(347 days)
Not Found
No
The summary describes image processing but does not mention AI, ML, or any related technologies like deep learning or neural networks. The focus is on real-time visualization and fluorescence imaging.
No
The device is a visualization system used for imaging during surgery, not for directly treating or diagnosing a disease or condition.
No
Explanation: The device is a visualization system used by surgeons during minimally invasive surgery. It provides real-time visible and near-infrared fluorescence imaging to assist with surgical procedures and assessment of anatomical structures, but it does not diagnose conditions. Its purpose is to aid the surgeon, not to render a diagnosis.
No
The device description explicitly lists multiple hardware components: EyeRSurgn Console with Camera Head, IRLightSurgN Light Source, and a 10mm ICG Laparoscope. While it includes software for image processing, it is not solely software.
Based on the provided text, the SmartSurgN Visualization System is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- SmartSurgN's Function: The SmartSurgN Visualization System is used during minimally invasive surgery to provide real-time imaging inside the living body (in vivo). It visualizes anatomical structures like vessels, blood flow, tissue perfusion, and bile ducts using visible and near-infrared light, often in conjunction with an intravenously administered contrast agent (ICG).
- No Sample Testing: The device does not perform any tests on biological samples. It is a visualization tool used directly on the patient during a surgical procedure.
Therefore, the SmartSurgN Visualization System falls under the category of an in vivo imaging system used for surgical guidance and visualization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OWN
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic visible (VIS), near-infrared (NIR) fluorescence imaging
Anatomical Site
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)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons/minimally invasive surgery
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)
The SmartSurgN Visualization System was successfully tested for performance, including a benchmark study with the predicate devices to assess endoscopic video imaging in visible and near-infrared conditions. Additionally, the SmartSurgN Visualization System was assessed in an animal model for simulated surgical environment feedback from clinicians. Testing was conducted for safety and electromagnetic compatibility IEC 60601-1 and 60601-1-2 per standards. Additional validations and testing were conducted for system software, ICG illumination, laser excitation, signal-to-noise ratio, biocompatibility, manual cleaning, sterilization and packaging.
Clinical testing was not required to demonstrate substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Karl Storz Endoscopic ICG Imaging System (K152583), da Vinci Fluorescence Imaging Vision System (K124031)
Reference Device(s)
Not Found
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.
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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
1
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 Incorporated
1038 Leigh Ave, Suite 101B
San Jose, CA 95126 USA |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jocelyn Long
jocelyn.long@smartsurgn.com
408-802-8586 |
| Date of Preparation: | September 30, 2022 |
| Device Identification: | Trade Name:
SmartSurgN Visualization System
Common Name: Endoscopic Video Imaging System Classification
Name: 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 of
an ICG 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 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. |
| 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. |
| Technological
Comparison
Summary: | The SmartSurgN Visualization System utilizes the same technology
as predicate devices Karl Storz Endoscopic ICG Imaging System
(K152583) and Intuitive Surgical da Vinci Fluorescence Imaging
Vision System (K124031). |
| | The EyeRSurgN Console and EyeRSurgN Camera Head are
substantially equivalent to the camera control unit and camera head
in the Karl Storz Endoscopic Imaging System cleared for use in
K152583. |
| | The SmartSurgN Visualization System and the Karl Storz
Endoscopic ICG Imaging System include rigid, rod lens scopes.
Both systems offer scopes with 0° and 30° direction of view. The
working length of the scopes in both systems is 31cm. |
| | The IRLightSurgN Illuminator is substantially equivalent to the
illuminator included in the Intuitive Surgical da Vinci Fluorescence
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
camera head. The Storz predicate has three imaging sensors. |
| | ● The SmartSurgN Visualization System Console output signal
is HDMI at 4K60 in addition to SDI at 1080p60; the
predicate device only has an output at SDI 1080p60. |
| | The technological differences do not present any safety or
effectiveness concerns. |
| Non-Clinical
Performance Data: | The SmartSurgN Visualization System was successfully tested for
performance, including a benchmark study with the predicate
devices to assess endoscopic video imaging in visible and near-
infrared conditions. Additionally, the SmartSurgN Visualization
System was assessed in an animal model for simulated surgical
environment feedback from clinicians. Testing was conducted for
safety and electromagnetic compatibility IEC 60601-1 and 60601-
1-2 per standards. Additional validations and testing were
conducted for system software, ICG illumination, laser excitation,
signal-to-noise ratio, biocompatibility, manual cleaning, sterilization
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
the Karl Storz Endoscopic ICG Imaging System (K152583) and
Intuitive Surgical da Vinci Fluorescence Imaging Vision System
(K124031) devices with regards to device design, materials,
operating materials and performance characteristics. The use of the
SmartSurgN Visualization System for its intended use does not
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.