(112 days)
Not Found
No
The device description and intended use clearly describe a physical bone graft material and a collagen membrane, along with templates for cutting the membrane. There is no mention of software, algorithms, or any computational processing that would indicate the use of AI or ML.
Yes
The device is intended for augmentation, reconstruction, and filling of bone and periodontal defects, which are therapeutic interventions.
No
The device description and intended use clearly state that it is for regeneration, augmentation, and filling of defects, not for diagnosing conditions.
No
The device description clearly states that the device is a convenience kit containing physical components: Geistlich Bio-Oss Collagen® (bone mineral granules and collagen fibers) and Geistlich Bio-Gide® Perio (collagen membrane). It also includes physical templates. There is no mention of any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended uses of Geistlich Bio-Gide® Perio and Geistlich Bio-Oss Collagen® clearly indicate they are materials implanted into the body to aid in bone and tissue regeneration in dental and periodontal procedures. They are not used to test samples outside the body.
The device is a combination of implantable materials for surgical procedures, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
Geistlich Bio-Gide® Perio is intended for the following uses:
- 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;
- Guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge;
- Filling of periodontal defects;
- Filling of defects after root resection, apicoectomy, and cystectomy;
- Filling of extraction sockets to enhance preservation of the alveolar ridge;
- Elevation of the maxillary sinus floor;
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR);
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Product codes
NPM, NPL
Device Description
Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio.
Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form and is sterilized by gamma irradiation.
Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications.
The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm.
Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
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)
A published nonclinical animal study provides histological evidence that Geistlich Bio-Gide® Perio, in combination with Geistlich Bio-Oss Collagen®, regenerates bone in 5 mm diameter rabbit femoral defects. Several published clinical studies demonstrate improvements in clinical attachment levels and probing pocket depths through 5-year follow-up versus the control (access flap surgery). Histological evaluation of teeth in a case series demonstrated periodontal regeneration. The results of these published studies demonstrate the substantial equivalence of Geistlich Bio-Gide® Perio and Geistlich Bio-Oss Collagen® to their respective predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K092428, K033815, K974399, K050446, K042197, K960724
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
DEC 2 7 2011
510(k) Summary
GEISTLICH PERIO-SYSTEM COMBI-PACK
SPONSOR
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland
| Contact Person: | Daniel Kracov, Arnold & Porter, LLP |
|---|---|
| e-mail: | Daniel.Kracov@aporter.com |
| Phone: | (202)942-5120 |
| Date Prepared: | December 13, 2011 |
DEVICE NAME
| Proprietary Name: | Geistlich Perio-System Combi-Pack (containing one
unit of Geistlich Bio-Oss Collagen® and one
unit of Geistlich Bio-Gide® Perio) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Names: | Natural Bone Grafting Material Plus Collagen
Resorbable Bilayer Membrane for GTR/GBR |
| Classification Name: | Bone grafting material, animal source (NPM)
Barrier animal source intraoral (NPL) |
PREDICATE DEVICES
Bio-Oss Collagen® (K092428, K033815, K974399) Bio-Gide® (K050446, K042197, K960724)
DEVICE DESCRIPTION
1
Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio.
Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form and is sterilized by gamma irradiation.
Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications.
The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm.
Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
INTENDED USE
Geistlich Bio-Gide® Perio is intended for the following uses:
- 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;
- Guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge;
2
-
Filling of periodontal defects;
-
Filling of defects after root resection, apicoectomy, and cystectomy;
-
Filling of extraction sockets to enhance preservation of the alveolar ridge;
-
Elevation of the maxillary sinus floor;
-
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR);
-
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
The two products are being packaged together as a convenience kit for the ease of clinician use in periodontal regenerative procedures. In addition, Geistlich Bio-Gide® Perio will be packaged and sold as individual units.
TECHNOLOGICAL CHARACTERISTICS
Geistlich Bio-Oss Collagen® and Geistlich Bio-Gide® Perio, the two component devices of Geistlich Perio-System Combi-Pack, have the same technological characteristics (e.g., design, material) and intended use of their respective predicate devices, Bio-Oss Collagen® and Bio-Gide®.
PERFORMANCE DATA
A published nonclinical animal study provides histological evidence that Geistlich Bio-Gide® Perio, in combination with Geistlich Bio-Oss Collagen®, regenerates bone in 5 mm diameter rabbit femoral defects (1). Several published clinical studies demonstrate improvements in clinical attachment levels and probing pocket depths through 5-year follow-up versus the control (access flap surgery) (2,3,4). Histological evaluation of teeth in a case series demonstrated periodontal regeneration (5).
The results of these published studies demonstrate the substantial equivalence of Geistlich Bio-Gide® Perio and Geistlich Bio-Oss Collagen® to their respective predicate devices.
- Lysiak-Drwal K, Dominiak M, Solski L, Zywicka B, Pielka S, Konopka T, Gerber 1. H. Early histological evaluation of bone defect healing with and without guided
3
bone regeneration techniques: Experimental animal studies. Postepy Hig Med Dosw (online) 2008;62:282-288.
- Sculean A, Berakdar M, Chiantella GC, Donos N, Arweiler NB, Brecx M. Healing 2. of intrabony defects following treatment with a bovine-derived xenograft and collagen membrane. A controlled study. J Clin Periodontol. 2003;30:73-80, 2003.
- Sculean A, Chiantella GC, Windisch P, Arweiler NB, Brecx M, Gera I. Healing of 3. intra-bony defects following treatment with a composite bovine-derived xenograft (Bio-Oss Collagen) in combination with a collagen membrane (Bio-Gide Perio). J Clin Periodontol. 2005;32:720-724.
- Sculean A, Schwarz F, Chiantella GC, Donos N, Arweiler NB, Brecx M, Becker J. 4. Five-year results of a prospective, randomized, controlled study evaluating treatment of intra-bony defects with a natural bone mineral and GTR. J Clin Periodontol. 2007;34:72-77.
- Sculean A, Stavropoulos A, Windisch P, Keglevich T, Karring T, Gera I. Healing ഗ് of human intrabony defects following regenerative periodontal therapy with a bovine-derived xenograft and guided tissue regeneration. Clin Oral Invest. 2004;8:70-74.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with flowing lines, representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 7 2011
Geistlich Pharma AG C/O Mr. Daniel A. Kracov Arnold & Porter LLP 555 Twelfth Street, NW Washington, D.C. 20004
Re: K112575
Trade/Device Name: Geistlich Perio-System Combi-Pack Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM, NPL Dated: December 20, 2011 Received: December 21, 2011
Dear Mr. Kracov:
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 approvisions 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.
5
Page 2 - Mr. Kracov
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 modi matt 1 Dr. mas made a statutes and regulations administered by other Federal agencies. of the Act of any I vact's requirements, including, but not limited to: registration r ou must compty with and 07); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing (reporting of incurents 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compilance: "Theo, prease not 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 r ou into 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use
510(k) Number (if known): Kl l2 5 7 5
Device Name: Geistlich Perio-System Combi-Pack
Indications For Use:
Geistlich Bio-Gide® Perio is intended for the following uses:
Geistlich Dio-Olde - Peno is ants 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 for presction, cystectorny, removal of retained teeth;
- Guided bone regeneration in dehiscence defects;
- Guided bone regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
-
Augmentation or reconstructive treatment of the alveolar ridge;
-
Filling of periodontal defects;
-
Filling of perfodoman dolotter
Filling of defects after root resection, apicoectorny, and cystectorny, -
Filling of defootballs ansockets to enhance preservation of the alveolar ridge;
-
Elevation of the maxillary sinus floor;
-
Elevation of the maxillary sinus noor,
-
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR);
Guided Bone Regeneration (GBR),
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR),
| Prescription Use | X |
|---|---|
| (21 CFR 801 Subpart C) |
AND/OR
| Over-The-Counter Use | ______ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
(Please do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: