(84 days)
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.
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.
The provided text describes a 510(k) premarket notification for "The AUTOTAC System™," a medical device intended to fixate and stabilize barrier membranes in tissue regeneration. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with performance metrics typically found in clinical efficacy trials for novel devices.
Therefore, much of the requested information regarding specific acceptance criteria, study methodologies, and performance metrics is not available in the provided document. The 510(k) pathway primarily relies on demonstrating equivalence in terms of intended use, technological characteristics, and safety/effectiveness, often through non-clinical testing and comparison to legally marketed predicate devices.
Here's what can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence: Effective for fixation of barrier membranes without new health risks and a predictable means to achieve clinical success in guided bone and/or tissue regeneration. | Evaluated by consulting clinicians in animal tests 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. |
| Mechanical Strength (Pull-Out): Pull-out strength equivalent to predicate devices. | Mechanical tests demonstrated that the pull-out strength of the AUTOTAC System™ was equivalent to the predicate devices. |
| Material Compatibility (Shear Loading): The resorbable membrane will not deleteriously affect the implanted tack under shear loading. | In-vitro mechanical tests demonstrated that the resorbable membrane will not deleteriously affect the implanted tack under shear loading. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for animal tests, laboratory studies, or mechanical tests. The document refers to "animal tests and laboratory studies" and "in-vitro mechanical tests" broadly.
- Data Provenance: The studies mentioned are "animal tests" and "laboratory studies," implying pre-clinical data. The country of origin is not specified, but the submission is to the US FDA. The studies are prospective in the sense that they were conducted for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: "Consulting clinicians" were involved in evaluating the system in animal and laboratory tests. The specific number is not provided.
- Qualifications: "Consulting clinicians" are mentioned. No further details on their specific qualifications (e.g., area of specialization, years of experience) are provided.
4. Adjudication Method for the Test Set
- No information on adjudication methods is provided. The evaluation by "consulting clinicians" is mentioned, implying expert assessment, but the process of reaching consensus or resolving discrepancies is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in the provided text. This type of study is more common for diagnostic imaging AI systems to evaluate physician performance with and without AI assistance, which is not relevant to this device (a physical implant/fixation system).
6. Standalone (Algorithm Only) Performance Study
- No, a "standalone" performance study (in the context of an algorithm's performance without human intervention, as typically seen with AI/software as a medical device) was not conducted. The AUTOTAC System is a physical medical device. The "standalone" concept doesn't apply to the same degree as it would for a diagnostic algorithm. The device's performance is inherently tied to its use by a clinician.
7. Type of Ground Truth Used
- For the functional effectiveness, the "ground truth" seems to have been established through expert clinical observation and assessment in animal models and laboratory settings, determining "effectiveness for fixation of barrier membranes without new health risks" and leading to "clinical success."
- For mechanical tests, the "ground truth" for equivalence in pull-out strength and resistance to shear loading would be quantitative measurements of these physical properties compared to predicate devices, presumably against engineering specifications or established performance benchmarks.
8. Sample Size for the Training Set
- This concept is not applicable here. The AUTOTAC System is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device would be its iterative design, development, and testing processes.
9. How the Ground Truth for the Training Set Was Established
- As stated above, the concept of a "training set" doesn't apply to this physical device. Therefore, no information on how its ground truth was established is relevant or provided.
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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.
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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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§ 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.