711
Indications for Use
510(k) Number (if known): K073711
Device Name:
MUCOGRAFT® Collagen Matrix.
Indications for Use:
Simultaneous use of GBR-membrane (MUCOGRAFT®) and implants; covering of implants placed in immediate extraction sockets; covering of implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; covering of bone defects after root resection; cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects; guided tissue regeneration procedures in periodontal and recession defects.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
Susan Runore
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number.
W02-EAST:9EJJ1\200052247.1