(113 days)
Not Found
No
The device description and intended use are focused on biological materials (collagen, bone mineral) for regenerative procedures. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is used for augmentation, reconstruction, and filling of bone and tissue defects, all of which are considered therapeutic applications.
No
The device is a convenience kit containing materials for augmenting or reconstructing bone and tissue, not for diagnosing conditions.
No
The device description clearly states that the device is a "convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®." These are described as physical materials (bone mineral granules, collagen fibers, and a collagen membrane) and are sterilized by gamma irradiation. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are for surgical procedures involving bone and tissue regeneration in the oral cavity (dental and periodontal applications). These are therapeutic and reconstructive uses, not diagnostic tests performed on samples taken from the body.
- Device Description: The device is a kit containing bone mineral granules and a collagen membrane. These are materials implanted into the body to aid in healing and regeneration. They are not reagents, instruments, or systems used to examine specimens from the human body for diagnostic purposes.
- Lack of Diagnostic Language: The description and intended uses do not mention any diagnostic procedures, analysis of biological samples, or determination of a disease state.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on facilitating tissue repair and regeneration within the body.
N/A
Intended Use / Indications for Use
Geistlich Combi-Kit Collagen is a convenience kit that provides one (1) unit Gelstich and seatings Collagen membrane and one (1) unit Geistlich Bio-Oss Collagen® block in one (1) package.
Geistlich Bio-Gide® 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; and
- 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); and
- Filling of per-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Geistlich Bio-Oss® is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge;
- Filling of infrabony 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); and
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Product codes (comma separated list FDA assigned to the subject device)
NPM
Device Description
Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation.
Geistlich Bio-Oss Collagen® 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-Oss Collagen® is the same as its predicate device, Bio-Oss Collagen®.
Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. 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 bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16mm x 22 mm. With the exception of the size of the membrane packaged in the convenience kit, Geistlich Bio-Gide® is the same as its predicate device, Bio-Gide®.
Geistlich Bio-Oss® spongiosa (cancellous) granules and Geistlich Bio-Oss® Block are natural non-antigenic porous bone mineral matrices. They are produced by removal of all organic components from bovine bone. Due to their natural structure, Geistlich Bio-Oss® and Geistlich Bio-Oss® Block, are physically and chemically comparable to the mineralized matrix of human bone. Geistlich Bio-Oss® is the same as its predicate device, Bio-Oss®.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, periodontal defects, bone 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.
K092428, K033815, K974399, K050446, K042197, K960724, K033815, K970321, K952618
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
K112572
DEC 2 8 2011
2. 510(k) Summary
This 510(k) was submitted for two reasons: (1) to provide a convenience kit Geistlich Combi-Kit Collagen (composed of one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®), and (2) to modify the Instructions for Use of Geistlich Bio-Oss Collagen®, Geistlich Bio-Gide®, and Geistlich Bio-Oss®.
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 12, 2011 |
DEVICE NAME
| Proprietary Name: | Geistlich Combi-Kit Collagen
- Geistlich Bio-Oss Collagen®
- Geistlich Bio-Gide®
Geistlich Bio-Oss® |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| 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) |
1
PREDICATE DEVICES
Bio-Oss Collagen® (K092428, K033815, K974399) Bio-Gide® (K050446, K042197, K960724) Bio-Oss® and Bio-Oss® Blocks (K033815, K970321, K952618)
INTENDED USE
Geistlich Bio-Gide® 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).
Geistlich Bio-Oss® is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge;
- Filling of infrabony 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);
2
- 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 regenerative procedures.
DEVICE DESCRIPTION
Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation.
Geistlich Bio-Oss Collagen® 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-Oss Collagen® is the same as its predicate device, Bio-Oss Collagen®.
Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. 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 bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16mm x 22 mm. With the exception of the size of the membrane packaged in the convenience kit, Geistlich Bio-Gide® is the same as its predicate device, Bio-Gide®.
Geistlich Bio-Oss® spongiosa (cancellous) granules and Geistlich Bio-Oss® Block are natural non-antigenic porous bone mineral matrices. They are produced by removal of all organic components from bovine bone. Due to their natural structure, Geistlich Bio-Oss® and Geistlich Bio-Oss® Block, are physically and chemically comparable to the mineralized matrix of human bone. Geistlich Bio-Oss® is the same as its predicate device, Bio-Oss®.
TECHNOLOGICAL CHARACTERISTICS
3
Geistlich Bio-Oss Collagen® and Geistlich Bio-Oss® have the same design, same chemical composition, and same materials as their respective predicate devices, and are substantially equivalent to their predicate devices, Bio-Oss Collagen® and Bio-Oss®.
Geistlich Bio-Gide® has the same design, same chemical composition, and same materials as its predicate device, Bio-Gide®. Although the dimensions of the membrane to be included in the Geistlich Combi-Kit Collagen convenience kit have been modified slightly, this difference does not change the intended use of the device. Thus, Geistlich Bio-Gide® is substantially equivalent to its predicate device, Bio-Gide®.
4
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 image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Geistlich Pharma AG C/O Mr. Daniel A. Kravoc Arnold & Porter LLP 555 Twelfth Street, N.W. Washington, Distruct of Columbia 20004
DEC 2 8 2011
Re: K112572
Trade/Device Name: Geistlich Combi-Kit Collagen Geistlich Bio-Oss® Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM 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 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.
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 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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.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 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/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
Enclosure
6
K 112572
Indications for Use
510(k) Number (if known):
((2572
Device Name: Geistlich Combi-Kit Collagen
Indications For Use:
Indications in of OSE.
Gelstlich Combi-Kit Collagen is a convenience kit that provides one (1) unit Gelstich and seatings Collagen membrane and one (1) unit Geistlich Bio-Oss Collagen® block in one (1) package.
Geistlich Bio-Gide® 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, cystectorny, removal of retained teeth;
- Guided bone regeneration in dehiscence defects; and
- 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, apicoectorny, 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); and
- Filling of per-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
| 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112577
7
Indications for Use
510(k) Number (if known):
Device Name: Geistlich Bio-Oss®
Indications For Use:
Geistlich Bio-Oss® is intended for the following uses:
-
Augmentation or reconstructive treatment of the alveolar ridge;
-
Filling of infrabony periodontal defects;
-
Filling of defects after root resection, apicoectorny, and cystectorny;
-
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); and
-
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
AND/OR Prescription Use D) (21 CFR 801 Subpart C)
Over-The-Counter Use (Part 21 CFR 801 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Parmer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
...
510(k) Number: K112572