(278 days)
CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children above 13 years of age).
CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:
- · trauma and vascular pathologies, either associated or non-associated to cranial decompression;
- · removal of tumors;
- · reabsorption of autologous bone;
- · rejection of other prosthetic materials;
- · congenital malformations.
Not Found
This document is a 510(k) clearance letter for the "CustomizedBone Service," a preformed nonalterable cranioplasty plate. The letter itself does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a 510(k) summary. It confirms the device's substantial equivalence to predicate devices.
Therefore, I cannot extract the detailed information requested regarding acceptance criteria and the study that proves the device meets them from the provided text.
The document states: "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..." This indicates that the clearance is based on a demonstration of substantial equivalence, which often relies on comparison to a legally marketed predicate device rather than on new extensive clinical trials for performance acceptance criteria in the same way a PMA or a de novo device might.
To provide the requested information, I would need access to the actual 510(k) submission summary or detailed study reports from the manufacturer, which are not present in this regulatory clearance letter.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2016
FIN-CERAMICA FAENZA SPA % Mary Beth Henderson, PhD, MBA VP Regulatory Affairs & Quality Systems, Senior Principal Advisor Regulatory & Clinical Research Institute, Inc. 5353 Wayzata Blvd., Suite 505 Minneapolis, Minnesota 55416-1334
Re: K160707
Trade/Device Name: CustomizedBone Service Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN, PJN Dated: November 7, 2016 Received: November 8, 2016
Dear Dr. Henderson:
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
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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,
MichaelJ. Hoffmann -S
Carlos L. Peña, PhD, MS for 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) K160707
Device Name CustomizedBone Service
Indications for Use (Describe)
CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children above 13 years of age).
CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:
- · trauma and vascular pathologies, either associated or non-associated to cranial decompression;
- · removal of tumors;
- · reabsorption of autologous bone;
- · rejection of other prosthetic materials;
- · congenital malformations.
Type of Use (Select one or both, as applicable)
| Production Use (21 CFR 601 Subpart D) | Compassionate Use (21 CFR 601 Subpart E) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------ |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).