(65 days)
Not Found
No
The device description details a mechanical distraction device with no mention of AI/ML components or functions.
Yes
Explanation: The device is intended to lengthen the mandibular bone for patients with conditions like mandibular micrognathia or hemifacial microsomia, which are medical conditions that the device treats.
No
The device is described as an "intraoral distraction device" intended for "mandibular bone lengthener." Its function is to apply tension to an osteotomy site to lengthen the mandible, which is a therapeutic rather than diagnostic action. It treats conditions like mandibular micrognathia or hemifacial microsomia, but it does not diagnose them.
No
The device description clearly outlines physical components (threaded self drilling fixation pins, mandibular distraction frame, distraction rod and key) that are implanted and used to mechanically lengthen bone. This is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states this device is an "intraoral distraction device" used as a "mandibular bone lengthener." It is a physical device implanted to mechanically lengthen bone.
- Intended Use: The intended use is for treating conditions like mandibular micrognathia or hemifacial microsomia through "mandibular distraction osteogenesis," which is a surgical procedure.
- Components: The components (pins, frame, rod, key) are all mechanical parts used for surgical intervention, not for analyzing biological samples.
The device is a surgical implant used for a therapeutic purpose, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
It is intended for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia.
Product codes
Not Found
Device Description
The device consists of three major components: the threaded self drilling fixation pins, the mandibular distraction frame and the distraction rod and key. The pins attach the frame to the mandible. The distraction rod attaches to the frame and is rotated via the key to apply tension to the frame and osteotomy site. Directions regarding distraction are given to the patient by the physician. Frames are available for up to 18 mm or 28 mm of distraction depending upon the condition of the mandible. All components of this device are for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
K945674, 1945500, K914558, K962272
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K96464/9
JAN 2 4 1997
510(k) Summary
| Device Proprietary Name: | Vazquez-Diner Intraoral Distraction Device |
|---|---|
| Device Common Name: | Mandibular Bone Distractor |
| Classification Name: | Smooth or metallic bone fixation fastener |
| 21 CFR 888 3040 | |
| Name of Submitter: | Howmedica Leibinger Inc. |
| Contact Person: | Kristyn R. Waski |
| Product Engineer, Special Projects | |
| Howmedica Leibinger Inc. | |
| 14540 Beltwood Pkwy. East | |
| Dallas, TX 75244 | |
| Telephone: | (972) 392-3636 x266 |
| Fax: | (972) 392-7258 |
| Date Prepared: | November 19, 1996 |
Summary:
This submission describes an intraoral distraction device. It is intended for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia. The device consists of three major components: the threaded self drilling fixation pins, the mandibular distraction frame and the distraction rod and key. The pins attach the frame to the mandible. The distraction rod attaches to the frame and is rotated via the key to apply tension to the frame and osteotomy site. Directions regarding distraction are given to the patient by the physician. Frames are available for up to 18 mm or 28 mm of distraction depending upon the condition of the mandible. All components of this device are for single use.
Equivalence for this device is based on similarities in intended use. material, design and operational principle to the Howmedica Mandibular Bone Lengthener (K945674). the Wells Johnson Fixation System (1945500), the Synthes Mini Lengthening Apparatus (K914558) and the Synthes Mandible Distractor (K962272). Each of these devices is intended for use as a mandibular bone lengthener and is manufactured from stainless steel. The designs are equivalent in that they include distraction frames which are attached to the mandible by means of fixation pins on either side of the osteotomy. The Howmedica Mandibular Bone Lengthener. the Wells Johnson Fixation System and the Synthes Mini Lengthening Apparatus are each external fixation systems while the Vazquez-Diner Intraoral Distraction Device and the Synthes Mandible Distractor are intraoral/subcutaneous fixation systems. The basic operational principle of distraction osteogenesis through controlled tensioning of the device construct and osteotomy site is similar for each of these devices