(136 days)
No
The summary describes patient-specific plates designed based on imaging data and a software workflow, but there is no mention of AI or ML being used in the design process or any other aspect of the device or its associated software. The focus is on additive manufacturing and a validated software workflow.
Yes
The device is intended for stabilizing maxillofacial fractures and reconstruction, which are therapeutic interventions.
No
The device is a plating system for surgical fixation and reconstruction, not for identifying a medical condition or disease.
No
The device description explicitly states the device includes additively manufactured patient-specific plates, which are hardware components. While there is a software workflow mentioned, the core device is a physical implant system.
Based on the provided text, the Stryker Facial iD Plating System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a plating system intended for surgical procedures involving osteotomy, stabilization of fractures, and reconstruction of maxillofacial anatomy. It is an implantable device used in vivo (within the body) during surgery.
- Lack of Mention of Samples or Testing: There is no mention of the device being used to analyze biological samples or perform diagnostic tests.
Therefore, the Stryker Facial iD Plating System is a surgical implant/device, not an IVD.
N/A
Intended Use / Indications for Use
The Stryker Facial iD Plating System is intented for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).
Specific Indications for Use:
-Orthognathic surgery
-Reconstructive maxillofacial surgery
-Mandible and maxillofacial trauma surgery.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The Stryker Facial iD Plating 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 orthognathic surgery, reconstructive maxillofacial surgery, and mandible and maxillofacial trauma surgery.
The Subject Device plate(s) are additively manufactured patient-specific plates, and the patient-specific design of the plates allows certain features to be configured to meet the individual needs of each patient. The Subject Device plate(s) are provided with a printed version of the surgeon-approved Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Model. Additionally, the Subject Device is compatible with a separately provided Marking / Cutting Guide accessory.
The Facial iD Plating Systems contains the following applications and design options:
- Plate Material: Commercially pure titanium
- Type of design: Patient specific
- Ranges of shapes: Straight, L-plate, Y-plate, Interconnected combinations of the above.
- Range of length: 20 mm maximum bar length
- Midface applications (Orthognathics, Trauma and Reconstruction)
- Screw systems: 1.7 mm, 2.0 mm MP
- Plate profile height: 0.8 mm – 1.5 mm
- Bar widths: 2.5 mm – 4.5 mm
- Mandible applications (Orthognathics and Trauma)
- Screw systems: 2.0 mm, 2.0 mm MP
- Plate profile height: 1.2 mm – 1.7 mm
- Bar widths: 3.0 mm – 7.25 mm
- Chin applications (Orthognathics)
- Screw systems: 1.7 mm, 2.0 mm MP
- Plate profile height: 0.8 mm – 1.7 mm
- Bar widths: 2.5 mm – 4.5 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and CBCT
Anatomical Site
Maxillofacial
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilization:
- Standard: ISO 17665-1, ISO 14937
- Results: The results of the steam sterilization validation show that the implants, accessories and models can be sterilized to a SAL of 10E-6 using the recommended steam sterilization instructions.
Biocompatibility:
- Standard: FDA guidance “Use of International Standard ISO- 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process”, issued June 16, 2016
- Tests:
- Cytotoxicity (DIN EN ISO 10993-5): Test results indicated no cytotoxic effect.
- Sensitization and Intra-cutaneous reactivity (ISO 10993-10): in compliance with requirements of the ISO 10993-10 guidelines.
- Systemic toxicity (ISO 10993-11): in compliance with requirements of the ISO 10993-11 guidelines.
- Assessment of allowable limits for leachable substances (ISO 10993-17): - no toxicological concern remains - further biological testing are considered not justified.
- Chemical characterization (ISO 10993-18): chemical characterization as per report.
Mechanical:
- Standard: ASTM F382, ASTM STP 731
- Results: Test results indicated the subject device have higher static bending strength and has non-inferior fatigue bending properties compared to the reference device.
Cleaning Validation:
- Standard: ANSI/AAMI TRI 30, ASTM E2314
- Results: Test results indicated that the subject device is safe to be cleaned as per the recommended cleaning instructions.
Transportation Validation:
- Standard: ASTM D642, ASTM F1886M
- Results: Test results indicated that the subject device is safe to be shipped as per the recommended shipping instruction.
Compatibility Testing:
- Standard: Combination of user need validation lab and engineering rationale
- Results: The subject device is compatible with the Stryker Universal fixation system.
Performance Bench Testing: Mechanical strength testing was performed on the Subject Device plate(s). The Subject Device met all pre-defined acceptance criteria, and the results of the tests support the substantial equivalence of the Subject Device to the Predicate Device, and to the reference devices.
Software output validation: An output validation of the entire software workflow including data transfer, imaging (CT and CBCT), bone model generation, plate design and additive manufacturing data preparation is included within this submission. The Subject Device met all pre-defined acceptance criteria, and the results of the validation support the substantial equivalence of the Subject Device to the Predicate Device, and to the reference devices.
Animal Testing: Not required.
Clinical Testing: Not required.
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.
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
§ 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 Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 7, 2018
Stryker Zainab Amini Regulatory Affairs Specialist 750 Trade Centre Way - Suite 200 Portage, Michigan 49002
Re: K182305
Trade/Device Name: Stryker Facial iD Plating System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: December 6, 2018 Received: December 10, 2018
Dear Zainab Amini:
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. 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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mary S. Mary S. Runner -S Runner -S3 Date: 2019.01.07
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K182305
Device Name Stryker Facial iD Plating System
Indications for Use (Describe)
The Stryker Facial iD Plating System is intented for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).
Specific Indications for Use:
-Orthognathic surgery
-Reconstructive maxillofacial surgery
-Mandible and maxillofacial trauma surgery.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
K182305
510(k) Summary
4
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 Zainab Amini Regulatory Affairs Specialist Person: Stryker Craniomaxillofacial 750 Trade Centre Way
Portage, MI 49002 Phone: 269-389-8349 Fax: 877-648-7114
- January 3rd, 2019 Date prepared:
- DEVICE II.
- Trade Name: Stryker Facial iD Plating System
- Common or Usual Bone Plating System name: Classification Bone Plate; 21 CFR §872.4760 name:
- Regulatory Class: Class II
- Product Code: JEY
III. PREDICATE DEVICE
Primary Predicate: K170272, TruMatch CMF Titanium 3D Printed Implant System.
5
SUBJECT DEVICE DESCRIPTION IV.
The Stryker Facial iD Plating 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 orthognathic surgery, reconstructive maxillofacial surgery, and mandible and maxillofacial trauma surgery.
The Subject Device plate(s) are additively manufactured patient-specific plates, and the patientspecific design of the plates allows certain features to be configured to meet the individual needs of each patient. The Subject Device plate(s) are provided with a printed version of the surgeonapproved Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Model. Additionally, the Subject Device is compatible with a separately provided Marking / Cutting Guide accessory.
| Application independent envelope attributes | |
|---|---|
| Plate Material | Commercially pure titanium |
| Type of design | Patient specific |
| Ranges of shapes | Straight, L-plate, Y-plate, Interconnected combinations of the |
| above. | |
| Range of length | 20 mm maximum bar length |
| Midface applications (Orthognathics, Trauma and Reconstruction) | |
| Screw systems | 1.7 mm, 2.0 mm MP |
| Plate profile height | 0.8 mm – 1.5 mm |
| Bar widths | 2.5 mm – 4.5 mm |
| Mandible applications (Orthognathics and Trauma) | |
| Screw systems | 2.0 mm, 2.0 mm MP |
| Plate profile height | 1.2 mm – 1.7 mm |
| Bar widths | 3.0 mm – 7.25 mm |
| Chin applications (Orthognathics) | |
| Screw systems | 1.7 mm, 2.0 mm MP |
| Plate profile height | 0.8 mm – 1.7 mm |
| Bar widths | 2.5 mm – 4.5 mm |
The Facial iD Plating Systems contains the following applications and design options:
6
V. Reference Devices:
K022185, Stryker Universal CMF System
The Stryker Universal CMF System is intended for osteotomy, stabilization, and rigid fixation of craniomaxillofacial fractures and reconstruction. The Universal CMF System consists of an implant module for the respective anatomical and indicated areas with each containing various screw, and plate versions and shapes. These plates can be modified with bending instruments, such as cutters and benders, for an anatomical fit. The plates are attached to the bone with screws from the Stryker Universal CMF System. The Stryker Universal CMF System was cleared in K022185 and serves as the Reference Device for the Subject Device, as the Subject Device performance testing is in comparison to this Reference Device to make a substantial equivalence determination.
K132519, Stryker Customized Mandible Recon Plate Kit
The CMRP Kit (CMRP) is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions and is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction. The CMRP was cleared in K132519 and serves as a similar cleared Reference Device as well, which shows a similar implant design software and design process, shows implant compatibility with the anatomical model, and the utilization of customized marking / cutting and drill Guides which are similar to those offered for use with the Subject Device Stryker Facial iD Plating System.
7
| TABLE 1: COMPARISON OF INDICATIONS FOR USE | ||
|---|---|---|
| Subject Device | Predicate Device | |
| The Stryker Facial iD Plating System is | ||
| intended for osteotomy, stabilization and | ||
| rigid fixation of maxillofacial fractures | ||
| and reconstruction in adults and | ||
| adolescents (age 12 and higher). | The TruMatch CMF Titanium 3D | |
| Printed Implant System is intended | ||
| for bone repositioning, fixation and | ||
| reconstruction of the maxillofacial | ||
| skeleton, midface, mandible and chin | ||
| in adolescents (greater than 12 to 21 | ||
| years of age) and adults. | ||
| Indications for Use | Specific Indications for Use: | Specific Indications for Use: |
| -Orthognathic surgery | -Orthognathic surgery | |
| -Reconstructive maxillofacial surgery | -Reconstructive mandible and | |
| maxillofacial surgery | ||
| -Mandible and maxillofacial trauma | ||
| surgery. | -Mandible and maxillofacial trauma | |
| surgery. |
VI. INDICATIONS FOR USE
The overall Intended Uses of the Subject Device and Predicate Device are identical. The specific Indications for Use of the Subject Device and Predicate Device is similar, however, the slight difference in Indication for Use between the Subject Device and the Predicate Device does not constitute a new intended use, and does not raise any questions of safety and effectiveness. Therefore, substantial equivalence is shown between the Subject Device and Predicate Devices.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Subject Device is compared to the Predicate Device for substantial equivalence of technological characteristics based on the following criteria:
- A. Principle of Operation
- B. Technological Characteristics
A. Principle of Operation
The operating principle for the Subject Device is to reconstruct, stabilize and/or provide rigid fixation in the maxillofacial anatomy.
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B. Technological Characteristics
The fixation method, material, non-sterilization method, patient-specific offering, plate design including the guides and accessories are similar when comparing the Subject and Predicate Device. While the operating principle, fixation method, materility and sterilization method (minus the additive manufacturing and patient-specific designs for the Reference Device, K022185) are identical when comparing the Subject and Stryker Universal CMF Reference Device. The Subject Device performance testing was done in comparison to the Reference Device to demonstrate substantial equivalence.
| Feature | Subject Device | Primary Predicate Device -
TruMatch System | Explanation of
Differences |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Principle of Operation | The principle of operation for
the Subject Device is to
reconstruct, stabilize and/or
provide rigid fixation in the
maxillofacial anatomy. | The principle of operation for
the Predicate Device is to
reconstruct, stabilize and/or
provide rigid fixation in the
maxillofacial anatomy. | Similar |
| Fixation Method | Stryker Universal CMF
Screw Systems | Synthes Screw System | Similar |
| Material | commercially pure titanium | commercially pure titanium | Similar |
| Manufacturing Method | Additive | Additive | Similar |
| Sterilization Method | Moist Heat | Moist Heat | Similar |
| Provided Sterile | No | No | Similar |
| Patient-Specific
Configuration | Yes | Yes | Similar |
Table 12-2: Technological Characteristics Comparison
Reference Devices: K022185 (Stryker Universal CMF System) serves as a Reference Device for performance testing comparison to the Subject Device. K132519 (Stryker Customized Mandible Recon Plate Kit (CMRP)) serves as a Reference Device to the Subject Device for the implant design software and design process, implant compatibility with the anatomical models, and the utilization of the customized marking/cutting and drilling Guides.
VIII. PERFORMANCE DATA
The following performance tests were performed in support of the substantial equivalence determination:
510(k) Summary K182305 - Stryker
9
Table 2: This table provides a summary of the testing in comparison to the Reference Devices and non-clinical performance testing.
| Performance Testing Overview and Applicable Standards | ||
|---|---|---|
| Test | Standard (testing method) | Results |
| Sterilization | ISO 17665-1 - Sterilization of health care | |
| products - Moist heat - Part 1: | ||
| Requirements for the development, | ||
| validation and routine control of a | ||
| sterilization process for medical devices | ||
| ISO 14937 -Medical devices - | ||
| Sterilization of health care products - | ||
| General requirements for characterization | ||
| of a sterilization agent and the | ||
| development, validation and routine | ||
| control of a sterilization process for | ||
| medical devise. | The results of the steam | |
| sterilization validation | ||
| show that the implants, | ||
| accessories and models | ||
| can be sterilized to a SAL of | ||
| 10E-6 using the | ||
| recommended steam | ||
| sterilization instructions | ||
| Biocompatibility | FDA guidance “Use of International Standard ISO- 10993-1, "Biological | |
| Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk | ||
| management process”, issued June 16, 2016 | ||
| Cytotoxicity | ||
| DIN EN ISO 10993-5 – Biological | ||
| evaluation of medical devices - Part 5: | ||
| Tests for in vitro cytotoxicity | Test results indicated no | |
| cytotoxic effect. | ||
| Sensitization and Intra-cutaneous | ||
| reactivity | ||
| ISO 10993-10: Tests for irritation and | ||
| delayed type | ||
| hypersensitivity – Kligman Maximization | ||
| test | in compliance with | |
| requirements of the ISO | ||
| 10993-10 guidelines | ||
| Systemic toxicity | ||
| ISO 10993-11: Tests for systemic toxicity | ||
| Systemic injection test | in compliance with | |
| requirements of the ISO | ||
| 10993-11 guidelines | ||
| Assessment of allowable limits for | ||
| leachable substances | ||
| ISO 10993-17 (2009) “Biological | - no toxicological concern | |
| remains |
- further biological testing are
considered not
justified |
| | medical devices — Part 17: Establishment
of
allowable limits for leachable substances”
Chemical characterization | chemical characterization as per report |
| | ISO 10993-18 - Biological evaluation of
medical devices - Part 18: Chemical
characterization of materials | |
| Mechanical | ASTM F382 – Standard specifications
and test method for metallic bone plates | Test results indicated the
subject device have higher
static bending strength and
has non-inferior fatigue
bending properties compared
to the reference device. |
| | ASTM STP 731 - Tables for estimating
median fatigue limit | |
| Cleaning
Validation | ANSI/AAMI TRI 30 - A compendium of
processes, materials, test methods, and
acceptance criteria for cleaning reusable
medical devices | Test results indicated that the
subject device is safe to be
cleaned as per the
recommended cleaning
instructions. |
| | ASTM E2314 - Standard Test Method for
Determination of Effectiveness of
Cleaning Processes for Reusable Medical
Instruments Using a Microbiologic
Method (Simulated Use Test) | |
| Transportation
Validation | ASTM D642 - Standard Test Method for
Determining Compressive Resistance of
Shipping Containers, Components, and
Unit Loads | Test results indicated that the
subject device is safe to be
shipped as per the
recommended shipping
instruction. |
| | ASTM F1886M - Standard Test Method
for Determining Integrity of Seals for
Flexible Packaging by Visual Inspection | |
| Compatibility
Testing | Combination of user need
validation lab and engineering
rationale | The subject device is
compatible
with the Stryker Universal
fixation system. |
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Performance Bench Testing
As stated above, mechanical strength testing was performed on the Subject Device plate(s). The mechanical strength testing results are included within this submission. The Subject Device met all pre-defined acceptance criteria, and the results of the tests support the substantial equivalence of the Subject Device to the Predicate Device, and to the reference devices
11
Software output validation
An output validation of the entire software workflow including data transfer, imaging (CT and CBCT), bone model generation, plate design and additive manufacturing data preparation is included within this submission. The Subject Device met all pre-defined acceptance criteria, and the results of the validation support the substantial equivalence of the Subject Device to the Predicate Device, and to the reference devices.
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.
IX. CONCLUSIONS
The results of the performance tests demonstrate that the Subject Device 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 of the Subject Device to the Predicate Device, and to the reference devices.