(29 days)
The VS3-Iridium System is intended to provide real-time visible and near infrared fluorescence imaging in both open and minimally invasive procedures.
Upon intravenous administration and use of an ICG consistent with its approved labeling, the VS3-Iridium System is used to perform fluorescence imaging visualization of vessels, blood flow and tissue perfusion before during and after general minimally invasive surgical procedures and plastic, micro-, reconstructive surgeries.
Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-Iridium System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved labeling, the VS3-Iridium 785 nm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The VS3-Iridium System is an advanced stereoscopic visualization system made up of a combination of hardware and software to provide high definition visible and near infrared (IR) fluorescent imaging. The visualization system can incorporate an endoscope for minimally invasive surgical procedures and a microscope positioned above the patient during open surgical procedures.
The VS3-Iridium System including the endoscope and the microscope is designed to work with an approved infrared dye (Indocyanine green (ICG) or pafolacianine sodium injection or pafolacianine). ICG may be excited at excitation at either 785 or 805 nm, and pafolacianine is excited only by the 785 nm wavelength. The principle of operation is the same for both infrared dyes. That is, the VS3-Iridium System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera, enabling qualitative and quantitative measurement of the IR intensity. Near IR fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow.
The VS3-Iridium System allows the capture of normal (white) light image in parallel with the fluorescence IR image and displays both to the surgeon to provide a view of the anatomy. In addition, the VS3-Iridium System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.
This document describes a 510(k) premarket notification for the VS3-Iridium System (VS3-IR), an advanced stereoscopic visualization system. The filing seeks to re-frame the indications for use statement to align with the specific indications of legally marketed Indocyanine green (ICG) products and pafolacianine, and to eliminate the need for the VS3-Iridium Fluorescence ICG Kit.
Here's an analysis of the provided information about acceptance criteria and supporting studies:
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Table of acceptance criteria and reported device performance:
The document explicitly states: "No performance data are needed to support the modified indications for use. As noted above, there are no technological changes associated with the proposed labeling changes. Additionally, no new surgical procedures or tissue types are being referenced in the modified indications for use."
Therefore, there is no table of acceptance criteria or reported device performance for this specific 510(k) submission, as the changes are purely administrative regarding the Indications for Use statement and the removal of an accessory, not a modification to the device's technological characteristics or its core performance. The FDA granted substantial equivalence based on the device being "the same or similar" to previously cleared versions.
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Sample size used for the test set and the data provenance: Not applicable. No new performance data was required for this 510(k) submission as there were no technological changes to the device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new performance data was required for this 510(k) submission.
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Adjudication method for the test set: Not applicable. No new performance data was required for this 510(k) submission.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The VS3-Iridium System is described as a visualization system for real-time visible and near infrared fluorescence imaging, not an AI-assisted diagnostic or interpretative tool that would involve human readers improving with AI assistance. This submission specifically deals with changes to the Indications for Use, not a new AI component or performance evaluation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The VS3-Iridium System is a visualization system used by a surgeon, implying human-in-the-loop operation. This submission does not introduce or evaluate any new standalone algorithmic performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No new performance data was required for this 510(k) submission.
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The sample size for the training set: Not applicable. This submission concerns re-framing indications for use and removing an accessory, not a new algorithm development or training.
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How the ground truth for the training set was established: Not applicable. As above, this submission concerns re-framing indications for use and removing an accessory, not a new algorithm development or training.
Summary of the Study and Rationale for No New Performance Data:
The core of this 510(k) submission (K223020) is a "special 510(k) premarket notification to re-frame the indications for use statement to be consistent with specific indications of legally marketed ICG products, eliminating the need for the VS3-Iridium Fluorescence ICG Kit."
The manufacturer, Visionsense, Ltd., argues that:
- There are no changes in the technological characteristics of the visualization system hardware, software, or accessories.
- The only change in the system configuration is to obsolete the VS3-IR ICG Kit.
- The proposed changes in the indications for use statement are to reflect the previous discontinuation of a 3D module and associated endoscopes, streamline ICG-related indications, and reflect that these indications are derived from approved ICG drug labeling.
- These changes are considered a "simple statement of product functionality that has always been present and does not represent any new use for the system."
- There are "no questions related to safety or effectiveness of the device when used as labeled," and the change is "not considered a critical change to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device."
Based on these justifications, the FDA determined that "No performance data are needed to support the modified indications for use." The device was deemed substantially equivalent to its own previously cleared versions (K150018, K152204, K183453, K191851, K210265) because the modifications were administrative and did not alter the technological characteristics or intended use in a way that would raise new questions of safety or effectiveness.
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October 28, 2022
Visionsense Ltd. Guy Wroclawski Senior Regulatory Affairs Specialist 20 Hamagshimim St. Petach Tikva, Hamerkaz, Central District 4934829 Israel
Re: K223020
Trade/Device Name: VS3-Iridium System (VS3-IR) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN Dated: September 28, 2022 Received: September 29, 2022
Dear Guy Wroclawski:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 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,
Colin Kejing Chen 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
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Indications for Use
510(k) Number (if known) K223020
Device Name VS3-Iridium System (VS3-IR)
Indications for Use (Describe)
The VS3-Iridium System is intended to provide real-time visible and near infrared fluorescence imaging in both open and minimally invasive procedures.
Upon intravenous administration and use of an ICG consistent with its approved labeling, the VS3-Iridium System is used to perform fluorescence imaging visualization of vessels, blood flow and tissue perfusion before during and after general minimally invasive surgical procedures and plastic, micro-, reconstructive surgeries.
Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-Iridium System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved labeling, the VS3-Iridium 785 nm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
| 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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K223020
510(k) Summary
VS3-Iridium System (VS3-IR)
The contents of the 510(k) Summary have been provided in conformance with 21 CFR 807.92.
1. Submitter
510(k) Summary:
Date summary prepared: October 19, 2022
510(k) Submitter/Holder:
Visionsense, Ltd. 20 Hamagshimim St. Petach Tikva, Hamerkaz 4934829 Israel
Contact Person:
Guy Wroclawski Senior Regulatory Affairs Specialist Medtronic, Visualization Telephone: (972) 50-204-9052 Fax: (972) 3-924-4335 Email: guy.wroclawski@medtronic.com
2. Subject Device
| Trade Name: | VS3-Iridium System (VS3-IR) |
|---|---|
| VS3-IR systemconfiguration | Camera (K150018, K152204, K183453, K191851, K210265) |
| Laser Light Source (LLS) (K150018, K152204, K183453, K191851, K210265) | |
| VS3-IR-MMS (K150018, K152204, K183453, K191851, K210265) | |
| VS3-IR-Endoscope (K152204, K183453, K191851) | |
| CCU (K150018, K152204, K183453, K191851, K210265) | |
| Display Monitor (K150018, K152204, K183453, K191851, K210265) | |
| Xenon Light Source (K150018, K152204, K183453, K191851, K210265) | |
| Endoscopic Light Cable (K150018, K152204, K183453, K191851, K210265) | |
| Light Integrator (K150018, K152204, K183453, K191851, K210265) |
Common Name: Near-IR visualization system
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| ClassificationName: | Endoscope and accessories (21 CFR 876.1500) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Product Code: | OWN | ||||||||
| Regulatory Class: | II | ||||||||
| Predicate Device | |||||||||
| Trade Name: | VS3-Iridium System (VS3-IR) | ||||||||
| VS3-IR system | Camera (K150018, K152204, K183453, K191851, K210265) | ||||||||
| configuration | Laser Light Source (LLS) (K150018, K152204, K183453, K191851, K210265) | ||||||||
| VS3-IR-MMS (K150018, K152204, K183453, K191851, K210265) | |||||||||
| VS3-IR-Endoscope (K152204, K183453, K191851) | |||||||||
| CCU (K150018, K152204, K183453, K191851, K210265) | |||||||||
| Display Monitor (K150018, K152204, K183453, K191851, K210265) | |||||||||
| Xenon Light Source (K150018, K152204, K183453, K191851, K210265) | |||||||||
| Endoscopic Light Cable (K150018, K152204, K183453, K191851, K210265) | |||||||||
| Light Integrator (K150018, K152204, K183453, K191851, K210265) | |||||||||
| ICG Kit (K150018, K152204, K183453, K191851) | |||||||||
| 510(k) Number: | There are five predicate 510(k) submissions for this 510(k). A description of each510(k) is provided along with each 510(k) submission number. | K150018 (cleared the MMS configuration, 805 nm wavelength plus the VS3-IR ICGKit) | K152204 (cleared the endoscopic configuration, 805 nm wavelength) | K183453 (cleared the 785 nm wavelength, both MMS and endoscopic) | K191851 (cleared the lymphatic visualization indication, both 785 nm and 805 nm) | K210265 (cleared the 785 nm system for use with pafolacianine) | Manufacturer: | Visionsense. Ltd. | |
| 510(k) Number: | There are five predicate 510(k) submissions for this 510(k). A description of each510(k) is provided along with each 510(k) submission number. | ||||||||
| K150018 (cleared the MMS configuration, 805 nm wavelength plus the VS3-IR ICGKit) | |||||||||
| K152204 (cleared the endoscopic configuration, 805 nm wavelength) | |||||||||
| K183453 (cleared the 785 nm wavelength, both MMS and endoscopic) | |||||||||
| K191851 (cleared the lymphatic visualization indication, both 785 nm and 805 nm) | |||||||||
| K210265 (cleared the 785 nm system for use with pafolacianine) | |||||||||
| Manufacturer: | Visionsense. Ltd. |
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4. Device Description
The VS3-Iridium System is an advanced stereoscopic visualization system made up of a combination of hardware and software to provide high definition visible and near infrared (IR) fluorescent imaging. The visualization system can incorporate an endoscope for minimally invasive surgical procedures and a microscope positioned above the patient during open surgical procedures.
The VS3-Iridium System including the endoscope and the microscope is designed to work with an approved infrared dye (Indocyanine green (ICG) or pafolacianine sodium injection or pafolacianine). ICG may be excited at excitation at either 785 or 805 nm, and pafolacianine is excited only by the 785 nm wavelength. The principle of operation is the same for both infrared dyes. That is, the VS3-Iridium System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera, enabling qualitative and quantitative measurement of the IR intensity. Near IR fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow.
The VS3-Iridium System allows the capture of normal (white) light image in parallel with the fluorescence IR image and displays both to the surgeon to provide a view of the anatomy. In addition, the VS3-Iridium System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.
This special 510(k) premarket notification is to re-frame the indications for use statement to be consistent with specific indications of legally marketed ICG products, eliminating the need for the VS3-Iridium Fluorescence ICG Kit.
5. Indications for Use
The VS3-Iridium System is intended to provide real-time visible and near infrared fluorescence imaging in both open and minimally invasive procedures.
Upon intravenous administration and use of an ICG consistent with its approved labeling, the VS3-Iridium System is used to perform fluorescence imaging visualization of vessels, blood flow and tissue perfusion before, during, and after general minimally invasive surgical procedures and plastic, micro-, reconstructive surgeries.
Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-Iridium System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved labeling, the VS3-Iridium 785 nm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
6. Difference in indications for use statements
The proposed changes in the indications for use statement are required to reflect the previous discontinuation of the 3D module and associated endoscopes, streamline the ICG-related indications and reflect that these indications are derived from approved ICG drug labeling.
This is a simple statement of product functionality that has always been present and does not represent any new use for the system. There are no questions related to safety or effectiveness of the device when used as labeled, and the change is not considered a critical change to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device.
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| Characteristic | Currently cleared VS3-IridiumSystem(Predicate) | VS3-Iridium System(Proposed Device) | Differencesbetween theSubject andPredicatedevices |
|---|---|---|---|
| Basic principle | The VS3-Iridium System allows thecapture of normal (white) lightimages in parallel with thefluorescence IR image and displaysboth to the surgeon to provide aview of the anatomy. | The VS3-Iridium System allowsthe capture of normal (white)light images in parallel with thefluorescence IR image anddisplays both to the surgeon toprovide a view of the anatomy. | None |
| Imaging | Fluorescent and White LightImaging | Fluorescent and White LightImaging | None |
| Imaging Head | Silicon Image Sensor in the Camera | Silicon Image Sensor in theCamera | None |
| Light Source | Infrared Laser | Infrared Laser | None |
| Excitation LightSourceWavelength VS3-IR- | 785nm or 805 nm | 785nm or 805 nm | None |
| Light Source forVisible ImageVS3-IR- | LED | LED | None |
| SpectralBandwidth ofVisible LightSource | 400nm - 700 nm | 400nm - 700 nm | None |
| VS3-IR-MMSPosition | 20cm to 45cm above patient | 20cm to 45cm above patient | None |
| Laparoscopes | Yes | Yes | None |
| PatientContactingMaterials | The Endoscopes and Cable used forminimally invasive procedure havedirect patient contact.The components used for opensurgical imaging do not directlycontact the patient. | The Endoscopes and Cable usedfor minimally invasiveprocedure have direct patientcontact.The components used for opensurgical imaging do not directlycontact the patient | None |
| Excitation LightSource Intensity | 6 mW/cm2 at 40 cmMax of 47 mW/cm2 | 6 mW/cm2 at 40 cmMax of 47 mW/cm2 | None |
| Characteristic | Currently cleared VS3-IridiumSystem(Predicate) | VS3-Iridium System(Proposed Device) | Differencesbetween theSubject andPredicatedevices |
| and MaximumLight Intensity | |||
| EmissionCapture | IR camera | IR camera | None |
| Display bothVisible and IRimages | Yes | Yes | None |
7. Technological Characteristics
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8. Comparison of Technological Characteristics with the Predicate Device
There are no changes in technological characteristics in the visualization system hardware, software, or accessories associated with the labeling changes.
The only change in the system configuration is to obsolete the VS3-IR ICG Kit, which is no longer relevant for the system.
9. Performance Data
No performance data are needed to support the modified indications for use. As noted above, there are no technological changes associated with the proposed labeling changes. Additionally, no new surgical procedures or tissue types are being referenced in the modified indications for use.
10. Conclusions
The proposed VS3-Iridium System is the same or similar to the VS3-Iridium System legally marketed under the previously cleared 510(k) clearances.
§ 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.