(159 days)
No
The summary describes patient-specific implants designed based on CT scans, but there is no mention of AI or ML being used in the design process or any other aspect of the device or system. The focus is on additive manufacturing and patient-specific design, which can be achieved through traditional CAD/CAM methods.
No.
The Stryker Facial iD System is intended for osteotomy, stabilization, and rigid fixation of maxillofacial fractures and reconstruction. It is explicitly designed for structural support and repair, not for treating or preventing disease or affecting the body's structure or function to cure ailments, which are characteristics of a therapeutic device.
No.
The document states that the device is "intended for osteotomy, stabilization of maxillofacial fractures and reconstruction," which describes a surgical treatment rather than a diagnostic process.
No
The device description explicitly states that the device includes "additively manufactured patient-specific implants," which are hardware components.
Based on the provided information, the Stryker Facial iD System 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 about a person's health. This information is used for diagnosis, monitoring, or screening.
- Stryker Facial iD System's Function: The description clearly states that the Stryker Facial iD System is intended for surgical procedures involving osteotomy, stabilization, and reconstruction of maxillofacial fractures. It involves patient-specific implants that are surgically placed in the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is entirely focused on surgical intervention and providing physical support and reconstruction.
Therefore, the Stryker Facial iD System falls under the category of a surgical implant and related instruments, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Facial iD System is intended for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).
Specific Indications for Use:
- Orbital reconstructive/ trauma surgery
Product codes
JEY
Device Description
The Stryker Facial iD System (Subject Device) is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher), with the specific Indications for Use in orbital reconstructive and/or trauma surgery. The Subject Device is not intended for use in the orbital roof and can only be used if no exposure of the intracranial compartment is presented, and not intended for cranial use.
The Subject Device implants are additively manufactured patient-specific implants, and the patient-specific design of the implants allows certain features to be configured to meet the individual needs of each patient. The Subject Device implants are provided with a Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Additionally, the Subject Device is compatible with a separately provided Model. Customized Surgical Guides, Templates and Anatomical Models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient CT scan
Anatomical Site
maxillofacial anatomy (orbital and surrounding anatomy, excluding the orbital roof); orbital floor area
Indicated Patient Age Range
adults and adolescents (age 12 and higher)
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
Mechanical bench testing:
The Subject Device performance testing was done in comparison to the Reference Devices (K221855) to demonstrate substantial equivalence. All tests have been performed with the corresponding worst-case design considering the entire design envelope and all design features. To demonstrate the mechanical performance a compression test as well as 4-point bending (acc. to ASTM F382) were performed to compare properties of the Subject Device against the previously cleared Reference Device (K221855) implants. The mechanical stability of the Subject Device was determined to be substantially equivalent to the Reference Devices (K221855).
Biocompatibility Testing:
Biocompatibility was evaluated in accordance with ISO 10993-1 and cytotoxicity was evaluated in accordance with DIN EN ISO 10993-5 and DIN EN ISO 10993-12.
Based on the device categorization the respective endpoints for biological evaluation were addressed by testing and/or justifications. The results of biocompatibility testing conclude the Subject Device is biocompatible and meets the requirements of biocompatibility ISO standards.
The results of the cytotoxicity showed that the Subject Device implants demonstrated substantial equivalence with regards to cytotoxicity.
Cleaning & Sterilization:
Cleaning and sterilization testing (acc. to DIN EN ISO 17665-1, ISO 17665-2, ISO 14937) was conducted for the Subject Device and the acceptance criteria were met.
Steam sterilization validations were performed accordance with ISO 17665-2 respectively ISO 14937 to a sterility assurance level (SAL) of 10-6 using the biological indicator (BI) overkill method. All test method acceptance criteria were met.
The end-user test validation of the Subject Device showed that the subject device is performing as intended in the specified use conditions. Therefore, the Subject Device met all pre-defined acceptance criteria, and the results of the performed tests show that no new risks regarding performance testing are raised with the Subject Device.
Animal Testing: Not required.
Clinical Testing: Not required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K193143, K221855, K142568, K173039
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 U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
January 13, 2024
Stryker Craniomaxillofacial Jonathan Schell Sr Staff RA Specialist 1941 Stryker Way Portage, Michigan 49002
Re: K232350
Trade/Device Name: Stryker Facial iD System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: August 04, 2023 Received: December 21, 2023
Dear Jonathan Schell:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia,
2
Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232350
Device Name Stryker Facial iD System
Indications for Use (Describe)
The Stryker Facial iD System is intended for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).
Specific Indications for Use:
- Orbital reconstructive/ trauma surgery
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) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
| X | Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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K232350
510(k) Summary
This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
- I. SUBMITTER
| 510(k) Owner: | Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
D-79111 Freiburg, Germany |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/ Contact Person: | Jonathan Schell, RAC
Sr. Staff Regulatory Affairs Specialist
Stryker Craniomaxillofacial
1941 Stryker Way
Portage, MI, 49002
Phone: 484-889-5804
Fax: 877-648-7114 |
| Date prepared: | January 13, 2024 |
| II. DEVICE | |
| Trade Name: | Stryker Facial iD System |
| Common or Usual
name: | Bone Plating System |
| Classification
name: | Bone Plate; 21 CFR §872.4760 |
| Regulatory Class: | Class II |
| Product Code: | JEY |
III. PREDICATE DEVICE
Predicate Device: K210731, KLS Martin Individual Patient Solutions
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Reference Devices: K193143, Stryker Facial iD Plating System; K221855, Stryker Universal CMF System; K142568 Stryker MEDPOR TITAN 3D Orbital Floor Implant; K173039 TruMatch CMF Titanium 3D Printed Implant
SUBJECT DEVICE DESCRIPTION IV.
The Stryker Facial iD System (Subject Device) is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher), with the specific Indications for Use in orbital reconstructive and/or trauma surgery. The Subject Device is not intended for use in the orbital roof and can only be used if no exposure of the intracranial compartment is presented, and not intended for cranial use.
The Subject Device implants are additively manufactured patient-specific implants, and the patient-specific design of the implants allows certain features to be configured to meet the individual needs of each patient. The Subject Device implants are provided with a Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Additionally, the Subject Device is compatible with a separately provided Model. Customized Surgical Guides, Templates and Anatomical Models.
V. INDICATIONS FOR USE
| Subject Device | Predicate Device | |
|---|---|---|
| K210731 | ||
| Intended | ||
| Use/Indication | ||
| for Use | The Stryker Facial iD System is | |
| intended for osteotomy, | ||
| stabilization and rigid fixation of | ||
| maxillofacial fractures and | ||
| reconstruction in adults and | ||
| adolescents (age 12 and higher). | ||
| Specific Indication for Use: | ||
| Orbital reconstructive / trauma | ||
| surgery | KLS Martin Individual Patient | |
| Solutions (IPS) is intended as a | ||
| pre-operative software tool for | ||
| simulating / evaluating surgical | ||
| treatment options as a software | ||
| and image segmentation system | ||
| for the transfer of imaging | ||
| information from a medical | ||
| scanner such as a CT based | ||
| system. The input data file is | ||
| processed by the IPS software | ||
| and the result is an output data | ||
| file that may then be provided as | ||
| digital models or used as input in | ||
| an additive manufacturing | ||
| portion of the system that | ||
| produces physical outputs |
Table 5- 1: Comparison of Intended Use/Indications For Use.
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| | including implants, anatomical
models, guides, splints, and case
reports for use in maxillofacial,
midface, & mandibular surgery. |
|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | KLS Martin Individual Patient
Solutions (IPS) implant devices
are intended for use in the
stabilization, fixation, and
reconstruction of the
maxillofacial / midface and
mandibular skeletal regions in
children (2 years of age to