(94 days)
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,
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.
The provided document is a 510(k) summary for the BIO-GIDE® resorbable bilayer membrane, seeking clearance for an additional indication: guided tissue regeneration in periodontal defects. The submission primarily relies on substantial equivalence to predicate devices and literature review rather than a de novo clinical study with specific acceptance criteria and detailed performance metrics of the device itself.
Therefore, the requested information components related to acceptance criteria, specific device performance, sample size for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly available in the provided text related to the BIO-GIDE® device's performance.
The document mainly focuses on comparing the new generation BIO-GIDE® with its predicate devices (previous BIO-GIDE® and BioMend Extend™) for the expanded indication. It cites existing clinical studies from the literature to support the safety and effectiveness of the principle of guided tissue regeneration with collagen membranes, to which the BIO-GIDE® is deemed substantially equivalent.
Here's an attempt to answer based on the available information, noting the missing data:
1. Table of acceptance criteria and the reported device performance
The submission does not define specific quantitative "acceptance criteria" for the BIO-GIDE® device's performance for its new indication in the way one might expect for an AI algorithm or a novel functional device. Instead, the "acceptance" is based on demonstrating substantial equivalence to legally marketed predicate devices for the specified indications. The performance is inferred from the established efficacy of the predicate devices and the cited literature on similar collagen membranes used for guided tissue regeneration.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied by Substantial Equivalence and Literature Review) |
|---|---|
| Safe and effective for guided tissue regeneration (GTR) in periodontal defects, comparable to predicate devices. | The device is deemed substantially equivalent to predicate devices (BIO-GIDE® K960724 and BioMend Extend™ K992216) which are already cleared for GTR in periodontal defects. Similar materials (collagen), operating principles (cell occlusive, implantable, resorbable, hemostatic), and biocompatibility are highlighted. The numerous cited clinical studies of collagen membranes (including BIO-GIDE® and similar products) for GTR support its expected performance in enhancing regeneration of the periodontal apparatus. |
| Biocompatible | Yes (Explicitly stated in Comparison Chart) |
| Non-pyrogenic | Yes (Explicitly stated in Comparison Chart) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of a de novo clinical trial for the BIO-GIDE® device itself. The evidence is derived from a review of previously published clinical studies. Therefore, individual sample sizes would vary across the cited literature, and these studies were not conducted as a test set specifically for this 510(k) submission.
- Data Provenance: The cited studies are peer-reviewed publications. The geographic origin of these studies is not specified in the 510(k) summary but typically would be international. They are clinical studies, hence prospective data collection for their original purposes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The submission relies on scientific literature discussing the clinical outcomes of Guided Tissue Regeneration (GTR) using collagen membranes, not on a ground truth established by experts for a specific test set within this 510(k) submission. Clinical outcomes (e.g., changes in probing depth, attachment levels) assessed by clinicians in the referenced studies would serve as the "ground truth" for those studies.
4. Adjudication method for the test set
Not applicable. This was not a trial involving expert adjudication of device performance in a test set.
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 for guided tissue/bone regeneration, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used
The "ground truth" is derived from clinical outcomes data reported in the referenced scientific literature regarding the effectiveness of guided tissue regeneration using collagen membranes for periodontal defects. These outcomes typically include measurements like:
- Probing depth reduction
- Clinical attachment level gain
- Bone fill
- Histological evidence of regeneration (in some studies)
8. The sample size for the training set
Not applicable. There is no training set in the context of this device submission. The device is a physical product, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable.
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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 BoneRegeneration |
| 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
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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 CollagenMembrane | BIO-GIDE® ResorbableBilayer 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. |
| Incorporate Same BasicDesign | Yes | Yes |
| Utilizes the Same OperatingPrinciple | Cell occlusiveImplantableResorbableHemostatic | Cell occlusiveImplantableResorbableHemostatic |
| Incorporates SameMaterials? | Yes, Type I Collagen | Yes, Type I and Type IIICollagen |
| Sterilization Process | ETO | Gamma Irradiation |
| Biocompatible | Yes | Yes |
| Non-pyrogenic | Yes | Yes |
| Shelf Life | 24 Months | 36 Months |
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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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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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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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
§ 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.