(109 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and physical form of the mesh, with no mention of AI or ML technologies.
No.
The MatrixNEURO Preformed Mesh is an implantable device used for fixation of cranial bones during surgical procedures; it does not directly treat or alleviate a disease or condition in a therapeutic manner.
No
Explanation: The device is a preformed mesh implant made of titanium, intended for fixation of cranial bones during surgical procedures like reconstruction and fracture repair. It is a structural implant, not a device used to gather or analyze medical information to diagnose a condition.
No
The device description explicitly states it consists of bone fixation implants made from titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "bone fixation implant" made of titanium, designed to be used with screws. This is a physical implant used in surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not fit that description.
The information clearly indicates this is a surgical implant used for structural support within the body, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.
Product codes
GWO
Device Description
The MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The proposed MatrixNEURO Preformed Meshes are precontoured to cover common cranial defects manufactured from grade 2 titanium that are designed for use with MatrixNEURO Cranial Plating System screws. The Preformed Meshes are offered sterile packed and are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial 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
Non-clinical testing and analyses comparing the proposed devices to the predicate include:
- Load at 2 mm of displacement .
- . Max Load.between 0 and 2 mm displacement
- . Stiffness at 2 mm of displacement
The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO Preformed Mesh is comparable to that of the predicate.
Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. A registered trademark symbol is located to the right of the word.
Special510(k) Summary
Page 1 of 2
| Date Prepared | February 20, 2014 | JUN 1 3 2014 |
|---|---|---|
| Submitter | Synthes (USA) | |
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| United States of America | ||
| Contact | Alan T. Haley | |
| haley.alan@synthes.com | ||
| 484.356.9763 (voice) | ||
| 484.356.9682 (fax) | ||
| Device Name | MatrixNEURO Preformed Mesh | |
| (part of the MatrixNEURO Cranial Plating System) |
Device Classification Information
| Product
Code | Device Name | Device
Class | Regulation
Number | Regulation Description |
|-----------------|----------------------------------------------|-----------------|----------------------|-------------------------------------------|
| GWO | Plate, Cranioplasty,
Preformed, Alterable | 2 | 882.5320 | Preformed alterable
cranioplasty plate |
Predicate Devices
Synthes MatrixNEURO Cranial Plating System (K123723)
Indications for Use
MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.
Device Description
The MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The proposed MatrixNEURO Preformed Meshes are precontoured to cover common cranial defects manufactured from grade 2 titanium that are designed for use with MatrixNEURO Cranial Plating System screws. The Preformed Meshes are offered sterile packed and are intended for single use only.
1
Image /page/1/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. To the right of the word is a small circle with an R inside, indicating a registered trademark. The word and logo are placed on a white background.
5 510(k) Summary (continued)
Comparison to Predicate Devices
Indications
The indications for proposed preformed meshes are identical to the predicate device.
Technological similarities between the predicate MatrixNEURO Reconstruction Mesh and the proposed MatrixNEURO Preformed Mesh:
- Same principles of operation metallic implants for the fixation of bone. .
- . Same thickness as the predicate.
- . Same mesh pattern (hourglass) as the predicate.
- Same bar width as the predicate.
- Same screw recess type (single-sided) as the predicate .
- Same screw recess inner and outer diameter as the predicate and therefore compatible with . same screws.
- . Same strength-based color coding gradient as the predicate.
- . Same material as the predicate.
- Both the proposed device and the predicate are provided sterile-packed. .
Technological differences between the predicate MatrixNEURO Reconstruction Mesh and the proposed MatrixNEURO Preformed Mesh:
- The proposed devices are precontoured to cover common cranial defects and may be further . contoured by the surgeon as necessary to fit the needs of each patient. The predicate device is
- provided flat and may be contoured by the surgeon as necessary to fit the needs of each of ﺘ patient.
Non-clinical performance data
Non-clinical testing and analyses comparing the proposed devices to the predicate include:
- Load at 2 mm of displacement .
- . Max Load.between 0 and 2 mm displacement
- . Stiffness at 2 mm of displacement
The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO Preformed Mesh is comparable to that of the predicate.
Clinical performance data
Clinical testing was not necessary for the determination of substantial equivalence.
Substantial Equivalence
The proposed devices have the same intended use as the predicate devices. The non-clinical performance data discussed in this submission demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the predicate devices. It is concluded that the information included in this submission supports substantial equivalence.
(end of summary)
Synthes MatrixNEURO Cranial Plating System
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure embracing a globe, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 13, 2014
Synthes (USA) Products, LLC Mr. Alan Haley Senior Regulatory Affairs Specialist 1301 Goshen Pkwy. West Chester, PA 19380
K140462 Re:
Trade/Device Name: MatrixNEURO Preformed Mesh Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO Dated: May 5, 2014 Received: May 16, 2014
Dear Mr. Haley:
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.
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
3
Page 2 - Mr. Alan Haley
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" (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 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,
່າ:
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K140462
Device Name
MatrixNEURO Preformed Mesh (part of the MatrixNEURO Cranial Plating System)
Indications for Use (Describe)
MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Pena -S
5
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