The Flexible Video-Choledo-Cysto-Ureteroscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Choledo-Cysto-Ureteroscope System is also indicated for the examination of bile ducts surgically, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
Device Story
Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) is a medical electronic optical instrument for visualizing human cavities (bladder, ureter, biliary, pancreatic ducts). Device consists of a flexible insertion tube with mechanical bending system and a distal CMOS digital imaging sensor. Input: optical images from human cavity; transformation: lens system converts light to electrical signals, processed by an imaging processor board; output: video displayed on a monitor for physician observation. Used in medical facilities by physicians. Output assists in real-time diagnostic and therapeutic decision-making during endoscopic procedures. Benefits include minimally invasive visualization and access to internal anatomy for diagnosis and treatment.
Clinical Evidence
No clinical data included. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-18), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993), sterilization validation, EO residual testing, transportation testing, photobiological safety, and optical/color performance metrics (MTF, SNR, dynamic range, color reducibility).
Technological Characteristics
System includes flexible endoscope probe with CMOS sensor and imaging processor. Features LED 2W light source (30,000 hrs life). Imaging output via CVBS, DVI, S-VIDEO; includes 10.1-inch integrated screen. Connectivity includes USB 2.0 (FAT32). Biocompatibility per ISO 10993; electrical safety per IEC 60601-1/2-18; EMC per IEC 60601-1-2. Sterilization via EO.
Indications for Use
Indicated for patients requiring endoscopic examination of the urinary tract, percutaneous examination of the kidney interior, or surgical examination of bile ducts, including diagnostic and therapeutic procedures performed with additional accessories.
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
Flexible Video-Choledo-Cysto-Ureteroscope System (K211686)
Submission Summary (Full Text)
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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.
October 22, 2024
Shanghai SeeGen Photoelectric Technology Co., Ltd. Yihua Ma RA Supervisor 3 Floor, Building No.1, 4299 JinDu Road, Minhang District Shanghai. 201108 CHINA
Re: K241532
Trade/Device Name: Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET, KQM Received: September 11, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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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,
**Mark R. Kreitz -S**
for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K241532
Device Name
Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
#### Indications for Use (Describe)
The Flexible Video-Choledo-Cysto-Ureteroscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Choledo-Cysto-Ureteroscope System is also indicated for the examination of bile ducts surgically, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
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### *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:
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# 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<br>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<br>Prepared: | May 30, 2024 |
### 5.2 Device
| Device Name: | Flexible Video-Choledo-Cysto-Ureteroscope<br>System |
|----------------------|--------------------------------------------------------------------------------------|
| Common Name: | Choledochoscope and Accessories, Flexible/Rigid;<br>Camera, Surgical and Accessories |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 876.1500 |
| Classification Name: | Endoscopic Video Imaging System/Component, GU |
| Product Code: | KQM,FET |
### 5.3 Predicate Device
| Device Name: | Flexible Video-Choledo-Cysto-Ureteroscope<br>System, K211686 |
|--------------------|-----------------------------------------------------------------------------------------------------------|
| Common Name: | Choledochoscope and Accessories, Flexible/Rigid;<br>Camera, Surgical and Accessories;<br>LED light Source |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | FGB, FBN, FET, FAJ, FGA |
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#### 5.4 Device Description
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-Choledo-Cysto-Ureteroscope is a kind of medical electronic optical instrument, also known as optical camera, which can enter into the human bladder, ureter, 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 it's monitor output for doctor observation and diagnosis.
#### 5.5 Indication for Use:
Flexible Video-Choledo-Cysto-Ureteroscope System is indicated for The endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Choledo-Cysto-Ureteroscope System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
### 5.6 Substantial Equivalence and Technological Characteristics
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Image /page/6/Picture/1 description: The image shows the logo for SEEGEN. The logo is red and black, with the word "SEEGEN" in large, bold letters. Below the word "SEEGEN" is the phrase "vision borderless" in smaller letters. To the right of the word "SEEGEN" are some Chinese characters.
| Item | Imaging Processor System(Including Light Source)<br>(Proposed Device),Model:PL-2100 | Imaging Processor System(Including Light Source),<br>K211686(Primary Predicate Device), Model:PL-1000 | Comment |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Indication for Use | Signals from the endoscope are converted to the image and<br>displayed on an inspection monitor. | Signals from the endoscope are converted to the image<br>and displayed on an inspection monitor. | Same |
| Target patients: | Patients who are considered suitable for the application of<br>this product by the physician | Patients who are considered suitable for the application of<br>this product by the physician | Same |
| User<br>qualifications | Physicians (experts who have been approved by the<br>endoscopic medical safety administrator at each medical<br>facility. If the eligibility requirements are defined by an<br>official body such as a government entity and/or an<br>academic society, follow such requirements.) Specific<br>training to use this product is not required. | Physicians (experts who have been approved by the<br>endoscopic medical safety administrator at each medical<br>facility. If the eligibility requirements are defined by an<br>official body such as a government entity and/or an<br>academic society, follow such requirements.) Specific<br>training to use this product is not required. | Same |
| Place of use | Medical facility | Medical facility | Same |
| Power input | 100-240V~50/60Hz48VA | 100-240V~50/60Hz45VA | Similar |
| Imaging output | CVBS&DVI&S-VIDEO | HDMI | Different |
| Light Source | LED 2W | LED 2W | Same |
| Lamp Life | 30,000 hrs | 30,000 hrs | Same |
| Screen | 10.1 inches | N/A | Different |
| USB Flash<br>Memory | USB 2.0(Max:128G;FAT32) | USB 2.0(Max:128G;FAT32) | Same |
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K241532
Page 4 of 5
| Image: SEEEEN 视介光电 | | | | |
|--------------------|--|--|--|--|
| vision borderless | | | | |
| illumination | ≥2000LUX | ≥2000LUX | Same |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Resolution | d = 10mm, the MTF50 value of the SFR at the center part shall not be lower than 200lw / pH, and the MTF50 value at 70% of the field of view position shall not be lower than the MTF50 value at 80% of the center position. | d = 10mm, the MTF50 value of the SFR at the center part shall not be lower than 200lw / pH, and the MTF50 value at 70% of the field of view position shall not be lower than the MTF50 value at 80% of the center position. | Same |
| Filed of<br>View | 110°±10% | 110°±10% | Same |
| Observe<br>the depth<br>of field | 5-50mm<br>MTF50 ≥ 200 (LW / PH) | 5-50mm<br>MTF50 ≥ 200 (LW / PH) | Same |
| Direction of View | 0°±2° | 0°±2° | Same |
| TV<br>distortion | < 15% | < 15% | Same |
| SNR and<br>Dynamic<br>Range | SNR≥10<br>DR≥90 | SNR≥10<br>DR≥90 | Same |
| Color<br>reducibility<br>y test | ΔE≤23<br>ΔC≤23 | ΔE≤23<br>ΔC≤23 | Same |
| Shading | Lightness non-uniformity DL≥70<br>Luminance non-uniformity Dγ≥95 | Lightness non-uniformity DL≥70<br>Luminance non-uniformity Dγ≥95 | Same |
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Image /page/8/Picture/0 description: The image shows the logo for SEEGEN, a company specializing in vision technology. The logo features the company name in a stylized, bold font, with the tagline "vision borderless" underneath. To the right of the company name are Chinese characters, likely representing the company's name or a related concept in Chinese. The overall design is modern and sleek, reflecting the company's focus on innovation and cutting-edge technology in the field of vision.
#### 5.7 Substantial Equivalence
The new image processor,(PL-2100), 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-Choledo-Cysto-Ureteroscope System has been successfully tested for its functions. 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, optical and colour performance test.
#### 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-Choledo-Cysto-Ureteroscope System is substantially equivalent to Boston Scientific Corporation's currently marketed Flexible Video-Choledo-Cysto-Ureteroscope System, K211686.
