MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT

K110684 · Vanduzen Dba Medcad · GXN · Jun 24, 2011 · Neurology

Device Facts

• Record ID: K110684
• Device Name: MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
• Applicant: Vanduzen Dba Medcad
• Product Code: GXN · Neurology
• Decision Date: Jun 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MedCAD AccuShape™ PEEK Patient Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.

Device Story

Device consists of patient-specific cranioplasty plates; manufactured from implantable grade polyether-ether-ketone (PEEK). Input data: patient CT imaging. Process: computer-aided design (CAD) used to determine implant dimensions based on CT data; precision manufacturing to create custom-fit prosthetic. Output: individually sized/shaped cranial implant (nominal thickness 3mm, range 2-5mm); includes 2mm drainage holes. Used by surgeons in clinical settings to repair cranial defects. Implant attached to native bone via commercially available fasteners. Benefits: provides custom anatomical reconstruction for cranial voids.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes sterilization validation, dimensional accuracy measurements, and material testing to confirm structural integrity and biocompatibility.

Technological Characteristics

Material: Implantable grade polyether-ether-ketone (PEEK). Design: Patient-specific, CAD-generated. Dimensions: 2-5mm thickness; 10x10mm to 200x200mm parts. Features: 2mm drainage holes (10mm spacing). Sterilization: Non-sterile, requires physician-performed sterilization. Connectivity: None (standalone).

Indications for Use

Indicated for patients requiring correction of cranial defects or replacement of bony voids in the cranial skeleton.

Regulatory Classification

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.

Predicate Devices

• Synthes Patient Specific Cranial/Craniofacial Implants (K033868)
• OsteoSymbionics Patient-Specific Cranial Implant (K072601)

Submission Summary (Full Text)

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## Med CAD

## 5. 510(k) SUMMARY

| Submitter: | MedCAD<br>824 Exposition Avenue, Suite 3<br>Dallas, Texas 75226 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Nancy Hairston<br>President<br>TEL: [phone] extension 300<br>FAX: [phone]<br>[e-mail] |
| Date Prepared: | March 09, 2011 |
| Trade Name: | MedCAD AccuShape™ PEEK Patient Specific Cranial Implant (PSCI) |
| Common Name: | Patient Specific Cranial Implant (PSCI) |
| Classification Name: | Preformed nonalterable cranioplasty plate |
| Product Code: | GXN |
| Classification: | Class II, 21 CFR 882.5330 |
| Predicate Device: | K033868 - Synthes Patient Specific Cranial/Craniofacial Implants<br>K072601 - OsteoSymbionics Patient-Specific Cranial Implant |
| Device Description: | The MedCAD AccuShape™ PEEK Patient Specific Cranial Implant devices are<br>individually sized and shaped implantable prosthetic cranioplasty plates intended to<br>correct defects / replace voids in the cranial skeleton of a specific patient. The<br>implants are designed using the patient's CT imaging data and precision<br>manufactured from implantable grade polyether-ether-ketone (PEEK) material.<br>The devices have a nominal thickness of 3mm, ranging from 2-5mm depending on<br>the anatomical location. The device can be supplied as one or as multiple parts due<br>to material constraints and/or the complexity of the device, with each part ranging<br>in size from 10 x 10 (mm) to 200 x 200 (mm). The implants are provided with 2mm<br>drainage holes spaced 10 mm apart from center to center with an edge margin of 10<br>mm.<br>The devices are non-pyrogenic and are provided non-sterile for sterilization by the<br>physician prior to implantation. The implants are attached to the native bone with<br>commercially available cranioplasty fasteners. |
| Statement of<br>Intended Use: | The MedCAD AccuShape™ PEEK Patient Specific Cranial Implant is designed<br>individually for each patient and intended to correct defects / replace bony voids in<br>the cranial skeleton. |

824 Exposition Ave. Suite 3, Dallas, TX 75226 Phone: [phone] Fax: [phone]

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## Med CAD

The MedCAD AccuShape™ PEEK Patient Specific Cranial Implant device is Summary of Technological substantially equivalent to the predicate devices regarding use of electronic CT Characteristics: images and computer aided design in determining patient specific implant dimensions, use of implantable grade polymer as the device material, and resulting technological characteristics including biocompatibility, sterilization method, strength, stiffness, elasticity, density, and radiolucency. Summary of Biological laboratory tests including thorough sterilization validation have been Non-Clinical Test conducted for the MedCAD Patient Specific Cranial Implant devices and material. Data: These tests have proven the devices to be pyrogen-free and sterile, when used in accordance with the product instructions. Precision measurements have validated the dimensional accuracy and stability of the devices. In addition, material testing has been performed to demonstrate structural integrity. Together, these non-clinical tests assure that the MedCAD AccuShape™ PEEK Patient Specific Cranial Implant safety and effectiveness are substantially equivalent to those of the predicate devices. Conclusion: MedCAD considers the MedCAD AccuShape™ PEEK Patient Specific Cranial Implant to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, materials, test results, and established medical use.

824 Exposition Ave. Suite 3, Dallas, TX 75226 Phone: [phone] Fax: [phone]

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized lines or shapes, possibly representing a stylized bird or a similar design element.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-00002

VanDuzen dba MedCAD c/o Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson, Suite 280 Richardson, TX 75080

JUN 2 4 2011

Re: K110684

Trade/Device Name: MedCAD AccuShape™ PEEK Patient Specific Cranial Implant Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: May 31, 2011 Received: June 01, 2011

Dear Ms. Rutherford:

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

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Page 2 - Ms. Diane Rutherford

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.html 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket nouification" (21CFR 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/ReportalProblem/deliault.html 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYour/Industry/default.htm.

Sincerely yours,
Kesia Alexander

Image /page/3/Picture/7 description: The image shows the name and title of Malvina B. Eydelman, M.D. She is the Director of the Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices. The image also mentions the Office of Device Evaluation and the Center for Devices and Radiological Health.

Enclosure

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## INDICATIONS FOR USE

510(k) Number: K110684

Device Name: MedCAD AccuShape™ PEEK Patient Specific Cranial Implant

Indications for Use:

The MedCAD AccuShape™ PEEK Patient Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.

Prescription Use _ X (21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDHR, Office of Device Evaluation (ODE)

Division Sign-Off

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K110684