BLUEPRINT Patient Specific Instrumentation

{0}------------------------------------------------ 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" arranged 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 December 27, 2016 Tornier Sas Aymen Azaiez Regulatory Affairs Specialist 161 rue Lavoisier 38330 Montbonnot Saint-Martin, France Re: K161789 Trade/Device Name: BLUEPRINTTM Patient Specific Instrumentation Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: November 24, 2016 Received: November 28, 2016 Dear Aymen Azaiez: 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. {1}------------------------------------------------ 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, Caroline Rhim -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use #### 510(k) Number (if known) #### K161789 Device Name BLUEPRINT™ Patient Specific Instrumentation #### Indications for Use (Describe) #### The hardware The Aequalis Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans. Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids and the Aequalis PerFORM + glenoids. #### The software The BLUEPRINT 3D planning software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINT 3D planning software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems. The software supports DICOM standard to import the CT-Scan (Computed Tomography) images of the patient. Only CT-Scan modality can be loaded with BLUEPRINT3D planning software. BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan. This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan. The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide. BLUEPRINT 3D planning software does not include any system to manufacture the guide. BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for Diagnostic purpose. Type of Use (Select one or both, as applicable) X 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) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Tornier Implants Chirurgicaux. The word "TORNIER" is in large, bold, blue font. Below that, the words "Implants Chirurgicaux" are in a smaller, bold, blue font. # Summary of Safety and Effectiveness information Special 510(k) Premarket - BLUEPRINT™ Patient Specific Instrumentation | 1) Device name | | |----------------------|----------------------------------------------------------------------------| | Trade name: | BLUEPRINT™ Patient Specific Instrumentation | | Common name: | Patient specific instrumentation + 3D planning software | | Classification name: | Prosthesis, Shoulder, Semi-constrained, Metal/Polymer Cemented (§888.3660) | # 2) Submitter : TORNIER SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin- France Registration Number: 3000931034 ## 3) Company contact : Tornier SAS Mr Aymen AZAIEZ Regulatory Affairs Specialist 161 rue Lavoisier 38334 Montbonnot Tel: 00 33 4 76 61 35 00 Fax: 00 33 4 76 61 35 59 e-mail : aymen.azaiez(@)wright.com ## 4) Classification | Device class: | Class II | |-----------------------|------------| | Classification panel: | Orthopedic | | Product code: | KWS | ## 5) Equivalent / Predicate device : Primary: BLUEPRINTTM Patient Specific Instrumentation, Tornier SAS (K143374) Primary: BLUEPRINT™ Patient Specific Instrumentation, Tornier SAS (K160555) Reference: Aequalis PerFORM+ Shoulder System (K150583) Reference: Aequalis PerFORM+ Shoulder System (K160975) Image /page/4/Picture/11 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is formed by two overlapping shapes, creating a unique and modern design. The color of the logo is a muted blue or lavender, giving it a soft and professional appearance. The hexagon provides a clear and defined border for the central element. TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A {5}------------------------------------------------ ## 6) Device description : BLUEPRINT™ Patient Specific Instrumentation is composed of two components: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software). BLUEPRINT™ Patient Specific Instrumentation which includes the Aequalis Glenoid Guides and BLUEPRINT 3D planning software is the responsibility of Tornier is the legal manufacturer for the hardware and the software. ## The hardware The Aequalis Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of the Aequalis PerFORM shoulder prostheses and the Aequalis PerFORM + shoulder prostheses. The Aequalis Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D planning software. ## The software BluePrint 3D Planning software is composed of one software component connected to an Online Management System (OMS). The software installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (= total anatomic shoulder replacement). It is intended to help -plan an operation by allowing surgeons to: - position and select the glenoid implant, ● - design a patient specific pin guide. This submission seeks clearance for: - Hardware: adding Aequalis PerFORM + glenoids (K150583 and K160975) to the indications for use of the Titanium and Polyamide Aequalis PerFORM Anatomic Glenoid Guides (respectively K160555 and K143374) - Software: - - Adding Aequalism PerFORM + prosthesis (K150583 and K160975) into the O pre-operative surgical planning part. - 0 Updating of the contraindications These modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device. Image /page/5/Picture/18 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is constructed from thick, uniform lines, giving it a modern and geometric appearance. The hexagon and the 'T' are both rendered in a light blue or lavender color, providing a soft and clean aesthetic. The logo is simple, memorable, and could represent a company or organization with a name starting with the letter 'T'. Tél. : 33 (0)4 76 61 35 00 TORNIER S.A.S. Fax : 33 (0)4 76 61 35 33 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Tornier Implants Chirugicaux. The word "TORNIER" is in large, bold, blue font. Below that, the words "Implants Chirugicaux" are in a smaller, bold, blue font. # Intended Use # The hardware The Aequalis Glenoid Guides are intended to be used as surgical instruments to assist in the intraoperative positioning of glenoid components used with total anatomic shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CTscans. ## The software The BLUEPRINT 3D planning software is intended to be used as a medical software to assist in pre-operative surgical planning for shoulder surgery. # 7) Materials : There is no change regarding the material of the subject Aequalis Perform Anatomic Glenoid Guides. The commercially available Aequalis Glenoid Guides are manufactured from medical grade polyamide 2200 or Titanium. # 8) Indications : # The hardware The Aequalis Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans. Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM and Aequalis PerFORM + glenoids. # The software The BLUEPRINT 3D planning software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINT 3D planning software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems. The software supports DICOM standard to import the CT-Scan (Computed Tomography) images of the patient. Only CT-Scan modality can be loaded with BLUEPRINT 3D planning software. BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan. This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan. The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide. BLUEPRINT 3D planning software does not include any system to manufacture the guide. BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for diagnostic purpose. Image /page/6/Picture/21 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is formed by two overlapping shapes, creating a three-dimensional effect. The color of the logo is a muted blue or lavender. The logo appears clean and modern. TORNIER S.A.S. Tél. : 33 (0)4 76 61 35 00 161, rue Lavoisier Fax : 33 (0)4 76 61 35 33 38334 MONTBONNOT CEDEX FRANCE S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the text "TORNIER Implants Chirugicaux". The word "TORNIER" is in a larger, bolder font than the words "Implants Chirugicaux". The text is in a dark blue color. #### 9) Summary of technological characteristics ## Table 1 Main features comparison | Main features<br>or system<br>characteristics | BLUEPRINTTM<br>Patient Specific<br>Instrumentation<br>SUBJECT<br>DEVICE<br>SYSTEM | BLUEPRINTTM<br>Patient Specific<br>Instrumentation<br>(K143374)<br>PRIMARY | BLUEPRINTTM<br>Patient Specific<br>Instrumentation<br>(K160555)<br>PRIMARY | Aequalis<br>PerFORM+<br>Shoulder<br>System<br>(K150583)<br>Reference | Aequalis<br>PerFORM+<br>Shoulder<br>System<br>(K160975)<br>Reference | |-----------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------| | Material | Ti6AI4V<br>Polyamide 2200 | Polyamide 2200 | Ti6AI4V | UHMWPE<br>CoCr | UHMWPE<br>CoCr | | Standard | ISO 5832-3<br>USP Class VI<br>compatible | USP Class VI<br>compatible | ISO 5832-3 | ISO 5834-2, ISO<br>5832-7 | ISO 5834-2, ISO<br>5832-7 | | Manufacturing | 3D printing | 3D printing | 3D printing | Traditional<br>machining | Traditional<br>machining | | Product Code | KWS | KWS | KWS | KWS | KWS | | Surgical<br>procedure | Total anatomic<br>shoulder<br>arthroplasty | Total anatomic<br>shoulder<br>arthroplasty | Total anatomic<br>shoulder<br>arthroplasty | Total anatomic<br>shoulder<br>arthroplasty | Total anatomic<br>shoulder<br>arthroplasty | | Single-use | Yes | Yes | Yes | Yes | Yes | | Sterile | No | No | No | Yes | Yes | | Manufacturer | Tornier SAS | Tornier SAS | Tornier SAS | Tornier, Inc. | Tornier, Inc. | | Software | Assist surgeon in<br>pre-operative<br>surgical planning | Assist surgeon in<br>pre-operative<br>surgical planning | Assist surgeon in<br>pre-operative<br>surgical planning | NA | NA | Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices. ## 10) Performance data BLUEPRINT™ Patient Specific Instrumentation was validated through rationalized equivalences (technical, clinical and biological) proving the compatibility of BLUEPRINT™ Patient Specific Instrumentation with both Aequalis™ PerFORM and Aequalis™ PerFORM+ implants and to assess that no new safety or effectiveness questions were raised with this device. Image /page/7/Picture/7 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is rendered in a light purple or blue color and appears to be constructed from geometric shapes. The hexagon also has the same light purple or blue outline, providing a clean and modern look to the logo. TORNIER S.A.S. Tél. : 33 (0)4 76 61 35 00 161, rue Lavoisier Fax : 33 (0)4 76 61 35 33 38334 MONTBONNOT CEDEX FRANCE S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A {8}------------------------------------------------ # Table 2: Performance Data | Validation &/or Verification Method | Acceptance Value /Criteria | Results | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------------| | Verify that the patient-specific solution is<br>compatible with the instrumentation of<br>AequalisTM PerFORM+ in terms of technical,<br>biological and clinical equivalences | Proven technical, biological and<br>clinical equivalences | Acceptable | | Compare post-operative clinical data with pre-<br>operative plans to verify the accuracy of the<br>patient-specific solution in AequalisTM<br>PerFORM+ configuration | Correct positioning of the main pin | Acceptable | | Perform tests of software features when the<br>AequalisTM PerFORM+ is selected | No dysfunction of the software<br>features and the AequalisTM<br>PerFORM+ is correctly displayed | Acceptable | # 11) Substantial equivalence conclusion Based upon this comparative study, substantial equivalence of BLUEPRINT™ Patient Specific Instrumentation to the predicates can be demonstrated on the following grounds. according to the FDA's Guidelines for Substantial Equivalence Decision making Process: - BLUEPRINT™ Patient Specific Instrumentation (pending device) is compared to the predicate devices and the reference devices. - BLUEPRINTM Patient Specific Instrumentation (pending device) has the sufficiently equivalent intended use as the predicate devices: BLUEPRINT™ Patient Specific Instrumentation (K143374) and BLUEPRINT™ Patient Specific Instrumentation (K160555), - -BLUEPRINT 3D planning software (pending device) is equivalent to the BLUEPRINT 3D planning software (K143374) and BLUEPRINT™ Patient Specific Instrumentation (K160555). - -BLUEPRINT 3D planning software (pending device) user manual is similar in indications precautions, warnings, and instructions as the predicate device: (K143374) and (K160555). - Major technological characteristics are equivalent between BLUEPRINT™ Patient Specific -Instrumentation (pending device) and the predicate devices: - Equivalence of general features - - -Equivalent surgical procedures - Equivalent intended use, indications for use - - -Equivalent material Therefore, in the light of the above information, the BLUEPRINT™ Patient Specific Instrumentation is considered equivalent to the predicate devices and no safety and effectiveness issues were raised with this device. Image /page/8/Picture/15 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is formed by two overlapping shapes, creating a three-dimensional effect. The color of the logo is a light blue or lavender. The logo appears to be simple and modern. Tél. : 33 (0)4 76 61 35 00 TORNIER S.A.S. Fax : 33 (0)4 76 61 35 33 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A