(138 days)
No
The description focuses on the optical and hardware components of the system for fluorescence imaging and visualization, with no mention of AI or ML algorithms for image analysis, interpretation, or other functions.
No
The device is described as an intraoperative fluorescence imaging system used for visualization, not direct treatment or therapy. It aids in surgical procedures by providing imaging, but it does not perform a therapeutic function itself.
No
The device is used to perform intraoperative fluorescence angiography and imaging; it does not mention making a diagnosis.
No
The device description explicitly lists multiple hardware components including cameras, light sources, a CCU, a display monitor, and endoscopes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used intraoperatively to perform fluorescence angiography and imaging of the lymphatic system. This involves visualizing structures within the patient's body during surgery.
- Device Description: The device is a vision system (camera, light source, endoscope/microscope) designed to work with an intravenously or interstitially administered imaging agent (ICG). It captures and displays images of the surgical field and the fluorescence emitted by the ICG within the patient.
- Nature of IVDs: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not analyze samples taken from the body; it visualizes structures in vivo.
The device is clearly an in vivo imaging system used during surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Upon intravenous administration and use of an ICG consistent with its approved label, the Iridium Module of the VS3-IR System is used to perform intraoperative fluorescence angiography.
Upon interstitial administration and use of ICG consistent with its approved label, the Endoscope configuration of the VS3-IR System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Product codes
OWN, GCJ
Device Description
Clearance was originally given for the Visionsense Stereoscopic Vision System (VSII) in K073279, K081102, K082667, and K082355. Clearance was given for a 3D High Definition version of the VSII System called the VS3 Stereoscopic High Definition Vision System (VS3) in K123467, K131434, K141002. Clearance included the HD3D Camera, Laser Light Source (LLS), VS3 3D Endoscope, Camera Control Unit (CCU), Display Monitor, Xenon Light Source, and Endoscopic Light Cable.
Clearance was given for an iridium version of the VS3 system called the "VS3-IR System" in K150018 and K152204. This system introduced an iridium miniature microscope in K150018 and an iridium endoscope in K152204. The cleared system added a Light Integrator and an ICG Kit. The VS3-IR utilizes the VS3 system with a special Miniature Microscope (MMS) that is positioned 20cm to 45cm above the patient during the surgical procedure. The VS3-IR can also be used with an Iridium Endoscope to perform minimally invasive procedures. The VS3-IR is designed to work with Indocyanine Green (ICG) which is an IR fluorescence imaging agent and is supplied in the "VS3-IR Fluorescence ICG Kit". Each cleared "VS3-IR Fluorescence ICG Kit" contains six 25mg vials of sterile ICG imaging agent and six 10ml vials of sterile Water for Injection. ICG is a sterile, water soluble, tricarbocyanine dye with a peak spectral absorption at 785nm or 805nm in blood plasma or blood. ICG contains not more than 5.0% sodium iodide. ICG is to be administered intravenously. The sterile Water for Injection provided with the ICG, pH of 5.0 to 7.0, is used to dissolve the ICG. Before injection of ICG for each patient's imaging procedure, the ICG must be reconstituted using the sterile Water for Injection. ICG in blood has excitation at 785nm or 805nm. The VS3-IR system provides excitation light to the surgical field to excite the dye molecules, captures emission from the dye using an IR camera and measures the fluorescence signal intensity. The system enables high definition imaging for both fluorescence and visible light imaging, with real-time overlay of fluorescence and visible light images for display on the monitor. The system permits recording surgical procedures, storing them on removable storage devices, and playing the procedures back.
Clearance was given for adding three working channels to the VS3 in K153548 and the accessory "Trans-Anal Introducer" was cleared in K171208.
The VS3-IR system (805nm) was cleared for adding the excitation wavelength of 785nm in K183453. The "Indication for Use" cleared in K183453 is:
"The 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.
The MMS configuration of the Iridium Module of the VS3-IR System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.
The Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery."
The present 510(k) application K191851 provides clearance of the VS3-IR system for expanding the scope of indications to include usage in the lymphatic system with use of an ICG consistent with its approved label. As the VS3-IR may be still be co-packaged with the currently cleared "VS3-IR Fluorescence ICG Kit" within the indications for use cleared under prior 510(k) clearance, the device labeling will instruct not using the currently cleared "VS3-IR Fluorescence ICG Kit" for use in the lymphatic system when the VS3-IR is intended for this indication and associated administration modality. This clearance enables the VS3-IR system to be also cleared for use in the indications in Section V with use of an ICG consistent with its approved label, including in terms of indications and associated administration modalities.
Use of ICG consistent with its approved label may refer to either the VS3 Iridium ICG kit cleared through the reference device (K183453: VS3-IR) or to use an ICG consistent with its approved label for lymphatic mapping, no copackaging is being introduced for indications involving lymphatic mapping.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence imaging, White light imaging, Near Infrared fluorescence imaging
Anatomical Site
Lymphatic system, lymphatic vessels, lymph nodes, internal surgical sites, ventricles, structures within the brain, anterior and posterior spinal procedures, shoulder and knee arthroscopic procedures, tissue, free flaps, biliary ducts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons performing intraoperative procedures.
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)
Through performance testing the subject device has demonstrated substantial equivalence to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
November 25, 2019
Medtronic % Ray Kelly Consultant Arazy Group Consultants Inc. 3422 Leonardo Ln New Smyrna Beach, Florida 32168
Re: K191851
Trade/Device Name: VS3-IR Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN, GCJ Dated: October 25, 2019 Received: October 28, 2019
Dear Ray Kelly:
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.
1
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 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.
Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020
See PRA Statement below.
Page 1
510(k) Number (if known)
Device Name
VS3-IR
Upon intravenous administration and use of an ICG consistent with its approved label, the Iridium Module of the VS3-IR System is used to perform intraoperative fluorescence angiography.
Upon interstitial administration and use of ICG consistent with its approved label, the Endoscope configuration of the VS3-IR System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
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) |
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
Medtronic
Visionsense Ltd. (Medtronic) 20 Hamagshimim Street Petach Tikva 4934829 Israel www.medtronic.com
510(k) Summary K191851
I. SUBMITTER
Visionsense Ltd. (Medtronic) 20 Hamagshimim Street Petach Tikva 4934829 Israel www.medtronic.com Contact Person: Benjamin Rochette Tel: +33634603245
Date Prepared: November 25, 2019
II. DEVICE
Name of Device: VS3-IR Common or Usual Name: Confocal Optical Imaging Classification Name: Endoscope and Accessories (21 CFR 876.1500) Regulatory Class: II Product Code: OWN
III. PREDICATE DEVICE
PINPOINT Endoscopic Fluorescence Imaging System, K182606 This predicate has not been subject to a design-related recall. Classification Name: Endoscope and Accessories (21 CFR 876.1500) Regulatory Class: II Product Code: OWN Reference Device: VS3-IR, K183453
4
IV. DEVICE DESCRIPTION
Clearance was originally given for the Visionsense Stereoscopic Vision System (VSII) in K073279, K081102, K082667, and K082355. Clearance was given for a 3D High Definition version of the VSII System called the VS3 Stereoscopic High Definition Vision System (VS3) in K123467, K131434, K141002. Clearance included the HD3D Camera, Laser Light Source (LLS), VS3 3D Endoscope, Camera Control Unit (CCU), Display Monitor, Xenon Light Source, and Endoscopic Light Cable.
Clearance was given for an iridium version of the VS3 system called the "VS3-IR System" in K150018 and K152204. This system introduced an iridium miniature microscope in K150018 and an iridium endoscope in K152204. The cleared system added a Light Integrator and an ICG Kit. The VS3-IR utilizes the VS3 system with a special Miniature Microscope (MMS) that is positioned 20cm to 45cm above the patient during the surgical procedure. The VS3-IR can also be used with an Iridium Endoscope to perform minimally invasive procedures. The VS3-IR is designed to work with Indocyanine Green (ICG) which is an IR fluorescence imaging agent and is supplied in the "VS3-IR Fluorescence ICG Kit". Each cleared "VS3-IR Fluorescence ICG Kit" contains six 25mg vials of sterile ICG imaging agent and six 10ml vials of sterile Water for Injection. ICG is a sterile, water soluble, tricarbocyanine dye with a peak spectral absorption at 785nm or 805nm in blood plasma or blood. ICG contains not more than 5.0% sodium iodide. ICG is to be administered intravenously. The sterile Water for Injection provided with the ICG, pH of 5.0 to 7.0, is used to dissolve the ICG. Before injection of ICG for each patient's imaging procedure, the ICG must be reconstituted using the sterile Water for Injection. ICG in blood has excitation at 785nm or 805nm. The VS3-IR system provides excitation light to the surgical field to excite the dye molecules, captures emission from the dye using an IR camera and measures the fluorescence signal intensity. The system enables high definition imaging for both fluorescence and visible light imaging, with real-time overlay of fluorescence and visible light images for display on the monitor. The system permits recording surgical procedures, storing them on removable storage devices, and playing the procedures back.
Clearance was given for adding three working channels to the VS3 in K153548 and the accessory "Trans-Anal Introducer" was cleared in K171208.
The VS3-IR system (805nm) was cleared for adding the excitation wavelength of 785nm in K183453. The "Indication for Use" cleared in K183453 is:
"The 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.
The MMS configuration of the Iridium Module of the VS3-IR System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.
5
The Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery."
The present 510(k) application K191851 provides clearance of the VS3-IR system for expanding the scope of indications to include usage in the lymphatic system with use of an ICG consistent with its approved label. As the VS3-IR may be still be co-packaged with the currently cleared "VS3-IR Fluorescence ICG Kit" within the indications for use cleared under prior 510(k) clearance, the device labeling will instruct not using the currently cleared "VS3-IR Fluorescence ICG Kit" for use in the lymphatic system when the VS3-IR is intended for this indication and associated administration modality. This clearance enables the VS3-IR system to be also cleared for use in the indications in Section V with use of an ICG consistent with its approved label, including in terms of indications and associated administration modalities.
Use of ICG consistent with its approved label may refer to either the VS3 Iridium ICG kit cleared through the reference device (K183453: VS3-IR) or to use an ICG consistent with its approved label for lymphatic mapping, no copackaging is being introduced for indications involving lymphatic mapping.
V. INDICATIONS FOR USE
Upon intravenous administration and use of an ICG consistent with its approved label, the Iridium Module of the VS3-IR System is used to perform intraoperative fluorescence angiography.
Upon interstitial administration and use of ICG consistent with its approved label, the Endoscope configuration of the VS3-IR System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
6
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THEPREDICATE DEVICE
| Subject Device | Predícate Device |
|---|---|
| K191851 (VS3-IR) | K182606 (PINPOINT) |
| Upon intravenous administration and use of an | |
| ICG consistent with its approved label, the | |
| Iridium Module of the VS3-IR System is used to | |
| perform intraoperative fluorescence angiography. | Upon intravenous administration of |
| TRADENAME (ICG drug product), the | |
| PINPOINT Endoscopic Fluorescence Imaging | |
| System is used with TRADENAME to perform | |
| intraoperative fluorescence angiography, and it is | |
| also indicated for use in fluorescence imaging of | |
| biliary ducts, and when indicated, during | |
| intraoperative cholangiography. | |
| Upon interstitial administration and use of ICG | |
| consistent with its approved label, the Endoscope | |
| configuration of the VS3-IR System is used to | |
| perform intraoperative fluorescence imaging and | |
| visualization of the lymphatic system, including | |
| lymphatic vessels and lymph nodes. | Upon interstitial administration of |
| TRADENAME (ICG drug product), the | |
| PINPOINT System is used to perform | |
| intraoperative fluorescence imaging and | |
| visualization of the lymphatic system, including | |
| lymphatic vessels and lymph nodes. |
7
| Design Attributes | | Subject Device
K191851 (VS3-IR) | Predícate Device
K182606 (PINPOINT) |
|-----------------------------------------|------------------|-----------------------------------------------------|-----------------------------------------------------|
| Sterilization | | Steam Autoclave | Steam Autoclave |
| Imaging Head | | Silicon Image Sensor in the
Camera | Silicon Image Sensor in the
Camera |
| Light Source | | Infrared Laser | Infrared Laser |
| Imaging Agent | | IR fluorescence dye (i.e.
Indocyanine Green-ICG) | IR fluorescence dye (i.e.
Indocyanine Green-ICG) |
| Excitation Light | VS3-IR-Endoscope | 785nm, 805nm | 805nm |
| Source
Wavelength | VS3-IR-MMS | 785nm, 805nm | NA |
| Light Source for | VS3-IR-Endoscope | Xenon up to 500mW | Mercury |
| Visible Image | VS3-IR-MMS | LED | NA |
| Spectral | VS3-IR-Endoscope | 400nm - 700nm | 400nm - 700nm |
| Bandwidth of
Visible Light
Source | VS3-IR-MMS | 400nm - 700nm | NA |
| Imaging Distance | VS3-IR-Endoscope | 7mm to 70mm | 7mm to 70mm |
| | VS3-IR-MMS | 20cm to 45cm | NA |
| Excitation Light
Source Intensity | VS3-IR-Endoscope | 54mW/cm² at 2cm;
500mW total output | Pinpoint IR light source is
pulsed |
| and Maximum
Light Intensity | VS3-IR-MMS | 6mW/cm² at 40cm;
Max of 47mW/cm² | NA |
| Field of View | VS3-IR-Endoscope | 70° to 95° | 70° to 95° |
| | VS3-IR-MMS | 55° | NA |
| Scope Length | VS3-IR-Endoscope | 300 mm | 300 mm |
| | VS3-IR-MMS | NA | NA |
| Scope Diameter | VS3-IR-Endoscope | 5.5mm, 10mm | 5.5mm, 10mm |
| | VS3-IR-MMS | NA | NA |
| Angles of View | VS3-IR-Endoscope | 0°, 30° | 0°, 30° |
| | VS3-IR-MMS | NA | NA |
| Imaging | VS3-IR-Endoscope | Fluorescent and White Light
Imaging | Fluorescent and White Light
Imaging |
| | VS3-IR-MMS | Fluorescent and White Light
Imaging | NA |
| Emission Band | VS3-IR-Endoscope | 800nm to 850nm | 825nm to 850nm |
| | VS3-IR-MMS | 800nm to 850nm | NA |
| Emission Capture | | IR camera | IR camera |
| Display both Visible and IR images | | Yes | Yes |
| Working Length-Endoscope | | 5mm - 30cm | 10mm - 33cm |
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
8
BIOCOMPATIBILITY:
Biocompatibility evaluation was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Patient contacting components (3D camera, 3D endoscopes, and VS3-IR-Endoscopes) of the VS3-IR System are constructed of Stainless Steel. Aluminum, and Glass components, which are the same materials that are used in the 3D camera, 3D endoscope, and VS3-IR-Endoscope originally cleared in K152204, K131434, K123467, K183453.
The Stainless Steel, Aluminum, and Glass materials that are used to construct the 3D camera, 3D endoscope, and VS3-IR-Endoscopes of the VS3-IR System are processed and manufactured in the same manner as the Stainless Steel, Aluminum, and Glass that are used in the predicate 3D camera. 3D endoscope, and VS3-IR-Endoscope originally cleared in K152204, K131434. K123467, K183453.
The device is a surface-contacting device in contact with mucosal membranes. The contact duration is limited exposure (contact is up to 24 hours).
ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMC): Electrical safety and EMC testing were conducted on the VS3-IR System. The system complies with the IEC 60601-1, IEC 60601-2-18, IEC 60601-1-6, and IEC 60825-1 standards for safety and the IEC 60601-1-2 standard for EMC.
SOFTWARE VERIFICATION AND VALIDATION:
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern.
CYBERSECURITY:
The VS3-IR System is a locked-down stand-alone device is not connected to a network and is not accessible in any way other than through the device's user interface. The operating system on the device is fully locked down and all user access to the OS is disabled. USB ports are only accessible for exporting videos and reading configuration data. The system cannot be booted from USB and spurious or malicious software cannot be run from USB. Direct access to USB file system is prevented due to OS lock-down.
VII. CONCLUSIONS
Through performance testing the subject device has demonstrated substantial equivalence to the predicate.