(192 days)
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.
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.
This document is a 510(k) premarket notification for a medical device called the "Mandible External Fixator - MR Conditional." It focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices, particularly regarding its MRI compatibility.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a formal table of acceptance criteria with specific numerical thresholds for general device performance. Instead, it describes the acceptance criteria implicitly through the non-clinical tests performed for MR Conditional labeling. The "reported device performance" is then stated as successfully meeting the requirements of these tests.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| No adversely affected by magnetically induced displacement force | Mandible External Fixator is not adversely affected |
| No adversely affected by magnetically induced torque | Mandible External Fixator is not adversely affected |
| No adversely affected by radio frequency (RF) heating | Mandible External Fixator is not adversely affected |
| No unacceptable image artifacts in the MR environment | Mandible External Fixator is not adversely affected |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Non-clinical testing to support MR Conditional labeling include assessments of magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts."
- Sample size: The document does not specify the sample size used for these non-clinical tests. It implies that the tests were performed on representative samples of the Mandible External Fixator components.
- Data provenance: The data is non-clinical performance data (laboratory testing) conducted to support the MR Conditional labeling. The country of origin of the data is not explicitly stated, but as the submitter is "Synthes USA Products, LLC" in "West Chester, PA, United States of America," it is likely that the testing was performed in the United States or at facilities supporting their US operations. The data is not retrospective or prospective clinical data as no clinical testing was performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to this submission. The "ground truth" for non-clinical MR Conditional testing is based on established industry standards and regulatory guidance for evaluating the safety of devices in an MRI environment (e.g., ASTM standards for MR safety). It does not involve expert consensus on medical images or clinical outcomes. Therefore, no experts were used to establish ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the evaluation of MR safety testing results does not involve human adjudication in the way clinical diagnostic studies might. The results are typically objectively measured and compared against predefined safety thresholds.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (Mandible External Fixator) and focuses on its material properties and safety in an MRI environment, not on diagnostic image interpretation or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical fixator, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical MR Conditional evaluation is based on established scientific principles, engineering standards (e.g., ASTM F2503 for MR Conditional labeling), and regulatory guidance concerning the interaction of materials with magnetic fields, radiofrequency energy, and their impact on image quality. It's an objective measurement against defined safety limits, not a subjective assessment by medical experts or clinical outcomes data.
8. The sample size for the training set
This question is not applicable. Since no AI algorithm is involved, there is no "training set." The testing performed was non-clinical and focused on the physical device's characteristics.
9. How the ground truth for the training set was established
This question is not applicable as there was no training set since no AI algorithm was developed or evaluated.
{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, LLC1302 Wrights Lane EastWest Chester, PA 19380United States of America |
| Contact: | Susan LewandowskiLewandowski.susan@synthes.comTelephone: 610-719-5852Facsimile: 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 MandibularFixator and/orDistractor | 2 | 21 CFR872.4760 | 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.
§ 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.