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510(k) Data Aggregation
K Number
K203115Device Name
ARVIS Surgical Navigation System
Manufacturer
Insight Medical Systems Inc.
Date Cleared
2021-07-14
(271 days)
Product Code
OLO
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Insight Medical Systems Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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
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<br>and Computer module. |
| 3 | Computer Module | Runs the ARVIS® Application Software. |
| 4 | External Battery | Removable/swappable. Provides power to the Eyepiece<br>Assembly and the Computer module. |
| 5 | Eyepiece Cable | Connects Eyepiece to the Belt Pack. |
|---|----------------------------|-----------------------------------------------------------------------------------------------------------------|
| 6 | Battery Charging<br>System | Charges External Battery when system is not in use.<br>Intended to be used outside the operating room. |
| 9 | Instrument Set | Surgical tools, including trackers, mounts, adapters, etc.<br>that are required to perform surgical procedures. |
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