BioArchitects Patient Specific Cranial/Craniofacial Plate

K151692 · Bioarchitects USA, LLC · GXN · Nov 20, 2015 · Neurology

Device Facts

• Record ID: K151692
• Device Name: BioArchitects Patient Specific Cranial/Craniofacial Plate
• Applicant: Bioarchitects USA, LLC
• Product Code: GXN · Neurology
• Decision Date: Nov 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioArchitects Patient Specific Cranial/Craniofacial Plate implant device is intended to replace bony voids in the cranial and/or craniofacial skeleton (e.g., frontal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, ethmoid process, vomer). It is a patient specific device.

Device Story

Patient-specific cranial/craniofacial plate; replaces bony voids in skull/face. Input: patient CT or MRI data. Transformation: additive manufacturing (3D printing) via Electron Beam Melting (EBM) of Ti6Al4V ELI titanium alloy powder. Output: custom-fit titanium plate. Used in surgical settings by surgeons. Surgeon approves design via engineering drawings prior to fabrication. Fixation: off-the-shelf commercially available screw systems. Benefit: provides structural reconstruction of cranial/craniofacial defects.

Clinical Evidence

Bench testing only. Static tensile testing performed on plate sections and plate tabs (worst-case scenario). Results showed average ultimate stress approximately 8 times higher and Young's modulus approximately 3 times higher than the highest-performing comparable device. Tensile strength of plate tabs was 3.84 times that of the predicate fixation system.

Technological Characteristics

Material: Ti6Al4V ELI titanium alloy (ASTM F3001-14). Manufacturing: Electron Beam Melting (EBM) additive manufacturing. Form factor: Patient-specific custom geometry derived from CT/MRI. Fixation: Commercially available screw systems. Sterilization: Non-sterile (shipped).

Indications for Use

Indicated for patients requiring replacement of bony voids in the cranial and/or craniofacial skeleton, including frontal, temporal, occipital, nasal, parietal, lacrimal, zygomatic, sphenoid, ethmoid, and vomer bones.

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 Implant (K053199)

Reference Devices

• Biomet HTR-PEKK Patient-Matched Implant (K053199)
• Medtronic TiMesh Pre-Shaped Cranial Mesh Implants (K974017)

Submission Summary (Full Text)

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 20, 2015

BioArchitects USA, LLC % Mr. Frank Ferguson CEO Ferguson Medical International Device Consultants LLC 332 Laskin Road, Suite 437 Virginia Beach, Virginia 23451

Re: K151692

Trade/Device Name: BioArchitects Patient Specific Cranial/Craniofacial Plate Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: October 19, 2015 Received: October 20, 2015

Dear Mr. Ferguson:

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 device

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Carlos L. Pena -SA

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) K151692

Device Name

BioArchitects Patient Specific Cranial/Craniofacial Plate

Indications for Use (Describe)

The Bio Architects Patient Specific Cranial/Craniofacial Plate implant device is intended to replace bony voids in the cranial and/or craniofacial skeleton (e.g., frontal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, ethmoid process, vomer). It is a patient specific device.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21CFR Part 807.92 for the BioArchitects Patient Specific Cranial/Craniofacial Plate implant device.

DATE PREPARED: 19 November 2015

#### APPLICANTS NAME AND ADDRESS:

BioArchitects USA, LLC Attn: Mark E. Ulrich, CEO 219 East 69th Street Suite 2K New York, NY 10021 Phone: [phone] [e-mail]

#### APPLICANTS CONTACT PERSON:

Ferguson Medical International Device Consultants LLC Attn: Frank Ferguson, CEO 332 Laskin Road Suite 437 Virginia Beach, VA 23451 Phone: [phone] [e-mail]

#### DEVICE NAME:

Common Name of the Device: Cranial or Craniofacial Plate Trade/Proprietary Name: BioArchitects Patient Specific Cranial/Craniofacial Plate Classification: 21 CFR 882.5330 Preformed Nonalterable Cranioplasty Plate Panel: 84 Product Code: GXN

### LEGALLY MARKETED DEVICE TO WHICH BIOARCHITECTS IS CLAIMING SUBSTANTIAL EQUIVALENCE:

Primary Predicate Device: Synthes Patient Specific Cranial/Craniofacial Implant Reference Predicate Devices: Biomet HTR-PEKK Patient-(PSCI) (K053199). Matched Implant (K121818) and Medtronic TiMesh Pre-Shaped Cranial Mesh Implants (K974017).

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### DEVICE DESCRIPTION:

The BioArchitects Patient Specific Cranial/Craniofacial Plate implant device is a single piece device constructed individually for each patient. It is intended to replace bony voids in the cranial and craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, sphenoid bone, ethmoid process, vomer). It is a patient specific device. The implant is made of titanium alloy produced via Electron Beam Melting (EBM) additive manufacturing/3D printing, permitting high temperature fusion of the powdered raw material (Ti6Al4V ELI in accordance with ASTM F3001-14).

The BioArchitects plate implants come in a variety of configurations that depend upon the geometry of the application. The surgeon approves the design of the cranial/craniofacial plate by comparing his/her dimension and configuration specifications to an engineering drawing prior to construction of the implant device.

#### INDICATIONS FOR USE:

The BioArchitects Patient Specific Cranial/Craniofacial Plate implant device is intended to replace bony voids in the cranial and/or craniofacial skeleton (e.q., frontal bone, temporal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, sphenoid bone, ethmoid process, vomer). It is a patient specific device.

## SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE:

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| Feature/<br>Characteristic | Subject Device | Synthes Patient<br>Specific<br>Cranial/Craniofacial<br>Implant (PSCI) | Biomet HTR-<br>PEKK Patient-<br>Matched Implant | Medtronic TiMesh Pre-<br>Shaped Cranial Mesh<br>Implants |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | | K053199 | K121818 | K974017 |
| Product Code(s) | GXN | GXN | GXN | GXN |
| Classification | Class II | Class II | Class II | Class II |
| Intended Use | The BioArchitects<br>Patient Specific<br>Cranial/Craniofacial<br>Plate implant device is<br>intended to replace<br>bony voids in the<br>cranial and/or<br>craniofacial<br>skeleton (e.g., frontal<br>bone, temporal bone,<br>occipital bone, nasal<br>bone, parietal bone,<br>supraorbital process,<br>lacrimal bone,<br>zygomatic bone,<br>sphenoid bone,<br>ethmoid process,<br>vomer). It is a patient<br>specific device. | Synthes (USA) Patient<br>Specific<br>Cranial/Craniofacial<br>implant is intended to<br>replace bony voids in<br>the cranial and/or<br>craniofacial skeleton. | The OsteoFAb<br>Patient Specific<br>Cranial Device<br>(OPSCD) is intended<br>for the replacement<br>of bony voids in the<br>cranial skeleton. | The TiMesh System is<br>intended for use in any<br>oral-maxilo-cranial-facial<br>surgical reconstructive<br>procedure, either<br>orthnathic or trauma,<br>wherein rigid or semi-rigid<br>internal fixation is utilized as<br>a means of holding bone<br>fragments together.<br>Alternatively, the TiMesh<br>System is also indicated for<br>use in reinforcing weak bony<br>tissues in orthopedic surgical<br>repairs, such as pelvic<br>reconstruction, acetabular<br>reconstruction, and cement<br>restriction. This product is<br>not intended for spinal use. |
| Material(s) | Titanium alloy | Commercially pure<br>titanium or PEEK | PEKK | Titanium alloy |
| Technical<br>Specifications | Custom sized to each<br>patient using CT or<br>MRI data | Custom sized to each<br>patient using CT data | Custom sized to<br>each patient using<br>CT data | Custom sized to each<br>patient using CT data |
| Manufacturing<br>Method | 3D printed using<br>electron beam melting<br>additive manufacturing | Machined | 3D printed using<br>laser sintering<br>additive<br>manufacturing | Machined |
| Fixation Method | Commercially available<br>screw systems | Synthes plates and<br>screw systems | Commercially<br>available plate and<br>screw systems | Medtronic plates, screws,<br>and wires |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |

Both the subject device and all predicates are the same in that they all derive the patient imaging data from CT scan sources. The material used for the subject device is the same as the reference predicate.

Both the subject device and the Medtronic reference predicate are constructed from titanium allov, while the primary predicate has a different material, which may be either commercially pure titanium or PEEK (polyetheretherketone). The Biomet reference predicate is also manufactured from a material (PEKK, polyetherketone) which is also different from the titanium alloy of the subject device.

The manufacturing technologies differ among the devices. The subject device is most closely similar to the Biomet reference predicate: Both utilize an additive 3D printing manufacturing technique, the Biomet device manufactured using laser sintering while the subject device uses electron beam melting (EBM), which is also a type of sintering process.

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Both the primary predicate Synthes device and Medtronic predicate are fixed onto the bony surface using their own, captive screw and plate systems, while the subject device and the Biomet predicate utilize off-the-shelf commercially available screws.

Both the subject device and all predicates are the same in that devices are all shipped non-sterile to the end user.

# PERFORMANCE DATA:

The BioArchitects Patient Specific Cranial/Craniofacial Plate was mechanically tested for tensile and elastic strength, with test results similar to those of predicate.

Performance Testing Summary Table

| Test | Test Method Summary | Results |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cranial Plate Static<br>Tensile Test | The objective of this test was to<br>perform static tensile testing on<br>sections of the BioArchitects Patient<br>Specific Cranial/Craniofacial Plate<br>device. Pate samples were cut into<br>sections to prepare specimens for<br>testing.<br>For the test setup, the upper tensile<br>grip was attached to the machine<br>actuator using a U-joint. The lower<br>tensile grip was attached to the axial<br>bad eel. The plate specimen was<br>gripped at both ends, leaving two<br>holes exposed between the tensile<br>grips. A nominal gage length of<br>30mm was used for each test<br>specimen. Photographs of the tensile<br>strength test setup are included in the<br>Test Report. | The BioArchitects Patient Specific<br>Cranial/Craniofacial plate device has<br>an average ultimate stress of<br>approximately 8 times that of the<br>comparable device with the highest<br>ultimate stress. Furthermore, the<br>BioArchitects Patient Specific<br>Cranial/Craniofacial Plate device has<br>an average Young's modulus of<br>approximately 3 times that of the<br>comparable device with the highest<br>Young's modulus.<br>Results are presented in a side by<br>side comparison table in the Test<br>Report. |
| Cranial Plate Tab<br>Static Tensile Test | The plate tab is the thinnest portion of<br>the device, and therefore presents the<br>worst case in terms of mechanical<br>strength.<br>The objective of this test was to<br>perform a static tensile pull to failure<br>test on the subject device compared<br>to the predicate.<br>For the test method, gage pins were<br>placed through the screw hole in the<br>attachment plate (tab) and the<br>assembly placed in a gripping fixture.<br>The test was conducted using a<br>hydraulic actuator. | The BioArchitects Patient Specific<br>Cranial/Craniofacial Plate device has<br>an average tensile strength<br>approximately 3.84 times that of the<br>predicate fixation system.<br>Specific results are presented in the<br>test report. |

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## CONCLUSIONS:

Based upon testing and comparison to the predicate device, the BioArchitects Patient Specific Cranial/Craniofacial Plate has the same intended use and similar technological characteristics. The device performs as intended and does not raise new safety or effectiveness issues.