(49 days)
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
A temporarily implantable material (non-resorbable) for use as a spacemaking barrier in the treatment of periodontal bone defects.
The Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film reinforced with a titanium framework. The membrane has a nominal thickness of 250 microns. Membranes are supplied sterile in sealed pouches in a variety of shapes and sizes.
The biocompatibility of polytetrafluoroethylene (PTFE) and titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been conducted with this device.
Here's an analysis of the provided text regarding the Cytoplast Regentex Titanium 250 Non-Absorbable Barrier Membrane, presented in the requested format. It's important to note that the provided 510(k) summary focuses heavily on substantial equivalence to predicate devices rather than detailed performance studies with specific acceptance criteria and outcome data. Therefore, many sections will indicate "Not Applicable" or that the information is "Not provided in the document."
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Biocompatibility | Established through a long history of use of polytetrafluoroethylene (PTFE) and titanium in a variety of implant devices. |
| Effectiveness: Ability to function as a space-making barrier in the treatment of periodontal defects. | Concluded to be "safe and effective for its intended use and performs at least as well as the legally marketed predicate devices" based on substantial equivalence. Specifically, it is "identical in composition, function, and intended use to legally marketed predicate devices such as Gore-Tex™ Regenerative Material." |
| Performance compared to predicate devices. | "Performs at least as well as the legally marketed predicate devices." |
2. Sample size used for the test set and the data provenance
Not provided in the document. The submission relies on substantial equivalence to predicate devices, rather than a new performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no new performance study with a test set requiring expert ground truth establishment is described. The device's safety and effectiveness are established through comparison to predicate devices, whose performance would have been established previously.
4. Adjudication method for the test set
Not applicable.
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 barrier membrane, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a barrier membrane, not an algorithm.
7. The type of ground truth used
Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices based on their prior regulatory approvals and clinical use. No new ground truth for a novel device performance study is described.
8. The sample size for the training set
Not applicable. The submission does not describe a training set as it is not an AI/ML device or a device requiring a specific training regimen for its function.
9. How the ground truth for the training set was established
Not applicable.
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UG - 6 1997
510 (k) SUMMARY
ADMINISTRATIVE l.
Submitter: Osteogenics Co. 3234 64th Street Lubbock, TX 79413 (806) 792-2311
Contact Person: Barry K. Bartee, DDS
Date of Preparation: June 2, 1997
ll. DEVICE NAME
Proprietary Name: Cytoplast™ Regentex Titanium 250
Common Name: Non-Absorbable Barrier Membrane
Classification Name: Implant, Endosseous For Bone Filling And/Or Augmentation.
PREDICATE DEVICES III.
Gore-Tex'" Reqenerative Material (K960292; W.L Gore & Associates, Inc.) Cytoplast " GBR Membrane (K964342; Osteogenics Co.)
IV. DEVICE DESCRIPTION
The Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film reinforced with a titanium framework. The membrane has a nominal thickness of 250 microns. Membranes are supplied sterile in sealed pouches in a variety of shapes and sizes.
The biocompatibility of polytetrafluoroethylene (PTFE) and titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been conducted with this device.
V. INTENDED USE
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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VI. COMPARISON TO PREDICATE DEVICES
The Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is identical in composition, function, and intended use to leqally marketed predicate devices such as Gore-Tex™ Regenerative Material. Except for the presence of a reinforcing titanium framework, the Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is also identical in composition, function, and intended use to the legally marketed predicate Cytoplast " GBR membrane.
Accordingly, Osteogenics Co. concluded that the Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is safe and effective for its intended use and performs at least as well as the legally marketed predicate devices.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Osteogenics Company C/O Richard Hamer Associates, Incorporated 6401 Meadows West Drive Fort Worth, Texas 76132
AUG - 6 1997
Re: K972278 Trade Name: Cytoplast Regentex Titanium 250 Requlatory Class: Unclassified Product Code: LYC Dated: June 17, 1997 Received: June 18, 1997
Dear Mr. Hamer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood manufacturing practice, labelinq, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Farts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq
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Page 2 - Mr. Hamer
Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosed
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ol Paqe 1 1
510(k) Number (if known):
Cytoplast ''' Regentex Titaņium 250 Device Name: Non-Absorbable Barrier Membrane ...
Indications for Use:
A temporarily implantable material (non-resorbable) for use as a spacemaking barrier in the treatment of periodontal bone defects.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDITIER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Num
Prescription Use
(Per 21 CFR 801.109)
()R
Over the Counter Use No
(Optional Format 1-2 96)
§ 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.