(122 days)
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 12 years of age and older.
The Stryker PEEK Customized Cranial Implant (CCI) product offerings provide customized cranial or craniofacial (craniofacial region is defined as the orbital rim, zygoma, and adjacent bone) patient specific implants based on CT data and surgeon input. This traditional 510(k) is submitted to add an additional indication for use to augment and/or restore soft tissue deformities in the cranial and craniofacial skeleton; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
This document, a 510(k) Summary for the Stryker PEEK Customized Cranial Implant Kit, outlines the device's indications for use and compares it to a predicate device. However, it explicitly states that biocompatibility testing, performance bench testing, animal testing, and clinical testing were NOT required as a basis for substantial equivalence for the new indication for use being sought in this submission (K153248).
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for a study proving the device meets acceptance criteria, cannot be provided from this document.
The document explains that substantial equivalence for the new indication (augmentation and/or restoration of soft tissue deformities, specifically PTH) was based on a literature review and case history to demonstrate that the expanded indication does not raise new questions of safety or effectiveness compared to the predicate device.
Specifically, the document states:
- "A literature review was performed to identify relevant clinical literature with applicable data to show that, when compared to the predicate device, the new Indication for use added to the subject device does not raise new questions of safety or effectiveness. The results of this review provides evidence of this fact." (Page 4)
- "To support the inclusion of the PLUS design option, and the corresponding indication for use, Stryker has leveraged clinical literature and case history. A summary of the clinical literature verifies that PTH reflects a deficiency in the bulk of the temporalis muscle or overlying temporal fat pad. Surgical results with augmented implant designs have been published upon and shown to be clinically successful in addressing PTH." (Page 5)
In summary, this document does not contain a study with acceptance criteria and a test performed against them. It relies on a literature review and case history to support the expanded indications for use.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2016
Stryker Craniomaxillofacial Mr. Jonathan Schell Senior Regulatory Affairs Specialist 750 Trade Centre Way, Suite 200 Portage, Michigan 49002
Re: K153248
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: February 8, 2016 Received: February 9, 2016
Dear Mr. 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 (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.
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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,
William J.
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for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153248
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 12 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. KGBoetzinger Strasse 41D-79111 Freiburg, Germany |
|---|---|
| Submitter/ ContactPerson: | Jonathan SchellSr. Regulatory Affairs SpecialistStryker Craniomaxillofacial750 Trade Centre WayPortage, MI 49002Phone: 269-389-5596Fax: 877-648-7114 |
| Date prepared: | November 6, 2015 |
| II.DEVICE | |
| Trade Name: | Stryker PEEK Customized Cranial Implant Kit |
| Common or Usualname: | Customized Cranial Implant |
| Classificationname: | Preformed alterable cranioplasty plate 21 CFR §882.5320 |
| Regulatory Class: | Class II |
| Product Code: | GWO |
III. PREDICATE DEVICE
Predicate: Stryker PEEK Customized Cranial Implant Kit – K121153
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
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The Stryker PEEK Customized Cranial Implant (CCI) product offerings provide customized cranial or craniofacial (craniofacial region is defined as the orbital rim, zygoma, and adjacent bone) patient specific implants based on CT data and surgeon input. This traditional 510(k) is submitted to add an additional indication for use to augment and/or restore soft tissue deformities in the cranial and craniofacial skeleton; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
INDICATIONS FOR USE V.
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 12 years of age and older.
The Indications for Use statement of the PEEK CCI with the PLUS design is different than the predicate device, but this difference does not constitute a new Intended Use. Both the PEEK CCI with the PLUS design and the predicate device have the same Intended Use to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton. Also, this difference does not alter the intended therapeutic use of the device nor does the difference affect the safety and effectiveness of the device relative to the predicate device.
A literature review was performed to identify relevant clinical literature with applicable data to show that, when compared to the predicate device, the new Indication for use added to the subject device does not raise new questions of safety or effectiveness. The results of this review provides evidence of this fact.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The PEEK CCI with the PLUS 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 with the PLUS design remains the same as the predicate: the PEEK Customized Cranial Implant is intended to be used to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton.
B. Technological and Operational Characteristics
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The addition of a new indication for use to the PEEK CCI does not alter the technological characteristics of the actual customized cranial or craniofacial implant. The technological characteristics remain the same as the predicate:
- Same operating principle: to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton.
- Same mode of fixation: fixated to the native bone with Stryker Neuro, Midface, and, or, Upperface self-tapping screws. The Stryker Neuro, Midface, and, or, Upperface standard drill bits are used to drill the pilot hole.
- Same material: Implants are made of medical grade PEEK Optima LT1. Both predicate and subject devices are milled out of a block using industrial milling machines.
- Same design: Provides a "drop-in-fit" without a need for intra-operative modifications. If minor intra-operative size reduction is required, the implant can be trimmed with standard surgical burrs by the surgeon.
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 or location of contact, or reprocessing methods for the PEEK CCI. The same manufacturing processes and identical materials are used in the predicate device and the Subject device.
Performance Bench Testing
Performance Bench testing was not required as a basis for substantial equivalence.
Animal Testing
Animal testing was not required as a basis for substantial equivalence.
Clinical Testing
To support the inclusion of the PLUS design option, and the corresponding indication for use, Stryker has leveraged clinical literature and case history. A summary of the clinical literature verifies that PTH reflects a deficiency in the bulk of the temporalis muscle or overlying temporal fat pad. Surgical results with augmented implant designs have been published upon and shown to be clinically successful in addressing PTH.
To that end. Stryker has incorporated surgeon design input into a customized implant with an augmented contour. In all patient-specific reconstructions, the level of implant augmentation may be adjusted based on surgeon clinical knowledge of the patient condition and the
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surgical approach. This culmination of surgeon input and case history results in the CCI PLUS, which has shown that the augmented contour of the CCI PLUS potentially counteracts the asymmetry observed in PTH cases.
VIII. CONCLUSIONS
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.
§ 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).