(74 days)
Not Found
No
The summary describes a physical implantable barrier material and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a "temporarily implantable material" intended for use in the oral cavity for "space maintaining barrier over bone" and for "augmentation" around implants. These uses indicate that it is intended to affect the structure or function of the body, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a "temporarily implantable material intended to be used as a space maintaining barrier over bone" and for "augmentation," indicating it is a therapeutic or reconstructive device, not one used for diagnosis.
No
The device description clearly states it is a "temporarily implantable material" composed of Polytetrafluoroethylene, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "temporarily implantable material intended to be used as a space maintaining barrier over bone" in the oral cavity. This describes a device used in vivo (within the body) for a structural or barrier function.
- Device Description: The description details the material composition (PTFE) and physical characteristics (membrane, dimensions, sterile). This aligns with a medical device used for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo as an implantable barrier.
N/A
Intended Use / Indications for Use
IMTEC BioBarrier is a temporarily implantable material intended to be used as a space maintaining barrier over bone. It is intended for use in the oral cavity. The material is conformable to a variety of shapes as required for specific anatomical limitations.
The IMTEC BioBarrier is additionally indicated for:
- simultaneous use of GBR-membrane (BioBarrier) and implants: -
- augmentation around implants placed in immediate extraction sockets; -
- augmentation around implants placed in delayed extraction sockets; -
- localized ridge augmentation for later implantation. 1
Because of its elasticity, the IMTEC BioBarrier should be used in combination with space-making bone graft materials, e.g., autogenous bone or bone substitutes.
Product codes (comma separated list FDA assigned to the subject device)
NPK
Device Description
IMTEC/BIOBARRIER is a non-absorbable guided tissue membrane composed of 100% Polytetrafluoroethylene. It is provided in various dimensions and can be cut to a preferred shape or size The device will be marketed as a sterile device. It is available in either Porous (5 u) or Non-Porous, "full density" PTFE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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.
Osteohealth, Bio-gide, K960724
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
MAR - 3 1998
510 (k) Summary
SUBMITTED BY:
M. K. Patterson, Jr. PhD Sr Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401 (405) 223-4456
F.D.A Registration Number: 1645158 Owner / Operator Number: 9003407
Date Submitted: December 20 ,1997
CLASSIFICATION/COMMON OR USUAL NAME/ DEVICE NAME:
Classification Name: AUGMENTATION MEMBRANE, 76LYC. Common/ Usual Name: GUIDED TISSUE MEMBRANE, PTFE. Proprietary Name: IMTEC/ BIOBARRIER MEMBRANE (K950306 / K972240)
PREDICATE DEVICE:
Osteohealth, Bio-gide, K960724
DEVICE DESCRIPTION:
IMTEC/BIOBARRIER is a non-absorbable guided tissue membrane composed of 100% Polytetrafluoroethylene. It is provided in various dimensions and can be cut to a preferred shape or size The device will be marketed as a sterile device. It is available in either Porous (5 u) or Non-Porous, "full density" PTFE.
1
INDICATIONS FOR USE:
IMTEC BioBarrier is a temporarily implantable material intended to be used as a space maintaining barrier over bone. It is intended for use in the oral cavity. The material is conformable to a variety of shapes as required for specific anatomical limitations.
The IMTEC BioBarrier is additionally indicated for:
- simultaneous use of GBR-membrane (BioBarrier) and implants: -
- augmentation around implants placed in immediate extraction sockets; -
- augmentation around implants placed in delayed extraction sockets; -
- localized ridge augmentation for later implantation. 1
Because of its elasticity, the IMTEC BioBarrier should be used in combination with space-making bone graft materials, e.g., autogenous bone or bone substitutes.
PRINCIPLES OF OPERATION:
IMTEC/ BIOBARRIER is manufactured from biocompatable,100% PTFE. It has been demonstrated to serve as a temporary mechanical barrier to undesirable tissue growth into an osseous cavity. It is designed to be a passive barrier which reduces the migration of epithelial and gingival connective tissue into a bony repair site. The material is firm enough to provide sufficient mechanical support over a site while maintaining adequately supple characteristics during placement such that tissue compliance related problems are reduced.
CONTRAINDICATIONS:
It is critical that when used in dental implant repair applications that the implant is stable. It may NOT be used to stabilize a failed implant. Contraindications customary to the use of bone grafts and membrane techniques should be observed. These include, but are not limited to, current local infection, vascular impairment, uncontrolled diabetes, chronic high dose of steroids, clotting disorders, current anticoagulant therapy, etabolic bone disease, and other metabolic or systemic disorders which will affect bone or wound healing.
2
COMPLICATIONS:
Possible complications with any oral reconstructive surgery include infection, closure perforation, abcess formation, bone loss, pain, soft tissue irregularities, and additional complications associated with anesthesia and dental surgery. Specific to this surgery is augmentation material perforation or exfoliation. Depending on the type and severity of the complications the removal of the membrane may be indicated.
MATERIALS OF CONSTRUCTION:
IMTEC/ BIOBARRIER is constructed of 100% polytetrafluoroethylene (PTFE).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
The uses of IMTEC/BIOBARRIER are similar to the currently marketed predicate devices which are used for Guided Bone Regeneration (GBR) in conjunction with endosseous dental implant placement and repair.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 eagle with three human profiles incorporated into its design. The eagle is positioned in the center of a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling it.
Public Health Service
OCT 1 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
Mr. M.K. Patterson, Jr. Ph.D. Sr. Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401
Re: K974752
Trade Name: Imtec/Biobarrier Membrane Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPK Dated: December 19, 1997 Received: December 19, 1997
Dear Dr. Patterson:
This letter corrects our substantially equivalent letter of March 3, 1998.
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 (1111), is may 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.
4
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,
Sattie Y. Michael 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
Image /page/4/Picture/7 description: The image is a circular logo with the text "FDA Centennial" in the center. The logo also includes the years "1906-2006" at the top. The text around the circle reads "Celebrating 100 Years of Service & Public Health Protection". There are also stars included in the logo.
Protecting and Promoting Public Health
5
1974753
510(k) Number (if known):
IMTEC BIOBARRIER MEMBRANE Device Name:
Indications For Use:
IMTEC BioBarrier is a temporarily implantable material intended to be used as a space maintaining barrier over bone. It is intended for use in the oral cavity. The material is conformable to a variety of shapes as required for specific anatomical limitations.
The IMTEC BioBarrier is additionally indicated for:
- simultancous use of GBR-membrane (BioBarrier) and implants:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation.
Because of its clasticity, the IMTEC BioBarrier should be used in combination with space-making bone graft malerials, e.g., autogenous bone or bone substitutes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF YEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susen Runner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 1974752
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)