(192 days)
Not Found
No
The description focuses on mechanical components and their function in stabilizing fractures, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to "stabilize and provide treatment for fractures of the maxillofacial area," indicating a therapeutic purpose.
No
The device is described as an external fixator intended to stabilize and treat fractures, not to diagnose them.
No
The device description explicitly lists physical components such as clamps, screws, wires, and rods, which are hardware.
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 and Intended Use: The description and intended use of the Mandible External Fixator clearly indicate it is a surgical device used to physically stabilize and treat fractures of the jawbone. It is implanted or applied externally to the body to provide structural support.
- Lack of Biological Sample Testing: There is no mention of this device being used to analyze biological samples or perform any kind of diagnostic test on bodily fluids or tissues.
Therefore, based on the provided information, the Mandible External Fixator is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Product codes
MON, MQN
Device Description
The Mandible External Fixator consists of the following components: Adjustable Parallel Pin Clamp; Adjustable Clamp; 2.5mm/4.0mm Schanz Screws; 2.0 mm K-wires; 2.5 mm K-wires;; 4.0 mm Pre-bent Titanium Rods; and 4.0 mm Carbon Fiber Rods. The rods and Schanz screws are available in various lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillofacial area, mandibular
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
Non-clinical testing to support MR Conditional labeling include assessments of magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts.
The non-clinical performance data demonstrate that the Mandible External Fixator, when used in the MR environment using specified MR parameters and uses, is not adversely affected by magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts.
Clinical testing was not necessary.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 28, 2015
Synthes USA Products, LLC Ms. Susan Lewandowski Project Leader, Regulatory Affairs - SMF 1302 Wrights Lane West Chester, PA 19380
Re: K143285
Trade/Device Name: Mandible External Fixator - MR Conditional Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MON Dated: April 28, 2015 Received: April 29, 2015
Dear Ms. Lewandowski:
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.
1
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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143285
Device Name Mandible External Fixator - MR Conditional
Indications for Use (Describe)
The Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular icon to the left of the word "SYNTHES" in bold, black letters. There is a horizontal line underneath the word "SYNTHES". The icon appears to be a stylized representation of a person.
K143285
510(k) Summary
| Date Prepared: | April 28, 2015 |
|---|---|
| Submitter: | Synthes USA Products, LLC |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| United States of America | |
| Contact: | Susan Lewandowski |
| Lewandowski.susan@synthes.com | |
| Telephone: 610-719-5852 | |
| Facsimile: 484-356-9682 | |
| Device Name: | Mandible External Fixator - MR Conditional |
Device Classification Information:
| Product Code | Device Name | Device Class | Regulation Number | Regulation Description |
|---|---|---|---|---|
| MQN | External Mandibular | |||
| Fixator and/or | ||||
| Distractor | 2 | 21 CFR | ||
| 872.4760 | Bone Plate |
Predicate Devices:
Indications for Use:
The Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Device Description:
The Mandible External Fixator consists of the following components: Adjustable Parallel Pin Clamp; Adjustable Clamp; 2.5mm/4.0mm Schanz Screws; 2.0 mm K-wires; 2.5 mm K-wires;; 4.0 mm Pre-bent Titanium Rods; and 4.0 mm Carbon Fiber Rods. The rods and Schanz screws are available in various lengths.
4
Comparison to Predicate Devices:
Indications
The Mandible External Fixator has the same Indications for Use as the predicate devices.
Technological Similarities and Difference of Mandible External Fixator to the Predicates
- The predicate devices are the same as the devices included within this submission: . components have not changed since their respective original clearances
- The difference between the subject devices and the predicate devices is the addition of MR Conditional scanning information to the labeling
Non-clinical performance data:
Non-clinical testing to support MR Conditional labeling include assessments of magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts.
The non-clinical performance data demonstrate that the Mandible External Fixator, when used in the MR environment using specified MR parameters and uses, is not adversely affected by magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts.
Clinical performance data:
Clinical testing was not necessary.
Substantial Equivalence:
The proposed devices have the same intended use as the predicate devices. The nonclinical testing included in this submission demonstrates that the Mandible External Fixator, when used in the MR environment using specified MR parameters and uses, is not adversely affected by magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts.
It is concluded that the information included in this submission supports substantial equivalence.