(229 days)
No
The description focuses on the customization of implants based on patient CT data and traditional manufacturing processes, with no mention of AI or ML for design, analysis, or other functions.
Yes
The device is a surgical implant intended for reconstruction, repair, augmentation, or restoration of contour, which directly addresses a medical condition or deformity.
No
The device is an implant used for reconstruction, augmentation, or repair of the craniofacial skeleton, not for diagnosing conditions. It uses patient CT data for customization but does not provide a diagnosis.
No
The device is a physical implant manufactured from high-density polyethylene resin, not solely software. While it uses CT imaging data and software for customization, the final product is a tangible medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The OmniPore® Customized Surgical Implants are described as physical implants made of high-density polyethylene intended for surgical reconstruction and augmentation of the craniofacial skeleton. They are implanted directly into the patient's body.
- Lack of Specimen Analysis: The device does not involve the analysis of any biological specimens taken from the patient. While it uses CT imaging data of the patient to create the implant, it doesn't analyze the patient's tissues, fluids, or other biological samples.
The device is a surgical implant, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
OmniPore® Customized Surgical Implants are intended for non-weight bearing applications of craniofacial reconstruction/ cosmetic surgery and repair of craniofacial trauma. OmniPore Customized Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.
Product codes
KKY
Device Description
The OmniPore® Customized Surgical Implants are marketed as single patient use sterile implants that physicians request as customized surgical implants which use identical materials and manufacturing to the OmniPore® Surgical Implants but are made to a predetermined patient's measurements and size requirements. The applications include non-load bearing augmentation and/or reconstruction of the craniofacial skeleton. The OmniPore Customized Surgical Implants are created from the patient's CT imaging data provided from the physician. The OmniPore Customized Surgical Implants are manufactured from the same material, manufactured under the same processes, and packaged the same as the OmniPore Surgical Implants.
The raw material used for the OmniPore Customized Surgical Implants is high-density polyethylene resin which has a long history of use in surgical implantable products. The interconnecting open pore structure of the OmniPore Customized Surgical Implants allow for tissue in-growth. Additionally, animal histology has shown fibrovascular in-growth occurs into the open pore structure of OmniPore Customized Surgical Implants.
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
patient's CT imaging data
Anatomical Site
craniofacial skeleton
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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® Customized Surgical Implant materials are equivalent materials as the previously cleared OmniPore Surgical Implant devices so the biocompatibility and sterilization validation to validate that they are sterile devices for implantation was justified from the predicate testing. The OmniPore Customized Surgical Implants are equivalent materials as the previously cleared OmniPore Surgical Implant devices so the mechanical testing specific to impact testing, purity testing per USP, and porosity testing was justified from the OmniPore Surgical Implant device testing. The software verification testing documentation for the OmniPore Customized Surgical Implants was provided to justify equivalence against the MEDPOR® Customized Surgical Implant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, connected by flowing lines that resemble ribbons or streams. The profiles are silhouetted and layered, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 14, 2014
Matrix Surgical Holdings, LLC/Matrix Surgical USA % Regulatory Resources Group, Inc. Julie Stephens 111 Laurel Ridge Drive Alpharetta, Georgia 30004
Re: K133046
Trade/Device Name: OmniPore® Customized Surgical Implants Regulation Number: 21 CFR 878.3500 Regulatory Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: Class II Product Code: KKY Dated: April 08, 2014 Received: April 09, 2014
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
1
device-related 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/Resourcesfor You/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 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,
David Krause -S
- for Binita Ashar, MD, MBA, FACS Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
cc: DMC 510(k) Staff Division D.O.
2
Indications for Use
510(k) Number (if known):
Device Name: OmniPore® Customized Surgical Implants
Indications for Use:
OmniPore® Customized Surgical Implants are intended for non-weight bearing applications of craniofacial reconstruction/ cosmetic surgery and repair of craniofacial trauma. OmniPore Customized Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.
X Prescription Use (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)
Peter E. Hudson -S
Page 1 of 1
3
Matrix Surqical USA Traditional 510(k) - OmniPore® Customized Surgical Implants
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 Holdings, LLC / Matrix Surgical USA
575 14th Street, NW
Atlanta, GA 30318
Phone: (404) 862-3794
Fax: (404) 869-8208 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Stephens, President/Consultant
Regulatory Resources Group, Inc. |
May 12, 2014 - Revised Date Submitted:
Device Name and Classification:
| Trade/Proprietary Name: | OmniPore® Customized Surgical Implants |
|---|---|
| Common Name: | Surgical Implants, Cranial and Facial |
| Classification Name: | Polytetrafluoroethylene with carbon fibers |
| composite implant material | |
| Product Code: | KKY |
Legally Marketed Predicate Device:
Matrix Surgical USA - OmniPore® Surgical Implants - 510(k) # K123908 POREX Surgical Inc. (now owned by Stryker® Craniomaxillofacial) - MEDPOR® Customized Surgical Implant - 510(k) # K083621
Device Description:
The OmniPore® Customized Surgical Implants are marketed as single patient use sterile implants that physicians request as customized surgical implants which use identical materials and manufacturing to the OmniPore® Surgical Implants but are made to a predetermined patient's measurements and size requirements. The applications include non-load bearing augmentation and/or reconstruction of the craniofacial skeleton. The OmniPore Customized Surgical Implants are created from the patient's CT imaging data provided from the physician. The OmniPore Customized Surgical Implants are manufactured from the same material, manufactured under the same processes, and packaged the same as the OmniPore Surgical Implants.
The raw material used for the OmniPore Customized Surgical Implants is high-density polyethylene resin which has a long history of use in surgical implantable products. The interconnecting open pore structure of the OmniPore Customized Surgical Implants allow for tissue in-growth. Additionally, animal histology has shown fibrovascular in-growth occurs into the open pore structure of OmniPore Customized Surgical Implants.
The implants are single use and provided sterile by ethylene oxide (EO) terminal sterilization.
4
Matrix Surqical USA Traditional 510(k) - OmniPore® Customized Surgical Implants
510(k) SUMMARY
Indications for Use:
OmniPore® Customized Surgical Implants are intended for non-weight bearing applications of craniofacial reconstruction/ cosmetic surgery and repair of craniofacial trauma. OmniPore Customized 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, sterilization facilities, performance standards, and indications for use are used with the OmniPore Customized Surgical Implants as with the OmniPore Surgical Implants.
Differences
There are slight differences in the Omnized Surgical Implants when compared against the MEDPOR predicate specific to manufacturing and sterilization facility locations.
Summary of Testing:
The OmniPore® Customized Surgical Implant materials are equivalent materials as the previously cleared OmniPore Surgical Implant devices so the biocompatibility and sterilization validation to validate that they are sterile devices for implantation was justified from the predicate testing. The OmniPore Customized Surgical Implants are equivalent materials as the previously cleared OmniPore Surgical Implant devices so the mechanical testing specific to impact testing, purity testing per USP, and porosity testing was justified from the OmniPore Surgical Implant device testing. The software verification testing documentation for the OmniPore Customized Surgical Implants was provided to justify equivalence against the MEDPOR® Customized Surgical Implant.
Substantial Equivalence Conclusions:
The OmniPore® Customized 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 anv issues of safety or effectiveness. Testing results support the determination of substantial equivalence with the results demonstrating that the OmniPore Customized Surgical Implants have equivalent results as the predicate devices.