(625 days)
Not Found
No
The provided text describes a mechanical distraction system and does not mention any AI or ML components, image processing, or data-driven algorithms.
Yes
The device is described as treating various medical conditions such as craniosynostosis, midface retrusion, and hypoplasia, indicating a therapeutic purpose.
No
This device is a surgical system designed to physically distract parts of the craniofacial skeleton for treatment purposes, not to diagnose medical conditions.
No
The device description clearly outlines physical components such as a distractor frame, activation rod, plates, and an activation key, indicating it is a hardware-based medical device.
No, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Leibinger Advance Internal Midface Distraction System is a surgical implant used to physically distract (separate and gradually lengthen) bones in the craniofacial skeleton. It is used in vivo (within the living body) to treat conditions like craniosynostosis and midface retrusion.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens.
Therefore, based on the provided information, the Leibinger Advance Internal Midface Distraction System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Leibinger Advance Internal Midface Distraction System is intended to be used for cranial, monobloc and/or midface distraction osteogenesis of the craniofacial skeleton.
The Leibinger Advance Internal Midface Distraction System is indicated for the treatment of syndromic and non-syndromic craniosynostosis, midface retrusion, congenital midfacial hypoplasia, and craniofacial dysostosis in patients two years of age and older.
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: a 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
craniofacial skeleton, cranial, monobloc, midface
Indicated Patient Age Range
two years of age and older.
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)
No clinical testing was performed to support this submission.
The Leibinger Advance Internal Midface Distraction System successfully passed all tests conducted with regards to biocompatibility, cleaning, sterilization, corrosion resistance, determination of moments of inertia of plates, four point bending of distractor with plates, in-plane and out-of-plane bending tests.
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, K003883, K092743
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
JAN - 9 2014
| 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 § 888.3040 |
| Proposed Regulatory Class: | Class II |
| Product Codes: | JEY - Bone Plate |
| Submitter: | Stryker Craniomaxillofacial
750, Trade Centre Way
Portage MI 49002
Phone: (269) 389-4260 |
| Contact: | Jamshed Badarpura
Regulatory Compliance Analyst
Phone: (269) 389-4260
Jamshed.badarpura@stryker.com |
| Date Prepared: | April 23, 2012 |
| Predicate Devices: | Cohen Distractor (K972154),
Synthes Midface Distractor (K022005),
Molina Orbital Malar Distractor (K003883),
Leibinger Advance Internal Midface Distraction
System (K092743). |
510(k) Summary of Safety and Effectiveness
Description :
The Leibinger Advance Internal Midface Distraction System is a distraction system consisting of the following major components: a 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.
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Intended Use:
The Leibinger Advance Internal Midface Distraction System is intended to be used for cranial, monobloc and/or midface distraction osteogenesis of the craniofacial skeleton.
Indications:
The Leibinger Advance Internal Midface Distraction System is indicated for the treatment of syndromic and non-syndromic craniosynostosis, midface retrusion, congenital midfacial hypoplasia, and craniofacial dysostosis in patients two years of age and older.
Technological Characteristics:
The Leibinger Advance Internal Midface Distraction System is similar to its predicate devices in the following technological characteristics:
l. Operational Principle:
The basic operational principle for the predicate devices, as well as the subject device is the same for midface and cranial distraction. The method of site preparation and insertion are similar for all of the devices.
2. Material Information:
The distractor is made of stainless steel and titanium alloy. The activation rod is made of stainless steel and has an outer sheath of Polytetrafluoro-ethylene (PTFE). Plates and screws are made of either pure titanium or titanium alloy. All materials in the system are biocompatible, corrosion-resistant and non-toxic in the biological environment.
3. Design:
The Leibinger Advance Internal Midface Distraction System has operational design principles identical to the predicate Cohen Distractor System determined substantially equivalent via 510(k) K972154. Both use an external activation key to interface with a percutaneous activation rod to initiate distraction of the distractor frame unit. The plates are nearly identical in design with only the configuration of screw holes and sizes differing.
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4. Packaging:
The devices of the Leibinger Advance Internal Midface Distraction System will be delivered non-sterile, same as the predicate.
Clinical:
No clinical testing was performed to support this submission.
Non-Clinical Testing:
The Leibinger Advance Internal Midface Distraction System successfully passed all tests conducted with regards to biocompatibility, cleaning, sterilization, corrosion resistance, determination of moments of inertia of plates, four point bending of distractor with plates, in-plane and out-of-plane bending tests.
Substantial Equivalence Discussion:
The Leibinger Advance Internal Midface Distraction System is substantially equivalent to below listed legally marketed predicate devices in regards to intended use, design, materials, and operational principles. It is also as safe and as effective for the proposed indications as the predicate devices.
- Howmedica Osteonics Cohen Distractor: K972154 .
- Synthes Midface Distractor: K022005 .
- Molina Orbital Malar Distractor: K003883 .
- Leibinger Advance Internal Midface Distraction System (K092743) .
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2014
Stryker Craniomaxillofacial Mr. Jamshed Badarpura Regulatory Compliance Analyst 750, Trade Centre Way Portage, MI 49002
Re: K121235
Trade/Device Name: The Leibinger Advance Internal Midface Distraction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: JEY Dated: January 3, 2014 Received: January 6, 2014
Dear Mr. Badarpura:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2 - Mr. Badarpura
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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K121235
Device Name: The Leibinger Advance Internal Midface Distraction System
Indications for Use:
The Leibinger Advance Internal Midface Distraction System is indicated for the treatment of syndromic and non-syndromic craniosynostosis, midface retrusion, congenital midfacial hypoplasia, and craniofacial dysostosis in patients two years of age and older.
Over-The-Counter Use Prescription Use X 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)
Mary S. Runner -S 2014.01.09 09:32:37:02:00,
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