(271 days)
Augmedics Xvision
No
The description focuses on optical tracking and software calculations based on anatomical landmarks, without mentioning AI/ML algorithms for image processing, decision support, or other functions.
No
This device is a surgical navigation system designed to assist surgeons in positioning and aligning implants during orthopedic surgery, not to treat a disease or condition itself.
No
The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants and making intraoperative measurements during surgery, not for diagnosing a medical condition.
No
The device description explicitly lists multiple hardware components including cameras, a display, a computer module, a battery, cables, and an instrument set, in addition to the software.
Based on the provided information, the ARVIS Surgical Navigation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ARVIS Function: The ARVIS system is a surgical navigation system that uses cameras and trackers to assist surgeons in positioning and aligning implants during orthopedic surgery. It works by tracking the position of instruments relative to the patient's anatomy in real-time during the procedure.
- No Specimen Analysis: The ARVIS system does not analyze any biological specimens from the patient. Its function is entirely focused on providing spatial guidance and measurements during surgery.
Therefore, the ARVIS Surgical Navigation System falls under the category of a surgical navigation or guidance system, not an IVD.
N/A
Intended Use / 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
Product codes
OLO
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 procedure-specific 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. |
| 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. |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical - stereo infrared cameras.
Anatomical Site
Hip, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic surgeons and operating room staff who perform hip and knee arthroplasty.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data
- Cleaning process Validation: Validated that the ARVIS® Instruments can be adequately cleaned.
- Sterilization Validation: Demonstrated compatibility with FDA-cleared reprocessing equipment, feasible reprocessing instructions, and a sterility assurance level (SAL) of 10^-6.
- Software Verification and Validation Testing: Demonstrated that all requirements and specifications were implemented, risk mitigations operated correctly, and the software conforms to user needs and intended uses.
- Electromagnetic Compatibility (EMC) testing: Compliant with applicable Standards for Electromagnetic Compatibility.
- Electrical Safety testing: Compliant with applicable Standards for Electrical Safety.
- Safety and Performance Bench Testing: Met performance specifications and demonstrated substantial equivalence to predicate device performance.
- Simulated Clinical Validation Testing: Conducted in a human cadaveric setting, included validation of user requirements and navigation accuracy.
Clinical Testing: No clinical testing was conducted for a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Augmedics Xvision
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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)
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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 (