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.

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.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called MUCOGRAFT®, a resorbable bilayer membrane used for guided tissue and bone regeneration. The submission aims to establish substantial equivalence to previously cleared predicate devices, specifically BIO-GIDE® (K960724; K042197; and K050446) and MUCOGRAFT® (K012423), with an additional indication for "guided tissue regeneration procedures in periodontal defects."

The document states that the new MUCOGRAFT® is physically identical to the previously cleared MUCOGRAFT® (K012423), and the primary basis for substantial equivalence is the existing clearances and the comparison to BIO-GIDE® (K042197) which already includes the new indication sought for guided tissue regeneration in periodontal defects.

Therefore, the submission does not describe a new study to prove the device meets acceptance criteria. Instead, it relies on the substantial equivalence principle, asserting that the device is essentially the same as already cleared devices, particularly the predicate device BIO-GIDE® for the new indication.

Given this, many of the requested details about acceptance criteria and study design are not present in this 510(k) summary. I can, however, extract the comparative information presented in lieu of specific acceptance criteria from a new study.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not present a formal table of "acceptance criteria" against newly generated "reported device performance" from a dedicated study for the MUCOGRAFT® device. Instead, it demonstrates substantial equivalence to predicate devices based on product characteristics and intended use. The table provided is a comparison of MUCOGRAFT® to its predicate device, BIO-GIDE®, highlighting their similarities, which serves as the basis for regulatory acceptance.

Feature	BIO-GIDE® Resorbable Bilayer Membrane (Predicate Device)	MUCOGRAFT® Resorbable Bilayer Membrane (Proposed Device)	Basis of Acceptance / Statement
Intended Use	Used for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. (Also other GBR indications from K042197)	Used for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. (Also other GBR indications from K012423)	Identical Intended Use (for the specific indication sought). The new indication for MUCOGRAFT® mirrors that of the previously cleared BIO-GIDE® for which it is claiming equivalence.
Incorporates Same Basic Design	Yes	Yes	Identical Design.
Utilizes Same Operating Principle	Cell occlusive, Implantable, Resorbable, Hemostatic	Cell occlusive, Implantable, Resorbable, Hemostatic	Identical Operating Principle. Both are bilayer collagen membranes with a cell-occlusive layer and a porous layer.
Incorporates Same Materials?	Yes, Type I and Type III Collagen	Yes, Type I and Type III Collagen	Identical Materials. Both are derived from porcine collagen Type I and III.
Sterilization Process	Gamma Irradiation	Gamma Irradiation	Identical Sterilization Process.
Biocompatible	Yes	Yes	Identical Biocompatibility. Assumed due to identical materials and processing for a previously cleared device.
Non-pyrogenic	Yes	Yes	Identical Non-pyrogenicity. Assumed due to identical materials and processing for a previously cleared device.
Shelf Life	36 Months	36 Months	Identical Shelf Life.

2. Sample size used for the test set and the data provenance

Not applicable. The submission does not describe a new test set or study conducted for this specific 510(k) submission. It relies on the equivalence to previously cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new study for ground truth establishment is described.

4. Adjudication method for the test set

Not applicable. No new test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a resorbable membrane, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a resorbable membrane, not an algorithm.

7. The type of ground truth used

Not applicable (for this submission). For the original clearance of the predicate devices (BIO-GIDE® and initial MUCOGRAFT®), the ground truth for their effectiveness would have been established through pre-clinical testing, animal studies, and potentially clinical trials (outcomes data, histological evidence of regeneration, etc.) as required for their initial 510(k) clearances. This specific submission relies on referencing those prior clearances.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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510(k) Summary

K061244

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 BoneRegeneration
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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K061244

నే. DEVICE DESCRIPTION

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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K061244

Table 1: BIO-GIDE® Resorbable Bilayer Membrane (Predicate Device) vs. MUCOGRAFT® Resorbable Bilayer Membrane Comparison Chart

	BIO-GIDE® ResorbableBilayer Membrane	MUCOGRAFT®Resorbable Bilayer Membrane
Intended Use	Used for guided tissueregeneration procedures inperiodontal defects to enhanceregeneration of the periodontalapparatus.	Used for guided tissueregeneration procedures inperiodontal defects to enhanceregeneration of the periodontalapparatus.
Incorporates Same BasicDesign	Yes	Yes
Utilizes Same OperatingPrinciple	Cell occlusiveImplantableResorbableHemostatic	Cell occlusiveImplantableResorbableHemostatic
Incorporates Same Materials?	Yes, Type I and Type IIICollagen	Yes, Type I and Type IIICollagen
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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K061244

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

Regulation Number and Section

§ 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.