(249 days)
Not Found
No
The summary describes a physical bone screw and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device provides mechanical stabilization, which is a structural rather than a therapeutic function.
No
Explanation: The device is a bone screw used for temporary fixation of the maxilla and mandible, which is a therapeutic rather than a diagnostic function. It is used to stabilize rather than to identify a disease or condition.
No
The device description clearly states it is a "small bone screw," which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is a "small bone screw intended for use in temporary maxillomandibular fixation." This is a physical implant used to stabilize bones.
- Intended Use: The intended use is for "temporary maxillomandibular fixation to provide indirect stabilization of the maxilla, mandible, or both." This is a mechanical function, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
This submission describes a small bone screw intended for use in temporary maxillomandibular fixation to provide indirect stabilization of the maxilla, mandible, or both.
Product codes
DZE
Device Description
The Leibinger® IMF Screw is 2.0 mm in diameter and ranges from 10.5-18.5 mm in total length (6-14 mm in threaded length). There is a hole in the screw head through which a wire can be passed to fix the maxilla and mandible. The device is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillomandibular
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)
Not Found
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.
K820944, K# Unknown, K912932, K963740
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
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Andrew B. Rogers Director, Product Development and Special Projects Howmedica Leibinger, Incorporated 14540 Beltwood Parkway East Dallas. Texas 75244
Re: K963030
Trade/Device Name: Leibinger IMF Screw Regulation Number: 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: March 12, 1997 Received: March 13, 1997
Dear Mr. Rogers:
This letter corrects our substantially equivalent letter of March 12, 1997 regarding the incorrect product code of Leibinger IMF Screw.
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.
JUN 2 - 2005
1
Page- Mr. Rogers
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Syrite M'chui Dms.
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
2
K96 3030
510(k) Summary
Leibinger® IMF Screw Device Proprietary Name: Small Bone Screw Device Common Name: Intraosseous Fixation Screw or Wire Classification Name: 21 CFR 872. 4880 76 DZL Name of Submitter: Howmedica Leibinger Inc. Contact Person: Kristyn R. Waski QA/RA Engineer Howmedica Leibinger Inc. 14540 Beltwood Pkwy. East Dallas, TX 75244 Telephone: (972) 392-3636 x266 (972) 392-7258 Fax: Date Prepared: March 12, 1997
Summary:
This submission describes a small bone screw intended for use in temporary maxillomandibular fixation to provide indirect stabilization of the maxilla, mandible, or both. The Leibinger® IMF Screw is 2.0 mm in diameter and ranges from 10.5-18.5 mm in total length (6-14 mm in threaded length). There is a hole in the screw head through which a wire can be passed to fix the maxilla and mandible. The device is for single use only.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Unisplint Dental Arch Bar (K820944); the Synthes Minihook and Cortical Screw (K# Unknown); the Synthes Cortical Bone Screw (K912932); and the Leibinger®-Luhr® Small Mandibular Bone Screws (K963740). The Dental Arch Bars, Minihook and Cortical Screw and Cortical Bone Screw are intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both. The Leibinger® IMF Screw and the Synthes Cortical Bone Screw can both be manufactured from commercially pure titanium; the Leibinger® IMF Screw and the Leibinger®-Luhr® Small Mandibular Bone Screws can both be manufactured from Ti(6A1.4V). The basic operational principle is similar for the cortical screw and arch bar devices.