(129 days)
No
The summary describes a stereotaxic image guidance system that fuses real-time camera imaging with medical imagery and surgical navigation data. There is no mention of AI, ML, or related terms, nor is there any description of training or test sets typically associated with AI/ML development. The performance studies focus on verification and validation of hardware, software, and instrumentation, not on the performance metrics common for AI/ML algorithms.
No.
The device is an image guidance system intended for spatial positioning and orientation of surgical instruments, which aids surgeons during procedures but does not directly treat a disease or condition.
No
The Paradigm System is an image guidance system used for spatial positioning and orientation of surgical instruments during spine surgery, not for diagnosing medical conditions. Its purpose is to aid in precise instrument placement, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that 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," indicating the presence of hardware components beyond just software. The performance studies also include "Non-Clinical Hardware, Software, and Instrumentation Verification Tests."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Paradigm System is a surgical navigation system used during surgery to guide instruments based on medical images. It does not perform any tests on patient samples outside the body.
- Intended Use: The intended use clearly states it's for "spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures." This is a surgical guidance function, not a diagnostic test.
Therefore, the Paradigm System falls under the category of surgical guidance or navigation systems, not In Vitro Diagnostics.
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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT derived patient images
Anatomical Site
Spinal, thoracic to sacrum vertebrae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons during 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
Non-Clinical Design Validation conducted in Cadaveric Model
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. Proprio performed the following testing to ensure the safety and effectiveness of the Paradigm System device:
•Non-Clinical Hardware, Software, and Instrumentation Verification Tests
•Non-Clinical Design Validation conducted in Cadaveric Model
•Compliance Conformity Assessments
Key Results: 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.
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.
Northern Digital K033621
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Below the FDA logo is the word "ADMINISTRATION".
February 21, 2025
Proprio, Inc. Shannon Eubanks Vice President, Hardware Engineering and Regulatory 111 W. John St., Suite 308 Seattle, Washington 98119
Re: K243258
Trade/Device Name: Paradigm System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 22, 2025 Received: January 23, 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" (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.
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 Rue"). 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-device-advicecomprehensive-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-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
2
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
3
Indications for Use
Submission Number (if known)
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)
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4
Traditional 510(k) Summary
| Submitter: | Proprio, Inc. |
|---|---|
| Contact Person: | Shannon Eubanks |
| VP of HW 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 (K222291) | |
| 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. |
5
| | Paradigm System
(Subject Device) | Paradigm System
(Predicate Device) | Comment | | | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Device Overview | | | | | | |
| 510(k) Number | K243258 | K222291 | | | | |
| Decision Date | | April 21, 2023 | | | | |
| Manufacturer | Proprio, Inc. | Proprio, Inc. | | | | |
| Classification | Class II | Class II | Same | | | |
| Product Code | OLO | OLO | Same | | | |
| Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 | Same | | | |
| Medical Specialty | Neurology | Neurology | Same | | | |
| 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. | Same | | | |
| | 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 | Same | |
| | | | | 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. | Same |
| | | Components | | Cart, Arm, Sensor Array, External
Monitor, Surgical Instruments,
Software | Cart, Arm, Sensor Array, External
Monitor, Surgical Instruments,
Software | Same |
| | | Energy Source | | 120V | 120V | Same |
| Sterilization
Method -
Surgical
Instruments | | Steam | Steam | Same | | |
| Minimum SAL | 1 x 10-6 | 1 x 10-6 | Same | | | |
| Required
Accessories | Reflective Markers (Northern
Digital K033621) | Reflective Markers (Northern
Digital K033621) | Same | | | |
| Optional
Accessories | Paradigm Drape | Any drape | New accessory, not
required for
Paradigm System
performance | | | |
| Sterilization
Method –
drape | Ethylene Oxide | Not applicable | Required
sterilization for
optional drape
accessory | | | |
| Minimum SAL | 1 x 10-6 | Not applicable | Required to claim
sterile, single-use
for drape | | | |
6
7
| 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. Proprio
performed the following testing to ensure the safety and effectiveness of the Paradigm
System device:
•Non-Clinical Hardware, Software, and Instrumentation Verification Tests
•Non-Clinical Design Validation conducted in Cadaveric Model
•Compliance Conformity Assessments
The following standards were used in testing: |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | •IEC 60601-1:2005/AMD1: 2012 and AMD2: 2020 Medical electrical equipment. General
requirements for basic safety and essential performance
•IEC 60601-1-2:2014+ AMD:1 2020 Medical Electrical Equipment – Part 1-2, General
Requirements for Basic Safety and Essential Performance - Collateral Standard
Electromagnetic Compatibility |
| | •IEC TS 60601-4-2: 2024 Medical Electrical Equipment – Part 4-2, Guidance and
interpretation - Electromagnetic immunity: performance of medical electrical equipment
and medical electrical systems
•IEC 60601-1-6:2010/AMD1:2013 and AMD2:2020 Medical Electrical Equipment - Part 1-
6, General Requirements for Basic Safety and Essential Performance - Usability
•IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and |
| | requirements
•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 |
| | •ISO 11135:2014 Sterilization of health-care products - Ethylene oxide
•ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1
•IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes
•AAMI TIR 28: 2016 Product adoption and process equivalence for ethylene oxide
sterilization |
| 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. |