SmartSurgN Visualization System

K213943 · Smartsurgn Incorporated · OWN · Nov 29, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K213943
• Device Name: SmartSurgN Visualization System
• Applicant: Smartsurgn Incorporated
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Nov 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The SmartSurgN Visualization System is intended to provide real-time endoscopic visible (VIS) and real-time near-infrared (NIR) fluorescence imaging. Upon intravenous administration and use of an ICC consistent with its approved label the SmartSurgN Visualization System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) using near-infrared imaging. Fluorescence imaging of biliary ducts with the SmartSurgN Visualization System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Device Story

System provides real-time endoscopic visible (VIS) and near-infrared (NIR) fluorescence imaging during minimally invasive surgery. Components: EyeRSurgN Console, EyeRSurgN Camera Head, IRLightSurgN Light Source, 10mm ICG Laparoscope (0° or 30°). Light source illuminates surgical site; user selects imaging mode (Regular, IRMax, IRFlo, IRTrue) to determine spectrum. Camera head captures images; console processes data; output displayed on medical-grade monitor via HDMI or 3G-SDI. Used with ICG dye (fluoresces at 806 nm under NIR light) to visualize vessels, blood flow, tissue perfusion, and biliary ducts. Operated by surgeons in clinical settings. Output assists surgeons in intraoperative anatomical assessment; complements standard white light and intraoperative cholangiography.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including performance comparisons with predicate devices, animal model simulation for clinician feedback, electromagnetic compatibility (IEC 60601-1, 60601-1-2), software validation, ICG illumination, laser excitation, signal-to-noise ratio, biocompatibility, cleaning, and sterilization.

Technological Characteristics

System includes rigid, rod lens laparoscopes (31cm length, 0°/30°). Light source provides visible and NIR spectrum illumination. Camera head utilizes four CMOS sensors. Connectivity via HDMI (4K60) or 3G-SDI (1080p60). Complies with IEC 60601-1 and 60601-1-2. Sterilization and biocompatibility validated.

Indications for Use

Indicated for patients undergoing minimally invasive surgery requiring real-time endoscopic visible and near-infrared fluorescence imaging for visual assessment of vessels, blood flow, tissue perfusion, and extra-hepatic bile ducts (cystic, common bile, or common hepatic). Used with intravenous ICG.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Karl Storz Endoscopic ICG Imaging System (K152583)
• da Vinci Fluorescence Imaging Vision System (K124031)

Submission Summary (Full Text)

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November 29, 2022

SmartSurgN Incorporated Jocelyn Long Chief Compliance Officer 3150 Almaden Expressway Suite 252 San Jose. California 95118

Re: K213943/S001

Trade/Device Name: SmartSurgN Visualization System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN Dated: September 30, 2022 Received: October 3, 2022

Dear Jocelyn Long:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jianting Wang -S

Jianting Wang 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) K213943

Device Name SmartSurgN Visualization System

#### Indications for Use (Describe)

The SmartSurgN Visualization System is intended to provide realtime endoscopic visible (VIS) and real-time nearinfrared (NIR) fluorescence imaging. Upon intravenous administration and use of an ICC consistent with its approved label the SmartSurgN Visualization System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) using near-infrared imaging. Fluorescence imaging of biliary ducts with the SmartSurgN Visualization System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

| | 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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Image /page/3/Picture/0 description: The image features the logo for SmartSurgN. The logo consists of a stylized graphic on the left, which appears to be a green and blue abstract shape. To the right of the graphic is the text "SmartSurgN" in a sans-serif font, with "SmartSurg" in a darker gray and the "N" in a lighter gray.

## 510(k) Summary - K213943

This summary statement is submitted in accordance with the requirements of CFR §807.92.

| Submitter: | SmartSurgN Incorporated<br>1038 Leigh Ave, Suite 101B<br>San Jose, CA 95126 USA |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jocelyn Long<br>[e-mail]<br>408-802-8586 |
| Date of Preparation: | September 30, 2022 |
| Device Identification: | Trade Name:<br>SmartSurgN Visualization System<br>Common Name: Endoscopic Video Imaging System Classification<br>Name: Endoscope and Accessories |
| Product Code: | OWN |
| Regulation: | 21 CFR part 876.1500 |
| Predicate Devices: | Karl Storz Endoscopic ICG Imaging System (K152583)<br>da Vinci Fluorescence Imaging Vision System (K124031) |
| Indications for Use: | The SmartSurgN Visualization System is intended to provide real-<br>time endoscopic visible (VIS) and real-time near-infrared (NIR)<br>fluorescence imaging. Upon intravenous administration and use of<br>an ICG consistent with its approved label the SmartSurgN<br>Visualization System enables surgeons to perform minimally<br>invasive surgery using standard endoscopic visible light as well as<br>visual assessment of vessels, blood flow and related tissue<br>perfusion, and at least one of the major extra-hepatic bile ducts<br>(cystic duct, common bile duct and common hepatic duct) using<br>near-infrared imaging. Fluorescence imaging of biliary ducts with<br>the SmartSurgN Visualization System is intended for use with<br>standard of care white light and, when indicated, intraoperative<br>cholangiography. The device is not intended for standalone use for<br>biliary duct visualization. |
| Device Description: | The SmartSurgN Visualization System is designed to provide real-time endoscopic visible (VIS) and real-time near-infrared (NIR) fluorescence imaging during minimally invasive surgery. The SmartSurgN Visualization System is comprised of the following main components: EyeRSurgn Console with Camera Head IRLightSurgN Light Source 10mm ICG Laparoscope, 0° or 30° The SmartSurgN Visualization System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the SmartSurgN Visualization System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.<br>During the use of the SmartSurgN Visualization System, the IRLightSurgN provides the light source for illumination of the surgical site. The IRLightSurgN is capable of outputting light in the visible light spectrum as well as in the near infrared spectrum. The user selects the image capture mode (Regular, IRMax, IRFlo, IRTrue) which determines the light spectrum used to capture imaging.<br>The IRLightSurgN is connected to the SmartSurgN Laparoscope using a commercially available fiber optic light cable. Additionally, the SSN Laparoscope connects to the EyeRSurgN Camera Head.<br>Images are acquired by the EyeRSurgN Camera Head and transmitted to the EyeRSurgN Console. Images are processed by the EyeRSurgN Console and outputted to a medical grade monitor.<br>The SmartSurgN Visualization System can be used with any medical grade monitor with a HDMI or 3G-SDI input connection.<br>The SmartSurgN Visualization System is intended to be used in conjunction with commercially available indocyanine green imaging (ICG) kits. ICG is a tricarbocyanine dye which fluoresces after excitation under near infrared light at 806 nm, permitting visualization of anatomical structures. |
| Technological<br>Comparison<br>Summary: | The SmartSurgN Visualization System utilizes the same technology<br>as predicate devices Karl Storz Endoscopic ICG Imaging System<br>(K152583) and Intuitive Surgical da Vinci Fluorescence Imaging<br>Vision System (K124031). |
| | The EyeRSurgN Console and EyeRSurgN Camera Head are<br>substantially equivalent to the camera control unit and camera head<br>in the Karl Storz Endoscopic Imaging System cleared for use in<br>K152583. |
| | The SmartSurgN Visualization System and the Karl Storz<br>Endoscopic ICG Imaging System include rigid, rod lens scopes.<br>Both systems offer scopes with 0° and 30° direction of view. The<br>working length of the scopes in both systems is 31cm. |
| | The IRLightSurgN Illuminator is substantially equivalent to the<br>illuminator included in the Intuitive Surgical da Vinci Fluorescence<br>Imaging Vision System and cleared for use in K124031. |
| | The differences between the subject and predicate devices are: |
| | ● The inclusion of a fourth imaging sensor (IR CMOS) in the<br>camera head. The Storz predicate has three imaging sensors. |
| | ● The SmartSurgN Visualization System Console output signal<br>is HDMI at 4K60 in addition to SDI at 1080p60; the<br>predicate device only has an output at SDI 1080p60. |
| | The technological differences do not present any safety or<br>effectiveness concerns. |
| Non-Clinical<br>Performance Data: | The SmartSurgN Visualization System was successfully tested for<br>performance, including a benchmark study with the predicate<br>devices to assess endoscopic video imaging in visible and near-<br>infrared conditions. Additionally, the SmartSurgN Visualization<br>System was assessed in an animal model for simulated surgical<br>environment feedback from clinicians. Testing was conducted for<br>safety and electromagnetic compatibility IEC 60601-1 and 60601-<br>1-2 per standards. Additional validations and testing were<br>conducted for system software, ICG illumination, laser excitation,<br>signal-to-noise ratio, biocompatibility, manual cleaning, sterilization<br>and packaging. |
| Clinical Performance | Clinical testing was not required to demonstrate substantial |
| Data: | equivalence to the predicate devices. |
| Conclusion: | The SmartSurgN Visualization System is substantially equivalent to<br>the Karl Storz Endoscopic ICG Imaging System (K152583) and<br>Intuitive Surgical da Vinci Fluorescence Imaging Vision System<br>(K124031) devices with regards to device design, materials,<br>operating materials and performance characteristics. The use of the<br>SmartSurgN Visualization System for its intended use does not<br>raise new or different questions of safety or effectiveness. |

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Image /page/4/Picture/0 description: The image shows the logo for SmartSurgN. The logo consists of a green and blue abstract shape on the left, followed by the text "SmartSurg" in a dark gray sans-serif font. The "N" in "SmartSurgN" is slightly smaller and raised, indicating it may be a superscript.

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Image /page/5/Picture/0 description: The image contains the logo for SmartSurgN. The logo features a green and blue abstract design on the left, resembling a stylized medical symbol. To the right of the symbol, the text "SmartSurgN" is written in a simple, sans-serif font, with "SmartSurg" in a darker shade and "N" in a lighter shade.

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Image /page/6/Picture/0 description: The image contains the logo for SmartSurgN. The logo features a stylized green and blue graphic to the left of the company name. The text "SmartSurgN" is written in a sans-serif font, with the "N" in superscript.