(60 days)
Not Found
No
The description focuses on customized implants based on CT scans and surgeon requests, with no mention of AI or ML in the design or manufacturing process.
Yes
The device is indicated for augmenting bony and/or soft tissue deformities in craniofacial defects, which is a therapeutic purpose.
No
Explanation: The device is an implant for augmenting bony and/or soft tissue deformities. It is used in treatment and structural support, not for diagnosing conditions.
No
The device description explicitly states the device is a customized implant molded from porous high density polyethylene (HDPE), which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Stryker CMF MEDPOR Customized Implant is a physical implant designed to augment bony and soft tissue defects in the craniofacial region. It is surgically implanted into the patient's body.
- Intended Use: The intended use is for the augmentation of deformities, not for testing or analyzing specimens from the body.
The information provided clearly describes a surgically implanted device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Stryker CMF MEDPOR Customized Implant is indicated for the augmentation of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
Product codes
FWP
Device Description
The Stryker CMF MEDPOR Customized Implant (CI) product offerings provide customized craniofacial patient specific implants designed at the request of a surgeon. The customized craniofacial implants are molded from porous high density polyethylene (HDPE) and the MEDPOR material provides a porous structure which allows for tissue ingrowth. The MEDPOR CI is manufactured to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request.
This traditional 510(k) is submitted to add an additional indication for use for the augmentation and/or restoration of ... soft tissue deformities in the cranial and craniofacial skeleton; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
craniofacial defects
cranial and craniofacial skeleton
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
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.
Stryker has incorporated surgeon design input into a customized implant with an augmented contour. The culmination of surgeon input and approval and case history results in the CI PLUS, which has shown that the augmented contour of the CI PLUS counteracts the asymmetry observed in certain neurosurgical procedures.
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
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2016
Stryker Mr. Jonathan Schell Senior Regulatory Affairs Specialist 750 Trade Centre Way, Suite 200 Portage, Michigan 49002
Re: K153508
Trade/Device Name: Stryker CMF MEDPOR Customized Implant Regulation Number: 21 CFR 878.3550 Regulation Name: Chin Prosthesis Regulatory Class: Class II Product Code: FWP Dated: December 4, 2015 Received: December 7, 2015
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,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153508
Device Name Stryker CMF MEDPOR Customized Implant
Indications for Use (Describe)
The Stryker CMF MEDPOR Customized Implant is indicated for the augmentation of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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: | Jonathan Schell
Sr. Regulatory Affairs Specialist
Stryker Craniomaxillofacial
750 Trade Centre Way
Portage, MI 49002
Phone: 269-389-5596
Fax: 877-648-7114 |
| Date prepared: | December 4, 2015 |
| II. | DEVICE |
| Trade Name: | Stryker MEDPOR Customized Implant |
| Common or Usual
name: | Prosthesis, chin, internal |
| Classification
name: | Chin prosthesis, 21 CFR §878.3550 |
| Regulatory Class: | Class II |
| Product Code: | FWP |
PREDICATE DEVICE III.
Predicate: Stryker MEDPOR Customized Implant– K143173
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
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The Stryker CMF MEDPOR Customized Implant (CI) product offerings provide customized craniofacial patient specific implants designed at the request of a surgeon. The customized craniofacial implants are molded from porous high density polyethylene (HDPE) and the MEDPOR material provides a porous structure which allows for tissue ingrowth. The MEDPOR CI is manufactured to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request.
This traditional 510(k) is submitted to add an additional indication for use for the augmentation and/or restoration of ... soft tissue deformities in the cranial and craniofacial skeleton; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
V. INDICATIONS FOR USE
The Stryker CMF MEDPOR Customized Implant is indicated for the augmentation and/or restoration of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
The MEDPOR CI PLUS has an additional indication for use which is not included in the Predicate device an added PLUS design option, but this difference does not constitute a new Intended Use. Both the MEDPOR CI PLUS 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The MEDPOR CI PLUS is compared to its predicate device for substantial equivalence based on the following criteria:
- A. Principle of Operation
- B. Technological Characteristics
The only changes associated with the subject device design, relative to the predicate device, result from the additional indication for use. The additional indication for use corresponds to
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Image /page/5/Picture/0 description: The image shows the Stryker logo in black. The logo is a stylized wordmark with a unique font. The letters are bold and have rounded edges. The registered trademark symbol is located in the upper right corner of the logo.
a contour design selection option during the ordering process, and enhanced surgeon input during the design process. The remaining technological characteristics of the subject device, when compared to the predicate device, are unchanged.
A. Principle of Operation
The basic operational principle of the MEDPOR CI PLUS remains the same as the predicate: the MEDPOR Customized 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
The addition of a new indication for use to the MEDPOR CI 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-drilling screws.
- -Same material: Implants are made from high density polyethylene (HDPE).
- Same design: the customized craniofacial implants are molded from HDPE to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request.
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 sterilization methods for the MEDPOR CI PLUS. The identical manufacturing processes and materials are used in both the subject and predicate 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
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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 surgical approach. This culmination of surgeon input and approval and case history results in the CI PLUS, which has shown that the augmented contour of the CI PLUS counteracts the asymmetry observed in certain neurosurgical procedures.
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.