(145 days)
No
The summary describes a patient-specific surgical implant designed based on surgeon input and CT scan data, manufactured from porous polyethylene. There is no mention of AI or ML being used in the design process or the device's function. The software mentioned is for design and uses internal control systems similar to the predicate device.
No
The device is an implant for craniofacial reconstruction and cosmetic surgery, not a device that applies therapy.
No
The device is an implant used for reconstruction and augmentation, not for diagnosing medical conditions.
No
The device description clearly states the device is a physical implant made of high-density porous polyethylene, provided as a kit with a back-up implant and an optional template. While software is mentioned for the design process, the device itself is a physical implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- SU-POR Device Function: The SU-POR Patient-Specific Surgical Implant is a physical implant designed to be surgically placed within the patient's body for reconstruction, repair, or augmentation of the craniofacial skeleton. It does not analyze biological specimens.
- Intended Use: The intended use clearly describes a surgical implant for structural purposes, not for diagnostic testing of samples.
Therefore, based on the provided information, the SU-POR Patient-Specific Surgical Implant is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SU-POR Patient-Specific Surgical Implant in Customized shapes to meet the needs of Individual patients are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. SU-POR Patient-Specific Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillifacial skeleton.
Product codes
FWP
Device Description
The SU-POR Patient-Specific Surgical Implant is provided as a kit of two identical implants, one of which serves as a back-up implant. The SU-POR Patient-Specific Surgical Implant also provides the surgeon an option of a non-sterile non-implantable template made of the same high-density porous polyethylene to be utilized by the surgeon to assist in modifying the implant prior to placement. The SU-POR Patient-Specific Surgical Implant is manufactured from high-density porous polyethylene to fit the individual needs of a patient based on design input identified by the surgeon. The interconnecting porous structure of the material allows for host tissue ingrowth. The SU-POR Patient-Specific Surgical Implant may be fixed into place using surgical plates and screws. The SU-POR Patient-Specific Surgical Implant is provided as a single-use sterile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan data
Anatomical Site
craniofacial, craniomaxillifacial skeleton
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
Bench Testing: SU-POR Patient-Specific Surgical Implant designs are created from information provided by the surgeon that is individualized for a specific patient. The design is verified and validated according to Poriferous' procedures for product design and development. There is no functionality or performance change in comparison specifically to the cleared predicate SU-POR Surgical Implants - K140437. Additional bench testing is not required as a basis of substantial equivalence.
Biocompatibility Testing: There is no change in the material, duration, or location of contact or sterilization method from the cleared predicate SU-POR Surgical Implants - K140437. Therefore, biocompatibility was not required as a basis for substantial equivalence.
Software Verification and Validation Testing: The Su-PoR Patient-Specific Implant does not directly contain software or have an electronic user interface. Software is used only in the design process for SU-Por Patient-Specific Surgical Implants. The manufacturing process does not incorporate the use of software. The same internal control systems in place for the cleared predicate SU-POR Surgical Implants - K140437 remain the same.
Animal Testing: Animal testing was conducted by Poriferous for the cleared predicate SU-POR Surgical Implants -K140437. There is no additional required animal testing as a basis for substantial equivalence.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
Poriferous LLC Mr. Jerri L. Mann Chief Regulatory Officer 535 Pine Road, Suite 206 Newnan, Georgia 30263
Re: K152463
Trade/Device Name: SU-POR Patient-Specific Surgical Implant Regulation Number: 21 CFR 878.3550 Regulation Name: Chin prosthesis Regulatory Class: Class II Product Code: FWP Dated: December 15, 2015 Received: December 21, 2015
Dear Mr. Mann:
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
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152463
Device Name SU-POR Patient-Specific Surgical Implant
Indications for Use (Describe)
SU-POR Patient-Specific Surgical Implant in Customized shapes to meet the needs of Individual patients are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. SU-POR Patient-Specific Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillifacial skeleton.
Type of Use (Select one or both, as applicable)
2 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)
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510(k) Summary
This 510(k) summary of safety and effectiveness information has been prepared and is being submitted in accordance with the requirements under 21CFR 807.92.
SUBMITTER
| 510(k) Owner: | Poriferous, LLC
535 Pine Road, Suite 206
Newnan, Georgia 30263-7640
Phone: (770) 683-3855
Fax: (770) 683-7459 |
| --------------- | --------------------------------------------------------------------------------------------------------------------------- |
|---|
| Submitter: | Jerri L Mann |
|---|---|
| Chief Regulatory Officer | |
| Poriferous, LLC |
- Date Prepared: July 6, 2015
DEVICE
| 510(k) Number: | |
|---|---|
| Trade Name: | SU-POR Patient-Specific Surgical Implant |
| Common Name: | Prosthesis, chin, internal |
| Classification Name: | Chin prosthesis (21CFR 878.3550) |
| Regulatory Class: | Class II |
| Product Code: | FWP |
PREDICATE DEVICES
Stryker CMF MEDPOR® Customized Implant - K143173 SU-POR Surgical Implants - K140437
DEVICE DESCRIPTION
The SU-POR Patient-Specific Surgical Implant is provided as a kit of two identical implants, one of which serves as a back-up implant. The SU-POR Patient-Specific Surgical Implant also provides the surgeon an option of a non-sterile non-implantable template made of the same high-density porous polyethylene to be utilized by the surgeon to assist in modifying the implant prior to placement. The SU-POR Patient-Specific Surgical Implant is manufactured from high-density porous polyethylene to fit the individual needs of a patient based on design input identified by the surgeon. The interconnecting porous structure of the material
4
allows for host tissue ingrowth. The SU-POR Patient-Specific Surgical Implant may be fixed into place using surgical plates and screws. The SU-POR Patient-Specific Surgical Implant is provided as a single-use sterile device.
INDICATIONS FOR USE
SU-POR Patient-Specific Surgical Implants in customized shapes to meet the needs of individual patients are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. SU-POR Patient-Specific Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillifacial skeleton.
TECHNOLOGICAL AND OPERATIONAL CHARACTERISTICS
SU-POR Patient-Specific Surgical Implants are developed utilizing individual patient data provided by the surgeon via various means including CT scan data, a physical model, drawing, or other dimension and design information. A member of Poriferous' engineering team works one-on-one with the surgeon to create a design to meet the individual needs of a specific patient.
SIMILARITIES AND DIFFERENCES TO PREDICATE DEVICES
The following table provides an overview comparison of SU-POR Patient-Specific Implants to Stryker CMF MEDPOR® Customized Implants and SU-POR Surgical Implants:
| | PROPOSED
DEVICE | PREDICATE #
1 | PREDICATE #
2 |
|---------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| DEVICE NAME | SU-POR
Patient-Specific
Surgical
Implant | SU-POR
Surgical
Implants | Stryker CMF
MEDPOR®
Customized
Implants |
| 510(k) NUMBER | | K140437 | K143173 |
| MATERIAL | Porous high-
density
polyethylene
(HDPE) | Porous high-
density
polyethylene
(HDPE) | Porous high-
density
polyethylene
(HDPE) |
| DESIGN | Patient-specific
shapes based
on precise
design
dimensions
indicated by
the surgeon via
various | Pre-formed
shapes,
including
sheets, blocks,
spheres, and
anatomical
shapes | Specific
reconstruction
boundaries
indicated by
the surgeon
vial submission
of CT scans |
5
| | methods
including CT
scan data, a
physical model,
drawing or
other
dimension and
design
information | | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------|
| STERILITY | Sterile | Sterile | Sterile |
| STERILIZATION
METHOD | EtO | EtO | EtO |
| PACKAGING | Double Tyvek
Pouch | Double Tyvek
Pouch | Double Tyvek
Pouch |
| BICOMPATIBLE | Yes | Yes | Yes |
| REUSABLE | No | No | No |
PERFORMANCE DATA
SU-POR Patient-Specific Surgical Implant designs are created from information provided by the surgeon that is individualized for a specific patient. The design is verified and validated according to Poriferous' procedures for product design and development.
Biocompatibility Testing
There is no change in the material, duration, or location of contact or sterilization method from the cleared predicate SU-POR Surgical Implants - K140437. Therefore, biocompatibility was not required as a basis for substantial equivalence.
Performance Bench Testing
There is no functionality or performance change in comparison specifically to the cleared predicate SU-POR Surgical Implants - K140437. Additional bench testing is not required as a basis of substantial equivalence.
Software Verification and Validation Testing
The Su-PoR Patient-Specific Implant does not directly contain software or have an electronic user interface. Software is used only in the design process for SU-Por Patient-Specific Surgical Implants. The manufacturing process does not incorporate the use of software. The same internal control systems in place for the cleared predicate SU-POR Surgical Implants - K140437 remain the same.
6
Animal Testing
Animal testing was conducted by Poriferous for the cleared predicate SU-POR Surgical Implants -K140437. There is no additional required animal testing as a basis for substantial equivalence.
Clinical Testing
Clinical testing was not required as a basis for substantial equivalence.
Conclusions
Based on the historical data and the information provided in this submission, SU-Por Patient-Specific Surgical Implants will perform when used as intended. The comparison of SU-POR Patient-Specific Surgical Implants to SU-POR Surgical Implants and Stryker CMF MEDPOR Customized Implants, based on the requirements of 21 CFR 807.87 and the information provided herein, demonstrates substantial equivalence and does not raise any new issues of safety or effectiveness.