(235 days)
No
The device description and performance studies focus on the material properties, physical design, and biocompatibility of the implant. While the design is based on anatomical data, there is no indication of AI/ML being used for image processing, diagnosis, or treatment planning. The device is a pre-formed implant, not a software or system that utilizes AI/ML algorithms.
Yes
The device is indicated for reconstructive treatment of orbital floor and/or medial wall trauma or bone excision, which is a therapeutic purpose.
No
This is a reconstructive implant, not a diagnostic device.
No
The device description clearly states the device is comprised of a pre-bent titanium mesh embedded within a porous polyethylene sheet, indicating it is a physical implant, not software.
Based on the provided information, the MEDPOR TITAN® 3D Orbital Floor Implant is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The MEDPOR TITAN® 3D Orbital Floor Implant is a physical implant designed to reconstruct the orbital floor and/or medial wall after trauma or bone excision. It is surgically implanted into the patient's body.
- Intended Use: The intended use is for reconstructive treatment, not for analyzing biological samples.
The device is a medical device, specifically an implantable device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MEDPOR TITAN® 3D Orbital Floor Implant is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The MEDPOR TITAN® 3D Orbital Floor Implants are comprised of a pre-bent titanium mesh embedded within a MEDPOR porous polyethylene sheet. The porous side allows tissue ingrowth while a nonporous Barrier sheet on the orbit facing side does not allow tissue ingrowth. The pre-bent shape approximates the shape and dimensions of the average normal orbital floor and medial wall (in order to facilitate the operative goal of restoring normal [pre-traumatic] orbital volume as accurately as possible). The pre-bent MEDPOR titanium plates are available in a small (L=32mm W=35mm, H=13mm) and a large size (L=36mm, W=37mm, H=17mm) along with left and right configurations. The implants can be trimmed and contoured to fit the specific needs of the patient.
The implants are designed based on an average anatomical model of CT-scan data taken from 300 subjects (92% Caucasian). The metadata of the 300 subjects that have been included in the generation of the average anatomical model is listed in Table 1. The selected scans were obtained from healthy subjects without any deformation of the bony orbital structures.
The associated accessories include the following previously cleared devices:
- Adjustable-width globe retractor
- Plate holding forceps
- -Stryker screws and accessories
The Subject device will be provided sterile, and is intended for single use only. The plate holding forceps and adjustable-width globe retractor are provided non-sterile and are reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT-scan data
Anatomical Site
orbital floor and/or medial wall trauma or bone excision
Indicated Patient Age Range
15 years of age and older.
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)
Biocompatibility Testing
The biocompatibility evaluation for the MEDPOR TITAN 3D Orbital Floor was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing included cytotoxicity testing.
The cytotoxicity testing was performed using DIN EN 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. The tests supported the biocompatibility of the device.
Performance Bench Testing
The following performance bench tests were completed.
- Transportation testing
- End user testing
- Packaging assessment
- Bending assessment
- Trimming assessment
- Stability test (globe support)
- -Sharp edge test
The Subject device met all pre-defined acceptance criteria and, in tests where it was compared to either the predicate or reference device, was found to not represent a new worst case. Overall, the results of the performance bench tests support the substantial equivalence of the Subject device.
Animal Testing
Animal testing was not required as a basis for substantial equivalence.
Clinical Testing
Clinical testing was not required as a basis for substantial equivalence.
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.
Stryker Universal Orbital Floor System - K133461
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.
MEDPOR Craniofacial Implants with Embedded Titanium Mesh – K040364
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.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol representing the human form, composed of three abstract figures facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2015
Stryker Ms. Julie Schoell M.S., RAC Staff Regulatory Affairs Specialist 750 Trade Centre Way - Suite 200 Portage, Michigan 49009
Re: K142568
Trade/Device Name: Stryker MEDPOR TITAN 3D Orbital Floor Implant Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: April 10, 2015 Received: April 13, 2015
Dear Ms. Schoell:
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.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/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 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,
Tina
Kiang-S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142568
Device Name Stryker MEDPOR TITAN® 3D Orbital Floor Implant
Indications for Use (Describe)
The MEDPOR TITAN® 3D Orbital Floor Implant is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older.
Type of Use (Select one or both, as applicable)
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Section 5. 510(k) Summary – K142568
This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
- l. SUBMITTER
| 510(k) Owner: | Stryker Leibinger GmbH& Co. KG
Boetzinger Strasse 41
D-79111 Freiburg, Germany |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/
Contact Person: | Julie Schoell, M.S., RAC
Staff Regulatory Affairs Specialist
Stryker Craniomaxillofacial
750 Trade Centre Way
Portage, MI 49002
Phone: 269-389-3419
Fax: 877-648-7114 |
| Registration
Number: | 8010177 |
| Date prepared: | April 29, 2015 |
| II. DEVICE | |
| Trade Name: | Stryker MEDPOR TITAN® 3D Orbital Floor Implant |
| Common or Usual
name: | Plate, Bone |
| Classification
name: | Bone Plate (21 CFR 872.4760) |
| Regulatory Class: | Class II |
| Product Code: | JEY |
III. PREDICATE DEVICE
Predicate Device: Stryker Universal Orbital Floor System - K133461
Reference Device: MEDPOR Craniofacial Implants with Embedded Titanium Mesh – K040364
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IV. DEVICE DESCRIPTION
The MEDPOR TITAN® 3D Orbital Floor Implants are comprised of a pre-bent titanium mesh embedded within a MEDPOR porous polyethylene sheet. The porous side allows tissue ingrowth while a nonporous Barrier sheet on the orbit facing side does not allow tissue ingrowth. The pre-bent shape approximates the shape and dimensions of the average normal orbital floor and medial wall (in order to facilitate the operative goal of restoring normal [pre-traumatic] orbital volume as accurately as possible). The pre-bent MEDPOR titanium plates are available in a small (L=32mm W=35mm, H=13mm) and a large size (L=36mm, W=37mm, H=17mm) along with left and right configurations. The implants can be trimmed and contoured to fit the specific needs of the patient.
The implants are designed based on an average anatomical model of CT-scan data taken from 300 subjects (92% Caucasian). The metadata of the 300 subjects that have been included in the generation of the average anatomical model is listed in Table 1. The selected scans were obtained from healthy subjects without any deformation of the bony orbital structures.
| Age [years] | Gender | Ethnic | |||
|---|---|---|---|---|---|
| 10-19 | 18 | f | 122 | ca | 276 |
| 20-29 | 19 | m | 178 | me | 3 |
| 30-39 | 20 | xx | 21 | ||
| 40-49 | 28 | ||||
| 50-59 | 36 | ||||
| 60-69 | 56 | ||||
| 70-79 | 72 | ||||
| 80-89 | 44 | ||||
| 90-99 | 6 |
TABLE 1: META DATA OF THE 300 CT SCANS
Age: 297 scans: age 15-95, 1 scan: age 14, 1 scan: unknown; average age: 59 years:
Gender: 122 female (f) and 178 male (m);
Ethnic Group: 276 Caucasians (ca), 3 Middle-East (me), 21 unknown (xx)
The associated accessories include the following previously cleared devices:
- Adjustable-width globe retractor -
- Plate holding forceps -
- -Stryker screws and accessories
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The Subject device will be provided sterile, and is intended for single use only. The plate holding forceps and adjustable-width globe retractor are provided non-sterile and are reusable.
INDICATIONS FOR USE V.
The MEDPOR TITAN® 3D Orbital Floor Implant is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older.
| | Subject Device | Predicate Device -
K133461 | Reference Device -
K040364 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The MEDPOR
TITAN® 3D Orbital
Floor Implant is
indicated for the
reconstructive
treatment of orbital
floor and/or medial
wall trauma or bone
excision in patients
15 years of age and
older. | The Stryker Universal
Orbital Floor System
is indicated for the
reconstructive
treatment of orbital
floor and/or medial
wall trauma or bone
excision in patients 15
years of age and
older. | MEDPOR Biomaterial
with Embedded
Titanium Mesh
Implants are intended
for non-weight bearing
applications of
craniofacial
reconstruction/cosmetic
surgery and repair of
craniofacial trauma. |
TABLE 2: COMPARISON OF INDICATIONS FOR USE
The Indications for Use statement for the MEDPOR TITAN 3D Orbital Floor Implant is identical to the predicate device Stryker Universal Orbital Floor System.
The Indications for Use statement for the MEDPOR TITAN 3D Orbital Floor Implant is not identical to the reference device MEDPOR Craniofacial Implants with Embedded Titanium Mesh Implants; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. The MEDPOR Craniofacial Implants with Embedded Titanium Mesh are indicated for a use in a range of anatomic areas for a variety of surgical applications. The Indications for use of the MEDPOR TITAN 3D Orbital Floor Implant falls within the scope of the broader Indications for Use statement of the reference device. The difference in the Indications statement for the proposed device in comparison to the reference device does not constitute a new intended use. Both the subject and predicate device have
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the same intended use for the reconstruction of the floor and/or medial wall of the orbit.
A review of the literature was performed to identify relevant clinical literature to represent applicable data on the performance of the Stryker MEDPOR TITAN 3D Orbital Floor Implant in the use of the orbital floor. Results of the data demonstrates the absences of unreasonable risk of illness or injury associated with use of the Stryker MEDPOR TITAN 3D Orbital Floor Implant for its intended uses and conditions of use; in this case, in a pediatric sub-population 15 to 21 years of age and for reconstruction of the craniofacial skeleton, of which the orbital floor and/or wall is indicated.
-
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The MEDPOR TITAN 3D Orbital Floor Implant is compared to its predicate devices for substantial equivalence based on the following criteria: -
A. Principle of Operation
-
B. Technological Characteristics
A. Principle of Operation
The basic operational principle of the Subject device, as well as the Predicate device, is to reconstruct the orbital floor and/or medial wall. The fixation method of both the Subject device and the Predicate device is with screws inserted through dedicated screw holes. Both the Subject device as well as the Predicate device can be trimmed and contoured to fit the specific needs of the patient. The Subject device and the Predicate device are permanent implants and have the same craniofacial/orbital area of application.
B. Technological and Operational Characteristics
At a high level, the Subject device and Predicate device are based on the following technological elements:
- -Same operating principle: reconstruct the orbital floor and/or medial wall
- Same mode of fixation: plate fixation with screws inserted through dedicated screw holes
- -Same patient contacting surface: orbital floor and wall
- Same area of contact and contact duration (tissue/bone/greater than 30 days)
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- Similar material: while the MEDPOR Craniofacial Implants with Embedded Titanium Mesh reference device has the same material, the Stryker Universal Orbital Floor System is provided only in titanium.
- Similar design: while the Stryker Universal Orbital Floor System has a pre-bent shape based on the same average anatomical model, the MEDPOR Craniofacial Implants with Embedded Titanium Mesh are provided in a 2D, non-bent shape.
- -Similar sizes and shapes compared to the Predicate device
- The MEDPOR TITAN 3D Orbital Floor Implant is provided sterile. While the MEDPOR Craniofacial Implants with Embedded Titanium Mesh reference device is provided sterile, the Stryker Universal Orbital Floor System is provided non-sterile.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the MEDPOR TITAN 3D Orbital Floor was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing included cytotoxicity testing.
The cytotoxicity testing was performed using DIN EN 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. The tests supported the biocompatibility of the device.
The MEDPOR TITAN 3D Orbital Floor Implant is considered a permanent implant, tissue contacting greater than 30 days. The implant is made from a combination of titanium mesh embedded within a MEDPOR porous polyethylene sheet with a nonporous Barrier on one side, the same as the Predicate devices. The titanium conforms to ASTM F67 for chemical composition. The same manufacturing processes and identical materials are used in the predicate devices and the Subject device.
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Performance Bench Testing
The following performance bench tests were completed.
- Transportation testing -
- End user testing -
- Packaging assessment -
- Bending assessment -
- Trimming assessment -
- Stability test (globe support) -
- -Sharp edge test
The Subject device met all pre-defined acceptance criteria and, in tests where it was compared to either the predicate or reference device, was found to not represent a new worst case. Overall, the results of the performance bench tests support the substantial equivalence of the Subject device.
Animal Testing
Animal testing was not required as a basis for substantial equivalence.
Clinical Testing
Clinical testing was not required as a basis for substantial equivalence.
VIII. CONCLUSIONS
The results of the non-clinical data demonstrate the MEDPOR TITAN 3D Orbital Floor Implants will perform as intended in the specified use conditions. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.