(63 days)
Not Found
No
The summary describes a physical biodegradable barrier for guided tissue regeneration and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures," which describes a therapeutic purpose.
No
The device is a biodegradable barrier used for guided tissue regeneration in periodontal surgical procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a physical membrane made from polyglycolic acid and polylactic acid + polylactic glycolic acid copolymer, intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, the BioMesh® Biodegradable GTR Barrier is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The BioMesh® device is a physical barrier implanted during surgery.
- The intended use and device description clearly state it is a surgical implant used to aid in tissue regeneration in periodontal defects. It is not used to analyze biological samples.
- There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
The BioMesh® Biodegradable GTR Barrier is a surgical implant used in guided tissue regeneration procedures.
N/A
Intended Use / Indications for Use
BioMesh® Biodegradable GTR Barrier is intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures.
BioMesh® Biodegradable GTR Barrier is indicated for use in the treatment of the following specific conditions:
- Two or three wall vertical defects.
- Class II furcations.
- Circumferrential defects.
- Recession type defects.
- Dehisence defects associated with dental implants
Product codes (comma separated list FDA assigned to the subject device)
LYC, NPK
Device Description
BioMesh® Biodegradable GTR Barrier is provided as a single membrane type, but in a variety of precut shapes and sizes. Shapes and sizes. As noted on the graphic representation at the left, five different shapes are offered. The BioMesh® Biodegradable GTR Barrier is shape optimized to provide a ready made pattern well suited to the selected operative site needing a minimum of surgeon modification. If desired, the surgeon can trim any of the available shapes to fit unique or unusual circumstances. The BioMesh® Biodegradable GTR Barrier is made from polyglycolic acid with a coating of polylactic acid + polylactic glycolic acid copolymer. The membrane is constructed with interconnective pores with an embossed surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periodontal defects
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.
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.
Not Found
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.
0
4/9/99
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
- Trade Name: 1.
BioMesh® Biodegradable GTR Barrier
Common Name(s): GTR Barrier
Classification Name(s): Unclassified device
-
- Establishment Name & Registration Number: Name: SAMYANG CORPORATION Number: Pendina
-
- Classification:
Device Class: ll Classification Panel: Dental Product Code(s): LYC
4. Equivalent Predicate Device:
SAMYANG CORPORATION believes that BioMesh® Biodegradable GTR Barrier is substantially equivalent to Resolut Regenerative Material as characterized in K932866, K962624 and K973594.
-
- Gore Resolut Regenerative Material, K932866, K962624 & K973594
Comparison of BioMesh® Biodegradable GTR Barrier brand GTR barrier to the predicate device(s) identified above based on available labeling, promotional materials, comparison testing, demonstrates the substantial equivalence of Biodegradable GTR Barrier.
- Gore Resolut Regenerative Material, K932866, K962624 & K973594
5. General Device Description:
BioMesh® Biodegradable GTR Barrier is provided as a single membrane type, but in a variety of precut shapes and sizes. Shapes and sizes. As noted on the graphic representation at the left, five different shapes are offered. The BioMesh® Biodegradable GTR Barrier is shape optimized to provide a ready made pattern well suited to the selected operative site needing a minimum of surgeon modification. If desired, the surgeon can trim any of the available shapes to fit unique or unusual circumstances. The BioMesh® Biodegradable GTR Barrier is made from polyglycolic acid with a coating of polylactic acid + polylactic glycolic acid copolymer. The membrane is constructed with interconnective pores with an embossed surface.
6. Applicant Name & Address:
SAMYANG CORPORATION
263 Yeonji-dong, Chongno-gu Seoul 110-725, Korea
1
7. Company Contact:
Mr. Dong-Kee Yoo SAMYANG CORPORATION 263 Yeonji-dong, Chongno-gu Seoul 110-725. Korea Tel. 011.82.2.740.7296 Fax 011.82.2.743.6626
8. Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax
Performance Standards: ರು
United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include U.S.P., ASTM, Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.
Storage, Packaging & Sterilization Information: 10.
Packaging. Packaging should be inspected on arrival for evidence of shipping damage. Damaged packaging may indicate the presence of unsafe product and it should not be used until carefully inspected. If the package or product is damaged, the product should not be used and should be returned. Once opened, the product should never be resterilized or reused. Storage. Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination. Rotate stock and observe shelf life dates. Discard when outdated or damaged. When used, the product must be placed into use following accepted surgical sterile technique. Sterilization. BioMesh® Biodegradable GTR Barrier is supplied "STERILE" and is terminally EtO sterilized in accordance with accepted standards.
| FEATURE | BioMesh | Resolut | SE? |
|---|---|---|---|
| Indications for Use: | Two or three wall vertical defects, Class II | ||
| furcations, Circumferrential defects, Recession | |||
| type defects, Dehisence defects associated with | |||
| dental implants | SAME | YES | |
| Material: | polyglycolic acid with a coating of polylactic acid + | ||
| polylactic glycolic acid copolymer | Equivalent | YES | |
| Structure: | microporous membrane made of biodegradable | ||
| polyglycolide, polylactide and d,l-lactide/glycolide | |||
| copolymer. The membrane is made up of | |||
| interconnective pores with an embossed surface. | Non-woven membrane yes, no | ||
| interconnecting pores, no | |||
| embossing | Equivalent | ||
| Tissue Integration: | Test result score 115 | Test result score 110 | YES |
| Biocompatability: | Good | Good | YES |
| Toxicity: | Good | Good | YES |
| Stability: | 5 Years | 5 Years | YES |
| Clinical Data: | Good | Good | YES |
| Manufacturer: | SAMYANG | GORE | YES |
| Product Code: | LYC | SAME | YES |
| K - Number: | Pending | K932866, K962624 & K973594 | YES |
11. Summary Comparison Table:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and form a single, abstract shape. The profiles are surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
OCT 1 0 2007
Samyang Corporation C/O Mr. David W. Schlerf Buckman Company, Incorporated 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389
Re: K990363
Trade Name: BioMesh® Biodegradable GTR Barrier Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPK Dated: December 28, 1998 Received: February 5, 1999
Dear Mr. Schlerf:
This letter corrects our substantially equivalent letter of April 9, 1999.
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 require approval or on or a 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 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 -
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 yours,
Sayite y. Michailous.
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/3/Picture/7 description: The image is a circular seal with the text "CALIFORNIA OLIVE ASSOCIATION" around the border. In the center of the seal, the text "1906-2006" is at the top, followed by the letters "COA" in a stylized font. Below the letters, the word "Centennial" is written, and there are three stars at the bottom of the seal.
ting Public Ho
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K990363 510(k) Number :_
Device Name(s): BioMesh® Biodegradable GTR Barrier
Intended Use(s) of the Device:
BioMesh® Biodegradable GTR Barrier is intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures.
Indications for Use:
BioMesh® Biodegradable GTR Barrier is indicated for use in the treatment of the following specific conditions:
-
- Two or three wall vertical defects.
-
- Class II furcations.
-
- Circumferrential defects.
-
- Recession type defects.
-
- Dehisence defects associated with dental implants
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susen Runse
(Division Sign-Off)
Division of Dental. Infection Control,
OR
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional format 1-2-96)
SAMYANG/MESH.DOC