(205 days)
Yes
The document explicitly mentions an "Initial Auto-segmentation module for revision cases containing metallic prosthesis," which is a common application of AI/ML in medical image processing.
No.
The device is a pre-surgical planner and patient-specific drill guides for shoulder replacement surgery, which are tools to assist a therapeutic procedure, but are not therapeutic themselves.
No
The "Intended Use / Indications for Use" section explicitly states, "Blueprint® is to be used for adult men and women patients 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® (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 Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device's Intended Use: The BLUEPRINT™ Patient Specific Instrumentation is intended for pre-surgical planning and guiding the placement of implants during shoulder replacement surgery. It uses patient-specific anatomical data from CT scans to create guides and plans for the surgical procedure.
- Lack of Specimen Examination: The device does not involve the examination of specimens taken from the human body. It operates on imaging data (CT scans) and assists in a surgical procedure.
Therefore, the device falls under the category of surgical planning and guidance systems, not In Vitro Diagnostics.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for 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 patient-specific preoperative CT scans.
Software: Blueprint® is an application that helps a surgeon plan their patients' shoulder prosthesis surgery. When possible, it generates the information required to produce patient specific components.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS, QHE
Device Description
BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and Blueprint® (software).
Hardware: The BLUEPRINT ™ Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software Blueprint®.
Software: Blueprint® 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
- Position and select glenoid and humeral implants,
- Simulate the prosthetic range of motion,
- Interact with implants and different computed measurements,
- Generate information required to design a patient-specific glenoid components when appropriate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan images showing the anatomical shoulder structure in a DICOM format.
Anatomical Site
Shoulder
Indicated Patient Age Range
adult men and women patients only whose bone maturity is reached
Intended User / Care Setting
orthopedic 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 software devices are supported by software verification and validation activities. These activities include functional tests, validation and compatibility for new implant integration, as well as the validation and reproducibility of anatomical measures, planning measures, planning features, and segmentation. The operating principle of the subject device is the same as that of the predicate device. The differences in design specifications do not raise different 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.
K111902, K160975, K150583, K151293, K140478, K132285, K100142, K081059, K061439, K050316, K030941, K140082, K122698, K143552, K183696, K201315, K191318, K211359, K220418, K202289
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
February 21, 2024
Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Tornier SAS Aymen Azaiez Principal Regulatory Affairs Specialist 161 Rue Lavoisier Montbonnot Saint Martin, 38330 France
Re: K232265
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: PHX, KWS, QHE Dated: January 22, 2024 Received: January 23, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and 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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Joseph P. Joseph P. Russell -S Russell -s Date: 2024.02.21 14:12:55 -05'00"
for: Farzana Sharmin, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232265
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® is a medical device for surgeons.
Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery.
Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format.
Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data.
Blueprint® allows surgeons to design patient specific instruments and Tornier Perform patient-matched primary reversed glenoid*) based on the pre-surgical plan.
Blueprint® leads to the generation of a planning report.
Blueprint® is to be used for adult men and women patients 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.
- Only if patient-specific instruments or Tornier Perform patient-matched primary reversed glenoid are available in your geography.
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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Summary of Safety and Effectiveness information Traditional 510(k) Premarket – BLUEPRINTTM Patient Specific Instrumentation
Date Prepared: February 21, 2024
Device name
BLUEPRINT™ Patient Specific Instrumentation Trade name: Common name: Patient Specific Instrumentation + Blueprint® 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@stryker.com |
Classification
| Device class: | Class II |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | PHX, KWS, QHE |
Equivalent / Predicate device
| Trade name | 510(k)
Number | Decision date | Applicant |
|--------------------------------------------------------------|------------------|-------------------|----------------|
| BLUEPRINTTM Patient Specific
Instrumentation (PRIMARY) | K211359 | November 12, 2021 | TORNIER
SAS |
| BLUEPRINTTM Patient Specific
Instrumentation (Additional) | K203315 | April 15, 2021 | TORNIER
SAS |
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Image /page/4/Picture/1 description: The image shows the word "TORNIER" in large, blue, sans-serif font, followed by a blue hexagon containing a stylized letter "T". The letter "T" inside the hexagon is also blue and has a unique design with geometric shapes. The overall design appears to be a logo or brand mark.
Device description
BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and Blueprint® (software).
BLUEPRINT™ Patient Specific Instrumentation which includes the BLUEPRINT™ Glenoid Guides and Blueprint® is the responsibility of Tornier SAS is the legal manufacturer for the hardware and the software.
Hardware
The BLUEPRINT ™ Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of glenoid prostheses.
The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software Blueprint®.
Software
Blueprint® 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
- Position and select glenoid and humeral implants, -
- . Simulate the prosthetic range of motion,
- Interact with implants and different computed measurements,
- Generate information required to design a patient-specific glenoid components when । appropriate.
Compatible Implants
The software can be used with the following the commercially available Stryker implants:
- Aequalis PerFORM Shoulder System (K111902), -
- Aequalis PerFORM+ Shoulder System (K160975 / K150583), -
- Aequalis Reversed Shoulder Prothesis (K151293 / K140478 / K132285 / K100142 / -K081059 / K061439 / K050316 / K030941),
- Aequalis Ascend Flex Shoulder System (K151293 / K140082 / K122698), -
- -Simpliciti Shoulder System (K143552).
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- Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed -Glenoid (K183696)
- Perform® Humeral System Stem (K201315) -
- -Aequalis™ Flex Revive Shoulder System (K191318)
- TORNIER PERFORM™ Patient-Matched Primary Reversed (K211359) -
- Tornier Perform® Humeral System Stemless (K220418) -
- -ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K202289)
Materials
The commercially available BLUEPRINT™ Glenoid Guides are manufactured from titanium (Ti6Al4V) 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.
Software
Blueprint® is an application that helps a surgeon plan their patients' shoulder prosthesis surgery. When possible, it generates the information required to produce patient specific components.
Indications
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® is a medical device for surgeons.
Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format.
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Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint® allows surgeons to design patient specific components (patient-specific instruments and Tornier Perform Patient-Matched Primary Reversed Glenoid*) based on the pre-surgical plan.
Blueprint® leads to the generation of a planning report.
Blueprint® is to be used for adult men and women patients 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. *Only if patient-specific instruments or Tornier Perform
Patient-Matched Primary Reversed Glenoid are available in your geography.
Comparison to Predicate Device
The subject device BLUEPRINT™ Patient Specific Instrumentation and the predicate device BLUEPRINT™ Patient Specific Instrumentation (K211359) have the same intended use, similar principal of operation and similar general technological features.
The subject device hardware is identical to the predicate device hardware.
Differences for subject device software include:
- Initial Auto-segmentation module for revision cases containing metallic prosthesis.
- User planning preferences settings ı
Performance data
Technological differences between the subject and predicate software devices are supported by software verification and validation activities. These activities include functional tests, validation and compatibility for new implant integration, as well as the validation and reproducibility of anatomical measures, planning measures, planning features, and segmentation. The operating principle of the subject device is the same as that of the predicate device.
The differences in design specifications do not raise different 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 by software verification and validation activities. The results support substantial equivalence to the predicate BLUEPRINT™ Patient Specific Instrumentation (K211359, cleared November 12, 2021).