(154 days)
No
The summary describes a mixed reality system for surgical guidance based on pre-operative CT scans and planning software. It focuses on visualization and real-time feedback using a head-mounted display and specialized instruments. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithmic learning. The performance studies focus on accuracy, repeatability, and functional testing, not on the performance metrics typically associated with AI/ML models (e.g., sensitivity, specificity, AUC).
Yes
The device aids surgeons in performing total shoulder arthroplasty, which is a medical procedure intended to treat or ameliorate a disease, injury, or medical condition, thus qualifying it as a therapeutic device.
No
Explanation: The device is intended for surgical visualization and guidance during total shoulder arthroplasty, specifically for guiding the placement of a glenoid pin. It aids in surgical procedures rather than diagnosing a condition.
No
The device description explicitly states that the system is composed of three main components: HOLOBLUEPRINT software, Microsoft® HoloLens 2 Goggles (hardware), and Instrumentation (hardware). It also mentions verification and validation of the hardware components.
Based on the provided information, the Blueprint® Mixed Reality system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Blueprint® System Function: The Blueprint® Mixed Reality system is used during surgery to visualize pre-operative plans and guide the placement of a pin in the patient's bone. It interacts directly with the patient's anatomy, not with specimens taken from the patient.
- Intended Use: The intended use clearly states its purpose is for use during Total Shoulder Arthroplasty to visualize pre-operative planning and guide pin placement. This is an intra-operative surgical guidance system.
Therefore, the Blueprint® Mixed Reality system falls under the category of a surgical guidance system or a medical device used for surgical planning and execution, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Blueprint® Mixed Reality system is indicated for use during Total Shoulder Arthroplasty using Stryker's FDA cleared implants that are also implants cleared for pre-operative planning with the Blueprint® Software. Blueprint® Mixed Reality system is intended to allow surgeons to visualize the Blueprint® 3D preoperative planning intra-operatively. Blueprint® Mixed Reality system is also indicated for stereotaxic surgery to guide the placement of a glenoid pin provided that registration between the patient's anatomical landmarks / surfaces can be established on the preoperative CT based plan. Blueprint® Mixed Reality system is to be only used for skeletally matured adult patients.
Product codes (comma separated list FDA assigned to the subject device)
OLO, LLZ
Device Description
The Blueprint® Mixed Reality system is used to intraoperatively display stereoscopic threedimensional images of the Blueprint shoulder arthroplasty preoperative plan and to guide and enable the insertion of a pin following the reaming axis aimed at preparing the glenoid fossa surface to facilitate the placement of the implant. The Blueprint Mixed Reality system allows the user to both see the patient in real-time and their internal boney anatomy displayed on seethrough screens of a head-mounted device (goggles).
The Blueprint Mixed Reality svstem assists surgeons in visualizing stereoscopic threedimensional images of the patient's boney anatomy and intraoperatively aid by guiding the pin during placement through real-time feedback.
The Blueprint Mixed Reality system is composed of three main components including the HOLOBLUEPRINT software, Microsoft® HoloLens 2 Goggles, and Instrumentation.
The Blueprint Mixed Reality system runs the HOLOBLUEPRINT software application on the Microsoft HoloLens 2 using Microsoft Windows Holographic Operating System. The Blueprint Mixed Reality system leverages the reference device by receiving planned glenoid cases as input for visualizing and guiding the placement of the pin during the shoulder arthroplasty procedure. The digital components of the system interface with specialized surgical instrumentation to enable intra-operative guidance through real-time feedback to the surgeon.
The components of the subject device are as follows:
HOLOBLUEPRINT™ Software
- . HOLOBLUEPRINT is designed and written by Tornier SAS specifically for use on the Microsoft HoloLens 2 goggles (hardware). The HOLOBLUEPRINT software is to be installed on the hardware to be used by the surgeon as part of the Blueprint Mixed Reality system.
HoloLens 2 goggles (HoloLens 2)
- . The HoloLens 2 is a Microsoft hardware that runs Microsoft Windows 10 Holographic Operating System. HoloLens 2 is a see-through, mixed reality headmounted smart glasses.
Instrumentations (Instruments)
There are four reusable instruments and one single-use (sterile) instrument designed specifically for use with the Blueprint Mixed Reality system (subject device). The subject device system instruments include a Glenoid Pin Guide, Glenoid Digitizer, Instruments Check Block, Coracoid Clamp, and a Depth Stop Pin (Sterile).
The subject device is compatible with all Tornier (Stryker) commercially FDA-cleared glenoid implants (Except Patient Matched Implants) available in the reference device (K211359). The compatibility of implants with the reference device was validated and verification was performed for glenoid guidance and visualization of the patient's boney anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
preoperative CT based plan
Anatomical Site
shoulder / glenoid
Indicated Patient Age Range
skeletally matured adult patients
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)
Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device. They include:
- Bench Testing conducted to demonstrate the HOLOBLUEPRINT™ software performs . as per the systems requirements and specifications. The accuracy and repeatability were tested.
- System Accuracy Validation The system was validated through cadaver testing to . determine its accuracy to establish the performance equivalency of the predicate device.
- Functional and Performance Testing the subject device was tested as required by IEC . 62304 standards and FDA Guidance document General Principles of Software Validation issued on January 11, 2002. The goal of the tests was as follows:
- Software Verification testing was performed to ensure all design outputs meet . specified requirements. The software for the subject device was considered a "moderate" level of concern as per the FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005).
- User needs Validation performed to ensure software specifications conform to . user needs and intended uses. The system was validated through cadaver and simulated use cases as per IEC 62366-1 standard. All requirements were met, and no new question of safety and effectiveness was raised.
- Systems Instruments testing was performed to confirm that all instruments .
- Biocompatibility, Cleaning, Sterilization, Packaging, and Shelf life for the subject device . instruments were assessed in accordance with recognized consensus standards.
The subject device components were also assessed in accordance with recognized consensus standards. All tests were successfully completed and passed.
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.
ExactechGPS® Total Shoulder Application (K173372)
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.
Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation (K211359)
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
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
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January 20, 2023
Tornier SAS Moyees Kamara Staff Specialist, Regulatory Affairs 161 rue LAVOISIER Montbonnot Saint Martin, 38330 France
Re: K222510
Trade/Device Name: Blueprint Mixed Reality system Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: December 20, 2022 Received: December 21, 2022
Dear Moyees Kamara:
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
1
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 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-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Shumava Ali -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222510
Device Name Blueprint® Mixed Reality system
Indications for Use (Describe)
Blueprint® Mixed Reality system is indicated for use during Total Shoulder Arthroplasty using Stryker's FDA cleared implants that are also implants cleared for pre-operative planning with the Blueprint® Mixed Reality system is intended to allow surgeons to visualize the Blueprint® 3D preoperative planning intra-operatively. Blueprint® Mixed Reality system is also indicated for stereotaxic surgery to guide the placement of a glenoid pin provided that registration between the patient's anatomical landmarks / surfaces can be established on the preoperative CT based plan. Blueprint® Mixed Reality system is to be only used for skeletally matured adult patients.
| 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 blue serif font, followed by a blue hexagon containing a stylized letter "T". The font is a classic serif style, with the letters evenly spaced and sized. The hexagon is a geometric shape with six sides, and the stylized "T" inside it is designed to complement the overall logo.
Date Prepared: August 17, 2022
Administrative Information
| Name: | Tornier SAS |
|---|---|
| Address: | 161 rue Lavoisier |
| 38330 Montbonnot Saint Martin | |
| France | |
| Contact Person: | Moyees Kamara, Jr. |
| Title: | Staff Specialist, Regulatory Affairs |
| Phone: | +1 240-869-8849 |
Device Information
| Name of Device: | Blueprint® Mixed Reality system |
|---|---|
| Common Name (s): | Orthopedic Stereotaxic Instrument |
| Regulatory Class: | II |
| Regulation: | 21 CFR 882.4560, Stereotaxic instrument |
| Product Codes: | OLO, LLZ |
Predicate Device Information
| Predicate: | ExactechGPS® Total Shoulder Application (K173372) |
|---|---|
| Reference Device: | Tornier Perform™ Patient-Matched Primary Reversed Glenoid and |
| BLUEPRINT™ Patient Specific Instrumentation (K211359) |
Device Description
The Blueprint® Mixed Reality system is used to intraoperatively display stereoscopic threedimensional images of the Blueprint shoulder arthroplasty preoperative plan and to guide and enable the insertion of a pin following the reaming axis aimed at preparing the glenoid fossa surface to facilitate the placement of the implant. The Blueprint Mixed Reality system allows the user to both see the patient in real-time and their internal boney anatomy displayed on seethrough screens of a head-mounted device (goggles).
The Blueprint Mixed Reality svstem assists surgeons in visualizing stereoscopic threedimensional images of the patient's boney anatomy and intraoperatively aid by guiding the pin during placement through real-time feedback.
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Image /page/4/Picture/0 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a logo consisting of a stylized letter "T" inside a hexagon. The logo is also colored in blue and has a modern, geometric design.
The Blueprint Mixed Reality system is composed of three main components including the HOLOBLUEPRINT software, Microsoft® HoloLens 2 Goggles, and Instrumentation.
The Blueprint Mixed Reality system runs the HOLOBLUEPRINT software application on the Microsoft HoloLens 2 using Microsoft Windows Holographic Operating System. The Blueprint Mixed Reality system leverages the reference device by receiving planned glenoid cases as input for visualizing and guiding the placement of the pin during the shoulder arthroplasty procedure. The digital components of the system interface with specialized surgical instrumentation to enable intra-operative guidance through real-time feedback to the surgeon.
The components of the subject device are as follows:
HOLOBLUEPRINT™ Software
- . HOLOBLUEPRINT is designed and written by Tornier SAS specifically for use on the Microsoft HoloLens 2 goggles (hardware). The HOLOBLUEPRINT software is to be installed on the hardware to be used by the surgeon as part of the Blueprint Mixed Reality system.
HoloLens 2 goggles (HoloLens 2)
- . The HoloLens 2 is a Microsoft hardware that runs Microsoft Windows 10 Holographic Operating System. HoloLens 2 is a see-through, mixed reality headmounted smart glasses.
Instrumentations (Instruments)
There are four reusable instruments and one single-use (sterile) instrument designed specifically for use with the Blueprint Mixed Reality system (subject device). The subject device system instruments include a Glenoid Pin Guide, Glenoid Digitizer, Instruments Check Block, Coracoid Clamp, and a Depth Stop Pin (Sterile).
The subject device is compatible with all Tornier (Stryker) commercially FDA-cleared glenoid implants (Except Patient Matched Implants) available in the reference device (K211359). The compatibility of implants with the reference device was validated and verification was performed for glenoid guidance and visualization of the patient's boney anatomy.
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Image /page/5/Picture/0 description: The image shows the word "TORNIER" in a large, blue, serif font. To the right of the word is a blue hexagon with a stylized "T" inside. The "T" is also blue and has a smaller hexagon inside of it.
Indications for Use
Blueprint® Mixed Reality system is indicated for use during Total Shoulder Arthroplasty using Stryker's FDA cleared implants that are also implants cleared for pre-operative planning with the Blueprint® Software. Blueprint® Mixed Reality system is intended to allow surgeons to visualize the Blueprint® 3D preoperative planning intra-operatively. Blueprint® Mixed Reality system is also indicated for stereotaxic surgery to guide the placement of a glenoid pin provided that registration between the patient's anatomical landmarks / surfaces can be established on the preoperative CT based plan. Blueprint® Mixed Reality system is to be only used for skeletally matured adult patients.
Contraindications
- Blueprint Mixed Reality system is not to be used for non-adult patients.
- Blueprint Mixed Reality system is not to be used for diagnostic purposes. .
- . Blueprint Mixed Reality system is not to be used with a range of implants other than commercially authorized and Mixed Reality compatible Stryker/Tornier implants.
- . Blueprint Mixed Reality system is not to be used by surgeons with a history of seizures or epilepsy
- Blueprint Mixed Reality system is not to be used by surgeons with vision issues that will ● not allow them to visualize the 3D interface clearly and comfortably.
- . Blueprint Mixed Reality system is unsuitable to be used on patients with insufficient coracoid bone stock which limits coracoid instrument fixation
Technological Characteristics Comparison to Predicate Device
The subject device, Blueprint Mixed Reality system, and the predicate device, ExactechGPS (K173372) share similar technological characteristics as follows:
- Intended Use and Indications for Use ●
- Principles of operations ●
- Target population and user ●
- General technological features
- Intraoperative use
- Main system components
- Surgical instruments for navigation with markers .
- . Device accuracy requirements
- Environmental use
- . Surgical Workflow and tracking system technology
Tornier SAS. Blueprint® Mixed Reality system
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Image /page/6/Picture/0 description: The image shows the logo for Tornier. The logo consists of the word "TORNIER" in large, blue, serif font, followed by a blue hexagon containing a stylized letter "T". The "T" within the hexagon is also blue and has a unique design, with a smaller hexagon shape inside the larger one.
The differences between the subject device, subject device, and predicate device include:
- . The camera positioning is a near-eye, head-mounted device (HoloLens 2) instead of a screen on a desktop monitor, mounted on a platform systems cart to display information to the surgeon.
- . The use of an active sensor versus passive sensors
- . The tracking system technology is RGB instead of visible images
The 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 technological characteristics do not raise new questions of safety and effectiveness over the predicate device as demonstrated in validation and verification testing performed.
Substantial Equivalence - Non-clinical Performance Evidence
Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device. They include:
- Bench Testing conducted to demonstrate the HOLOBLUEPRINT™ software performs . as per the systems requirements and specifications. The accuracy and repeatability were tested.
- System Accuracy Validation The system was validated through cadaver testing to . determine its accuracy to establish the performance equivalency of the predicate device.
- Functional and Performance Testing the subject device was tested as required by IEC . 62304 standards and FDA Guidance document General Principles of Software Validation issued on January 11, 2002. The goal of the tests was as follows:
- Software Verification testing was performed to ensure all design outputs meet . specified requirements. The software for the subject device was considered a "moderate" level of concern as per the FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005).
- User needs Validation performed to ensure software specifications conform to . user needs and intended uses. The system was validated through cadaver and simulated use cases as per IEC 62366-1 standard. All requirements were met, and no new question of safety and effectiveness was raised.
- Systems Instruments testing was performed to confirm that all instruments .
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Image /page/7/Picture/0 description: The image shows the word "TORNIER" in a blue serif font, followed by a blue hexagon containing a stylized "T" inside. The font is a classic serif, with a slightly condensed appearance. The hexagon is a simple geometric shape, and the stylized "T" inside is a modern design.
satisfy functional and performance requirements.
- Biocompatibility, Cleaning, Sterilization, Packaging, and Shelf life for the subject device . instruments were assessed in accordance with recognized consensus standards.
The subject device components were also assessed in accordance with recognized consensus standards. All tests were successfully completed and passed.
Substantial Equivalence - Clinical Evidence
Clinical testing was not deemed necessary for the determination of substantial equivalence.
Substantial Equivalence - Conclusions
The Blueprint Mixed Reality system (subject device) does not raise new questions of safety or effectiveness. Differences in technological characteristics have been addressed with performance testing. The results of performance testing for the subject device support substantial equivalence to the predicate device, ExactechGPS (K173372, cleared November 24, 2017).