The Dental Barrier Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier membrane for:

· Ridge augmentation for later implant insertion
· Augmentation around implants placed in immediate/delayed extraction sockets
· Localized ridge augmentation
· Alveolar ridge preservation/reconstruction
· Osseous fill around implants in peri-implantitis bone defects
· Over the window in lateral window sinus elevation procedures
· Intra-bony defects around teeth
· Treatment of recession defects, together with coronally positioned flap
· In furcation defects in multi-rooted teeth.

Device Description

The Matricel Dental Barrier Membrane is an intraoral porcine membrane intended to be used in dental applications as a barrier membrane for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) to support the growth of new tissue and bone. The Dental Barrier Membrane is composed of a network of highly purified porcine collagen (predominantly Type I with some Type III) and elastin fibers.

The Dental Barrier Membrane is offered in three sizes (15x20mm, 25x30mm and 30x40mm) with Rough and Smooth surfaces to accommodate physician preferences. The Smooth version is further processed to achieve a flattened surface, whereas the Rough version retains the natural fibrillar structure of the membrane. The Rough and Smooth membrane have identical technological, mechanical and chemical characteristics.

The product is packaged in double blister packs and sterilized by ethylene oxide. The Dental Barrier Membrane is supplied sterile and is indicated for single use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Matricel Dental Barrier Membrane, based on the provided text:

Matricel Dental Barrier Membrane Acceptance Criteria and Study Information

The acceptance criteria for the Matricel Dental Barrier Membrane are primarily based on achieving substantial equivalence to its predicate devices, Bio-Gide and Ossix Plus, through non-clinical testing. No clinical testing was submitted.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate devices. The reported device performance is demonstrated through various bench and animal tests, designed to show that the Matricel Dental Barrier Membrane's characteristics are comparable to the predicates and meet established standards.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Matricel Dental Barrier Membrane)
Material Source: Porcine	Porcine
Composition: Collagen Types I and III, and elastin	Collagen Types I and III, and elastin
Form: Membrane	Membrane
Resorbable: Yes	Yes (Comparable resorption characteristics to Bio-Gide)
Conformability: Flexible and conforms to defect site	Flexible and conforms to the defect site
Biocompatibility: Yes	Yes (Biocompatibility testing to ISO 10993-1 performed)
Sterilization: By ETO or Gamma Radiation	Ethylene oxide (Predicate Bio-Gide is Gamma radiation, Ossix Plus is ETO)
Shelf Life: 3 years	3 years (Comparable to Bio-Gide)
Packaging: Double blister package	Double blister package
Mechanical Properties: (e.g., tensile strength)	Met specifications (Bench testing to ASTM F2212-11)
Physical Properties: (e.g., peak denaturation temp, expansion after wetting)	Met specifications (Bench testing to ASTM F2212-11)
Biostability (Enzymatic Resistance): Comparable to predicates	Behaves as stable as predicate Bio-Gide
Inflammatory Response: Minimal/None	Does not elicit an inflammatory response (Animal Test)
Surface Weight: Typically >10 mg/cm²	>10 mg/cm² and within specifications of Bio-Gide
Non-pyrogenic: Yes	Yes

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as this was not a clinical study involving human patients. For the bench and animal tests:
- Bench testing details (e.g., number of membranes tested for tensile strength) are not specified.
- Animal testing involved a comparison to the predicate Bio-Gide, but the specific number of animals or samples is not provided.
Data Provenance: The studies were non-clinical (bench and animal tests). The country of origin for the data is implicitly Germany, where Matricel GmbH is located, as they are the submitter. The data is prospective for these specific tests conducted for the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was a non-clinical submission relying on bench and animal testing against established standards and comparisons to predicate devices, not on human expert interpretation of data like images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication process as it was a non-clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "No clinical testing was submitted in support of this 510(k) premarket notification." Therefore, there is no information on human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical medical device (dental barrier membrane), not an AI algorithm. Therefore, "standalone" performance in the context of AI does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on:

Established Specifications: Meeting predefined physical and mechanical specifications (e.g., tensile strength, peak denaturation temperature, expansion after wetting) as characterized in accordance with ASTM F2212-11.
Biocompatibility Standards: Adherence to ISO 10993-1 for biological safety.
Comparative Performance to Predicate Devices: Demonstrating comparable performance (e.g., enzymatic resistance, resorption characteristics) to the legally marketed predicate device Bio-Gide in animal studies.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as it is not an AI/ML device.

Summary

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Kr2369

FEB 2 4 2014

Revised 510(k) Summary for the Matricel GmbH Matricel Dental Barrier Membrane (per 21CFR 807.92)

1. SUBMITTER/510(K) HOLDER

Matricel GmbH
Kaiserstrasse 100
D-52134 Herzogenrath
Germany

Contact Person:	Dr. Ingo Heschel
Telephone:	+49 2407 5644-11
Fax:	+49 2407 5644-10
Email:	heschel@matricel.de
Date Prepared:	July 24, 2013

2. DEVICE NAME

Proprietary Name:	Matricel Dental Barrier Membrane
Common/Usual Name:	Barrier, animal source, intraoral
Classification Name:	Bone Grafting Material (21 CFR 872.3930)
Product Code:	NPL
Device Class:	2

3. PREDICATE DEVICES

· Bio-Gide (Ed. Geistlich Soehne AG fuer Chemische Industrie, K042197 and K050446)
· OssixTM Plus (ColBar LifeSciences Ltd., K053260)

4. DEVICE DESCRIPTION

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Smooth membrane have identical technological, mechanical and chemical characteristics.

The product is packaged in double blister packs and sterilized by ethylene oxide. The Dental Barrier Membrane is supplied sterile and is indicated for single use.

5. INDICATION FOR USE/INTENDED USE

The Dental Barrier Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier membrane for:

· Ridge augmentation for later implant insertion
· Augmentation around implants placed in immediate/delayed extraction sockets
· Localized ridge augmentation
· Alveolar ridge preservation/reconstruction
· Osseous fill around implants in peri-implantitis bone defects
· Over the window in lateral window sinus elevation procedures
· Intra-bony defects around teeth
· Treatment of recession defects, together with coronally positioned flap
· In furcation defects in multi-rooted teeth.

6. PRINCIPLES OF OPERATION

The process of GTR/GBR is facilitated by the use of resorbable implants such as the Dental Barrier Membrane and legally marketed barrier products, including the predicate devices Bio-Gide (subject of K042197 and K050446) and Ossix"14 Plus (subject of K053260). The Dental Barrier Membrane, like the predicate devices, achieves its principal intended action solely by providing a physical barrier to contain the bone graft material at the defect site and to exclude in-growth of surrounding tissue for a period of time long enough to allow bone regeneration to take place.

7. TECHNOLOGICAL CHARACTERISTICS

The proposed Dental Barrier Membrane and the predicate devices Bio-Gide (subject of K042197 and K050446) and Ossix" Plus (subject of K053260) have substantially equivalent indications for use. These porcine membranes are used to provide a barrier to support GBR and GTR. Both the proposed and predicate devices are derived from porcine tissue and share the similar technological and biochemical characteristics. Specifically, the Dental Barrier Membrane and Bio-Gide membranes contain Type I with some Type III collagen and elastin fibers. Furthermore, the available sizes and weight per unit surface area (surface weight) of the Dental Barrier

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Membrane is within the specifications of Bio-Gide. Both the proposed and predicate membranes are resorbable over time.

All membranes are sterile, packaged in double blister packages, and have a shelf life of 3 years. The Dental Barrier Membrane and Ossix "M Plus are sterilized by ethylene oxide and Bio-Gide is sterilized by gamma irradiation.

8. NON-CLINICAL TESTING

Bench testing, consisting of tensile strength, peak denaturation temperature, expansion after wetting were completed to demonstrate that the performance of the Dental Barrier Membrane met specifications. The Dental Barrier Membrane was characterized in accordance with ASTM F2212-11. Biocompatibility testing to ISO 10993-1 was performed to demonstrate the biological safety of the device.

Biostability (enzymatic resistance) testing was performed to assess the potential for degradation due to colonization with dental bacteria. Results demonstrated that the Dental Barrier Membrane behaves as stable as the predicate Bio-Gide when subjected to enzymatic degradation.

Animal testing was performed to compare the resorption characteristics of the proposed Dental Barrier Membrane and the predicate Bio-Gide. Results demonstrate that the two products do not elicit an inflammatory response at the implantation site and exhibit comparable resorption characteristics.

9. CLINICAL TESTING

No clinical testing was submitted in support of this 510(k) premarket notification.

10. CONCLUSIONS

The indications for use, principles of operation, and technological characteristics of the proposed Dental Barrier Membrane are substantially equivalent to the predicate devices Bio-Gide (subject of K042197 and K050446) and Ossix™ Plus (subject of K053260). Differences between the proposed and predicate devices are limited to minor differences in visual appearance; texture of membrane, and sterilization methods. These differences are minor and do not impact the safety and effectiveness of the device.

The safety, performance and effectiveness of the Dental Barrier Membrane for its intended use are demonstrated by bench and animal studies. Based on the evidence provided, Matricel believes that the proposed Dental Barrier Membrane is

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substantially equivalent to the predicates.

Table 5-1. Side-by-Side Comparison of Matricel Dental Barrier Membrane with
Predicate Devices

	MatricelDental Barrier Membrane*	Bio-Gide®(Ed. Geistlich Soehne Ag fuerChemische Industrie)	Ossix™ Plus(ColBar LifeScience Ltd.)
Regulatory Status	Proposed	K042197, K050446	K053260
Product Code	NPL	NPL	NPL
Intended Use	The Dental Barrier Membrane isintended for use during the processof guided bone regeneration (GBR)and guided tissue regeneration(GTR) as a biodegradable barriermembrane for:• Ridge augmentation for laterimplant insertion• Augmentation around implantsplaced in immediate/delayedextraction sockets• Localized ridge augmentation• Alveolar ridgepreservation/reconstruction• Osseous fill around implants inperi-implantitis bone defects• Over the window in lateralwindow sinus elevationprocedures• Intra-bony defects around teeth• Treatment of recession defects.together with coronallypositioned flap• In furcation defects in multi-rooted teeth	Bio-Gide® is recommended for:• Simultaneous use of GBR-membrane (Bio-Gide®) andimplants:• Augmentation around implantsplaced in immediate extractionsockets;• Augmentation around implantsplaced in delayed extractionsockets;• Localized ridge augmentation forlater implantation;• Alveolar ridge reconstruction forprosthetic treatment:• Filling of bone defects after rootresection, cystectomy, removal ofretained teeth:• Guided bone regeneration indehiscence defects; and• Guided tissue regenerationprocedures in periodontal defects.	Ossix™-Plus biodegradablecollagen membrane is intended foruse during the process of guidedbone regeneration (GBR) andguided tissue regeneration (GTR) asbiodegradable barrier for:• Ridge augmentation for laterimplant insertions.• Simultaneous ridge augmentationand implant insertions.• Ridge augmentation aroundimplants inserted in delayedextraction sites.• Ridge augmentation aroundimplants inserted in immediateextraction sites.• Alveolar ridge preservationconsequent to tooth (teeth)extraction(s).• Over the window in lateralwindow sinus elevationprocedures.• In implants with vertical boneloss due to infection, only in caseswhere satisfactory debridementand implant surface disinfectioncan be achieved.• In intra bony defects around teeth• For treatment of recessiondefects, together with coronallypositioned flap• In furcation defects in multirooted teeth
Material Source	Porcine	Porcine	Porcine
Composition	Collagen Types I and III, and elastin	Collagen Types I and III, and elastin	Collagen Type I***
Size	15x20mm, 25 x 30mm, 30 x 40 mm	13 x 25 mm, 25 x 25 mm, 40 x 50mm	15 mm x 25 mm, 25 mm x 30 mmand 30 mm x 40 mm
Surface weight **	>10 mg/cm²	>10 mg/cm2	Data not available
Form	Membrane	Membrane	Membrane
Cross-linking	No	No	Yes
Resorbable	Yes	Yes	Yes
Conformability	The membrane is flexible andconforms to the defect site	The membrane is flexible andconforms to the defect site	The membrane is flexible andconforms to the defect site
Non-pyrogenic	Yes	Data not available	Data not available
Biocompatibility	Yes	Yes	Yes
Sterilization	Ethylene oxide	Gamma radiation	Ethylene oxide
Shelf Life	3 years	3 years	Data not available
Packaging	Double blister package	Double blister package	Double blister package

The Matricel Dental Barrier Membrane is offered in rough and smooth versions

** Surface weight [weight of the product in mg divided by the surface area in cm³]
*** Source: http://iadr.confex.com/iadr/2010dc/webprogramed/Paper129086.html

*** Source: http://iadrc.confex.com/iadrc/2010dc/webprogrammod/Paper129086.htm

Matricel GmbH Additional Information - K123697 July 24, 2013

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Food and Drug Administration 10903 New Hampshire Avenue Document Comrol Center - WO66-G609 Silver Spring, MD 20993-0002

February 24, 2014

Matricel GmbH Dr. Ingo Heschel CEO Matricel GmbH Kaiserstrasse 100 D-52134 Herzogenrath Germany

Re: KI23697

Trade/Device Name: Matricel Dental Barrier Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: February 4, 2014 Received: February 4, 2014

Dear Dr. Heschel:

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. 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 addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA bas made a determination that your device complies with other requirements of the Act

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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); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Revised Indications for Use

510(k) Number (if known): K123697

Device Name: Matricel Dental Barrier Membrane

Indications for Use:

... ...

The Dental Barrier Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier membrane for:

· Ridge augmentation for later implant insertion
· Augmentation around implants placed in immediate/delayed extraction sockets
· Localized ridge augmentation
· Alveolar ridge preservation/reconstruction
· Osseous fill around implants in peri-implantitis bone defects
· Over the window in lateral window sinus elevation procedures
· Intra-bony defects around teeth
· Treatment of recession defects, together with coronally positioned flap
· In furcation defects in multi-rooted teeth.

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 Device Evaluation (ODE)

Mary S. Runner -S
2014.02.24
14:44:55 -05'00'
Susan Runner

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.