(255 days)
No
The device description and performance studies focus on the material properties and physical characteristics of the implant, with no mention of AI or ML for analysis, planning, or any other function.
Yes
The device is described as a surgical implant intended for reconstruction and repair, which are therapeutic applications.
No
Explanation: The device description states that the product is a "surgical implant" intended for "non-weight bearing applications of maxillofacial and orbital reconstruction, cosmetic surgery and repair of maxillofacial and orbital trauma." Surgical implants are therapeutic devices, not diagnostic devices.
No
The device description clearly states it is a physical surgical implant made of porous high-density polyethylene and titanium. It is a tangible product intended for implantation, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the OmniPore DUROMAX Surgical Implants are for "non-weight bearing applications of maxillofacial and orbital reconstruction, cosmetic surgery and repair of maxillofacial and orbital trauma." This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The description details the materials (porous high-density polyethylene and titanium), the physical characteristics (interconnecting open pore structure, ability to hold shape), and how it's used (single use sterile implants). This aligns with the description of a surgical implant.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens in vitro.
The mention of CT scans is for post-operative imaging to visualize the implant's position, not for diagnostic testing of bodily fluids or tissues.
Therefore, the OmniPore DUROMAX Surgical Implant is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
OmniPore® DUROMAX® Surgical Implants are intended for non-weight bearing applications of maxillofacial and orbital reconstruction, cosmetic surgery and repair of maxillofacial and orbital trauma.
Product codes
JEY
Device Description
The OmniPore DUROMAX Surgical Implants are an extension within the family of OmniPore Surgical Implants. OmniPore DUROMAX Surgical Implants include the addition of pure titanium within the porous high-density polyethylene. They are marketed as single use sterile implants with various sizes.
The material used for the OmniPore DUROMAX Surgical Implants is a porous high-density (HD) polyethylene. Polyethylene has a long history of use in surgical implantable products. The interconnecting open pore structure of the implants allow for tissue ingrowth. Both of the materials used to manufacture the OmniPore DUROMAX Surgical Implants, the porous HD polyethylene and pure titanium, have been utilized in reconstruction and soft tissue repair for many years. There is a long history of the use of porous polyethylene and titanium implants for enucleation and evisceration, as well as for reconstruction/cosmetic surgery and repair of the orbital skeletal framework, including orbital floors, walls, rims and roof, with a history of safety and performance. The interconnecting open pore structure of the OmniPore DUROMAX Surgical Implants allow for tissue ingrowth. Additionally, animal histology has shown fibrovascular ingrowth occurs into the open pore structure of porous surgical implants. The other advantage to the OmniPore DUROMAX Surgical Implants is that the titanium structure can be curved or rounded and will hold that shape in the internal orbital skeletal framework. The titanium material contained in OmniPore DUROMAX Surgical Implant is also radiopaque on post-operative CT (computed tomography) scans. The implants are single use and provided sterile by ethylene oxide (EO) terminal sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT (computed tomography) scans
Anatomical Site
maxillofacial and orbital, orbital skeletal framework, orbital floors, walls, rims and roof
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility risk assessment was completed as directed by FDA quidance under ISO 10993-1 and Parts 5, 10, and 11 biocompatibility requirements. Cytotoxicity, Irritation, and Material-Mediated Pyrogenicity testing was completed to demonstrate and support justification that the known biocompatible materials, HDPE reviewed under OmniPore Surgical Implants 510(k) # 123908, and the addition of pure titanium per ASTM F67 and ISO 5832-2 standards maintained compliance through manufacturing and sterilization for the final implants. Compliance was justified for the OmniPore DUROMAX Surgical Implants against previous sterilization validation per ISO 11135 with Sterility Assurance Level (SAL) at 108 and EO Residuals requirements per ISO 10993-7 were met. The OmniPore DUROMAX Surgical Implants are non-pyrogenic per USP 161, USP 85, and USP 151. Compliance was justified aqainst previous five (5) year shelf life testing and previous mechanical testing specific to impact testing per ASTM D5420, purity testing per USP 661, porosity and ingrowth testing per ASTM D4284 to the OmniPore Surgical Implants. Additional bench testing including bend, trim/cut, globe support, and fixation was completed to demonstrate that the addition of the titanium material supports substantial equivalence for the OmniPore DURÓMAX Surgical Implants [proposed device] to the OmniPore Surgical Implants [reference predicate device].
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Matrix Surgical Holdings, LLC/Matrix Surgical USA John O'Shaughnessy President/CEO
October 11, 2018
4025 Welcome All Road - Suite 120 Atlanta, GA 30349
Re: K180249
Trade/Device Name: OmniPore® DUROMAX® Surgical Implants Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: October 10, 2018 Received: September 13, 2018
Dear Julie Stephens:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S3
For Tina Kiang, Ph.D. Acting 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) K180249
Device Name OmniPore® DUROMAX® Surgical Implants
Indications for Use (Describe)
OmniPore® DUROMAX® Surgical Implants are intended for non-weight bearing applications of maxillofacial and orbital reconstruction, cosmetic surgery and repair of maxillofacial and orbital trauma.
Type of Use (Select one or both, as applicable)
| Repetitive Use (Part 21 CFR 321 Subpart B) |
|---|
| One-Time Contact Use (21 CFR 361.1) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Matrix Surgical USA Traditional 510(k) K180249 - OmniPore® DUROMAX® Surgical Implants
510(k) Summarv
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.
| Submitted By: | Matrix Surgical Holdings, LLC dba Matrix Surgical USA
4025 Welcome All Road - Suite 120
Atlanta, GA 30349
Phone: (404) 869-3794 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Stephens, President/Consultant
Regulatory Resources Group, Inc.
Phone: (678) 513-0693 |
| Date Submitted: | REVISED - October 10, 2018 |
Device Name and Classification:
| Trade/Proprietary Name: | OmniPore® DUROMAX® Surgical Implants |
|---|---|
| Common Name: | Bone Plate |
| Classification Name: | Bone Plate |
| Regulation: | 21 CFR 872.4760 |
| Class: | II |
| Product Code: | JEY |
Legally Marketed Predicate Devices:
Predicate: Synthes USA New Sterile Orbital Plates - 510(k) # K031761 Reference: OmniPore® Surgical Implants - 510(k) # K123908 Synthes [SynPOR] Porous Polyethylene Implants - 510(k) # K051879
Device Description:
The OmniPore DUROMAX Surgical Implants are an extension within the family of OmniPore Surgical Implants. OmniPore DUROMAX Surgical Implants include the addition of pure titanium within the porous high-density polyethylene. They are marketed as single use sterile implants with various sizes.
The material used for the OmniPore DUROMAX Surgical Implants is a porous high-density (HD) polyethylene. Polyethylene has a long history of use in surgical implantable products. The interconnecting open pore structure of the implants allow for tissue ingrowth. Both of the materials used to manufacture the OmniPore DUROMAX Surgical Implants, the porous HD polyethylene and pure titanium, have been utilized in reconstruction and soft tissue repair for many years. There is a long history of the use of porous polyethylene and titanium implants for enucleation and evisceration, as well as for reconstruction/cosmetic surgery and repair of the orbital skeletal framework, including orbital floors, walls, rims and roof, with a history of safety and performance. The interconnecting open pore structure of the OmniPore DUROMAX Surgical Implants allow for tissue ingrowth. Additionally, animal histology has shown fibrovascular ingrowth occurs into the open pore structure of porous surgical implants. The other advantage to the OmniPore DUROMAX Surgical Implants is that the titanium structure can be curved or rounded and will hold that shape in the internal orbital skeletal framework. The titanium material contained in OmniPore DUROMAX Surgical Implant is also radiopaque
4
Matrix Surqical USA Traditional 510(k) K180249 - OmniPore® DUROMAX® Surgical Implants
510(k) Summarv
on post-operative CT (computed tomography) scans. The implants are single use and provided sterile by ethylene oxide (EO) terminal sterilization.
Indications for Use:
OmniPore® DUROMAX® Surgical Implants are intended for non-weight bearing applications of maxillofacial and orbital reconstruction, cosmetic surgery and repair of maxillofacial and orbital trauma.
| Predicate Device
510(k) #: K031761 | Reference Predicate Device
510(k) #: K123908 | Reference Predicate Device
510(k) #: K051879 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Synthes USA New / Sterile
Orbital Plates | OmniPore® Surgical Implants | Synthes [SynPOR] Porous
Polyethylene Implants |
| The Synthes Craniofacial
Plates are intended for use
in selective trauma of the
midface and craniofacial
skeleton; craniofacial
surgery; reconstructive
procedures; and selective
orthognathic surgery of the
maxilla and chin. | OmniPore Surgical Implants in block,
sheet, and anatomical shapes are
intended for non-weight bearing
applications of craniofacial
reconstruction/cosmetic surgery and
repair of craniofacial trauma.
OmniPore Surgical Implants are also
intended for the augmentation or
restoration of contour in the
craniomaxillofacial skeleton. | Synthes Porous
Polyethylene implants are
intended for use in non-load
bearing applications in
craniofacial reconstruction,
cosmetic surgery, and repair
of craniofacial trauma. |
Comparison of Indications of Use to the Predicate Devices
The Indications for Use statement for OmniPore DUROMAX are equivalent to the predicate and reference predicate devices except for the difference of anatomical locations. This 510(k) submission includes the OmniPore DUROMAX Surgical Implants as a subset of the OmniPore Surgical Implants and are currently specific to "maxillofacial and orbital" anatomical locations and the Synthes 510(k)s, predicate and reference, included implants that were indicated for the cranial locations.
Technological Characteristics:
Comparison of Technological Characteristics to the Predicate Devices
The OmniPore DUROMAX Surgical Implants and the predicate devices have the same principles of operation to reconstruct the orbital floor and/or medial wall. The OmniPore DUROMAX Surgical Implants and the Synthes [SynPOR] Implants use the same materials, pure titanium embedded within porous high-density polyethylene. The Synthes Orbital plates include only pure titanium and the OmniPore Surgical Implants include only porous highdensity polyethylene. The dimensions of the implants are similar. The proposed and predicate implants can all be trimmed and shaped to fit specific curvature and shapes of the individual patient's anatomy. The proposed and predicate implants can all be used with the same fixation methods such as suture, wire, and/or fixation screws. Synthes recommends using the fixation screws they market and OmniPore recommends 1.5 mm titanium screws marketed by Biomet within their Facial and Neuro plate systems cleared under 510(k) # K121589 and # K121624. The proposed and predicate implants are permanent implants, provided sterile, single patient use only, and have non-pyrogenic claims. See Comparison Table on next page.
5
Matrix Surgical USA Traditional 510(k) K180249 - OmniPore® DUROMAX® Surgical Implants
510(k) Summarv
Comparison of Technological Characteristics to the Predicate Devices (Continued)
| Proposed Device
510(k) #: K180249 | Predicate Device
510(k) #: K031761 | Reference Predicate
Device
510(k) #: K123908 | Reference Predicate
Device
510(k) #: K051879 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| OmniPore DUROMAX
Surgical Implants | Synthes USA New /
Sterile Orbital Plates | OmniPore® Surgical
Implants | Synthes [SynPOR]
Porous Polyethylene
Implants |
| Anatomical Locations:
Implants for orbital or maxillofacial skeleton | | Anatomical Locations:
Implants for craniofacial skeleton which includes
orbital and maxillofacial skeleton | |
| Materials:
• HDPE
• Pure titanium | Materials:
• Pure titanium | Materials:
• HDPE | Materials:
• HDPE
• Pure titanium |
| Dimensions:
Titanium Material: Thickness - 0.2, 0.3 and 0.4 mm
HDPE Material: Thickness - 0.8, 1.0, 1.5, and 1.6 mm; Height (over Titanium) - 35 to 38 mm
Implant: Height - 43 to 50 mm; Width - 43 to 79 mm | | | |
| Fixation Methods:
For use with sutures,
K-wire, or 1.5 mm
titanium screws | Fixation Methods:
For use with 1.0 mm
or 1.3 mm titanium
screws | Fixation Methods:
For use with sutures,
K-wire, or surgical
fixation screws | Fixation Methods:
Compatible with 1.3
mm titanium screws |
Summary of Testing:
The biocompatibility risk assessment was completed as directed by FDA quidance under ISO 10993-1 and Parts 5, 10, and 11 biocompatibility requirements. Cytotoxicity, Irritation, and Material-Mediated Pyrogenicity testing was completed to demonstrate and support justification that the known biocompatible materials, HDPE reviewed under OmniPore Surgical Implants 510(k) # 123908, and the addition of pure titanium per ASTM F67 and ISO 5832-2 standards maintained compliance through manufacturing and sterilization for the final implants. Compliance was iustified for the OmniPore DUROMAX Surgical Implants against previous sterilization validation per ISO 11135 with Sterility Assurance Level (SAL) at 108 and EO Residuals requirements per ISO 10993-7 were met. The OmniPore DUROMAX Surgical Implants are non-pyrogenic per USP , USP , and USP . Compliance was justified aqainst previous five (5) year shelf life testing and previous mechanical testing specific to impact testing per ASTM D5420, purity testing per USP , porosity and ingrowth testing per ASTM D4284 to the OmniPore Surgical Implants. Additional bench testing including bend, trim/cut, globe support, and fixation was completed to demonstrate that the addition of the titanium material supports substantial equivalence for the OmniPore DURÓMAX Surgical Implants [proposed device] to the OmniPore Surgical Implants [reference predicate device].
Substantial Equivalence Conclusions:
The OmniPore DUROMAX Surgical Implants [proposed device] have the same principles of operation, an anatomical subpart of the general Indications for Use, and technological characteristics as the predicate devices.
The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21CFR 807, Subpat E under which a device can be market without premarket approval or reclassification. A determination of substantial equivalence under this notification is not intended to nor does it have any bearing whatsoever on the resolution of patent infringement or any other patent matters. No statements related to or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.