(347 days)
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.
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. 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. 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. 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. The SmartSurgN Visualization System can be used with any medical grade monitor with a HDMI or 3G-SDI input connection. 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.
The provided document does not contain the detailed information required to fill out all the requested sections regarding acceptance criteria and a study proving device performance, especially in the context of an AI-based device and human reader improvement.
This document is a 510(k) summary for the SmartSurgN Visualization System, which is an endoscopic imaging system. It focuses on demonstrating substantial equivalence to predicate devices, not on evaluating an AI algorithm's performance or its impact on human readers.
Specifically, the document states: "Clinical testing was not required to demonstrate substantial equivalence to the predicate devices." This directly indicates that the type of clinical or performance study involving human readers and detailed performance metrics as requested (e.g., acceptance criteria table, MRMC study, ground truth establishment) was not conducted or reported in this 510(k) submission.
While the document mentions "Non-Clinical Performance Data" including a "benchmark study with the predicate devices to assess endoscopic video imaging in visible and near-infrared conditions" and assessment in "an animal model for simulated surgical environment feedback from clinicians," these are general performance tests and not a detailed clinical study demonstrating AI-assisted performance or human reader improvement.
Therefore, most of the requested fields cannot be answered based on the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot provide. The document does not specify quantitative acceptance criteria or detailed performance results in the format of a table for an AI algorithm. It mentions "performance" and "benchmark study" but no specific metrics or targets met.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot provide. No information about test set sample size or data provenance is given for a human-in-the-loop or AI performance study. "Clinical testing was not required." The "animal model" assessment is mentioned, but details are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot provide. Since no clinical study or test set requiring ground truth for an AI algorithm or human reader performance is detailed, there's no information on experts or their qualifications for establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot provide. No information on adjudication methods is present.
5. 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
- No. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence to the predicate devices." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot determine. While the device itself is a "Visualization System" and not explicitly an "AI algorithm," its performance characteristics are assessed. The "benchmark study with the predicate devices to assess endoscopic video imaging" suggests standalone imaging performance was tested, but not necessarily an AI algorithm's specific performance. The document does not describe an AI algorithm or its standalone performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot provide. No ground truth establishment is described for a performance study of an AI algorithm.
8. The sample size for the training set
- Cannot provide. The document does not describe the development or training of an AI algorithm, or any associated training set.
9. How the ground truth for the training set was established
- Cannot provide. As no AI training set is mentioned, there's no information on how its ground truth might have been established.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Incorporated1038 Leigh Ave, Suite 101BSan Jose, CA 95126 USA |
|---|---|
| Contact: | Jocelyn Longjocelyn.long@smartsurgn.com408-802-8586 |
| Date of Preparation: | September 30, 2022 |
| Device Identification: | Trade Name:SmartSurgN Visualization SystemCommon Name: Endoscopic Video Imaging System ClassificationName: Endoscope and Accessories |
| Product Code: | OWN |
| Regulation: | 21 CFR part 876.1500 |
| Predicate Devices: | Karl Storz Endoscopic ICG Imaging System (K152583)da Vinci Fluorescence Imaging Vision System (K124031) |
| Indications for 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 ofan ICG consistent with its approved label the SmartSurgNVisualization System enables surgeons to perform minimallyinvasive surgery using standard endoscopic visible light as well asvisual assessment of vessels, blood flow and related tissueperfusion, and at least one of the major extra-hepatic bile ducts(cystic duct, common bile duct and common hepatic duct) usingnear-infrared imaging. Fluorescence imaging of biliary ducts withthe SmartSurgN Visualization System is intended for use withstandard of care white light and, when indicated, intraoperativecholangiography. The device is not intended for standalone use forbiliary 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.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.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.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.The SmartSurgN Visualization System can be used with any medical grade monitor with a HDMI or 3G-SDI input connection.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. |
| TechnologicalComparisonSummary: | The SmartSurgN Visualization System utilizes the same technologyas predicate devices Karl Storz Endoscopic ICG Imaging System(K152583) and Intuitive Surgical da Vinci Fluorescence ImagingVision System (K124031). |
| The EyeRSurgN Console and EyeRSurgN Camera Head aresubstantially equivalent to the camera control unit and camera headin the Karl Storz Endoscopic Imaging System cleared for use inK152583. | |
| The SmartSurgN Visualization System and the Karl StorzEndoscopic ICG Imaging System include rigid, rod lens scopes.Both systems offer scopes with 0° and 30° direction of view. Theworking length of the scopes in both systems is 31cm. | |
| The IRLightSurgN Illuminator is substantially equivalent to theilluminator included in the Intuitive Surgical da Vinci FluorescenceImaging 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 thecamera head. The Storz predicate has three imaging sensors. | |
| ● The SmartSurgN Visualization System Console output signalis HDMI at 4K60 in addition to SDI at 1080p60; thepredicate device only has an output at SDI 1080p60. | |
| The technological differences do not present any safety oreffectiveness concerns. | |
| Non-ClinicalPerformance Data: | The SmartSurgN Visualization System was successfully tested forperformance, including a benchmark study with the predicatedevices to assess endoscopic video imaging in visible and near-infrared conditions. Additionally, the SmartSurgN VisualizationSystem was assessed in an animal model for simulated surgicalenvironment feedback from clinicians. Testing was conducted forsafety and electromagnetic compatibility IEC 60601-1 and 60601-1-2 per standards. Additional validations and testing wereconducted for system software, ICG illumination, laser excitation,signal-to-noise ratio, biocompatibility, manual cleaning, sterilizationand 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 tothe Karl Storz Endoscopic ICG Imaging System (K152583) andIntuitive Surgical da Vinci Fluorescence Imaging Vision System(K124031) devices with regards to device design, materials,operating materials and performance characteristics. The use of theSmartSurgN Visualization System for its intended use does notraise 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.
§ 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.