(265 days)
Not Found
No
The description focuses on standard endoscopic imaging technology and image processing without mentioning AI or ML algorithms for analysis or interpretation.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device can be used "to perform various diagnostic and therapeutic procedures."
Yes
The "Intended Use / Indications for Use" section states that the device is indicated for "endoscopic examination in the urinary tract" and "examination of bile ducts surgically" to "perform various diagnostic and therapeutic procedures." It explicitly mentions "observation and diagnosis" in the device description.
No
The device description clearly outlines both hardware components (Flexible Video-Choledo-Cysto-Ureteroscope, Imaging Processor System including Light Source) and software/image processing. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Flexible Video-Choledo-Cysto-Ureteroscope System is an endoscopic device used for direct visual examination of internal body cavities (urinary tract, kidney, bile ducts). It captures images in vivo (within the living body) using a camera system.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It is a tool for direct visualization and performing procedures within the body.
Therefore, while it is a medical device used for diagnosis and treatment, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
FGB, FBN, FET, FAJ, FGA
Device Description
Flexible Video-Choledo-Cysto-Ureteroscope System is composed of sterile Flexible Video-Choledo-Cysto-Ureteroscope and an non-sterile Imaging Processor System (Including Light Source).The Flexible Video-Choledo-Cysto-Ureteroscope is composed of Control Section, Light-guiding Section, Connector Section, Insertion Tube and Distal End. The Control Section is pulled by the wire rope to control the bending direction of the Distal End.
The Light-guide section transmits the illumination light from the image processor to the Distal End. The Insertion Tube is used to guide it into other instruments or cavity of the body. The Distal End 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-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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS chips at distal end
Anatomical Site
urinary tract, interior of the kidney, bile ducts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Flexible Video-Choledo-Cysto-Ureteroscope System has been successfully tested for its functions and performance per ISO 8600-1/3/4 and mechanical characteristics. Safety testing war 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 and EO residual.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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February 22, 2022
Shanghai SeeGen Photoelectric Technology Co., Ltd % Nick Wang RA Specialist Shanghai Vanhe Consulting Co., Ltd 2F, Building No.1, 3938 Huqingping Road Shanghai, Shanghai 201713 China
Re: K211686
Trade/Device Name: Flexible Video-Choledo-Cysto-Ureteroscope System Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB, FBN, FET, FAJ, FGA Dated: January 17, 2022 Received: January 21, 2022
Dear Nick Wang:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-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-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,
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211686
Device Name
Flexible Video-Choledo-Cysto-Ureteroscope System
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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3
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K211686
Page 1 of 6
Section 5 510(k) Summary
4
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 | ||
| District, Shanghai, China | ||
| Contact Person: | Nick Wang | |
| RA Specialist | ||
| Shanghai Vanhe Consulting Co., Ltd | ||
| Address: 2F, Building No.1, 3938 Huqingping Road, Qingpu | ||
| District, Shanghai, China. | ||
| Phone: 0086-13585860297 | ||
| Email: vanheconsulting@126.com | ||
| Date Prepared: | May 27, 2021 |
5.2 Device
| Device Name: | Flexible Video-Choledo-Cysto-Ureteroscope System |
|---|---|
| Common Name: | Ureteroscope And Accessories, Flexible/Rigid; |
| Choledochoscope And Accessories, Flexible/Rigid; | |
| Endoscopic Video Imaging System/Component, | |
| Gastroenterology-Urology; | |
| Cystoscope and Accessories, Flexible/Rigid; | |
| Kit, Nephroscope | |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | FGB, FBN, FET, FAJ, FGA |
5.3 Predicate Device
| Device Name: | Flexible Video-Uretero-Choledochoscope System, K142556 |
|---|---|
| Common Name: | Ureteroscope And Accessories, Flexible/Rigid; |
| Choledochoscope And Accessories, Flexible/Rigid; | |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | FGB, FBN |
5
5.4 Device Description
Flexible Video-Choledo-Cysto-Ureteroscope System is composed of sterile Flexible Video-Choledo-Cysto-Ureteroscope and an non-sterile Imaging Processor System (Including Light Source).The Flexible Video-Choledo-Cysto-Ureteroscope is composed of Control Section, Light-guiding Section, Connector Section, Insertion Tube and Distal End. The Control Section is pulled by the wire rope to control the bending direction of the Distal End.
The Light-guide section transmits the illumination light from the image processor to the Distal End. The Insertion Tube is used to guide it into other instruments or cavity of the body. The Distal End 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-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:
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, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
| Item | Flexible Video-Choledo-Cysto-
Ureteroscope System(Proposed
Device
) | Flexible Video-Uretero-
Choledochoscope System,
K142556 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | The Flexible Video-Choledo-Cysto-
Ureteroscope System is indicated for | The KARL STORZ Flexible
Video-Uretero- |
| Item | Flexible Video-Choledo-Cysto-
Ureteroscope System(Proposed
Device
) | Flexible Video-Uretero-
Choledochoscope System,
K142556 |
| | 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. | Choledochoscope 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-Uretero-
Choledochoscope System is
also
indicated for the examination
of bile ducts, and using
additional accessories, to
perform various diagnostic
and therapeutic
procedures during
cholecystectomy |
| Imaging
Technology | CMOS chips at distal end | CMOS chips at distal end |
| Illumination
Source | LED | LED |
| Distal
End(mm) | UV-US110-H (OD:2.5mm)
UV-US100-H (OD:3.0mm) | 2.9 |
| Outer
Diameter | UV-100-E (OD:4.7mm)
UV-100T-E (OD:5.3mm)
UV-110-E (OD:4.7mm)
UV-110T-E (OD:5.3mm)
CHV-US100-H (OD:3.0mm)
CHV-100-E(OD:4.7mm)
CHV-100T-E(OD:5.3mm) | |
| Working
Length(mm) | 380, 600, 750 | 700 |
| Deflection(°)
of view | UV-US110-H
(UP/DOWN:275°/275°)
UV-US100-H
(UP/DOWN:275°/275°) | Up:270
Down:270 |
| Item | Flexible Video-Choledo-Cysto-
Ureteroscope System(Proposed
Device
) | Flexible Video-Uretero-
Choledochoscope System,
K142556 |
| | UV-100T-E
(UP/DOWN:210°/130°)
UV-110-E (UP/DOWN:210°/130° )
UV-110T-E
(UP/DOWN:210°/130°)
CHV-US100-
H(UP/DOWN:120°/120°)
CHV-100-E(UP/DOWN:160°/130°)
CHV-100T-
E(UP/DOWN:160°/130°) | |
| Field of View | 110° | 90° |
| Sterilization
Method | ETO Sterilization | Reusable |
5.6 Substantial Equivalence and Technological Characteristics
6
7
Page 5 of 6
| Device Name | Imaging Processor System (Including Light Source) | Image1 HD CCU(Predicate Device)K142556 | HUB |
|---|---|---|---|
| Brightness Control | Yes | Yes | |
| Enhancement Control(Contrast and Definition) | Yes | Yes | |
| Shutter Speed | 1/1141-1/13860 sec | 1/60-1/17000 sec | |
| White Balance | Yes | Yes | |
| Zoom | Yes | Yes | |
| Output Formats | NTSC/PAL/DVI | NTSC/PAL/VGA/DVI/SDI | |
| Image/Video Capture | Yes | Yes | |
| Video Format Inputs(Cameras) | SD and HD | SD and HD | |
| Video Format Outputs | SD and HD | SD and HD |
5.7 Substantial Equivalence
Flexible Video-Uretero-Choledochoscope System, K142556 is used as predicate device compared to proposed device Flexible Video-Choledo-Cysto-Ureteroscope 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
8
for its functions and performance per ISO 8600-1/3/4 and mechanical characteristics. Safety testing war 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 and EO residual.
5.8 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 Flexible Video-Uretero-Choledochoscope System, K142556.