(263 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.
Acceptance Criteria and Study for Paradigm System
The Paradigm System, a stereotaxic image guidance system, underwent verification and validation activities to assure it meets performance requirements. The provided documentation highlights general functional and safety testing as well as cadaveric model studies. This response compiles the stated information regarding acceptance criteria and the supporting studies.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with corresponding numerical performance metrics for the Paradigm System. Instead, it broadly states that "Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions." The document lists the types of testing performed and the standards used, implying that the acceptance criteria are met by demonstrating compliance with these tests and standards.
The studies mentioned are:
- 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 conclusion states: "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." This indicates that the device's performance was deemed acceptable relative to established safety and effectiveness benchmarks, likely derived from the predicate device and relevant standards.
2. Sample Size for Test Set and Data Provenance
The document states that a "Non-Clinical Design Validation conducted in Cadaveric Model" and a "Cadaveric Simulated Workflow Study Assessing Usability" were performed for testing.
- Sample Size: The exact sample size (number of cadavers or specific test cases) used for these cadaveric studies is not specified in the provided text.
- Data Provenance: The cadaveric studies are inherently prospective in their design, as they involve performing procedures on the cadavers in a controlled setting for the purpose of testing. The country of origin of the cadaveric data is not specified.
3. Number of Experts and Qualifications for Ground Truth Establishment
The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. The mention of "Cadaveric Simulated Workflow Study Assessing Usability" suggests involvement of users (e.g., surgeons) in the evaluation, but details on ground truth establishment are absent.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. Standalone Performance Study
The document refers to "Non-Clinical Hardware, Software, and Instrumentation Verification Tests" and "Non-Clinical Design Validation conducted in Cadaveric Model." While these indicate testing of the algorithm and system, it is not explicitly stated whether a "standalone (i.e., algorithm only without human-in-the-loop performance)" study was conducted. The nature of a stereotaxic image guidance system inherently involves integration with human procedural steps.
7. Type of Ground Truth Used
For the cadaveric studies, the specific type of ground truth used (e.g., expert consensus on target accuracy, direct measurement, pathology, outcomes data) is not explicitly stated. Given the device's purpose for spatial positioning and orientation, ground truth would likely involve highly accurate measurements of instrument tip position relative to anatomical targets within the cadaveric model, verified by a gold standard measurement technique.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set for any underlying algorithms within the Paradigm System. The description of the device's principle of operation mentions "fuses high-resolution, real-time camera imaging... with medical imagery (such as CT)" and "Preoperative CT data is uploaded to the console and the system software generates a 3D model of the patient's operative vertebrae," implying that algorithms are trained on such data.
9. How Ground Truth for the Training Set Was Established
The document does not describe how the ground truth for the training set was established.
In summary, while the document confirms that various tests were conducted to ensure the safety and effectiveness of the Paradigm System, detailed information regarding specific performance metrics, sample sizes for test and training data, expert qualifications, and ground truth establishment methods is largely absent in the provided 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 (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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K222291
2.0 510(k) Summary/Statement
Table 1: 510(k) Summary
| Submitter: | Proprio, Inc |
|---|---|
| Contact Person: | Shannon EubanksVP of HW Engineering and RegulatoryPhone: (425) 802-6063E-mail: seubanks@propriovision.com |
| 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:Envision 3DTM: Image Guidance System (K162375) |
| Device Description: | The Paradigm System is a stereotaxic image guidance system intendedfor the spatial positioning and orientation of spinal surgical instrumentsused by surgeons. The Paradigm System fuses high-resolution, real-timecamera imaging of the surgical site (such as the spine) with medicalimagery (such as CT) and surgical navigation data, such aspredetermined instrument trajectories for precise instrument placement.The Paradigm System encompasses non-sterile operating roomequipment components as well as sterilizable, reusable instruments, andoff-the-shelf sterile-packaged, single-use accessories.The Paradigm System is used with an external monitor. |
| Indication for Use: | The Paradigm System is a stereotaxic image guidance system intended forthe spatial positioning and orientation of spinal surgical instruments usedby surgeons during open surgical procedures with appropriate bonepreparation. The device is indicated for posterior approach spine surgerywhere reference to a rigid anatomical structure that can be identified onCT derived patient images for pedicle screw cannulation of the thoracic tosacrum vertebrae. |
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| Paradigm System(Subject Device) | Envision 3DTM: ImageGuidance System(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 forUse | The Paradigm System is a stereotaxicimage guidance system intended for thespatial positioning and orientation ofspinal surgical instruments used bysurgeons during open surgical procedureswith appropriate bone preparation. Thedevice is indicated for posterior approachspine surgery where reference to a rigidanatomical structure that can beidentified on CT derived patient imagesfor pedicle screw cannulation of thethoracic to sacrum vertebrae. | The Envision 3DTM: ImageGuidance System is a stereotaxicimage guidance system intendedfor the spatial positioning andorientation of neurosurgicalinstruments used by surgeons.The system is also intended to beused as the primary surgicalluminaire during image guidedsurgery. The device is indicatedfor posterior approach spinesurgery where reference to arigid anatomical structure can beidentified. | Subject device isnot the primaryluminaire. |
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| Paradigm System(Subject Device) | Envision 3DTM: ImageGuidance System(Predicate Device) | Comment | |
|---|---|---|---|
| Principle ofoperation | Paradigm System fuses high-resolution, real-time camera imagingof the surgical site (such as the spine)with medical imagery (such as CT)and surgical navigation data, such aspredetermined instrument trajectoriesfor precise instrument placement.The Paradigm System enables surgicalnavigation of instruments relative tothe patient spinal anatomy bycombining preoperative imagingsegmentation and intraoperativeregistration of the patient's liveanatomy. Preoperative CT data isuploaded to the console and the systemsoftware generates a 3D model of thepatient's operative vertebrae. The 3Dmodel is used for preoperativeplanning such as implant placementsor instrument trajectories. During theprocedure, once the patient's anatomyis exposed, the Prism Sensor Arrayacquires imaging to match thetopography of the live anatomy to the3D model. This intraoperativeregistration of live anatomy to the 3Dmodel creates a common coordinatespace between the preoperative CTdata and the patient anatomy. Thisenables virtual information to beoverlaid on the live anatomy duringthe procedure for intraoperativeguidance. | The Envision 3D systemprovides image registrationbetween preoperative scan dataand data capturedintraoperatively from theEnvision 3DTM integratedstructured light scannerand/or user selected points. Thesystem provides guidance databy displaying thelocations of wireless opticallytracked Envision 3DTM SpinalInstruments (examplesinclude pedicle probe and awl)relative to the patient. Positionand orientation data oftracked Envision 3DTM SpinalInstruments are linked to thepreoperative scan data usingthe Envision 3DTM workstation. | Subject deviceuses light fieldwhere predicateuses structuredlight scanner.Subject devicesegments eachvertebra where thepredicate as if itwere a singleanatomical body. |
| TechnicalComparison | Stereotaxic image guided surgicalnavigation system during spine | Stereotaxic image guidedsurgical navigation system | Subject device hasoption for |
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| Paradigm System(Subject Device) | Envision 3D™: ImageGuidance System(Predicate Device) | Comment | |
|---|---|---|---|
| surgery. Preoperative CT data issegmented and a 3D model isgenerated. Preoperative planning canbe performed. Intraoperative imagecapture using reflective markers onspinal instruments and registers thepatient's anatomy to the preoperative3D model for intraoperative guidanceduring the procedure. | during spine surgery.Preoperative CT data is loadedonto the cart. Intraoperativeregistration of the patient'sanatomy with the preloaded CTdata using 3D structured lightimages. Reflective markers onspinal instruments aid thesurgeon in viewing the positionand orientation of instrumentsrelative to registered pre-operative image data whileperforming the surgicalprocedure. | preoperativeplanning. | |
| Components | Cart, Arm, Sensor Array, ExternalMonitor, Surgical Instruments,Software | Cart, Arm, Head, trackedsurgical Envision 3D™ SpinalInstruments, 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 (Northern DigitalK033621) | Reflective Markers | Same |
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| Functional and SafetyTesting: | Verification and Validation activities have been conducted to provideassurance that the device meets the performance requirements under theindications for use conditions. Proprio performed the following testingto 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 Cadaveric Simulated Workflow Study Assessing Usability Compliance Conformity Assessments |
|---|---|
| The following standards were used in testing: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, andfundamental scientific technology is similar to the predicate device.Performance, safety and usability testing demonstrate that thedifferences 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).