The Flexible Video-Choledochoscope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Flexible Video-Choledochoscope System comprises two components: the Flexible Video- Choledochoscope and Imaging Processor System (Including Light Source). The Flexible Video-Choledochoscope is indicated for use in diagnostic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The imaging processor system (including the light source) provides illumination for Flexible Video-Choledochoscope and is also used to receive the signal from the endoscope, then convert it into an image and display it on the examination monitor.
Device Story
Flexible Video-Choledochoscope System consists of a sterile flexible endoscope and a non-sterile imaging processor with integrated LED light source. The endoscope features a distal tip with a CMOS sensor and lighting system, an insertion tube, and an operation section with wire-rope controls for tip bending. The processor receives electrical signals from the CMOS sensor, converts them into images, and outputs them to an external monitor. Used in clinical settings by physicians to visualize the pancreatico-biliary system for diagnosis and therapy. The device provides real-time visual feedback to assist clinicians in navigating the biliary/pancreatic ducts and guiding accessory instruments, potentially improving diagnostic accuracy and therapeutic outcomes.
Clinical Evidence
No clinical data. Bench testing only, including performance testing per ISO 8600-1/3/4, electrical safety, EMC, biocompatibility, and sterilization validation.
Technological Characteristics
Flexible endoscope with CMOS distal sensor; LED illumination; ETO sterilization. Components: operation section, light-guide, insertion tube, bending section. Connectivity: DVI, S-Video, CVBS, USB. Power: 100-240V, 50/60Hz. Protection: Class I, Type BF. Cooling: fan-based.
Indications for Use
Indicated for diagnostic and therapeutic endoscopic procedures in the pancreatico-biliary system, including hepatic ducts.
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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
SpyGlass DS and DS II Direct Visualization System (K183636)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 20, 2023
Shanghai SeeGen Photoelectric Technology Co., Ltd Yihua Ma RA Supervisor 3 Floor, Building No.1, 4299 JinDu Road, Minhang District Shanghai, Shanghai 201108 CHINA
Re: K22261
> Trade/Device Name: Flexible Video-Choledochoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBN, KQM, NTN, FET Dated: March 17, 2023 Received: March 21, 2023
Dear Yihua Ma:
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
{1}------------------------------------------------
Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,
# Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K22261
Device Name Flexible Video-Choledochoscope System
#### Indications for Use (Describe)
The Flexible Video-Choledochoscope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
The Flexible Video-Choledochoscope System comprises two components: the Flexible Video- Choledochoscope and Imaging Processor System (Including Light Source).
The Flexible Video-Choledochoscope is indicated for use in diagnostic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
The imaging processor system (including the light source) provides illumination for Flexible Video-Choledochoscope and is also used to receive the signal from the endoscope, then convert it into an image and display it on the examination monitor.
Type of Use (Select one or both, as applicable)
| <span style="font-family: sans-serif;"> <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12" x="0" y="0"></rect> <path d="M2,2 L10,10 M2,10 L10,2" stroke="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12" x="0" y="0"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image contains the logo for SEEGEN, a company specializing in vision technology. The logo features the company name in bold, stylized red letters, with the number '7' integrated into the design. Below the company name, the phrase 'vision borderless' is written in a smaller, light gray font, suggesting the company's focus on innovative visual solutions.
### 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
### 5.1 Submitter
| Submitted by: | Shanghai SeeGen Photoelectric Technology Co., Ltd. |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Address: 3 Floor, Building No.1, 4299 JinDu Road, Minhang<br>District, Shanghai, China |
| Contact Person: | Yihua Ma<br>RA Supervisor |
| | Shanghai SeeGen Photoelectric Technology Co., Ltd.<br>Address: 3 Floor, Building No.1, 4299 JinDu Road, Minhang<br>District, Shanghai, China<br>Phone: 0086-18616909737<br>Email: mayihua@seegen.com.cn |
| Date Prepared: | April 4, 2023 |
## 5.2 Device
| Device Name: | Flexible Video-Choledochoscope System |
|--------------------|--------------------------------------------------------------------------------------|
| Common Name: | Choledochoscope and Accessories, Flexible/Rigid;<br>Camera, Surgical and Accessories |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | FBN, KQM, NTN, FET |
## 5.3 Predicate Device
| Device Name: | SpyGlass DS and DS II Direct Visualization<br>System, K183636 |
|--------------------|-----------------------------------------------------------------------------------------------------------|
| Common Name: | Choledochoscope and Accessories, Flexible/Rigid;<br>Camera, Surgical and Accessories;<br>LED light Source |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 876.1 00 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | FBN, KQM, NTN |
{4}------------------------------------------------
#### 5.4 Device Description
Flexible Video-Choledochoscope System is composed of sterile Flexible Video-Choledochoscope and a non-sterile Imaging Processor System (Including Light Source). The Flexible Video-Choledochoscope is composed of Operation section, Light-guide Section, Insertion a Distal tip and bending section. The Operation Section is pulled by the wire rope to control the bending direction of the Distal tip.
The Light-guide section transmits the illumination light from the image processor to the Distal tip. The Insertion Tube is used to guide it into other instruments or cavity of the body. The Distal tip contains a camera system and a lighting system for illumination and observation.
Imaging Processor System (Including Light Source) is composed of lighting system, image processing board. The lighting system provides the light source for the endoscope probe at the back end. The image processing board receives electronic signals from the front-end camera module and processes them, and finally transmits them to the display through the video interface.
Flexible Video-Choledochoscope is a kind of medical electronic optical instrument, also known as optical camera, which can enter into the human biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends.
The product is equipped with tiny size digital imaging parts --photoelectric sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals into electrical signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on its monitor output for doctor observation and diagnosis.
#### 5.5 Indication for Use:
The Flexible Video-Choledochoscope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico - biliary system including the hepatic ducts.
The Flexible Video-Choledochoscope System comprises two components: the Flexible Video- Choledochoscope and Imaging Processor System (Including Light Source).
The Flexible Video-Choledochoscope is indicated for use in diagnostic and
{5}------------------------------------------------
# 5 三 二 二 二 7 视 心 节
# Section 5 510(k) Summary
therapeutic applications during endoscopic procedures in the pancreatico - biliary system including the hepatic ducts.
The imaging processor system (including the light source) provides illumination for Flexible Video-Choledochoscope, and is also used to receive the signal from the endoscope, then convert it into an image and display it on the examination monitor.
| Item | Flexible Video-<br>Choledochoscope System<br>(Proposed Device) | SpyGlass DS and DS II Direct<br>Visualization System,<br>K183636 | Comment |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Indication<br>for Use | The Flexible Video-<br>Choledochoscope System<br>is indicated for use in<br>diagnostic and therapeutic<br>applications during<br>endoscopic procedures in<br>the pancreatico-biliary<br>system including the<br>hepatic ducts. | The SpyGlass DS and DS II<br>Direct Visualization System<br>is indicated for use in<br>diagnostic and therapeutic<br>applications during<br>endoscopic procedures in the<br>pancreatico-biliary system<br>including the hepatic ducts. | Almost the<br>same. |
| | The Flexible Video-<br>Choledochoscope System<br>comprises two<br>components: the Flexible<br>Video- Choledochoscope<br>and Imaging Processor<br>System (Including Light<br>Source). | The SpyGlass DS and DS II<br>Direct Visualization System<br>comprises two components:<br>the SpyScope DS Access and<br>Delivery Catheter or<br>SpyScope DS II Access and<br>Delivery Catheter, and the<br>SpyGlass DS Digital | |
| | The Flexible Video-<br>Choledochoscope is<br>indicated for use in<br>diagnostic and therapeutic<br>applications during<br>endoscopic procedures in<br>the pancreatico-biliary<br>system including the<br>hepatic ducts. | Controller.<br>The SpyScope DS Access and<br>Delivery Catheter and<br>SpyScope DS II Access and<br>Deliver Catheter are intended<br>to provide direct visualization<br>and to guide both optical and<br>accessory devices for | |
| | The imaging processor<br>system (including the light<br>source) provides<br>illumination for Flexible<br>Video-Choledochoscope,<br>and is also used to receive<br>the signal from the<br>endoscope, then convert it<br>into an image and display | diagnostic and therapeutic<br>applications during<br>endoscopic procedures in the<br>pancreatico-biliary system<br>including the hepatic ducts.<br>The SpyGlass DS Digital<br>Controller is intended to | |
| | | Section 5 510(k) Summary | |
| | it on the examination<br>monitor. | provide illumination and<br>receive, process, and output<br>images from the SpyScope<br>DS Access and Delivery<br>Catheter or SpyScope DS II<br>Access and Delivery Catheter<br>for diagnostic and therapeutic<br>applications during<br>endoscopic procedures in the<br>pancreaticobiliary system<br>including the hepatic ducts. | |
| Imaging<br>Technology | CMOS chips at distal end | CMOS chips at distal end | Same. |
| Illumination<br>Source | LED | LED | Same. |
| Distal<br>End(mm)<br>Outer<br>Diameter | CHV-US100J-U (OD:3.3mm)<br>CHV-US110J-U<br>(OD:3.4mm) | 3.5 | Similar |
| Working<br>Length<br>(mm) | CHV-US100J-U (Working<br>Length:2000mm)<br>CHV-US110J-U (Working<br>Length: 2000mm) | 2140 | Similar |
| bending<br>angle (°) | CHV-US100J-U<br>(UP/DOWN:120°/120°,<br>LEFT/RIGHT: N/A)<br>CHV-US110J-U<br>(UP/DOWN:120°/120°,<br>LEFT/RIGHT:<br>120°/120° ) | SpyGlass DS AND SpyGlass DS<br>II (UP/DOWN:90°/90°,<br>LEFT/RIGHT:<br>90°/90° ) | Similar |
| Field of<br>View | $110°±10°$ | 120° | Almost the<br>same. |
| Sterilization<br>Method | ETO Sterilization | ETO Sterilization | Same. |
| Suction<br>Channel | Connect the suction pump<br>to the suction port and turn<br>on the suction. pump to<br>generate suction. | Suction holes are used for<br>extracting liquid through<br>intervention channels. | Same. |
| Water Jet<br>Channel | Connect the irrigation<br>pump to the water<br>injection, and inject the<br>irrigation solution through<br>the irrigation channel. | Irrigation holes are used to<br>inject irrigation solution<br>through two dedicated<br>irrigation channels to release<br>vision and stretch the pipeline. | Almost the<br>same. |
| Item | Flexible Video-Choledochoscope<br>System (Proposed Device)<br>The following type:<br>PL-1000 | SpyGlass DS Digital<br>Controller,<br>K183636(Primary<br>Predicate Device) | Comment |
| Indicati<br>on for<br>Use | The imaging processor system<br>(including the light source)<br>provides illumination for Flexible<br>Video-Choledochoscope, and is<br>also used to receive the signal from<br>the endoscope, then convert it into<br>an image and display it on the<br>examination monitor. | The SpyGlass DS Digital<br>Controller is intended to<br>provide illumination and<br>receive, process, and<br>output images from the<br>SpyScope DS Access and<br>Delivery Catheter or<br>SpyScope DS II Access<br>and Delivery Catheter for<br>diagnostic and therapeutic<br>applications during<br>endoscopic procedures in<br>the pancreaticobiliary<br>system including the<br>hepatic ducts.and Delivery<br>Catheter and SpyScope<br>DS II Access and Delivery<br>Catheter are intended to<br>provide direct<br>visualization and to guide<br>both optical and accessory | Almost the<br>same. |
| input<br>voltage | 100 - 240V | 100 – 240V | Same |
| frequenc<br>y | 50/60 Hz | 50/60 Hz | Same |
| Operatin<br>g<br>temperat<br>ure | 5-40°C | 10-35°C | Similar |
| Storage<br>temperat<br>ure | -20-50°C | -40-70°C | Similar |
| Type of<br>protectio<br>n against<br>electric<br>shock | Class I | Class I | Same |
| Protectio<br>n class of<br>applicati | BF | BF | Same |
| on parts | | | |
| light<br>source | Have | Have | Same |
| Light<br>control | Have | Have | Same |
| Light<br>source<br>brightnes<br>s<br>indicatio<br>n | Have | Have | Same |
| image<br>processin<br>g | Have | Have | Same |
| DVI | Have | Have | Same |
| VGA | / | VGA (1280×1024) | Same |
| S-Video | S-Video | S-Video | Same |
| CVBS | CVBS (720*576) | / | Same |
| USB | Have | Have | Same |
| Potential<br>equalizat<br>ion<br>terminal | Have | Have | Same |
| Heat<br>dissipati<br>on<br>design | Cooling fan | Cooling fan | Same |
| electrom<br>agnetic<br>radiation | Group 1 Class A | Group 1 Class A | Same |
| electrom<br>agnetic<br>immunit<br>y | Compliance with EMC standards | Compliance with EMC standards | Same |
## 5.6 Substantial Equivalence and Technological Characteristics
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image features the word "SEEGEN" in a stylized, bold, red font. To the right of "SEEGEN" are Chinese characters, and below them is the phrase "vision borderless" in a smaller font size. The overall design appears to be a logo or branding element.
{7}------------------------------------------------
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image contains the logo for SEEGEN, a company specializing in vision technology. The logo features the company name in bold, stylized red letters. Below the name is the slogan "vision borderless" in a smaller, lighter font. To the right of the company name are Chinese characters.
Section 5 510(k) Summary
#### 5.7 Substantial Equivalence
SpyGlass DS and DS II Direct Visualization System, K183636 are used as predicate device compared to proposed device Flexible Video-Choledochoscope System manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.
#### 5.8 Non-clinical Performance Data
The Flexible Video-Choledochoscope System has been successfully tested for its functions and performance per ISO 8600-1/3/4 and mechanical characteristics. Safety testing was performed including electrical safety IEC 60601-1 and IEC 60601-2-18, electromagnetic compatibility per IEC 60601-1-2 and biocompatibility of the patient contact materials per ISO 10993. Additional validations were conducted for the sterilization process, EO residual, transportation and Photobiological safety.
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for SEEGEN, a company that specializes in vision technology. The logo is composed of the company name in a stylized font, with the word "vision borderless" written below. The logo is simple and modern, and it conveys the company's focus on innovation and technology. The logo also includes Chinese characters next to the company name.
#### 5.9 Clinical Test Data
No Clinical Study is included in this submission.
## 5.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Shanghai SeeGen Photoelectric Technology Co., Ltd. has demonstrated that proposed device Flexible Video-Choledochoscope System is substantially equivalent to Boston Scientific Corporation's currently marketed SpyGlass DS and DS II Direct Visualization System, K183636.
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
