(156 days)
Not Found
No
The description focuses on customized implants based on CT data and surgeon input, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an implant for augmenting bony and/or soft tissue deformities, which falls under reconstructive or reparative rather than therapeutic.
No
The device is described as an implant kit for augmentation of bony and/or soft tissue deformities, not for diagnosing conditions.
No
The device description explicitly states it is a "PEEK Customized Cranial Implant Kit" and "provides customized cranial or craniofacial patient specific implants," indicating a physical implant component made of PEEK material, which is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a customized cranial implant used for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton. This is a physical implant placed within the body, not a device used to test samples outside the body.
- Input Data: While it uses CT data for customization, this data is used to design the physical implant, not to perform a diagnostic test on a biological sample.
Therefore, the PEEK Customized Cranial Implant Kit falls under the category of a surgical implant or medical device used for reconstructive purposes, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PEEK Customized Cranial Implant Kit is indicated for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 years of age and older.
Product codes (comma separated list FDA assigned to the subject device)
GWO
Device Description
The Stryker PEEK Customized Cranial Implant (CCI) product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT data
Anatomical Site
cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone)
Indicated Patient Age Range
3.5 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
Biocompatibility and sterility testing of the device is not required as a basis for substantial equivalence. There is no change in the material, duration of contact, or reprocessing methods for the PEEK CCI. As the design and manufacturing processes, materials, and packaging processes are identical for both the Predicate and the Subject Devices.
Performance Bench Testing
Both the Subject and Predicate Devices are designed and manufactured identically. As the Performance Bench testing of the Predicate Device are valid for the Subject Device, and because the performance bench testing of the both devices are identical, an additional performance bench testing was not required for the Subject Device as a basis for substantial equivalence.
Animal Testing
Animal testing was not required as a basis for substantial equivalence.
Clinical Testing
Clinical studies and findings show the potential benefits associated with the use of the device outweigh the potential risks associated with the Subject Device. Clinical studies provided within this submission indicates that the potential benefits for the patient will be greater from the use of the Subject Device when compared to the potential risks. The following table provides the scientific peer-reviewed publications describing the safe and effective application of alloplastic cranioplasties in patient 3.5 years of age and above.
- Nguyen et al. 2018: Report on clinical outcomes following cranioplasty in children with patient-specific PEEK, titanium, and PMMA implants. Follow-up of an average of 30 months. Patient-specific implants provide significant degrees of freedom to the surgeon which bone grafting would not be able to accommodate because of lack of donor availability or sheer complexity of contouring. The authors did not find any indications that the implants pose a problem with the growing skeleton and suggested safety at ages greater than 3 years.
- Rocque et al. 2018: Multicenter study at 13 institutions. Cranioplasty bone resorption is predicted by patient age. Reconstruction with PEEK implants is described in the study.
- Ma et al. 2018: Cranioplasty with autologous bone in 84 cases, 36 split calvarial graft reconstructions, six PEEK implants, 33 titanium meshes. Average follow-up: 4 years. Good symmetry and effective brain protection were achieved.
- Sainsbury et al. 2017: Bilateral malar reconstruction with customized PEEK implants based on CT data. The authors highlight the improved implant-bone surface interface with the customized medical devices.
- Fu et al. 2016: Comparison of clinical outcomes achieved with autologous and alloplastic cranioplasty in pediatric patients. 73% of the included patients received alloplastic implants (PEEK, PMMA, MEDPOR, titanium) while the remaining 28% were treated with autologous reconstructions. Patients were followed-up for up to 9 years. The authors conclude that alloplastic cranioplasty in the pediatric population is a safe alternative, when autologous cranial bone is not available.
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.
Not Found
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
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 11, 2019
Stryker Zainab Amini Regulatory Affairs Specialist 750 Trade Centre Way - Suite 200 Portage, Michigan 49002
Re: K190229
Trade/Device Name: Stryker PEEK Customized Cranial Implant Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO Dated: June 7, 2019 Received: June 10, 2019
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
1
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 devices or postmarketing safety reporting (21 CFR 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 (OS) 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 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,
Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K190229
Device Name
Stryker PEEK Customized Cranial Implant Kit
Indications for Use (Describe)
The PEEK Customized Cranial Implant Kit is indicated for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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3
K190229 stryker
Section 5. 510(k) Summary
This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
SUBMITTER I.
| 510(k) Owner: | Stryker Leibinger GmbH& Co. KG
Boetzinger Strasse 41
D-79111 Freiburg, Germany |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/ Contact
Person: | Zainab Amini
Regulatory Affairs Specialist
Stryker Craniomaxillofacial
750 Trade Centre Way
Portage, MI 49002
Phone: 269-389-8349
Fax: 877-648-7114 |
| Date prepared: | July 10, 2019 |
| II.
DEVICE | |
| Trade Name: | Stryker PEEK Customized Cranial Implant |
| Common or Usual
name: | Customized Cranial Implant |
| Classification
name: | Preformed alterable cranioplasty plate 21 CFR §882.5320 |
| Regulatory Class: | Class II |
| Product Code: | GWO |
PREDICATE DEVICE III.
Predicate: K153248, Stryker PEEK Customized Cranial Implant Kit
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Stryker PEEK Customized Cranial Implant (CCI) product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input.
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V. INDICATIONS FOR USE
The PEEK Customized Cranial Implant Kit is indicated for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 years of age and older.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The PEEK CCI for Children design is compared to its Predicate Device 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 PEEK CCI for Children is that the PEEK Customized Cranial Implant is intended to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial and craniofacial skeleton.
B. Technological and Operational Characteristics
Both the Subject and Predicate Devices have similar technological characteristics, and the operating principle, mode of fixation, and design and manufacturing processes are all identical.
VII. PERFORMANCE DATA
Biocompatibility Testing
Biocompatibility and sterility testing of the device is not required as a basis for substantial equivalence. There is no change in the material, duration of contact, or reprocessing methods for the PEEK CCI. As the design and manufacturing processes, materials, and packaging processes are identical for both the Predicate and the Subject Devices.
Performance Bench Testing
Both the Subject and Predicate Devices are designed and manufactured identically. As the Performance Bench testing of the Predicate Device are valid for the Subject Device, and because the performance bench testing of the both devices are identical, an additional performance bench testing was not required for the Subject Device as a basis for substantial equivalence.
Animal Testing
Animal testing was not required as a basis for substantial equivalence.
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Clinical Testing
Clinical studies and findings show the potential benefits associated with the use of the device outweigh the potential risks associated with the Subject Device. Clinical studies provided within this submission indicates that the potential benefits for the patient will be greater from the use of the Subject Device when compared to the potential risks. The following table provides the scientific peer-reviewed publications describing the safe and effective application of alloplastic cranioplasties in patient 3.5 years of age and above.
| Source | Summary |
|---|---|
| Nguyen et al. | |
| 2018 | Report on clinical outcomes following cranioplasty in |
| children with patient-specific PEEK, titanium, and PMMA | |
| implants. Follow-up of an average of 30 months. Patient- | |
| specific implants provide significant degrees of freedom to | |
| the surgeon which bone grafting would not be able to | |
| accommodate because of lack of donor availability or sheer | |
| complexity of contouring. The authors did not find any | |
| indications that the implants pose a problem with the | |
| growing skeleton and suggested safety at ages greater than | |
| 3 years. | |
| Rocque et al. | |
| 2018 | Multicenter study at 13 institutions. Cranioplasty bone |
| resorption is predicted by patient age. Reconstruction with | |
| PEEK implants is described in the study. | |
| Ma et al. | |
| 2018 | Cranioplasty with autologous bone in 84 cases, 36 split |
| calvarial graft reconstructions, six PEEK implants, 33 | |
| titanium meshes. Average follow-up: 4 years. Good | |
| symmetry and effective brain protection were achieved. | |
| Sainsbury et | |
| al. 2017 | Bilateral malar reconstruction with customized PEEK |
| implants based on CT data. The authors highlight the | |
| improved implant-bone surface interface with | |
| the | |
| customized medical devices. | |
| Fu et al. 2016 | Comparison of clinical outcomes achieved with autologous |
| and alloplastic cranioplasty in pediatric patients. 73% of the | |
| included patients received alloplastic implants (PEEK, | |
| PMMA, MEDPOR, titanium) while the remaining 28% | |
| were treated with autologous reconstructions. Patients were | |
| followed-up for up to 9 years. The authors conclude that | |
| alloplastic cranioplasty in the pediatric population is a safe | |
| alternative, when autologous cranial bone is not available. |
TABLE 1 RELEVANT CLINICAL DATA
Potential Benefits
Potential benefits associated with the Subject Device outweigh the potential risks. Overall, the Subject Device implant offers similar benefits as the Predicate Device because the physical principle of replacing missing bone is identical. However, through investigation it was identified that the Subject Device's targeted age group would have many potential benefits that are of greater importance/magnitude for young patients.
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Potential Risks
The potential risks associated with the device are increasing radiation exposure and growth issues. These risks have been assessed and mitigation is provided within this submission which reduces these potential risks for the patient.
| Potential Hazard | Potential Harm | Risk Mitigation in Labelling | |
|---|---|---|---|
| Growth related risks | Brain compression | ||
| against implant | Pain | ||
| Removal of implant | |||
| Brain/soft tissue injury | |||
| reversible | |||
| Brain/soft tissue injury | |||
| irreversible | IFU contains information | ||
| regarding growth disturbance | |||
| Implant interference | |||
| with growing bone | Poor aesthetics | ||
| resulting in implant | |||
| removal | |||
| Annoyance | IFU contains information | ||
| regarding growth disturbance | |||
| Loosening of | |||
| implant | Neurological symptoms | ||
| requiring surgery | |||
| Temporary neurological | |||
| symptoms | IFU contains information | ||
| regarding growth disturbance | |||
| Radiation related risks | New / additional | ||
| scan for implant | |||
| design required | Radiation induced | ||
| neoplasia |
TABLE 2 POTENTIAL RISKS IDENTIFIED FOR THE SUBJECT DEVICE:
To mitigate the risks, the Instructions for Use (IFU) includes information associated with growth related risks. The IFU and the scan protocol include information to minimize ionizing radiation dose by using low-dose and child-size CT- protocols when appropriate.
CONCLUSIONS
The clinical studies provided within this submission, show the safe and effective use of the patient specific alloplastic implants for the intended patient population. Table 1 provides references and summary of these clinical studies.
A Benefit and Risk Factor analysis was conducted for the Subject Device. Both the potential benefits and risks of the Subject Device are increased when compared to the Predicate Device. However, the overall benefit and risk ratio remains equivalent. The product labeling contains corresponding information regarding the potential risks of growth disturbance and radiation exposure for the intended patient population. Table 2 provides an overview of the risk mitigation measures.
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The safety and effectiveness of both the Subject and Predicate Devices are equivalent. Both devices are designed and manufactured identically, and they both have equivalent Intended Use and Technological Characteristics.
In conclusion, the potential benefits associated with the use of the Subject Device outweigh its potential risks for the patient. 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.
References
- Fu, K. J., Barr, R. M., Kerr, M. L., Shah, M. N., Fletcher, S. A., Sandberg, D. I., ... Greives, M. R. (2016). An outcomes comparison between autologous and alloplastic cranioplasty in the pediatric population. Journal of Craniofacial Surgerv, 27(3), 593-597. https://doi.org/10.1097/SCS.0000000000000000002491
- Ma, I. T., Symon, M. R., Bristol, R. E., Beals, S. P., Joganic, E. F., Adelson, P. D., ... Singh, D. J. (2018). Outcomes of Titanium Mesh Cranioplasty in Pediatric Patients. The Journal of Craniofacial Surgery, 29(1), 99-104. https://doi.org/10.1097/SCS.0000000000000004045
- Nguyen, P. D., Khechoyan, D. Y., Phillips, J. H., & Forrest, C. R. (2018). Custom CAD/CAM implants for complex craniofacial reconstruction in children: Our experience based on 136 cases. Journal of Plastic, Reconstructive and Aesthetic Surgery, 18(30251-1), 1-9. https://doi.org/10.1016/j.bjps.2018.07.016
- Rocque, B. G., Agee, B. S., Thompson, E. M., Piedra, M., Baird, L. C., Selden, N. R., ... Lam, S. K. (2018). Complications following pediatric cranioplasty after decompressive craniectomy: a multicenter retrospective study. Journal of Neurosurgery: Pediatrics, 22(3), 225-232. https://doi.org/10.3171/2018.3.PEDS17234.
- Sainsbury, D. C. G., George, A., Forrest, C. R., & Phillips, J. H. (2017). Bilateral Malar Reconstruction Using Patient-Specific Polyether Ether Ketone Implants in Treacher-Collins Syndrome Patients With Absent Zygomas. The Journal of Cramiofacial Surgery, 28(2), 515-517. https://doi.org/10.1097/SCS.0000000000003351