(129 days)
Not Found
No
The device description and intended use focus on mechanical components for bone distraction and stabilization. There is no mention of AI, ML, image processing, or data-driven analysis in the provided text.
Yes
The device is intended for the "Treatment of cranial or midfacial conditions" and provides "temporary stabilization and gradual lengthening of facial bones," which are therapeutic actions.
No
The device is described as a "distraction system" intended for "treatment of cranial or midfacial conditions" that provides "temporary stabilization and gradual lengthening of facial bones." It is a treatment device, not a diagnostic one.
No
The device description explicitly lists physical components such as a distractor frame, activation rod, plates, and activation key, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for the treatment of cranial and midfacial conditions through reconstructive osteotomy and segment advancement. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device components (distractor frame, activation rod, plates, activation key) are all mechanical parts designed for surgical implantation and manipulation of bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to physically alter bone structure.
N/A
Intended Use / Indications for Use
The Leibinger Advance Internal Midface Distraction System is intended to be used in conditions of the cranium and mid-face for which osteotomy and segmental advancement are indicated.
Treatment of cranial or midfacial conditions for which reconstructive osteotomy and segment advancement are indicated. The indications include conditions such as syndromic craniosynostosis (e. g. Apert, Crouzon, Pfeiffer, Antley Bixler) and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of facial bones of the cranium and the midface. It is not intended to be used in the mandible.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The Leibinger Advance Internal Midface Distraction System is a distraction system consisting of the following major components: distractor frame, which incorporates connection screws for the plates, a removable activation rod, plates, and an activation key. The plates and frame initially stabilize and then gradually distract the osteotomy. The removable activation rod, covered with a protective sheath, is connected to the frame and provides the point of attachment for the activation key used to initiate the distraction of the osteotomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium, mid-face, facial bones
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.
K972154, K022005, K964649, K003883
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
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness
JAN 1 5 2010
| Proprietary Name: | The Leibinger Advance Internal Midface
Distraction System |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone Distraction System |
| Classification Name and Reference: | Smooth or Threaded metallic bone fixation fastener
21 CFR §888.4760 |
| Proposed Regulatory Class: | Class II |
| Product Codes: | JEY - Bone Plate |
| For Information contact: | Stephanie Fitts
Director, Regulatory Affairs and Compliance
Howmedica Osteonics.Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-5405 Fax: (201) 831-4405 |
| Date Prepared: | September 4, 2009 |
Description:
The Leibinger Advance Internal Midface Distraction System is a distraction system consisting of the following major components: distractor frame, which incorporates connection screws for the plates, a removable activation rod, plates, and an activation key. The plates and frame initially stabilize and then gradually distract the osteotomy. The removable activation rod, covered with a protective sheath, is connected to the frame and provides the point of attachment for the activation key used to initiate the distraction of the osteotomy.
1
Intended Use:
The Leibinger Advance Internal Midface Distraction System is intended to be used in conditions of the cranium and mid-face for which osteotomy and segmental advancement are indicated.
Indications:
Treatment of cranial or midfacial conditions for which reconstructive osteotomy and segment advancement are indicated. The indications include conditions such as syndromic craniosynostosis (e. g. Apert, Crouzon, Pfeiffer, Antley Bixler) and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of facial bones of the cranium and the midface. It is not intended to be used in the mandible.
Substantial Equivalence:
The Leibinger Advance Internal Midface Distraction System is substantially equivalent to other commercially available cranial and midface distraction systems. The following devices are examples of predicate systems: Cohen Distractor (K972154), Synthes Midface Distractor (K022005), Vazquez-Diner Intraoral Distractor (K964649) and Molina Orbital Malar Distractor (K003883).
2
Food and Drug Administration 19905 New Hampshire Avenue Dacumem Control Room -WO68-0666 Silver Spring, MD 20997-9002
Stephanie M. Fitts, Ph.D. Director, Regulatory Affairs and Regulatory Compliance Howmedica Osteonics Corporation Stryker Craniomaxillofacial 325 Corporate Drive Mahwah, New Jersey 07430
JAN 1 5 2010
Re: K092743
Trade/Device Name: The Leibinger Advance Internal Midface Distraction System Regulation Number: 21 CFR 872:4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: December 29, 2009 Received: December 4, 2009
Dear Dr. Fitts:
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.
3
Page 2 - Dr. Fitts
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 (OS) 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 yours,
Anthom U. Nwin
Watson, BS, MS, MBA Anthony D. Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K092743 Deficiency Response Page 3 December 29, 2009
Indications for Use Statement
510(k) Number (if known): K092743
Device Name: The Leibinger Advance Internal Midface Distraction System
Indications for Use:
Treatment of cranial or midfacial conditions for which reconstructive osteotomy and segment advancement are indicated. The indications include conditions such as syndromic craniosynostosis (e. g. Apert, Crouzon, Pfeiffer, Antley Bixler) and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of facial bones of the cranium and the midface. It is not intended to be used in the mandible.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
RSBetz DDS for Dr. K.P. Muliy (Acting)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092743