(124 days)
Not Found
No
The description focuses on customized implants based on patient data and surgeon input, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for augmentation of bony and/or soft tissue deformities, which is a therapeutic intervention aimed at correcting an anatomical problem.
No
The device is an implant kit used for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton, which is a therapeutic purpose, not a diagnostic one. It uses patient data to create customized implants, but it does not analyze the data to provide a diagnosis.
No
The device description explicitly states it is an "Implant Kit" and a "patient specific implant solution," indicating a physical implant component, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The provided description clearly states that this device is a customized cranial implant. It is a physical object designed to be surgically implanted into the patient's skull to correct deformities.
- Intended Use: The intended use is for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
- Input Data: While it uses patient CT/CBCT data, this data is used for designing and manufacturing the implant, not for performing a diagnostic test on a biological sample.
Therefore, based on the provided information, this device falls under the category of a medical implant or surgical device, 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
GWO
Device Description
The PEEK Customized Cranial Implant Kit product provides a customized cranial or craniofacial patient specific implant solution based on patient CT/CBCT data and surgeon input. This submission is to expand the Stryker PEEK CCI product portfolio to include the single stage option.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT/CBCT 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
Biocompatibility Testing: Biocompatibility and sterility testing of the device is a basis for substantial equivalence. There is no change in the material, duration of contact, or reprocessing methods for the PEEK Customized Cranial Implant Kit. 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 similarly and manufactured identically. The majority of the Performance Bench testing of the predicate device is valid for the subject device. Additionally, an end-user validation lab was conducted to evaluate the subject device and to support the basis for substantial equivalence.
End-User Validation:
Test Methods Summary: Single Stage surgical procedure with/&without the following surgical aid options:
- Marking guides/guided; Virtual template/Navigation system; w/out surgical aid
- Implant Fit
Results: All V&V activities that were performed met their respective acceptance criteria. All end-user validation tasks were completed, passed successfully, and supports the substantial equivalence of the subject device to the predicate 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
February 9, 2021
Stryker Zainab Amini Senior Regulatory Affairs Specialist 750 Trade Centre Way - Suite 200 Portage, Michigan 49002
Re: K203055
Trade/Device Name: Stryker PEEK Customized Cranial Implant Kit Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO Dated: December 10, 2020 Received: December 11, 2020
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
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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,
Adam D. Pierce, Ph.D. 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
510(k) Number (if known) K203055
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) |
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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/
Author/Contact
Person: | Zainab Amini
Senior Regulatory Affairs Specialist
Stryker Craniomaxillofacial
750 Trade Centre Way
Portage, MI 49002
Phone: 269-290-8072
Fax: 877-648-7114 |
| Date prepared: | February 8, 2021 |
| II.
DEVICE | |
| Trade Name: | PEEK Customized Cranial Implant Kit |
| Common or Usual
name: | Customized Cranial Implant |
| Classification
name: | Preformed alterable cranioplasty plate 21 CFR §882.5320 |
| Regulatory Class: | Class II |
| Product Code: | GWO |
III. PREDICATE DEVICE
Predicate: K190229, Stryker PEEK Customized Cranial Implant Kit
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The PEEK Customized Cranial Implant Kit product provides a customized cranial or craniofacial patient specific implant solution based on patient CT/CBCT data and surgeon input. This submission is to expand the Stryker PEEK CCI product portfolio to include the single stage option.
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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 Customized Cranial Implant Kit 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 principle of operation for the PEEK Customized Cranial Implant Kit is 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 principle of operation, mode of fixation, and design specification and manufacturing processes are all identical. Additionally, the subject device can be used in a single stage surgical procedure with or without marking guides or a navigation system to transfer the resection outline.
VII. PERFORMANCE DATA
Biocompatibility Testing
Biocompatibility and sterility testing of the device is a basis for substantial equivalence. There is no change in the material, duration of contact, or reprocessing methods for the PEEK Customized Cranial Implant Kit. 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 similarly and manufactured identically. The majority of the Performance Bench testing of the predicate device is valid for the subject device. Additionally, an end-user validation lab was conducted to evaluate the subject device and to support the basis for substantial equivalence. Table below provides a summary of the end-user validation.
| Test | Test Methods Summary | Results |
|---|---|---|
| End-User | ||
| Validation | • Single Stage surgical procedure | |
| with/&without the following surgical | ||
| aid options: |
- Marking guides/guided; Virtual
template/Navigation system;
w/out surgical aid
• Implant Fit | All V&V activities that were performed
met their respective acceptance criteria.
All end-user validation tasks were
completed, passed successfully, and
supports the substantial equivalence of
the subject device to the predicate
device. |
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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 evidence presented demonstrates that the subject device is as safe and effective as the legally marketed predicate and does not change nor raise any new questions of safety and effectiveness. In conclusion, in accordance to the requirement of 21 CFR 807.87, the PEEK Customized Cranial Implant Kit is substantially equivalent with respect to the safety and effectiveness to the legally marketed predicate device, K190229.