(129 days)
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. 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.
The provided document is a 510(k) premarket notification acceptance letter from the FDA for the Paradigm System. It primarily discusses the device's substantial equivalence to a predicate device (also named Paradigm System) and lists relevant regulations and testing standards.
Crucially, this document does NOT contain details about the acceptance criteria and the specific study performance that proves the device meets those criteria. It mentions "Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements," and lists some standards used for testing (e.g., IEC 60601-1, ISO 14971, ASTM F2554-22 for positional accuracy). However, it does not provide the actual quantitative acceptance criteria or the results from these studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text. While ASTM F2554-22 (Standard Practice For Measurement Of Positional Accuracy Of Computer Assisted Surgical Systems) is mentioned, the specific acceptance thresholds and the measured positional accuracy of the Paradigm System are not detailed.
- Sample size used for the test set and the data provenance: The document mentions "Non-Clinical Design Validation conducted in Cadaveric Model" but does not specify the sample size (number of cadavers, number of anatomical sites, etc.) or the provenance of the cadavers.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the study details are missing.
- Adjudication method for the test set: Not applicable as the study details are missing.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: The device is a stereotaxic image guidance system, not an AI-assisted diagnostic imaging system that would typically undergo MRMC studies with human readers. The document does not mention any AI components that would assist human readers in image interpretation. Its function is to guide surgical instruments, fusing real-time camera imaging with medical imagery (CT) and surgical navigation data.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes a system for surgical guidance, implying a human (surgeon) is always in the loop. It does not mention a standalone algorithm evaluation.
- The type of ground truth used: For positional accuracy, the ground truth would typically be established by highly accurate measurement systems (e.g., optical tracking systems, CMMs) in a controlled environment, not expert consensus or pathology in the traditional sense of diagnostic AI. The document mentions "Non-Clinical Design Validation conducted in Cadaveric Model," which suggests physical measurements against a known fiducial or planned trajectory.
- The sample size for the training set: Not applicable, as detailed information on any AI/machine learning components or their training is not provided. The system uses "preoperative imaging segmentation" but doesn't elaborate on whether this involves deep learning requiring a dedicated training set.
- How the ground truth for the training set was established: Not applicable, as information on training sets is missing.
In summary, the provided FDA letter confirms the clearance of the Paradigm System based on substantial equivalence but does not disclose the detailed performance study results or the specific acceptance criteria met by the device. These details would typically be found in the full 510(k) submission, which is not included here.
{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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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: ParadigmSystem (K222291) |
| Device Description: | The Paradigm System is a stereotaxic image guidance systemintended for the spatial positioning and orientation of spinal surgicalinstruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as thespine) with medical imagery (such as CT) and surgical navigationdata, such as predetermined instrument trajectories for preciseinstrument placement. |
| The Paradigm System encompasses non-sterile operating roomequipment 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 systemintended for the spatial positioning and orientation of spinal surgicalinstruments used by surgeons during open surgical procedures withappropriate bone preparation. The device is indicated for posteriorapproach spine surgery where reference to a rigid anatomicalstructure that can be identified on CT derived patient images forpedicle 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 ForUse | The Paradigm System is astereotaxic image guidance systemintended for the spatial positioningand orientation of spinal surgicalinstruments used by surgeons duringopen surgical procedures withappropriate bone preparation. Thedevice is indicated for posteriorapproach spine surgery wherereference to a rigid anatomicalstructure that can be identified onCT derived patient images forpedicle screw cannulation of thethoracic to sacrum vertebrae. | The Paradigm System is astereotaxic image guidance systemintended for the spatial positioningand orientation of spinal surgicalinstruments used by surgeons duringopen surgical procedures withappropriate bone preparation. Thedevice is indicated for posteriorapproach spine surgery wherereference to a rigid anatomicalstructure that can be identified onCT derived patient images forpedicle screw cannulation of thethoracic to sacrum vertebrae. | Same | |||
| Principle ofoperation | Paradigm System fuses high-resolution, real-time cameraimaging of the surgical site (such asthe spine) with medical imagery(such as CT) and surgical navigationdata, such as predeterminedinstrument trajectories for preciseinstrument placement. | Paradigm System fuses high-resolution, real-time cameraimaging of the surgical site (such asthe spine) with medical imagery(such as CT) and surgical navigationdata, such as predeterminedinstrument trajectories for preciseinstrument placement. | ||||
| The Paradigm System enablessurgical navigation of instrumentsrelative to the patient spinalanatomy by combining preoperativeimaging segmentation andintraoperative registration of thepatient's live anatomy. PreoperativeCT data is uploaded to the consoleand the system software generates a3D model of the patient's operativevertebrae. The 3D model is used forpreoperative planning such asimplant placements or instrumenttrajectories. During the procedure,once the patient's anatomy isexposed, the Prism Sensor Arrayacquires imaging to match thetopography of the live anatomy tothe 3D model. This intraoperativeregistration of live anatomy to the3D model creates a commoncoordinate space between the | The Paradigm System enablessurgical navigation of instrumentsrelative to the patient spinalanatomy by combining preoperativeimaging segmentation andintraoperative registration of thepatient's live anatomy. PreoperativeCT data is uploaded to the consoleand the system software generates a3D model of the patient's operativevertebrae. The 3D model is used forpreoperative planning such asimplant placements or instrumenttrajectories. During the procedure,once the patient's anatomy isexposed, the Prism Sensor Arrayacquires imaging to match thetopography of the live anatomy tothe 3D model. This intraoperativeregistration of live anatomy to the3D model creates a commoncoordinate space between the | Same | ||||
| Paradigm System(Subject Device) | Paradigm System(Predicate Device) | Comment | ||||
| preoperative CT data and the patientanatomy. This enables virtualinformation to be overlaid on thelive anatomy during the procedurefor intraoperative guidance. | preoperative CT data and the patientanatomy. This enables virtualinformation to be overlaid on thelive anatomy during the procedurefor intraoperative guidance. | |||||
| TechnicalComparison | Stereotaxic image guided surgicalnavigation system during spinesurgery. Preoperative CT data issegmented and a 3D model isgenerated. Preoperative planningcan be performed. Intraoperativeimage capture using reflectivemarkers on spinal instruments andregisters the patient's anatomy to thepreoperative 3D model forintraoperative guidance during theprocedure. | Stereotaxic image guided surgicalnavigation system during spinesurgery. Preoperative CT data issegmented and a 3D model isgenerated. Preoperative planningcan be performed. Intraoperativeimage capture using reflectivemarkers on spinal instruments andregisters the patient's anatomy to thepreoperative 3D model forintraoperative guidance during theprocedure. | Same | |||
| Components | Cart, Arm, Sensor Array, ExternalMonitor, Surgical Instruments,Software | Cart, Arm, Sensor Array, ExternalMonitor, Surgical Instruments,Software | Same | |||
| Energy Source | 120V | 120V | Same | |||
| SterilizationMethod -SurgicalInstruments | Steam | Steam | Same | |||
| Minimum SAL | 1 x 10-6 | 1 x 10-6 | Same | |||
| RequiredAccessories | Reflective Markers (NorthernDigital K033621) | Reflective Markers (NorthernDigital K033621) | Same | |||
| OptionalAccessories | Paradigm Drape | Any drape | New accessory, notrequired forParadigm Systemperformance | |||
| SterilizationMethod –drape | Ethylene Oxide | Not applicable | Requiredsterilization foroptional drapeaccessory | |||
| Minimum SAL | 1 x 10-6 | Not applicable | Required to claimsterile, single-usefor drape |
{6}------------------------------------------------
{7}------------------------------------------------
| Functional andSafety Testing: | Verification and Validation activities have been conducted to provide assurance that thedevice meets the performance requirements under the indications for use conditions. Proprioperformed the following testing to ensure the safety and effectiveness of the ParadigmSystem device:•Non-Clinical Hardware, Software, and Instrumentation Verification Tests•Non-Clinical Design Validation conducted in Cadaveric Model•Compliance Conformity AssessmentsThe following standards were used in testing: |
|---|---|
| •IEC 60601-1:2005/AMD1: 2012 and AMD2: 2020 Medical electrical equipment. Generalrequirements for basic safety and essential performance•IEC 60601-1-2:2014+ AMD:1 2020 Medical Electrical Equipment – Part 1-2, GeneralRequirements for Basic Safety and Essential Performance - Collateral StandardElectromagnetic Compatibility | |
| •IEC TS 60601-4-2: 2024 Medical Electrical Equipment – Part 4-2, Guidance andinterpretation - Electromagnetic immunity: performance of medical electrical equipmentand 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 UsabilityEngineering to Medical Devices, including Amendment 1•ISO 10993-1:2018 Biological evaluation of medical devices: Part 1: Evaluation and testingwithin 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 medicaldevice•ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurancein health care facilities•ASTM F2554-22 Standard Practice For Measurement Of Positional Accuracy Of ComputerAssisted Surgical Systems•ANSI/AAMI ST98:2022 Cleaning validation of healthcare products – Requirements fordevelopment 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 oxidesterilization | |
| Conclusion: | The Paradigm System intended use, indications for use, and fundamental scientifictechnology is the same as the predicate device. Performance, safety and usability testingdemonstrate that the differences between the subject device and the predicate device do notraise new risks of safety and effectiveness. |
§ 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).