(156 days)
No
The document describes software for pre-surgical planning and guide design based on CT scans, but there is no mention of AI or ML algorithms being used for image analysis, planning, or any other function. The software allows surgeons to visualize, measure, and design, which are standard functionalities for medical imaging software.
No
The device, composed of guides and planning software, assists in surgical procedures by helping with positioning and planning, but it does not directly treat or cure a disease or condition.
No
The "Intended Use / Indications for Use" section explicitly states "BLUEPRINT™ 3D Planning Software is to be used for adult men and women only whose bone maturity is reached and should not be used for diagnostic purpose."
No
The device description explicitly states that the BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software). Therefore, it is not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The BLUEPRINT™ Patient Specific Instrumentation is a surgical planning and guidance system. It uses CT scan images of the patient's shoulder to create a pre-surgical plan and patient-specific drill guides for shoulder arthroplasty.
- Intended Use: The intended use is for pre-surgical planning and intraoperative guidance during shoulder surgery. It explicitly states the software "should not be used for diagnostic purpose."
- Input: The input is medical imaging data (CT scans), not biological specimens.
Therefore, the device's function, intended use, and input clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Hardware
The BLUEPRINT™ 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 or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
Software
BLUEPRINT™ 3D Planning Software is a medical device for surgeons. BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format.
BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific guides based on the pre-surgical plan.
BLUEPRINT™ 3D Planning Software leads to the generation of a planning report.
BLUEPRINT™ 3D Planning Software is to be used for adult men and women only whose bone maturity is reached and should not be used for diagnostic purpose.
Note: Measures and patient specific guide design are provided depending on the case profiles.
Product codes (comma separated list FDA assigned to the subject device)
KWS
Device Description
BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software).
BLUEPRINT™ Patient Specific Instrumentation which includes the BLUEPRINT™ Glenoid Guides and BLUEPRINT™ 3D Planning Software is the responsibility of Tornier. Tornier is the legal manufacturer for the hardware and the software.
Hardware
The BLUEPRINT IM Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses.
The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D Planning Software.
Software
BLUEPRINT™ 3D Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed).
It is intended to help to plan an operation by allowing surgeons to:
- Plan for shoulder arthroplasty cases
- i Position and select glenoid and humeral implants,
- -Simulate the prosthetic range of motion,
- Interact with implants and different computed measurements i
- Design a patient specific guide for the glenoid component when appropriate.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan images
Anatomical Site
Shoulder
Indicated Patient Age Range
adult men and women only whose bone maturity is reached
Intended User / Care Setting
surgeons
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)
Technological differences between the subject and predicate hardware devices are supported by the dimensional and cadaveric tests performed on the predicate device hardware (K162800) which remain applicable to the subject hardware device as the changes to the subject device do not impact functional dimensions or material.
Technological differences between the subject and predicate software devices are supported with verification and validation evaluations. The operating principle of the subject device is the same as that of the predicate device.
The differences in design specifications do not raise new questions of safety and effectiveness over the predicate device as demonstrated in validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Tornier SAS Aymen Azaiez Principal Regulatory Affairs Specialist 161 rue Lavoisier Montbonnot Saint Martin, 38330 France
April 15, 2021
Re: K203315
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: March 16, 2021 Received: March 17, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@;tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2021.04.15
For Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203315
Device Name BLUEPRINTTM Patient Specific Instrumentation
Indications for Use (Describe) Hardware
The BLUEPRINT™ 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 or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
Software
BLUEPRINT™ 3D Planning Software is a medical device for surgeons. BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format.
BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific guides based on the pre-surgical plan.
BLUEPRINT™ 3D Planning Software leads to the generation of a planning report.
BLUEPRINT™ 3D Planning Software is to be used for adult men and women only whose bone maturity is reached and should not be used for diagnostic purpose.
Note: Measures and patient specific guide design are provided depending on the case profiles.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "TORNIER" in a large, blue, sans-serif font. To the right of the word is a blue hexagon with a stylized "T" inside. The "T" is also blue and is made up of several lines that create a three-dimensional effect.
Traditional 510(k) Premarket - BLUEPRINTTM Patient Specific Instrumentation
Device name
BLUEPRINTTM Patient Specific Instrumentation Trade name: Common name: Patient Specific Instrumentation + 3D Planning Software Classification name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulation number: (§888.3660)
Submitter
| Name: | TORNIER SAS |
|---|---|
| Address: | 161 rue Lavoisier |
| 38330 Montbonnot Saint Martin- France | |
| Registration Number: | 3000931034 |
Company contact
| Company Name: | TORNIER SAS | ||
|---|---|---|---|
| Contact Person: | Mr Aymen AZAIEZ | ||
| Title: | Principal Regulatory Affairs Specialist | ||
| Address: | 161 rue Lavoisier | ||
| 38334 Montbonnot, France | |||
| Tel: | 00 33 6 48 38 10 36 | ||
| Fax: | 00 33 4 76 61 35 59 | ||
| Email: | aymen.azaiez@wright.com |
Classification
Device class: Class II Classification panel: Orthopedic Product code: KWS
Equivalent / Predicate device
| Trade name | 510(k) Number | Decision date | Applicant |
|---|---|---|---|
| BLUEPRINT™ Patient Specific | |||
| Instrumentation (PRIMARY) | K162800 | June 10, 2016 | TORNIER SAS |
| PROPHECY INVISION Pre- | |||
| operative Navigation System | |||
| (Reference) | K170968 | August 16, 2017 | Wright Medical |
| Technology, Inc. |
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Image /page/4/Picture/0 description: The image shows the logo for Tornier, a medical device company. The logo consists of the word "TORNIER" in large, blue, serif font, followed by a stylized symbol. The symbol is a blue hexagon with a "T" inside, also in blue. The logo is clean and professional, reflecting the company's focus on medical technology.
Device description
BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software).
BLUEPRINT™ Patient Specific Instrumentation which includes the BLUEPRINT™ Glenoid Guides and BLUEPRINT™ 3D Planning Software is the responsibility of Tornier. Tornier is the legal manufacturer for the hardware and the software.
Hardware
The BLUEPRINT IM Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses.
The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D Planning Software.
Software
BLUEPRINT™ 3D Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed).
It is intended to help to plan an operation by allowing surgeons to:
- Plan for shoulder arthroplasty cases
- i Position and select glenoid and humeral implants,
- -Simulate the prosthetic range of motion,
- Interact with implants and different computed measurements i
- Design a patient specific guide for the glenoid component when appropriate.
Materials
The commercially available BLUEPRINT™ Glenoid Guides are manufactured from titanium (Ti6A14V) according to ISO 5832-3.
Intended Use
Hardware
The BLUEPRINT™ Glenoid Guides are intended to be used as surgical instruments to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patientspecific preoperative CT scans.
Tornier SAS. BLUEPRINT™ Patient Specific Instrumentation
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Image /page/5/Picture/0 description: The image shows the word "TORNIER" in a large, blue, sans-serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of it. The letter "T" is also blue and is made up of two concentric hexagons. The logo is simple and modern.
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.
Indications For Use
Hardware
The BLUEPRINT™ 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 or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
Software
BLUEPRINT™ 3D Planning Software is a medical device for surgeons. BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format.
BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data.
BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific guides based on the pre-surgical plan.
BLUEPRINT™ 3D Planning Software leads to the generation of a planning report.
BLUEPRINT™ 3D Planning Software is to be used for adult men and women only whose bone maturity is reached and should not be used for diagnostic purpose.
Note: Measures and patient specific guide design are provided depending on the case profiles.
Comparison to Predicate Device
The subject device BLUEPRINT™ Patient Specific Instrumentation and the predicate device BLUEPRINT™ Patient Specific Instrumentation (K162800) have the same intended use, similar principal of operation and similar general technological features.
The subject device has similar manual segmentation as the reference device PROPHECY INVISION Pre-operative Navigation System.
Differences for subject BLUEPRINT™ Patient Specific Instrumentation include:
- For the hardware: nonfunctional dimensions, addition of a new guide reference similar to the predicate device, and packaging/label changes for clarity
Tornier SAS. BLUEPRINT™ Patient Specific Instrumentation
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Image /page/6/Picture/0 description: The image shows the word "TORNIER" in a large, bold, blue font. To the right of the word is a blue hexagon with a stylized letter "T" inside. The letter "T" is also blue and has a smaller version of itself inside.
- For the software, additional measurements, interaction with an application for automatic processing and an application for manual processing, and additional compatible Wright-Tornier implants.
Performance data
Technological differences between the subject and predicate hardware devices are supported by the dimensional and cadaveric tests performed on the predicate device hardware (K162800) which remain applicable to the subject hardware device as the changes to the subject device do not impact functional dimensions or material.
Technological differences between the subject and predicate software devices are supported with verification and validation evaluations. The operating principle of the subject device is the same as that of the predicate device.
The differences in design specifications do not raise new questions of safety and effectiveness over the predicate device as demonstrated in validation testing.
Substantial equivalence conclusion
The subject device, the BLUEPRINT™ Patient Specific Instrumentation, does not raise new questions of safety or effectiveness. Differences in technological characteristics have been addressed with verification and validation testing. The results support substantial equivalence to the predicate BLUEPRINT™ Patient Specific Instrumentation (K162800, cleared June 10, 2016).