(125 days)
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No
The summary describes a physical implant material and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is described as an "implant material" and "guided tissue membrane" used as a "temporary space making barrier over bone or other tissue." These descriptions indicate it's a material used in surgery, not a device directly treating a medical condition or disease.
No
Explanation: The device is described as an implant material used as a temporary space-making barrier, not for diagnosing conditions.
No
The device description clearly states it is an "implant material" and a "membrane," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a "temporary space making barrier over bone or other tissue." This describes a device that is implanted directly into the body to perform a physical function.
- Device Description: The description confirms it's an "implant material" and a "guided tissue membrane." These are terms associated with medical devices used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of these specimens.
Therefore, TefGen-LS is a medical device, but it falls under the category of an implantable device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
TefGen-LS is an implant material which is intended to be used as a temporary space making barrier over bone or other tissue.
Product codes
NPK
Device Description
TefGen-LS membrane is a 100% PTFE non-absorbable guided tissue membrane. The material is easily trimmed to a variety of shapes as required by specific cases.
Mentions image processing
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Mentions AI, DNN, or ML
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its head and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
OCT 1 0 2007
Mr. Bruce G. Ruefer President American Custom Medical, Company 2430 N. 7th Avenue, Suite 4 Bozeman, Montana 59715
Re: K965205 Trade Name: TefGen-LSTM Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPK Dated: March 12, 1997 Received: March 14, 1997
Dear Mr. Ruefer:
This letter corrects our substantially equivalent letter of April 30, 1997.
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 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.
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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,
Suyite Y. Michie Ouid.
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/1/Picture/7 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The logo features the letters "FDA" in a bold, stylized font at the center. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by text that reads "Celebrating a Century of Progress".
Protesting and Promoting Public Health
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APR 3.0 1997
TefGen-LS™ 510(k) SUMMARY OF SAFETY AND EFFICACY
| Prepared by: | Bruce G. Ruefer, President |
|---|---|
| Date: | December 20, 1996 |
| Classification Name: | Augmentation Membrane, 76LYC |
| Common/Usual Names: | Barrier Membrane; Guided Tissue Membrane; or GTR |
| Membrane. | |
| Proprietary Name: | TefGen-LS™ Guided Tissue Membrane |
| Establishment Reg. No. | 9006936 |
| Classification: | Class II |
| Performance Standards: | Not Applicable. |
| Substantial Equivalence: | The non-absorbable augmentation membrane is manufactured |
| by American Custom Medical and is equivalent in function to the | |
| augmentation membranes manufactured and marketed by both | |
| American Custom Medical and W.L. Gore which are currently on | |
| the market. | |
| Product Description | |
| & Intended Use: | TefGen-LS membrane is a 100% PTFE non-absorbable guided |
| tissue membrane. TefGen-LS is an implant material which is | |
| intended to be used as a temporary space making barrier over | |
| bone or other tissue. The material is easily trimmed to a variety of | |
| shapes as required by specific cases. | |
| Comparative Technological | |
| Characteristics: | TefGen-LS is a biocompatible 100% PTFE membrane, is non- |
| resorbable, is stiff enough to create a space, and is supple | |
| enough to be formed over the margins of a defect; as are the | |
| predicate devices. | |
| Safety & Efficacy: | TefGen-LS is composed of 100% polytetrafluoroethylene or PTFE. |
| PTFE is the most inert polymer known at this time. PTFE's use as | |
| an implant material in the cardiovascular area is well substantiated | |
| with over 3,000,000 PTFE vascular grafts implanted to date. Many | |
| other configurations of PTFE devices are marketed including soft | |
| tissue and cardiovascular PTFE patches, PTFE suture, PTFE barrier | |
| membranes, and PTFE ear implant devices. | |
| PTFE has been found to pass biocompatibility assays including | |
| U.S.P. Class VI, carcinogenicity studies, hemocompatibility studies, | |
| and others. PTFE has been proven many times over to be non- | |
| reactive to body fluids and tissues making it a material of choice for | |
| biomaterial applications. |
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TefGen-LS™ 510(k) SUMMARY OF SAFETY AND EFFICACY (cont)
ACM PTFE has been found to function as an acceptable Literature: augmentation membrane as noted in the following articles: "The Use of High-Density Polytetrafluoroethylene Membrane to Treat Osseous Defects: Clinical Reports", 8. Bartee, D.D.S., Implant Dentistry, 4, 1995, pgs. 21-26. "Evaluation of a Full Density Polytetrafluoroethylene (PTFE) Film to Promote Osteogenesis in the Rat Model", J. Carr, et.al., Oral Implantology, 21, 1995, pgs. 88-95. "Influence of Three Membrane Types on Healing of Skull Lesions", B. Crump, et.al, presented at the 1995 IADR Annual Meeting, Singapore, June, 1995. "The Influence of Three Membrane Types on Healing of Bone Defects", B. Crump, et.al., Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, Oct. 1996, pgs. 365-374. "High-density PTFE Membranes: Uses with Root-form Implants", J. Krauser, Dental Implantology Update, 7, pgs. 65-69, 1996. Clinical Research Associates Newsletter, 20:4, February 1996.
Conclusion:
The TefGen-LS membrane configuration is substantially equivalent to the currently marketed TefGen-FD membrane and currently marketed GORE-TEX augmentation membrane.