(239 days)
Not Found
No
The device description focuses on the mechanical components and materials of a skeletal anchorage system for orthodontic procedures. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
Explanation: The device is intended as an anchor in orthodontic procedures and provides a fixed anchorage point for facilitating orthodontic movement of teeth, which is a structural or mechanical function, not a therapeutic one that restores, corrects, or modifies physiological functions.
No
Explanation: The device is described as an anchor for orthodontic procedures, providing a fixed point for the attachment of orthodontic appliances to facilitate tooth movement. Its function is to provide mechanical support, not to diagnose a condition.
No
The device description clearly outlines physical components made of titanium (miniplates, miniscrews, connecting bar, fixation unit, blocking screw, connecting wire, hook, tube) that are surgically implanted. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be placed in the mouth for use as an anchor in orthodontic procedures." This describes a device used in vivo (within the body) for a structural purpose.
- Device Description: The description details a physical implantable device made of titanium, designed to be fixed to bone. It facilitates mechanical movement of teeth.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are typically used to test samples like blood, urine, or tissue outside of the body to detect diseases, conditions, or other health information. This device is clearly a surgical implant used for mechanical anchorage.
N/A
Intended Use / Indications for Use
The subject devices are intended to be placed in the mouth for use as an anchor in orthodontic procedures.
Product codes
DZE
Device Description
The Bollard Miniplate Skeletal Anchorage System provides a fixed anchorage point for the attachment of orthodontic appliances to facilitate orthodontic movement of teeth. Small stationary points connected to bone inside the mouth allow connection of wire, elastic, or other hardware.
The Bollard Miniplate Skeletal Anchorage System includes Commercially Pure Titanium miniplates fixed by miniscrews to the cortical bone. After insertion by the surgeon the miniplates are completely covered by soft tissue. The miniplates and miniscrews are sold sterile and are sterilized using Gamma Radiation per ISO 11137-1.
The bone anchor consists of a miniplate (M) with 2 or 3 holes, a round connecting bar (C), and a fixation unit (F) with a blocking screw (S). The miniplate is fixed to the bone by self-tapping or selfdrilling screws. The fixation unit contains 2 slots with a diameter of 0.045" (1.1mm). A square connecting wire with a maximum size of 0.032x0.032" can be inserted and tightly fixed by the blocking screw.
The Bollard miniplates are also offered with a hook. The Bollard with hook is smaller than the original model and contains a tube with section 0.020"x0.020". The hook can affix directly to elastics or coil springs.
The subject devices are used with standard instrumentation for orthodontic surgery including pliers, punches, screwdrivers, burrs, and grasping or holding instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 subject device is composed of well characterized and biocompatible material that meets applicable standards.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
DEC - 8 2009
510 (k) Summary
Date Prepared [21 CFR 807.92(a)(1)| Revised December 4, 2009
Submitter's Information [21 CFR 807.92(a)(1)|
This 510(k) is being submitted by Joseph Azary on behalf of Tita-Link
Regulatory Contact / Correspondent Joseph Azary Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Tel: (203) 922-0105 Fax: (203) 922-0130 Email: joseph.azary@orchid-orthopedics.com
NOTE: Please send all correspondence concerning this 510(k) premarket notification to the regulatory contact.
Sponsor / Manufacturer TITA-LINK DE Hinnisdaellaan, 2 1150 Brussels Belgium Contact: Dr. Hugo DeClerck Email: hugo.declerck@skynet.be
FDA Establishment Registration Number is pending.
Trade Name:
The device trade names are:
1
- Bollard Miniplate Skeletal Anchorage System .
Device Common, Usual, or Classification Names:
Endosseous Dental Implant
Classification
Classification of this device would fall under the responsibility of the Dental panel.
Class 2 device under the following product code / regulation:
DZE, 21 CFR 872.3640 o
Predicate Device [21 CFR 807.92(a)(3)]
KLS Martin - Ortho Anchorage System - K040891 Stryker Leibinger Skeletal Anchoring System - K041651
Indications for Use |21 CFR 807.92(a)(5)]
The subject devices are intended to be placed in the mouth for use as an anchor in orthodontic procedures.
Description of the Device [21 CFR 807.92(a)(4)|
The Bollard Miniplate Skeletal Anchorage System was invented by Dr. Hugo DeClerck.
The Bollard Miniplate Skeletal Anchorage System provides a fixed anchorage point for the attachment of orthodontic appliances to facilitate orthodontic movement of teeth. Small stationary points connected to bone inside the mouth allow connection of wire, elastic, or other hardware.
The Bollard Miniplate Skeletal Anchorage System includes Commercially Pure Titanium miniplates fixed by miniscrews to the cortical bone. After insertion by the surgeon the miniplates are completely covered by soft tissue. The miniplates and miniscrews are sold sterile and are sterilized using Gamma Radiation per ISO 11137-1.
The bone anchor consists of a miniplate (M) with 2 or 3 holes, a round connecting bar (C), and a fixation unit (F) with a blocking screw (S). The miniplate is fixed to the bone by self-tapping or selfdrilling screws. The fixation unit contains 2 slots with a diameter of 0.045" (1.1mm). A square connecting wire with a maximum size of 0.032x0.032" can be inserted and tightly fixed by the blocking screw.
2
The Bollard miniplates are also offered with a hook. The Bollard with hook is smaller than the original model and contains a tube with section 0.020"x0.020". The hook can affix directly to elastics or coil springs.
The subject devices are used with standard instrumentation for orthodontic surgery including pliers, punches, screwdrivers, burrs, and grasping or holding instruments.
Technological Characteristics [21 CFR 807.92(a)(6)|
TITA-LINK believes that the subject device is substantially equivalent to other devices that have previously received FDA 510(k) clearance including the predicate device.
Performance Data |21 CFR 807.92(b)(1)]
The subject device is composed of well characterized and biocompatible material that meets applicable standards.
Conclusion [21 CFR 807.92(b)(3)|
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device.
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold font. The text is centered in the image. The words are stacked on one line.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Tita-Link C/O Mr. Joseph Azary Senior Regulatory Consultant Orchid Design 80 Shelton Technology Center Shelton, Connecticut 06484
DEC - 8 2009
Re: K091051
Trade/Device Name: TTTA-LINK Bollard Miniplate Skeletal Anchorage System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Codes: DZE Dated: November 20, 2009 Received: November 30, 2009
Dear Mr. Azary:
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 application (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.
4
Page 2 - Mr. Azary
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/industry/support/index.html.
Sincerely vours.
for
Susan Runner, D.D.S. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K091051
Device Name: TITA-LINK Bollard Miniplate Skeletal Anchorage System
Indications for Use:
The subject devices are intended to be placed in the mouth for use as an anchor in orthodontic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Kein Mabey for. ASA
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K091051