(131 days)
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No
The summary describes a physical barrier membrane made of PTFE, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "space-making barrier in the treatment of periodontal defects," indicating its therapeutic purpose in addressing a medical condition.
No
Explanation: This device is a barrier membrane used in the treatment of periodontal defects, not for diagnosing a condition. It is an implantable material designed to create space, not to detect or identify diseases.
No
The device description clearly states it is a physical, implantable material made of polytetrafluoroethylene (PTFE) film, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects." This describes a device that is physically implanted into the body to perform a structural function.
- Device Description: The description details a physical membrane made of PTFE, designed to be implanted.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or diagnostic purposes.
Therefore, this device falls under the category of an implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
Product codes
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Device Description
The Cytoplast™ GBR Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film with a nominal thickness of 250 microns and supplied in a variety of shapes and sizes. Membranes are supplied sterile in sealed pouches.
The biocompatibility of polytetrafluoroethylene (PTFE) has been established through a long history of use in a variety of long-term PTFE implant devices, such as PTFE vascular prostheses and cardiovascular patches. The Cytoplast™ GBR Non-Absorbable Barrier Membrane has been shown to be non-cytotoxic.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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
MAR 1 1 1997
510 (k) SUMMARY
ADMINISTRATIVE 1.
Osteogenics Co. Submitter: 3234 64th Street Lubbock, TX 79413 (806) 792-2311
Contact Person: Barry K. Bartee, DDS
Date of Preparation: January 29, 1997
DEVICE NAME 11.
Proprietary Name: Cytoplast ™ GBR
Common Name: Non-Absorbable Barrier Membrane
Classification Name: Implant, Endosseous For Bone Filling And/Or Augmentation.
PREDICATE DEVICES =============================================================================================================================================================================
Gore-Tex™ Regenerative Material (K922627; W.L Gore & Associates, Inc.) TefGen-FD (K935137; American Custom Medical) Imtec Biobarrier Membrane (K950306; Imtec Corporation)
IV. DEVICE DESCRIPTION
The Cytoplast™ GBR Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film with a nominal thickness of 250 microns and supplied in a variety of shapes and sizes. Membranes are supplied sterile in sealed pouches.
The biocompatibility of polytetrafluoroethylene (PTFE) has been established through a long history of use in a variety of long-term PTFE implant devices, such as PTFE vascular prostheses and cardiovascular patches. The Cytoplast™ GBR Non-Absorbable Barrier Membrane has been shown to be non-cytotoxic.
V. INTENDED USE
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
1
VI. COMPARISON TO PREDICATE DEVICES
The Cytoplast ™ GBR Non-Absorbable Barrier Membrane is identical in composition, function, and intended use to legally marketed predicate devices such as Gore-Tex™ Regenerative Material, TefGen-FD, and the Imtec Biobarrier Membrane.
Accordingly, Osteogenics Co. concluded that the Cytoplast™ GBR Non - Absorbable Barrier Membrane is safe and effective for its intended use and performs at least as well as the legally marketed predicate devices.