(224 days)
Not Found
No
The 510(k) summary describes a passive implant made of porous polyethylene, with no mention of software, algorithms, or any technology that would incorporate AI/ML. The focus is on the material properties, sterilization, and biocompatibility.
No
The device is an implantable surgical material used for reconstruction and augmentation, not for treating a disease or condition.
No
Explanation: The device is described as surgical implants intended for reconstruction and augmentation. It is not used to diagnose a medical condition.
No
The device description clearly states that the device is a physical implant made of porous high-density polyethylene. It is a tangible product intended for surgical implantation, not a software application.
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® Surgical Implants are for surgical implantation in the craniofacial skeleton for reconstruction, cosmetic surgery, and trauma repair. This involves direct interaction with the patient's body.
- Device Description: The description reinforces that these are implants made of porous high-density polyethylene, designed for tissue ingrowth within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. They are used outside the body.
The OmniPore® Surgical Implants are designed to be placed inside the body, which is the opposite of how IVDs function.
N/A
Intended Use / Indications for Use
OmniPore® Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight 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.
Product codes (comma separated list FDA assigned to the subject device)
KKY
Device Description
The OmniPore® Surgical Implants are marketed as single use sterile implants with various shapes and sizes for different areas of the craniofacial skeleton. The applications include non-load bearing augmentation and/or reconstruction of the craniofacial skeleton.
The raw material used for the OmniPore® Surgical Implants is high-density polyethylene when molded into the implants becomes a porous high-density polyethylene. Polyethylene has a long history of use in surgical implantable products. The interconnecting open pore structure of the OmniPore® Surgical Implants allow for tissue in growth. Additionally, Animal histology has shown fibrovascular ingowth occurs into the open pore structure of OmniPore Surgical Implants. The material used to manufacture the OmniPore® Surgical Implants has been utilized in reconstruction and soft tissue repair for many years. There is a long history of the use of porous polyethylene implants for enucleation and evisceration, as well as for many applications in craniofacial reconstruction and augmentation, with a history of safety and performance.
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
Not Found
Anatomical Site
craniofacial skeleton
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 OmniPore Surgical Implants were tested to the biocompatibility standards to demonstrate that they are substantially equivalent materials as the predicate devices in regards to Cytotoxicity, ISO Systemic Toxicity, ISO Intracutaneous Study, USP Pyrogen Study, and ISO Muscle Implantation Study. The OmniPore Surgical Implants completed sterilization validation to validate that they are sterile devices for implantation as equivalent to the predicate devices. The OmniPore Surgical Implants completed mechanical testing specific to impact testing, purity testing per USP, and porosity testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.
0
10f2
Matrix Surgical USA Traditional 510(k) - OmniPore® Surgical Implants
JUL 3 1 2013
510(k) SUMMARY
.
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 USA
575 Pharr Rd NW #550873
Atlanta, GA 30305
Phone: (404) 862-3794
Fax: (404) 869-8208 |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Stephens, President/Consultant |
Date Submitted: July 26, 2013
Device Name and Classification:
| Trade/Proprietary Name: | OmniPore® Surgical Implants |
|---|---|
| Common Name: | Porous HD Polyethylene (HDPE) Implants |
| Classification Name: | Material, porous polymer, for maxillofacial reconstruction |
| Class: | II |
| Regulation: | 21 CFR 878.3500 |
| Product Code: | KKY |
Requlatory Resources Group, Inc.
Legally Marketed Predicate Devices:
POREX Surgical Inc. (now owned by Stryker® Craniomaxillofacial) - MEDPOR® Surgical Implant Material: Preformed Cranial and Facial Implants - 510(k) # K922489
Device Description:
The OmniPore® Surgical Implants are marketed as single use sterile implants with various shapes and sizes for different areas of the craniofacial skeleton. The applications include non-load bearing augmentation and/or reconstruction of the craniofacial skeleton.
The raw material used for the OmniPore® Surgical Implants is high-density polyethylene when molded into the implants becomes a porous high-density polyethylene. Polyethylene has a long history of use in surgical implantable products. The interconnecting open pore structure of the OmniPore® Surgical Implants allow for tissue in growth. Additionally, Animal histology has shown fibrovascular ingowth occurs into the open pore structure of OmniPore Surgical Implants. The material used to manufacture the OmniPore® Surgical Implants has been utilized in reconstruction and soft tissue repair for many years. There is a long history of the use of porous polyethylene implants for enucleation and evisceration, as well as for many applications in craniofacial reconstruction and augmentation, with a history of safety and performance.
The implants are single use and provided sterile by ethylene oxide (EO) terminal sterilization.
1
Matrix Surgical USA Traditional 510(k) - OmniPore® Surgical Implants
510(k) SUMMARY
Indications for Use:
OmniPore® Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight 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.
Similarities and Differences to the Predicate Devices:
Similarities
The same raw materials, manufacturing processes, packaging materials, performance standards, and the same indications for use are used in the OmniPore and the predicate devices.
Differences
There are slight differences in the OmniPore when compared against the predicates specific to manufacturing facility locations.
Summary of Testing:
The OmniPore Surgical Implants were tested to the biocompatibility standards to demonstrate that they are substantially equivalent materials as the predicate devices in regards to Cytotoxicity, ISO Systemic Toxicity, ISO Intracutaneous Study, USP Pyrogen Study, and ISO Muscle Implantation Study. The OmniPore Surgical Implants completed sterilization validation to validate that they are sterile devices for implantation as equivalent to the predicate devices. The OmniPore Surgical Implants completed mechanical testing specific to impact testing, purity testing per USP, and porosity testing.
Substantial Equivalence Conclusions:
The OmniPore® Surgical Implants have the same intended use and indications for use, and the same technological characteristics and principles of operation as the predicate devices. The minor differences do not raise any issues of safety or effectiveness. Testing results support the determination of substantial equivalence with the results demonstrating that the OmniPore Surgical Implants have equivalent results as the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a stylized representation of human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2013
Matrix Surgical USA % Ms. Julie Stephens President/Consultant 111 Laurel Ridge Drive Alpharetta, Georgia 30004
Re: K123908
Trade/Device Name: OmniPore® Surgical Implants Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: Class II Product Code: KKY Dated: July 1, 2013 Received: July 1, 2013
Dear Ms. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Julie Stephens
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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K123908
Device Name: OmniPore® Surgical Implants and Accessories
Indications for Use:
OmniPore® Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123908
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