Who is the manufacturer of ARVIS Surgical Navigation System?

Insight Medical Systems, Inc. filed the 510(k) submission for ARVIS Surgical Navigation System (K203115).

What is the FDA product code for ARVIS Surgical Navigation System?

OLO. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for ARVIS Surgical Navigation System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ARVIS Surgical Navigation System?

OrthAlign Plus System (K172462); Xvision Spine System (XVS) (K190929).

Who can help prepare an FDA 510(k) submission like ARVIS Surgical Navigation System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ARVIS Surgical Navigation System

K203115 · Insight Medical Systems, Inc. · OLO · Jul 14, 2021 · Neurology

Device Facts

Record ID	K203115
Device Name	ARVIS Surgical Navigation System
Applicant	Insight Medical Systems, Inc.
Product Code	OLO · Neurology
Decision Date	Jul 14, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

The ARVIS® System is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components.

Device Story

ARVIS Surgical Navigation System assists orthopedic surgeons during hip and knee arthroplasty. System uses head-mounted eyepiece with stereo infrared cameras, color camera, and display; belt-worn computer module; and trackers mounted on patient anatomy and surgical instruments. Cameras measure spatial locations and angles between trackers; software calculates instrument position relative to anatomy. Surgeon views real-time navigation data, prompts, and alerts on eyepiece display; controls system via voice commands and head tracking. No electronic hardware applied to patient. System provides intraoperative measurements to guide implant positioning and alignment, potentially improving surgical accuracy and patient outcomes. Used in operating room by surgeons and staff.

Clinical Evidence

No clinical testing performed. Evidence consists of non-clinical verification and validation, including cleaning and sterilization validation, software V&V, EMC and electrical safety testing, and bench performance testing. Simulated clinical validation was conducted in a human cadaveric setting to validate user requirements and navigation accuracy.

Technological Characteristics

System comprises head-mounted eyepiece (stereo IR cameras, color camera, IR laser, display) and belt-worn computer module. Uses optical (stereo IR) and inertial tracking. Materials: standard orthopedic-grade metals and polymers. Connectivity: cable-connected components. Sterilization: steam sterilization for reusable mechanical instruments; electronics are non-sterile. Software: application-specific navigation software.

Indications for Use

Indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. Aids in intraoperative measurements such as changes in leg length in Hip Arthroplasty. Compatible with straight acetabular impactors and specific offset impactors. Procedures include Total Knee Arthroplasty, Unicompartmental Knee Arthroplasty (Tibial Transverse Resection), and Hip Arthroplasty.

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

OrthAlign Plus System (K172462)
Xvision Spine System (XVS) (K190929)

Related Devices

K243980 — ARVIS Surgical Navigation System · Kico Knee Innovation Company Pty Limited · Mar 21, 2025
K153396 — Aesculap OrthoPilot Next Generation · Aesculap Implant Systems, LLC · May 16, 2016
K072267 — TOTAL HIP SURGETICS NAVIGATION SYSTEM · Praxim S.A · Dec 10, 2007
K031454 — ACUMEN SURGICAL NAVIGATION SYSTEM · Biomet, Inc. · Jul 8, 2004
K191507 — Intellijoint® Navigation System · Intellijoint Surgical, Inc. · Oct 1, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 14, 2021 Insight Medical Systems Inc. % Bob Duffy President Bob Duffy Associates. Inc. 16405 Summer Sage Rd. Poway, California 92064 Re: K203115 Trade/Device Name: ARVIS® Surgical Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 9, 2021 Received: June 11, 2021 Dear Bob Duffy: 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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 mediation-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, For 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203115 #### Device Name ARVIS® Surgical Navigation System #### Indications for Use (Describe) The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty - · Unicompartmental Knee Arthroplasty: Tibial Transverse Resection - · Hip Arthroplasty | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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." {3}------------------------------------------------ # 510(k) Summary This 510(k) Summary is being submitted in accordance with the requirements established by 21 CFR 807.92. | 1. | Submitter Information | | |----------------------|-----------------------------------|----------------------------------------------------------------------------------------------------------------------| | | Submitter: | Insight Medical Systems, Inc. | | | Address: | 8601 Ranch Road 2222 Building 1, Suite 104 Austin, TX 78730-2304 (USA) | | | Contact Person: | Nicholas R. van der Walt Chief Executive Officer Phone: (949) 468-7775 Email: nvanderwalt@insightmedsys.com | | | Date Prepared: | July 14, 2021 | | 2. | Subject Device | | | | Trade Name: | ARVIS® Surgical Navigation System | | | Common Name: | Orthopedic Stereotaxic Instrument | | | Classification: | 21 CFR 882.4560 | | | Classification Name: | Orthopedic Stereotaxic Instrument | | | Product Code: | OLO | | | FDA Panel: | 84 - Neurology | | | Class: | II | | 3. | Predicate Device | | | | 510(k) Number: | K172462 | | | Manufacturer: | OrthAlign, Inc. | | | Trade Name: | OrthAlign Plus System | | | Classification: | 21 CFR 882.4560 | | | Classification Name: | Orthopedic Stereotaxic Instrument | | | Product Code: | OLO | | | FDA Panel: | 84 - Neurology | | | Class: | II | | 510(k) Number: | K190929 | | | Manufacturer: | Augmedics Ltd. | | | Trade Name: | Xvision Spine System (XVS) | | | Classification: | 21 CFR 882.4560 | | | Classification Name: | Orthopedic Stereotaxic Instrument | | | Product Code: | OLO | | | FDA Panel: | 84 - Neurology | | | Class: | II | | {4}------------------------------------------------ ## 4. Reference Device ## 5. Device Description The ARVIS® Surgical Navigation System (ARVIS® System) is to be used by orthopedic surgeons and operating room staff who perform hip and knee arthroplasty. The ARVIS® System uses cameras to measure locations and angles between trackers mounted on the patient and trackers mounted on surgical instruments. By prompting the user through a procedurespecific workflow to register the reference tracker to anatomic landmarks, the ARVIS® Application Software calculates and displays positions of the instruments relative to the patient's anatomy. The Eyepiece Assembly contains stereo infrared (IR) tracking cameras, a color camera, a stereo display, IR illumination, and IR laser illuminator. The Eyepiece also includes a headlight. The Eyepiece communicates with the Belt Pack via a cable connection. The Belt Pack houses the computer module, the battery, and the power management board. The Belt Pack supplies power to the eyepiece and computer module. The computer module runs the ARVIS® Application Software. All system instructions, prompts, alerts, and outputs are displayed to the surgeon on the Eyepiece display. The ARVIS® System Eyepiece is worn on the surgeon's head via a surgical helmet. The ARVIS® Belt Pack is worn on the surgeon's belt or waistband. No electronic hardware is applied to the patient. The surgeon stands adjacent to the patient to operate. The ARVIS® Battery Charger is intended to be used outside the operating room. The ARVIS® System comprises the major elements listed in Table 1. | Item | Description | Purpose | |------|-------------------|------------------------------------------------------------------------------------------| | 1 | Eyepiece Assembly | Houses display, speakers, cameras, and other sensors. | | 2 | Belt Pack | System power management. Houses the External Battery and Computer module. | | 3 | Computer Module | Runs the ARVIS® Application Software. | | 4 | External Battery | Removable/swappable. Provides power to the Eyepiece Assembly and the Computer module. | Table 1: ARVIS® Surgical Navigation System Components. {5}------------------------------------------------ | 5 | Eyepiece Cable | Connects Eyepiece to the Belt Pack. | |---|----------------------------|-----------------------------------------------------------------------------------------------------------------| | 6 | Battery Charging System | Charges External Battery when system is not in use. Intended to be used outside the operating room. | | 9 | Instrument Set | Surgical tools, including trackers, mounts, adapters, etc. that are required to perform surgical procedures. | ### 6. Intended Use The ARVIS® System is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. The Intended Use of the ARVIS® System is substantially the same as that of the predicate device. Minor differences in wording are not critical to the intended surgical use of the device, and the difference does not affect the safety and effectiveness of the device when used as labeled. ## 7. Indications for Use The ARVIS® Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated. Example orthopedic surgical procedures include but are not limited to: - . Total Knee Arthroplasty - Unicompartmental Knee Arthroplasty: Tibial Transverse Resection - . Hip Arthroplasty #### 8. Technological Characteristics Table 2 provides a comparison of the technological characteristics between the ARVIS® System (Subject device) and the OrthAlign Plus System (Predicate device). | Characteristic | Subject Device | Predicate Device | Same / Different | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Materials | Metal grades common to orthopedic surgical instruments. Polymer grades common to orthopedic surgical instruments. Internal electronics. | Metal grades common to orthopedic surgical instruments. Polymer grades common to orthopedic surgical instruments. Internal electronics. | Same | | Characteristic | Subject Device | Predicate Device | Same / Different | | Biocompatibility Categorization (ISO 10993-1) | • External Communicating Device, Tissue/Bone/Dentin Communicating, with subsystems that have direct and potential indirect contact for a limited contact duration (< 24 hours). | • External Communicating Device, Tissue/Bone/Dentin Communicating, with subsystems that have direct and potential indirect contact for a limited contact duration (< 24 hours). | Same | | Main System Components | • Waist-mounted Belt Pack with non-sterile, reusable mobile computer module and system Battery. • Optical and inertial sensors, illumination, and display in non-sterile, reusable Head- mounted Eyepiece. • Reusable sterile mechanical instrument set. | • Sterile single-use computer module with internal, non- replaceable Battery. • Inertial sensors and display in sterile, single-use module. • Reusable electronic sensor with Battery. • Reusable sterile mechanical instrument set. | Different | | Operating Principle | • Computer processor uses positional information from tracked markers on anatomy or instruments to calculate and display measurements to the user. | • Computer processor uses positional information from sensors on anatomy or instruments to calculate and display measurements to the user. | Same | | Tracking Technology | • Optical - stereo infrared cameras. • Inertial – for head tracking and measurements relative to gravity. | • Inertial - accelerometer and gyroscope. • Optical - monocular camera (for hip registration probe scale reader). | Different | | Registration | • Instruments placed at indicated anatomic points. • System's optical and inertial sensors used to determine position and/or orientation of instruments or anatomy to which trackers or sensors are attached. | • Instruments placed at indicated anatomic points. • System's optical and inertial sensors used to determine position and/or orientation of instruments or anatomy to which trackers or sensors are attached. | Same | | Characteristic | Subject Device | Predicate Device | Same / Different | | User Interface | • Text and graphical output on LCD in Eyepiece. • Audible feedback Eyepiece- mounted internal speakers. • Eyepiece-mounted microphone. • Head tracking interface and voice commands to control and navigate the application software. | • Text and graphical output on LCD in single-use computer module. • Audible feedback from speakers in single-use computer module. • Physical buttons on sterile single-use module to control and navigate the application software. | Different | | Patient Interface | • Tracking markers and cutting guides pinned to bone. • Landmarks registered with mechanical probe tip. • No electronics applied to patient. | • Inertial sensors and cutting guides pinned to bone. • Landmarks registered with mechanical probe tip. • Battery-powered sensors mounted on patient. | Different | | Sterilization - reusable mechanical instruments | • Steam sterilization for reusable mechanical instruments. | • Steam sterilization for reusable mechanical instruments. | Same | | Sterilization - Electronic components | • No sterilization required for electronic components. | • EtO sterilization for single-use computer module. | Different | | Energy Type | • Electronics: Battery Power. • Instruments: Mechanical (Manual). | • Electronics: Battery Power. • Instruments: Mechanical (Manual). | Same | | Environmental Specifications | • Temperature: -30 to 50 °C. • Humidity: 10 to 90% RH; (non-condensing). • Pressure: 60 kPa to 106 kPa. | Specified storage and operating environments for typical transport and surgical environments. | Same | Table 2: Comparison of Technological Characteristics. {6}------------------------------------------------ {7}------------------------------------------------ As shown in Table 2, the following technological characteristics are the same for the ARVIS® System and the OrthAlign Plus System: - Materials a. - Biocompatibility Classification per ISO 10993-1 b. - Operating Principle C. - Registration d. - Environmental Specifications e. As also shown in Table 2, the following technological characteristics are different between the ARVIS® System and the OrthAlign Plus System: {8}------------------------------------------------ - 1. Main System Components - 2. Tracking Technology - 3. User Interface - 4. Patient Interface - 5. Sterilization Using a combination of Risk Management, design specifications and implementation, and verification and validation, these differences are not critical to the intended surgical use of the device, and do not affect the safety and effectiveness of the device when used as labeled. The Augmedics Xvision is named as a Reference Device because it includes the technological characteristic of a heads-up display similar to that in the subject device. #### 9. Non-Clinical Performance Data #### 9.1. Summary of Non-Clinical Testing Performed and Conclusions Drawn A program of non-clinical verification and validation testing was conducted that includes: - Cleaning process Validation ● - Sterilization Validation - Software Verification and Validation Testing ● - Electromagnetic Compatibility (EMC) testing ● - Electrical Safety testing ● - Safety and Performance Bench Testing ● - Simulated Clinical Validation Testing ● Cleaning process Validation was performed to validate that the ARVIS® Instruments can be adequately cleaned using the specified procedure provided in the Instructions for Use. Sterilization Validation was conducted to demonstrate that: - The ARVIS® Surgical Instruments are compatible with the necessary FDA-cleared a. reprocessing equipment, - The reprocessing instructions are technically feasible for implementation by users, and b. - The sterilization process has been validated to attain a sterility assurance level (SAL) of 10 °. c. Software Verification and Validation Testing was conducted to demonstrate that: - 1) All requirements and specifications in the ARVIS® Software Requirements Specification were implemented and operate correctly. - 2) All Risk Mitigations to be implemented in software were implemented and operated correctly, and - 3) the software conforms with the user needs and intended uses of the ARVIS® device. Electromagnetic Compatibility (EMC) testing was conducted to demonstrate that the ARVIS® System is compliant with applicable Standards for Electromagnetic Compatibility. Electrical Safety testing was conducted to demonstrate that the ARVIS® System is compliant with applicable Standards for Electrical Safety. Safety and Performance Bench Testing was conducted to demonstrate that the ARVIS® System meets its performance specifications and is substantially equivalent to the predicate device performance. {9}------------------------------------------------ Simulated Clinical Validation Testing was conducted to demonstrate that the particular requirements for the specified intended use can be consistently fulfilled by the ARVIS® System. This testing was conducted in a human cadaveric setting and included validation of user requirements and navigation accuracy. ### 9.2. Clinical Testing No clinical testing was conducted for a determination of substantial equivalence. #### 10. Overall Conclusion The documentation and test results provided in this submission and comparison of intended use, principle of operation, performance data, design and the overall technological characteristics, demonstrate that the ARVIS® Surgical Navigation System is as safe, as effective, and performs as well as the predicate device.