Paradigm System

K222291 · Proprio, Inc. · OLO · Apr 21, 2023 · Neurology

Device Facts

• Record ID: K222291
• Device Name: Paradigm System
• Applicant: Proprio, Inc.
• Product Code: OLO · Neurology
• Decision Date: Apr 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

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.

Device Story

Paradigm System is a stereotaxic image guidance system for spinal surgery. Inputs: preoperative CT scans; real-time camera imaging of surgical site via Prism Sensor Array. Operation: system segments CT data to generate 3D models of vertebrae; intraoperative registration matches live anatomy topography to 3D model; creates common coordinate space; overlays virtual information onto live anatomy for guidance. Output: visual display on external monitor showing instrument position/orientation relative to patient anatomy. Used in OR by surgeons. Benefits: precise instrument placement during pedicle screw cannulation; improved spatial positioning.

Clinical Evidence

Bench testing only. Evidence includes non-clinical hardware, software, and instrumentation verification tests, and non-clinical design validation conducted in a cadaveric model (cadaveric simulated workflow study). Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60825-1, IEC 62366-1, ISO 10993-1, ISO 14971, ISO 17665-1, AAMI/ANSI ST79, and ASTM F2554-18.

Technological Characteristics

Stereotaxic image-guided navigation system. Components: cart, arm, Prism Sensor Array, external monitor, surgical instruments. Energy: 120V. Sterilization: Steam (SAL 1x10^-6). Connectivity: Preoperative CT data upload to console. Software: 3D model generation via segmentation of CT data; intraoperative registration of live anatomy. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60825-1, IEC 62366-1, ISO 10993-1, ISO 14971, ISO 17665-1, AAMI/ANSI ST79, ASTM F2554-18.

Indications for Use

Indicated for patients undergoing posterior approach spine surgery requiring pedicle screw cannulation of thoracic to sacrum vertebrae, where rigid anatomical structures are identifiable on CT images.

Regulatory Classification

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.

Predicate Devices

• Envision 3DTM: Image Guidance System (K162375)

Reference Devices

• Reflective Markers (Northern Digital K033621)

Submission Summary (Full Text)

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April 21, 2023

Proprio, Inc. Shannon Eubanks Vice President, HW Engineering and Regulatory 111 W John Street Suite 308 Seattle, Washington 98119

Re: K222291

Trade/Device Name: Paradigm System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 20, 2023 Received: March 22, 2023

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 (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

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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 ([e-mail]) or phone [phone] 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

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### Indications for Use

510(k) Number (if known) K22291

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)

| <span style="font-size:10pt;"></span> | <span style="font-size:10pt;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt;"></span> | <span style="font-size:10pt;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## K222291

# 2.0 510(k) Summary/Statement

## Table 1: 510(k) Summary

| Submitter: | Proprio, Inc |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shannon Eubanks<br>VP of HW Engineering and Regulatory<br>Phone: [phone]<br>E-mail: [e-mail] |
| Trade Name: | Paradigm System |
| Common Name: | Orthopedic stereotaxic instrument |
| Classification: | Class II |
| Product Code: | OLO |
| Regulation | 21 CFR 882.4650 |
| Predicate Device(s): | The subject device is equivalent to the following device:<br>Envision 3DTM: Image Guidance System (K162375) |
| Device Description: | The Paradigm System is a stereotaxic image guidance system intended<br>for the spatial positioning and orientation of spinal surgical instruments<br>used by surgeons. The Paradigm System fuses high-resolution, real-time<br>camera imaging of the surgical site (such as the spine) with medical<br>imagery (such as CT) and surgical navigation data, such as<br>predetermined instrument trajectories for precise instrument placement.<br>The Paradigm System encompasses non-sterile operating room<br>equipment components as well as sterilizable, reusable instruments, and<br>off-the-shelf sterile-packaged, single-use accessories.<br>The Paradigm System is used with an external monitor. |
| Indication for Use: | The Paradigm System is a stereotaxic image guidance system intended for<br>the spatial positioning and orientation of spinal surgical instruments used<br>by surgeons during open surgical procedures with appropriate bone<br>preparation. The device is indicated for posterior approach spine surgery<br>where reference to a rigid anatomical structure that can be identified on<br>CT derived patient images for pedicle screw cannulation of the thoracic to<br>sacrum vertebrae. |

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| | Paradigm System<br>(Subject Device) | Envision 3DTM: Image<br>Guidance System<br>(Predicate Device) | Comment |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Device Overview | | | |
| 510(k) Number | To be determined | K162375 | |
| Decision Date | | December 29, 2016 | |
| Manufacturer | Proprio, Inc | 7D Surgical, 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<br>Use | The Paradigm System is a stereotaxic<br>image guidance system intended for the<br>spatial positioning and orientation of<br>spinal surgical instruments used by<br>surgeons during open surgical procedures<br>with appropriate bone preparation. The<br>device is indicated for posterior approach<br>spine surgery where reference to a rigid<br>anatomical structure that can be<br>identified on CT derived patient images<br>for pedicle screw cannulation of the<br>thoracic to sacrum vertebrae. | The Envision 3DTM: Image<br>Guidance System is a stereotaxic<br>image guidance system intended<br>for the spatial positioning and<br>orientation of neurosurgical<br>instruments used by surgeons.<br>The system is also intended to be<br>used as the primary surgical<br>luminaire during image guided<br>surgery. The device is indicated<br>for posterior approach spine<br>surgery where reference to a<br>rigid anatomical structure can be<br>identified. | Subject device is<br>not the primary<br>luminaire. |

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| | Paradigm System<br>(Subject Device) | Envision 3DTM: Image<br>Guidance System<br>(Predicate Device) | Comment |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of<br>operation | Paradigm System fuses high-<br>resolution, real-time camera imaging<br>of the surgical site (such as the spine)<br>with medical imagery (such as CT)<br>and surgical navigation data, such as<br>predetermined instrument trajectories<br>for precise instrument placement.<br><br>The Paradigm System enables surgical<br>navigation of instruments relative to<br>the patient spinal anatomy by<br>combining preoperative imaging<br>segmentation and intraoperative<br>registration of the patient's live<br>anatomy. Preoperative CT data is<br>uploaded to the console and the system<br>software generates a 3D model of the<br>patient's operative vertebrae. The 3D<br>model is used for preoperative<br>planning such as implant placements<br>or instrument trajectories. During the<br>procedure, once the patient's anatomy<br>is exposed, the Prism Sensor Array<br>acquires imaging to match the<br>topography of the live anatomy to the<br>3D model. This intraoperative<br>registration of live anatomy to the 3D<br>model creates a common coordinate<br>space between the preoperative CT<br>data and the patient anatomy. This<br>enables virtual information to be<br>overlaid on the live anatomy during<br>the procedure for intraoperative<br>guidance. | The Envision 3D system<br>provides image registration<br>between preoperative scan data<br>and data captured<br>intraoperatively from the<br>Envision 3DTM integrated<br>structured light scanner<br>and/or user selected points. The<br>system provides guidance data<br>by displaying the<br>locations of wireless optically<br>tracked Envision 3DTM Spinal<br>Instruments (examples<br>include pedicle probe and awl)<br>relative to the patient. Position<br>and orientation data of<br>tracked Envision 3DTM Spinal<br>Instruments are linked to the<br>preoperative scan data using<br>the Envision 3DTM workstation. | Subject device<br>uses light field<br>where predicate<br>uses structured<br>light scanner.<br>Subject device<br>segments each<br>vertebra where the<br>predicate as if it<br>were a single<br>anatomical body. |
| Technical<br>Comparison | Stereotaxic image guided surgical<br>navigation system during spine | Stereotaxic image guided<br>surgical navigation system | Subject device has<br>option for |

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| | Paradigm System<br>(Subject Device) | Envision 3D™: Image<br>Guidance System<br>(Predicate Device) | Comment |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| | surgery. Preoperative CT data is<br>segmented and a 3D model is<br>generated. Preoperative planning can<br>be performed. Intraoperative image<br>capture using reflective markers on<br>spinal instruments and registers the<br>patient's anatomy to the preoperative<br>3D model for intraoperative guidance<br>during the procedure. | during spine surgery.<br>Preoperative CT data is loaded<br>onto the cart. Intraoperative<br>registration of the patient's<br>anatomy with the preloaded CT<br>data using 3D structured light<br>images. Reflective markers on<br>spinal instruments aid the<br>surgeon in viewing the position<br>and orientation of instruments<br>relative to registered pre-<br>operative image data while<br>performing the surgical<br>procedure. | preoperative<br>planning. |
| Components | Cart, Arm, Sensor Array, External<br>Monitor, Surgical Instruments,<br>Software | Cart, Arm, Head, tracked<br>surgical Envision 3D™ Spinal<br>Instruments, Software | Same. |
| Energy Source | 120V | 120V | Same |
| Sterilization<br>Method -<br>Surgical<br>Instruments | Steam | Steam | Same |
| Minimum SAL | $1 x 10^{-6}$ | $1 x 10^{-6}$ | Same |
| Required<br>Accessories | Reflective Markers (Northern Digital<br>K033621) | Reflective Markers | Same |

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| Functional and Safety<br>Testing: | Verification and Validation activities have been conducted to provide<br>assurance that the device meets the performance requirements under the<br>indications for use conditions. Proprio performed the following testing<br>to ensure the safety and effectiveness of the Paradigm System device:<br>Non-Clinical Hardware, Software, and Instrumentation Verification Tests Non-Clinical Design Validation conducted in Cadaveric Model Cadaveric Simulated Workflow Study Assessing Usability Compliance Conformity Assessments |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The following standards were used in testing:<br>IEC 60601-1:2015 Medical electrical equipment. General requirements for basic safety and essential performance IEC 60601-1-2:2014 Medical Electrical Equipment – Part 1-2, General Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility IEC 60601-1-6:2010+AMD1:2013 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 Ed1Medical Devices – Part 1: Application of Usability Engineering To Medical Devices ISO 10993-1:2003 Biological evaluation of medical devices: Part 1: Evaluation and testing 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 AAMI / ANSI ST79:2017 Guide to Steam Sterilization ASTM F2554-18 Standard Practice For Measurement Of Positional Accuracy Of Computer Assisted Surgical Systems |
| Conclusion: | The Paradigm System intended use, indications for use, and<br>fundamental scientific technology is similar to the predicate device.<br>Performance, safety and usability testing demonstrate that the<br>differences between the subject device and the predicate device do not<br>raise new risks of safety and effectiveness. |