(23 days)
Not Found
No
The summary describes a mechanical system for fixating membranes and does not mention any AI or ML components or functions.
Yes.
The device is intended to fixate and stabilize barrier membranes for tissue and bone regeneration, which falls under therapeutic indications.
No
The device is described as a system for fixating and stabilizing barrier membranes for tissue regeneration, providing an anchoring mechanism for membranes to bone or tissue. Its function is to hold membranes in place for therapeutic purposes, 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 it is a physical device with hardware components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- AUTOTAC System™ Function: The AUTOTAC System™ is described as a system for fixating and stabilizing barrier membranes used for tissue and bone regeneration within the oral cavity or other clinical situations. It provides an anchoring mechanism for these membranes to bone or tissue at the surgical site.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens taken from the body. Its function is purely mechanical, providing physical support for membranes during a surgical procedure.
Therefore, the AUTOTAC System™ falls under the category of a surgical device or implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AUTOTAC System™ is intended to fixate and stabilize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue in the and normbloroonbable ituations 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 by either gamma or ETO sterilization and is not intended to be re-sterilized 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
The AUTOTAC System™ tissue tack was evaluated by consulting clinicians and laboratory studies and found to be 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 and shear strength of the AUTOTAC System™ tissue tack is sufficient to prevent premature movement of the periodontal membrane.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters, "K011675". The characters are written in a simple, clear style, with each digit and letter easily distinguishable. The text appears to be a code or identification number.
Special 510(k): Device Modification Summary of Safety and Effectiveness
Proprietary Name
JUN 2 2 2001
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 by either gamma or ETO sterilization and is not intended to be re-sterilized by the user.
Product Evaluation
The AUTOTAC System™ tissue tack was evaluated by consulting clinicians and laboratory studies and found to be 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 and shear strength of the AUTOTAC System™ tissue tack is sufficient to prevent premature movement of the periodontal membrane.
1
Indications for Use
The AUTOTAC System™ is intended to fixate and stabilize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue in the and normbloroonbable ituations that require membrane use/fixation.
Substantial Equivalence Information
The AUTOTAC System™ ETO-sterilized tissue tack is substantially equivalent to all features which could affect safety or effectiveness to the equivalorit to all foutures thk (K993493) due to the similarities in tack design, material and intended use.
2
Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text is centered and there is no other text or graphics in the image.
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design in the center. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The seal is presented in black and white.
JUN 2 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Donald E. Dalton Director of Quality Assurance Biohorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230, South Birmingham, Alabama 35243
Re : K011675 The Autotac System Trade/Device Name: 872.4880 Requlation Number: Requlatory Class: II Product Code: DZL Dated: May 29 ,2001 Received: May 30, 2001
Dear Mr. Dalton:
We have reviewed your Section 510(k) notification of incent to we have reviewed your boosed above and we have determined the market the devisorially equivalent (for the indications for device is subscanciary orgal to legally marketed predicate use stated in the chorobase, commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enactment date of chassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the reacrar tone, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual provisions of the ing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II if your device is class III (Premarket Approval), it may (Special Concessional controls. Existing major be subject to Back addroundevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with bubbeancearly odaManufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Forch In the Qualition (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug chrough periodic go mill verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. accron: "Illude device in the Eederal Register. Please note:
3
Page 2 - Mr. Dalton
this response to your premarket notification submission does this response to your premarket have under sections 531
not affect any obligation you might have under the Flectronic not affect any obligation you mages under the Electronic through 542 of the Act for devices and 1requlations.
This letter will allow you to begin marketing your device as This lecter will affow your over of your dovice The FDA described in your 510(K) prematic normalice to a legally
finding of substantial equivalence of your device for your finding of substantial equivailies of yolassification for your marketed predicate device resures in a crabbed.
device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling If you desire specific advice rollibers the office of regulation (21 crk Farc ove anase contact the Office of
vitro diagnostic devices), please contact the for questi vitro diagnostic devices), preab otionally, for questions on
Compliance at (301) 594-4622. Additionally, plaase contact Compliance at (301) 554 inin. In your device, please contact
the promotion and advertising of your device, algo, please no the promotion and advertising of your actives in the office of the Office the orress on and the misbranding by reference to premarket notification" (21CFR 807.97) . Other general premarker notification (arch over the Act may be information on your responsible and Manufacturers Assistance obtained from the DIVISION OF Bildir Handsons.
at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
1ts Incernet addross
"http://www.fda.gov/cdrh/dsma/dsmamajn.html".
Sincerely yo
A. Ulatowski Timothy 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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Page 1 of 1
(011675 510(k) Number (if known): _
The AUTOTAC System™ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
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)
Susan Runze
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (per 21 CFR 801.109) Over-the-Counter Use
OR