(84 days)
Biovision GMBH LEADfix Bioresorbable Membrane Pin System, 3i BIO TACK
Not Found
No
The description focuses on a mechanical fixation system and does not mention any AI/ML components or capabilities.
No.
The device is used to fixate and stabilize membranes for tissue regeneration, which is a supportive role in a therapeutic process rather than a direct therapeutic action itself.
No
The device is described as a system for fixating and stabilizing barrier membranes for tissue regeneration, providing an anchoring mechanism. Its function is to aid in a surgical procedure, not to diagnose a condition or disease.
No
The device description explicitly states that the system consists of "components and instruments" and describes a "Tissue Tack" fabricated from a polymer, indicating physical hardware components are part of the device.
Based on the provided information, the AUTOTAC System™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The AUTOTAC System™ is a surgical device intended for the physical fixation and stabilization of barrier membranes within the oral cavity or other surgical sites. It is used in vivo (within the living body) during a surgical procedure, not in vitro (in a lab setting) on patient specimens.
The description clearly outlines its function as a mechanical anchoring system for membranes during tissue regeneration procedures. This falls under the category of surgical or implantable devices, not IVD.
N/A
Intended Use / Indications for Use
The AUTOTAC System™ is intended to fixate and stablize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue in the oral cavity or in other clinical situations that require membrane use/fixation.
The AUTOTAC System™ is intended to fixate or stabilize bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity or in other clinical situations that require membrane use/fixation.
Product codes
DZL
Device Description
The AUTOTAC System™ consists of components and instruments designed to fixate and stabilize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity or in other clinical situations that require membrane use/fixation. The system provides an anchoring mechanism for the membranes to resident and adjacent bone or tissue at the surgical site. The Tissue Tack is fabricated from a well-known bioresorbable polymer and has a round, flat head, and two circular ribs on the shaft to prevent the implanted tack from slipping out. The tack is provided sterile and is not intended to be resterilized by the user.
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)
The AUTOTAC System™ was evaluated by consulting clinicians in animal tests and laboratory studies and found to effective for fixation of barrier membranes without new health risks and is a predictable means to achieve clinical success in guided bone and/or tissue regeneration.
Mechanical tests demonstrated that the pull-out strength of the AUTOTAC System™ was equivalent to the predicate devices. Furthermore, the resorbable membrane will not deleteriously affect the implanted tack under shear loading based on in-vitro mechanical tests.
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.
Biovision GMBH LEADfix Bioresorbable Membrane Pin System, 3i BIO TACK
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
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
BioHorizons Implant Systems, Inc. 510(k) Notification 10/13/99
N - 7 2000
510(k) Summary of Safety and Effectiveness
Proprietary Name
The AUTOTAC System™
Common Name
Screw, tack, membrane fixation pin
Classification Name Intraosseous fixation screw
Classification
Class II
Official Contact
BioHorizons Implant Systems, Inc. One Perimeter Park South Suite 230 South Birmingham, AL 35243 (205) 967-7880 Fax (205) 870-0304
Device Description
The AUTOTAC System™ consists of components and instruments designed to fixate and stabilize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity or in other clinical situations that require membrane use/fixation. The system provides an anchoring mechanism for the membranes to resident and adjacent bone or tissue at the surgical site. The Tissue Tack is fabricated from a well-known bioresorbable polymer and has a round, flat head, and two circular ribs on the shaft to prevent the implanted tack from slipping out. The tack is provided sterile and is not intended to be resterilized by the user.
Product Evaluation
The AUTOTAC System™ was evaluated by consulting clinicians in animal tests and laboratory studies and found to effective for fixation of barrier membranes without new health risks and is a predictable means to achieve clinical success in guided bone and/or tissue regeneration.
Mechanical tests demonstrated that the pull-out strength of the AUTOTAC System™ was equivalent to the predicate devices. Furthermore, the resorbable membrane will not deleteriously affect the implanted tack under shear loading based on in-vitro mechanical tests.
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BioHorizons Implant Systems, Inc. 510(k) Notification 10/13/99
Indications for Use
The AUTOTAC System™ is intended to fixate and stablize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue in the oral cavity or in other clinical situations that require membrane use/fixation.
Substantial Equivalence Information
The AUTOTAC System™ is substantially equivalent to all features which could affect safety or effectiveness to the Biovision GMBH LEADfix Bioresorbable Membrane Pin System and the 3i BIO TACK due to the similarities in tack design and intended use.
2
Image /page/2/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 image of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be emerging from or connected to each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2000
Mr. Winston D. Greer Vice-President of Operations Bio-Horizons Implant Systems, Incorporated One Perimeter Park South Suite 230 South Birmingham, AL 35243
K993493 Re : The AUTOTAC System™ Trade Name: Class: II Product Code: DZL October 13, 1999 Dated: Received: October 15, 1999
Dear Mr. Greer:
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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Title 21, Parts 800 to 895. A Federal Regulations, substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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
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Page 2 - Mr. Greer
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 acborizon in four in four 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BioHorizons Implant Systems, Inc. 510(k) Notification 10/13/99
Page 1 of 1
510(k) Number (if known):
Device Name: _____ The AUTOTAC System™
Indications for Use:
8 ..... The AUTOTAC System™ is intended to fixate or stabilize bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity or in other clinical situations that require membrane use/fixation.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (per 21 CFR 801.109) | ✓Suam Rann |
|---|---|
| ------------------------------------------ | ------------------------------------------------------------------------------------------ |
OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | 1993493 |
|---|---|
| --------------- | --------- |
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