(94 days)
K960724, K99216
Not Found
No
The device description and performance studies focus on the physical properties and clinical outcomes of a collagen membrane for guided tissue and bone regeneration, with no mention of AI or ML.
Yes
Explanation: The device is a resorbable bilayer membrane used for guided tissue and bone regeneration in various dental and periodontal defects, indicating its use in treating or restoring health conditions.
No
The device description and intended use indicate that BIO-GIDE® is a resorbable bilayer membrane used for guided tissue and bone regeneration, filling bone defects, and localized ridge augmentation. These are therapeutic and reconstructive purposes, not diagnostic.
No
The device description clearly states that BIO-GIDE® is a "resorbable bilayer membrane" made of "pure collagen" and is "physically identical" to a previously cleared device. This indicates it is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures for bone and tissue regeneration in the mouth (dental and periodontal applications). These are procedures performed on the patient's body, not tests performed on samples taken from the patient's body.
- Device Description: The description details a resorbable collagen membrane used as a physical barrier and scaffold for tissue growth. This is a medical device used in a surgical context, not a reagent or instrument for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely different.
N/A
Intended Use / Indications for Use
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,
Product codes (comma separated list FDA assigned to the subject device)
NPL
Device Description
BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration is physically identical to BIO-GIDE® (K960724), but labeled with an additional indication; guided tissue regeneration in periodontal defects. BIO-GIDE® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. BIO-GIDE® is sterilized in double blisters by gamma irradiation. BIO-GIDE® has a bilayer structure. The porous surface - facing the bone - allows the ingrowth of bone forming cells. The dense surface - facing the soft tissue - prevents the ingrowth of fibrous tissue into the bone defect. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment.
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)
Studies Submitted:
Romagna-Genon, C., Comparative Clinical Study of Guided Tissue Regeneration with a Bioabsorbable Bilayer Collagen Membrane and Subepithelial Connective Tissue Graft, J. Periodontol, 72 (9), p. 1258-1264, (2001)
Lekovic, V., et. al., Effectiveness of a Combination of Platelet-Rich Plasma, Bovine Porous Bone Mineral and Guided Tissue Regeneration in the Treatment of Mandibular Grade II Molar Furcations in Humans, J. Clin. Periodontol, (30), p. 746-51. (2003)
Houser, B.E., et. al., Clinical Evaluation of Anorganic Bovine Bone Xenograft with a Bioabsorbable Collagen Barrier in the Treatment of Molar Furcation Defects, The Int'l J. of Periodontics & Restorative Dentistry, 21(2), p. 161-69. (2001)
Camargo, P.M., et. al., A Controlled Re-Entry Study on the Effectiveness of Boyine Porous Bone Mineral Used in Combination with a Collagen membrane of Porcine Origin in the Treatment of Intrabony Defects in Humans, J. Clin. Periodontol (27), p. 889-896. (2000)
Sculean, A., et. al., Healing of Intrabony Defects Following Treatment with a Bovine Derived Xenograft and Collagen Membrane, J. Clin. Periodontol (30), p. 73-80. (2003)
Tonetti, M.S., et. al., Clinical Outcomes Following Treatment of Human Intrabony Defects with GTR/Bone Replacement Material or Access Flap Alone, J. Clin. Periodomol (To Be Published)
Camelo, M., Nevins, M.L., et. al., Clinical, Radiographic, and Histologic Evaluation of Human Periodontal Defects Treated with BIO-OSS® and BIO-GIDE®, The Int'l J. of Periodontics & Restorative Dentistry, 18(4), p. 321-331. (1998)
Camelo, M., Periodontal Regeneration with an Autogenous Bone-BIO-OSS® Composite Graft and a BIO-GIDE® Membrane, The Int'l J. of Periodontics & Restorative Dentistry, 21(2), p. 109-119. (2001)
Yamada, Satoru, Effect of Porous Xenographic Bone Graft with Collagen Barrier Membrane on Periodontal Regeneration, The Int'l J. of Periodontics & Restorative Dentistry, 22(4), p. 389-397. (2002)
Nevins, M.L., et. al., Evaluation of Periodontal Regeneration Following Grafting Intrabony Defects with BIO-OSS® Collagen: A Human Histologic Report, The Int'l J. of Periodontics & Restorative Dentistry, 23(1), p. 9-17. (2003)
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.
K960724, K99216
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
510(k) Summary
BIO-GIDE®
1. SPONSOR
Ed. Geistlich Soehne Ag für Chemische Industrie Geistlich Pharma Ag Bahnhofstrasse 40 CH-6110 Wolhusen SWITZERLAND
Contact Person: Peter S. Reichertz, (202) 408-9222 Date Prepared: August 12, 2004
2. DEVICE NAME
| Proprietary Name: | BIO-GIDE® |
|---|---|
| Common/Usual Name: | Resorbable Bilayer Membrane for Guided Tissue and Bone |
| Regeneration | |
| Classification Name: | Dental Bone Grafting Material |
3. PREDICATE DEVICES
BIO-GIDE® (K960724)
BioMend Extend® (K99216)
4. INTENDED USE
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,
ડ. DEVICE DESCRIPTION
BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration is physically identical to BIO-GIDE® (K960724), but labeled with an additional indication; guided tissue regeneration in periodontal defects. BIO-GIDE® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic
1
reactions. BIO-GIDE® is sterilized in double blisters by gamma irradiation. BIO-GIDE® has a bilayer structure. The porous surface - facing the bone - allows the ingrowth of bone forming cells. The dense surface - facing the soft tissue - prevents the ingrowth of fibrous tissue into the bone defect. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment.
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration is substantially equivalent to Geistlich's existing product, BIO-GIDE® (K960724), and BioMend Extend™ (K992216). The only difference between the new product and the BIO-GIDE® product previously cleared is the additional indication for guided tissue regeneration in periodontal defects. ("GTR"). The following is a table comparing BIO-GIDE® to BioMend Extend™, a collagen membrane cleared for GTR.
Table I: BioMend Extend™ Absorbable Collagen Membrane (Predicate Device) vs. BIO-GIDE® Resorbable Bilayer Membrane Comparison Chart
| | BioMend Extend™
Absorbable Collagen
Membrane | BIO-GIDE® Resorbable
Bilayer Membrane |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Incorporate Same Basic
Design | Yes | Yes |
| Utilizes the Same Operating
Principle | Cell occlusive
Implantable
Resorbable
Hemostatic | Cell occlusive
Implantable
Resorbable
Hemostatic |
| Incorporates Same
Materials? | Yes, Type I Collagen | Yes, Type I and Type III
Collagen |
| Sterilization Process | ETO | Gamma Irradiation |
| Biocompatible | Yes | Yes |
| Non-pyrogenic | Yes | Yes |
| Shelf Life | 24 Months | 36 Months |
- 2 -
2
Studies Submitted:
Romagna-Genon, C., Comparative Clinical Study of Guided Tissue Regeneration with a Bioabsorbable Bilayer Collagen Membrane and Subepithelial Connective Tissue Graft, J. Periodontol, 72 (9), p. 1258-1264, (2001)
Lekovic, V., et. al., Effectiveness of a Combination of Platelet-Rich Plasma, Bovine Porous Bone Mineral and Guided Tissue Regeneration in the Treatment of Mandibular Grade II Molar Furcations in Humans, J. Clin. Periodontol, (30), p. 746-51. (2003)
Houser, B.E., et. al., Clinical Evaluation of Anorganic Bovine Bone Xenograft with a Bioabsorbable Collagen Barrier in the Treatment of Molar Furcation Defects, The Int'l J. of Periodontics & Restorative Dentistry, 21(2), p. 161-69. (2001)
Camargo, P.M., et. al., A Controlled Re-Entry Study on the Effectiveness of Boyine Porous Bone Mineral Used in Combination with a Collagen membrane of Porcine Origin in the Treatment of Intrabony Defects in Humans, J. Clin. Periodontol (27), p. 889-896. (2000)
Sculean, A., et. al., Healing of Intrabony Defects Following Treatment with a Bovine Derived Xenograft and Collagen Membrane, J. Clin. Periodontol (30), p. 73-80. (2003)
Tonetti, M.S., et. al., Clinical Outcomes Following Treatment of Human Intrabony Defects with GTR/Bone Replacement Material or Access Flap Alone, J. Clin. Periodomol (To Be Published)
Camelo, M., Nevins, M.L., et. al., Clinical, Radiographic, and Histologic Evaluation of Human Periodontal Defects Treated with BIO-OSS® and BIO-GIDE®, The Int'l J. of Periodontics & Restorative Dentistry, 18(4), p. 321-331. (1998)
Camelo, M., Periodontal Regeneration with an Autogenous Bone-BIO-OSS® Composite Graft and a BIO-GIDE® Membrane, The Int'l J. of Periodontics & Restorative Dentistry, 21(2), p. 109-119. (2001)
Yamada, Satoru, Effect of Porous Xenographic Bone Graft with Collagen Barrier Membrane on Periodontal Regeneration, The Int'l J. of Periodontics & Restorative Dentistry, 22(4), p. 389-397. (2002)
Nevins, M.L., et. al., Evaluation of Periodontal Regeneration Following Grafting Intrabony Defects with BIO-OSS® Collagen: A Human Histologic Report, The Int'l J. of Periodontics & Restorative Dentistry, 23(1), p. 9-17. (2003)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
OCT 1 0 2007
Ed. Geistlich Soehne Ag Fur Chemische Industrie C/O Mr. Peter S. Reichertz Official Correspondent/U.S. Agent Sonnenschein Nath & Rosenthal LLP 1301 K Street NW, Suite 600 Washington, D.C. 20005
Re: K042197
Trade Name: BIO-GIDE® 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: August 12, 2004 Received: August 18, 2004
Dear Mr. Reichertz:
This letter corrects our substantially equivalent letter of November 15, 2004.
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 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,
Guyte Y. Mchaine Davis
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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Protesting and Promoting Public Health
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Image /page/5/Picture/0 description: The image shows the text "K042197" written in a handwritten style, with a line drawn underneath it. Below the line, the words "Indications for Use" are printed in a bold, serif font. The text is centered and appears to be part of a document or label.
510(k) Number (if known): KC42097
- BIO-GIDE® Resorbable Bilayer Membrane for Guided Tissue and Bone Device Name: Regeneration. Simultaneous use of GBR-membrane and implants; augmentation around Indications for Use: 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.
Seven Runor
(Division Sich-Off (Division Sirn-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Control, Dental De 510(k) Number: J
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)