(448 days)
Not Found
No
The device description and performance studies focus on the material properties and biological performance of a collagen membrane, with no mention of AI or ML.
No.
Explanation: The device is a barrier membrane used in dental procedures to support tissue and bone growth for various augmentation and regeneration purposes. It facilitates the body's natural healing processes rather than directly treating a disease or condition.
No
The device is a barrier membrane used in guided bone/tissue regeneration, which is a therapeutic rather than diagnostic function. It supports tissue growth, not the identification or assessment of a medical condition.
No
The device description clearly states it is an "intraoral porcine membrane" and describes its physical composition and packaging, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a biodegradable barrier membrane used during surgical procedures (GBR and GTR) to support tissue and bone growth. It is implanted directly into the body.
- Device Description: The description confirms it's an intraoral porcine membrane composed of collagen and elastin fibers, intended for physical implantation.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. IVDs are typically used in vitro (outside the body) to analyze samples like blood, urine, or tissue.
- Performance Studies: The performance studies focus on the physical and biological properties of the membrane itself (tensile strength, biocompatibility, biostability, resorption characteristics) and not on its ability to diagnose or provide diagnostic information.
In summary, the Dental Barrier Membrane is a medical device used in vivo (within the body) for surgical support, not an IVD used in vitro for diagnostic purposes.
N/A
Intended Use / 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.
Product codes
NPL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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
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
1
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
2
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
3
substantially equivalent to the predicates.
| Table 5-1. Side-by-Side Comparison of Matricel Dental Barrier Membrane with | ||||
|---|---|---|---|---|
| Predicate Devices |
| | Matricel
Dental Barrier Membrane* | Bio-Gide®
(Ed. Geistlich Soehne Ag fuer
Chemische Industrie) | Ossix™ Plus
(ColBar LifeScience Ltd.) |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Status | Proposed | K042197, K050446 | K053260 |
| Product Code | NPL | NPL | NPL |
| 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 | Bio-Gide® is recommended for:
• Simultaneous use of GBR-
membrane (Bio-Gide®) 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. | Ossix™-Plus biodegradable
collagen membrane is intended for
use during the process of guided
bone regeneration (GBR) and
guided tissue regeneration (GTR) as
biodegradable barrier for:
• Ridge augmentation for later
implant insertions.
• Simultaneous ridge augmentation
and implant insertions.
• Ridge augmentation around
implants inserted in delayed
extraction sites.
• Ridge augmentation around
implants inserted in immediate
extraction sites.
• Alveolar ridge preservation
consequent to tooth (teeth)
extraction(s).
• Over the window in lateral
window sinus elevation
procedures.
• In implants with vertical bone
loss due to infection, only in cases
where satisfactory debridement
and implant surface disinfection
can be achieved.
• In intra bony defects around teeth
• For treatment of recession
defects, together with coronally
positioned flap
• In furcation defects in multi
rooted 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 50
mm | 15 mm x 25 mm, 25 mm x 30 mm
and 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 and
conforms to the defect site | The membrane is flexible and
conforms to the defect site | The membrane is flexible and
conforms 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:
Matricel GmbH Additional Information - K123697 July 24, 2013
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird in flight. The logo is printed in black and white.
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
5
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.
Image /page/5/Picture/8 description: The image shows the name Kwame Ulmer in bold black font on the left side of the image. On the right side of the image is a logo that is made up of the letters EDA and a triangle. The letters and triangle are made up of lines and dots.
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
6
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