(102 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on surgeon-driven planning and guide generation based on CT scans and anatomical landmarks, not automated analysis or decision-making by the software.
No
The device, comprised of software for surgical planning and hardware (patient-specific drill guides), is intended to assist in surgical procedures (positioning glenoid components) but does not directly treat or restore the patient's health. It is a tool for surgical precision, not a therapy itself.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states "BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for Diagnostic purpose." This clearly indicates it is not a diagnostic device.
No
The device description explicitly states that the "BLUEPRINT™ Patient Specific Instrumentation is composed of two components: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software)." It also mentions seeking clearance for the hardware component (a guide made of Titanium).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: This device, BLUEPRINT™ Patient Specific Instrumentation, is a pre-surgical planning system and patient-specific surgical guide for shoulder arthroplasty. It uses CT scans to create a plan and a physical guide to assist the surgeon during the procedure.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its input is imaging data (CT scans), and its output is a surgical plan and a physical guide.
- Explicit Statement: The intended use explicitly states that the software "should not be used for Diagnostic purpose." While this refers to the software component, the overall system's function is not diagnostic in nature.
Therefore, this device falls under the category of surgical planning software and patient-specific surgical guides, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
KWS
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. 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 are exclusively reserved for this use.
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 to 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: a guide made of Titanium with an orientation hole which allows for controlling rotation of the commercially available implant, AequalisTM PerFORM
- Software modified to:
- Integrate a guide made of titanium,
- Add a glenoid sphere radius measurement.
These modifications do not affect the intended use or the indications for use of the device or alter the fundamental scientific technology of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT-Scan (Computed Tomography)
Anatomical Site
Shoulder, Glenoid
Indicated Patient Age Range
Adult patients only
Intended User / Care Setting
Orthopedic surgeons, pre-operative planning, intraoperative positioning
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)
Non clinical testing was performed on BLUEPRINT™ Patient Specific Instrumentation to assess that no new safety or effectiveness questions were raised with this device.
Study type: Validation and/or Verification Method, Patient Specific Guiding Wire test, Dimensional test of The titanium guide
Sample size: Not specified (used cadaver specimens)
Key results:
- Patient Specific Guiding Wire test: Version angle error, inclination angle error, main (central) entry point error and rotation entry point error must be compliant with device specifications. Result: Acceptable.
- Dimensional test of The titanium guide: The titanium guide meets dimensional specifications. Result: Acceptable.
This testing aimed to validate that the software measures in preoperative planning (implant positioning with a human cadaver) with the modified Blueprint Software generated a patient specific glenoid guide matching the patient anatomy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Version angle error, inclination angle error, main (central) entry point error and rotation entry point error compliance with device specifications.
Dimensional specifications of the titanium guide.
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.
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
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
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 an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2016
Tornier S.A.S. Aymen Azaiez Regulatory Affairs Specialist 161, Rue Lavoisier 38330 Montbonnot Saint Martin FRANCE
Re: K160555
Trade/Device Name: BLUEPRINT 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: February 22, 2016 Received: February 29, 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
1
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,
Mark N. Melkerson -S
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) K160555
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.
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
Summary of Safety and Effectiveness information Special 510(k) Premarket – BLUEPRINT™ Patient Specific Instrumentation
| 1) Device name | |
|---|---|
| Trade name: | BLUEPRINT™ Patient Specific Instrumentation |
| 510(k) Number: | K160555 |
| Common name: | Patient specific instrumentation + 3D planning software |
| Classification name: | Prosthesis, Shoulder, Semi-constrained, Metal/Polymer Cemented |
| (§888.3660) |
- 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@tornier.com
4) Classification
Device class: Class II Classification panel: Orthopedic Product code: KWS
5) Equivalent / Predicate device :
BLUEPRINTTM Patient Specific Instrumentation, Tornier SAS (K143374) Delta TT Acetabular System, Limacorporate S.p.A. (K112898)
4
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. 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 are exclusively reserved for this use.
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 to 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: a guide made of Titanium with an orientation hole which allows । for controlling rotation of the commercially available implant, AequalisTM PerFORM
- । Software modified to:
- · Integrate a guide made of titanium,
- o Add a glenoid sphere radius measurement.
These modifications do not affect the intended use or the indications for use of the device or alter the fundamental scientific technology of the device.
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 GFM-00000123 REV B - Tornier Appendix IV
5
Image /page/5/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.
arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans.
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 :
The commercially available Aequalis Glenoid Guides are manufactured from medical grade polyamide 2200. This 510k seeks clearance for guides made of medical grade titanium (Ti6Al4V).
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 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 patientspecific 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.
6
9) Summary of technological characteristics
| Table 1 Main features comparison | |||
|---|---|---|---|
| Main features or | |||
| system | |||
| characteristics | BLUEPRINTTM Patient Specific | ||
| Instrumentation | |||
| SUBJECT DEVICE SYSTEM | BLUEPRINTTM | ||
| Patient Specific | |||
| Instrumentation | |||
| (K143374) | |||
| PRIMARY | Delta TT Acetabular | ||
| System (K112898) | |||
| REFERENCE | |||
| Material | Ti6AI4V | Polyamide 2200 | Ti6AI4V |
| Standard | ISO 5832-3 | USP Class VI | |
| compatible | ISO 5832-3 | ||
| ASTM F 1472 | |||
| Manufacturing | 3D printing | 3D printing | 3D printing |
| Product Code | KWS | KWS | LPH, MBL |
| Surgical procedure | Total anatomic shoulder | ||
| arthroplasty | Total anatomic | ||
| shoulder arthroplasty | Hip replacement | ||
| Single-use | Yes | Yes | Yes |
| Sterile | No | No | Yes |
| Manufacturer | Tornier SAS | Tornier SAS | Limacorporate S.p.A. |
| Software | Assist surgeon in pre-operative | ||
| surgical planning | Assist surgeon in pre- | ||
| operative surgical | |||
| planning | NA |
ты
Implants Chirur
Device comparison showed that the proposed device is substantially equivalent:
- in intended use and performance characteristics to the predicate device ।
- in material to the reference device ।
10) Non-clinical testing
BLUEPRINT™ Patient Specific Instrumentation was validated through studies using cadaver specimens. Non clinical testing was performed on BLUEPRINT™ Patient Specific Instrumentation to assess that no new safety or effectiveness questions were raised with this device.
| Validation and / or
Verification Method | Acceptance Criteria description | Verification
and
Validation
Results |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Patient Specific
Guiding Wire test | Version angle error, inclination angle error, main
(central) entry point error and rotation entry point
error must be compliant with device specifications | Acceptable |
| Dimensional test of The
titanium guide | The titanium guide meets dimensional
specifications | Acceptable |
Table 2: Non-clinical testing
7
This testing aimed to validate that the software measures in preoperative planning (implant positioning with a human cadaver) with the modified Blueprint Software generated a patient specific glenoid guide matching the patient anatomy.
Implants Chirurgica
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 device and the reference device.
- -BLUEPRINT™ Patient Specific Instrumentation (pending device) has the same intended use as the predicate device: BLUEPRINT™ Patient Specific Instrumentation (K143374).
- BLUEPRINT 3D planning software (pending device) is equivalent to the BLUEPRINT -3D planning software (K143374).
- -BLUEPRINT 3D planning software (pending device) user manual is similar in indications precautions, warnings, and instructions as the predicate device: (K143374).
- -Major technological characteristics are equivalent between BLUEPRINT™ Patient Specific Instrumentation (pending device) and the predicate device:
- Equivalence of general features -
- -Equivalent surgical procedures
- Equivalent intended use, indications for use
- BLUEPRINT™ Patient Specific Instrumentation (pending device) is considered equivalent to the reference device Delta TT Acetabular System (K112898) in material.
- -BLUEPRINT™ Patient Specific Instrumentation (pending device) differs from the predicate device BLUEPRINT™ Patient Specific Instrumentation (K143374) regarding two features: the orientation hole intended to help the surgeon to control the rotation of the commercially available implant, Aequalis™ PerFORM, and glenoid sphere radius measurement to facilitate choosing the implant Aequalis™ PerFORM. These differences do not, however, change the fundamental technology, principle of operation for the drill guide/software or intended use.