(72 days)
Not Found
No.
The provided text explicitly states "Mentions AI, DNN, or ML: Not Found". While the system uses advanced image processing and 3D modeling for surgical guidance, there is no mention of an AI model being used for these functions or any other part of the device's operation.
No.
The device is described as a "stereotaxic image guidance system" intended for "spatial positioning and orientation of spinal surgical instruments," which aids surgeons during procedures. It does not provide therapy itself but rather guides the use of other instruments.
No
The device is described as an image guidance system for spatial positioning and orientation of surgical instruments, fusing real-time camera imaging with medical imagery (CT) for precise instrument placement and intraoperative guidance. It assists surgeons during procedures but does not diagnose conditions.
No
The device is not a software-only medical device because the description explicitly states it encompasses "non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories," indicating significant hardware components beyond just software. It also mentions an "external monitor," "Prism Sensor Array," and "real-time camera imaging."
No.
The device is an image guidance system for surgical instrument positioning and does not involve in vitro examination of specimens.
N/A
Intended Use / Indications for Use
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement.
The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories.
The Paradigm System is used with an external monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Spinal, thoracic to sacrum vertebrae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons / Open surgical procedures
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)
Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions and to establish substantial equivalence with the predicate. Proprio performed the following testing to ensure the safety and effectiveness of the Paradigm System:
- Non-Clinical Verification Tests
- Non-Clinical Design Validation
- Compliance Conformity Assessments
The following standards were used in testing:
- IEC 62366-1: 2015/AMD1:2020 Medical Devices – Part 1: Application of Usability Engineering to Medical Devices, including Amendment 1
- ISO 10993-1:2018 Biological evaluation of medical devices: Part 1: Evaluation and testing within a risk management process
- ISO 14971:2019 Medical devices – Application of risk management to medical devices
- ISO 17665-1:2006 Sterilization of health care products – Moist heat – Part:1 Requirements for the development, validation and routine control of a sterilization process for medical device
- ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ASTM F2554-22 Standard Practice For Measurement Of Positional Accuracy Of Computer Assisted Surgical Systems
- ANSI/AAMI ST98:2022 Cleaning validation of healthcare products – Requirements for development and validation of a cleaning process for medical devices
- IEC 62304 Edition 1.1 2015-06 Medical device software – Software life cycle processes
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.
Paradigm System (K243258)
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.
Not Found
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).
FDA 510(k) Clearance Letter - Paradigm System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 4, 2025
Proprio, Inc.
Shannon Eubanks
Vice President, Systems Engineering & Regulatory
111 W. John St., Suite 308
Seattle, Washington 98119
Re: K250879
Trade/Device Name: Paradigm System
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: April 4, 2025
Received: April 7, 2025
Dear Shannon Eubanks:
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"
Page 2
K250879 - Shannon Eubanks Page 2
(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).
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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
Page 3
K250879 - Shannon Eubanks Page 3
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K250879
Device Name
Paradigm System
Indications for Use (Describe)
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary Statement
Submitter: Proprio, Inc.
Contact Person: Shannon Eubanks
VP of Systems Engineering and Regulatory
Phone: (425) 802-6063
Email: seubanks@propriovision.com
Trade Name: Paradigm System
Common Name: Orthopedic stereotaxic instrument
Classification: Class II
Product Code: OLO
Regulation: 21 CFR 882.4560
Predicate Device(s): The subject device is equivalent to the following device: Paradigm System (K243258)
Device Description: The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement.
The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories.
The Paradigm System is used with an external monitor.
Indications For Use: The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.
K250879 Page 1 of 4
Page 6
| Paradigm System (Subject Device) | Paradigm System (Predicate Device) | Comment |
|---|---|---|
| Device Overview | ||
| 510(k) Number Decision Date | K250879 | K243258 February 21, 2025 |
| Manufacturer | Proprio, Inc. | Proprio, Inc. |
| Classification | Class II | Class II |
| Product Code | OLO | OLO |
| Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Medical Specialty | Neurology | Neurology |
| Indications For Use | The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae. | The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae. |
| Principle of operation | Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement. The Paradigm System enables surgical navigation of instruments relative to the patient spinal anatomy by combining preoperative imaging segmentation and intraoperative registration of the patient's live anatomy. Preoperative CT data is uploaded to the console and the system software generates a 3D model of the patient's operative vertebrae. The 3D model is used for preoperative planning such as implant placements or instrument trajectories. During the procedure, once the patient's anatomy is exposed, the Prism Sensor Array acquires imaging to match the topography of the live anatomy to the 3D model. This intraoperative registration of live anatomy to the 3D model creates a common coordinate space between the | Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement. The Paradigm System enables surgical navigation of instruments relative to the patient spinal anatomy by combining preoperative imaging segmentation and intraoperative registration of the patient's live anatomy. Preoperative CT data is uploaded to the console and the system software generates a 3D model of the patient's operative vertebrae. The 3D model is used for preoperative planning such as implant placements or instrument trajectories. During the procedure, once the patient's anatomy is exposed, the Prism Sensor Array acquires imaging to match the topography of the live anatomy to the 3D model. This intraoperative registration of live anatomy to the 3D model creates a common coordinate space between the |
K250879 Page 2 of 4
Page 7
| Paradigm System (Subject Device) | Paradigm System (Predicate Device) | Comment |
|---|---|---|
| Device Overview | ||
| 510(k) Number Decision Date | K250879 | K243258 February 21, 2025 |
| Manufacturer | Proprio, Inc. | Proprio, Inc. |
| Classification | Class II | Class II |
| Product Code | OLO | OLO |
| Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Medical Specialty | Neurology | Neurology |
| Indications For Use | The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae. | The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae. |
| Principle of operation | Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement. | Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement. |
| The Paradigm System enables surgical navigation of instruments relative to the patient spinal anatomy by combining preoperative imaging segmentation and intraoperative registration of the patient's live anatomy. Preoperative CT data is uploaded to the console and the system software generates a 3D model of the patient's operative vertebrae. The 3D model is used for preoperative planning such as implant placements or instrument trajectories. During the procedure, once the patient's anatomy is exposed, the Prism Sensor Array acquires imaging to match the topography of the live anatomy to the 3D model. This intraoperative registration of live anatomy to the 3D model creates a common coordinate space between the | The Paradigm System enables surgical navigation of instruments relative to the patient spinal anatomy by combining preoperative imaging segmentation and intraoperative registration of the patient's live anatomy. Preoperative CT data is uploaded to the console and the system software generates a 3D model of the patient's operative vertebrae. The 3D model is used for preoperative planning such as implant placements or instrument trajectories. During the procedure, once the patient's anatomy is exposed, the Prism Sensor Array acquires imaging to match the topography of the live anatomy to the 3D model. This intraoperative registration of live anatomy to the 3D model creates a common coordinate space between the |
K250879 Page 2 of 4
Page 8
| Paradigm System (Subject Device) | Paradigm System (Predicate Device) | Comment |
|---|---|---|
| preoperative CT data and the patient anatomy. This enables virtual information to be overlaid on the live anatomy during the procedure for intraoperative guidance. | preoperative CT data and the patient anatomy. This enables virtual information to be overlaid on the live anatomy during the procedure for intraoperative guidance. | |
| Technical Comparison | Stereotaxic image guided surgical navigation system during spine surgery. Preoperative CT data is segmented and a 3D model is generated. Preoperative planning can be performed. Intraoperative image capture using reflective markers on spinal instruments and registers the patient's anatomy to the preoperative 3D model for intraoperative guidance during the procedure. | Stereotaxic image guided surgical navigation system during spine surgery. Preoperative CT data is segmented and a 3D model is generated. Preoperative planning can be performed. Intraoperative image capture using reflective markers on spinal instruments and registers the patient's anatomy to the preoperative 3D model for intraoperative guidance during the procedure. |
| Components | Cart, Arm, Sensor Array, External Monitor, Surgical Instruments, Software | Cart, Arm, Sensor Array, External Monitor, Surgical Instruments, Software |
| Instruments | Dynamic Reference Frames, Awl, Pedicle Probes Drill Guide, Drill Bits, Depth Cannulas, Trocar | Dynamic Reference Frames, Awl, Pedicle Probes |
| Energy Source | 120V | 120V |
| Sterilization Method – Surgical Instruments | Steam | Steam |
| Minimum SAL | 1 x 10⁻⁶ | 1 x 10⁻⁶ |
| Required Accessories | Reflective Markers (Northern Digital K033621) | Reflective Markers (Northern Digital K033621) |
| Optional Accessories | Paradigm Drape | Paradigm Drape |
| Sterilization Method – drape | Ethylene Oxide | Ethylene Oxide |
| Minimum SAL | 1 x 10⁻⁶ | 1 x 10⁻⁶ |
K250879 Page 3 of 4
Page 9
Functional and Safety Testing:
Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions and to establish substantial equivalence with the predicate. Proprio performed the following testing to ensure the safety and effectiveness of the Paradigm System:
- Non-Clinical Verification Tests
- Non-Clinical Design Validation
- Compliance Conformity Assessments
The following standards were used in testing:
- IEC 62366-1: 2015/AMD1:2020 Medical Devices – Part 1: Application of Usability Engineering to Medical Devices, including Amendment 1
- ISO 10993-1:2018 Biological evaluation of medical devices: Part 1: Evaluation and testing within a risk management process
- ISO 14971:2019 Medical devices – Application of risk management to medical devices
- ISO 17665-1:2006 Sterilization of health care products – Moist heat – Part:1 Requirements for the development, validation and routine control of a sterilization process for medical device
- ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ASTM F2554-22 Standard Practice For Measurement Of Positional Accuracy Of Computer Assisted Surgical Systems
- ANSI/AAMI ST98:2022 Cleaning validation of healthcare products – Requirements for development and validation of a cleaning process for medical devices
- IEC 62304 Edition 1.1 2015-06 Medical device software – Software life cycle processes
Conclusion: The Paradigm System intended use, indications for use, and fundamental scientific technology is the same as the predicate device. Performance, safety and usability testing demonstrate that the differences between the subject device and the predicate device do not raise new risks of safety and effectiveness.
K250879 Page 4 of 4