(112 days)
Not Found
No
The description focuses on the optical and mechanical aspects of the device and the image processing system is described as converting light signals to electrical signals for display, without mentioning any AI/ML algorithms for analysis or interpretation.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "diagnostic and therapeutic applications."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in diagnostic and therapeutic applications". Additionally, the "Device Description" mentions that it can "enter into the human biliary and pancreatic duct for observation and diagnosis" and "display images on its monitor output for doctor observation and diagnosis."
No
The device description explicitly mentions mechanical parts, a flexible insertion tube, a system of bends, photoelective sensors (CMOS), a lens optical system, and an Imaging Processor System (Including Light Source), all of which are hardware components.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The Flexible Video-Choledochoscope is a medical instrument that is inserted into the body (in vivo) to visualize the pancreatico-biliary system. It uses an optical camera system to capture images for direct observation and diagnosis by a doctor.
- Intended Use: The intended use is for diagnostic and therapeutic applications during endoscopic procedures within the body.
The device is a tool for direct visualization and intervention within the body, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Flexible Video-Choledochoscope is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
Product codes
FBN, KQM
Device Description
Flexible Video-Choledochoscope is a kind of medical 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. This device must be used with a duodenoscope. The product is equipped with tiny size digital imaging parts -- photoelective sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light 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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pancreatico-biliary system including the hepatic 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
The following performance tests were conducted to substantial equivalence: mechanical performance: duodenosoone compatibility testing and flexible surgical instrument compatibility testing and comparison performance testing. No Clinical Study is included in this submission.
Key Metrics
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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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 & 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" in blue, and "ADMINISTRATION" in a smaller font size below.
March 7, 2025
Shanghai SeeGen Photoelectric Technology Co., Ltd. Die Li RA specialist 3 Floor, Building No.1, 4299 JinDu Road Minhang District Shanghai, China 201108 China
Re: K243535
Trade/Device Name: Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FBN Dated: February 7, 2025 Received: February 7, 2025
Dear Die Li:
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 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).
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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 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)
Device Name
Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
Indications for Use (Describe)
The Flexible Video-Choledochoscope is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
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)
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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 | |
| District, Shanghai, China | |
| Contact | |
| Person: | Die Li |
| RA Supervisor | |
| Shanghai SeeGen Photoelectric Technology Co., Ltd. | |
| Address: 3 Floor, Building No.1, 4299 JinDu Road, Minhang | |
| District, Shanghai, China | |
| Phone: 0086-18721292535 | |
| Email: lidie@seegen.com.cn | |
| Date | |
| Prepared: | Oct 10, 2024 |
5.2 Device
| Device Name: | Flexible Video-Choledochoscope |
|---|---|
| Common Name: | Choledochoscope and Accessories, Flexible/Rigid; |
| Camera, Surgical and Accessories; | |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | FBN, KQM |
5.3 Predicate Device
| Device Name: | Flexible Video-Choledochoscope System, K222261 |
|---|---|
| Common Name: | Choledochoscope and Accessories, Flexible/Rigid; |
| 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 |
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Flexible Video-Choledochoscope is a kind of medical 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.
This device must be used with a duodenoscope.
The product is equipped with tiny size digital imaging parts -- photoelective sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light 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 is indiagnostic and therapeutic applications during endoscopic procedures in the panceaticobiliary system including the hepatic ducts.
5.6 Substantial Equivalence and Technological Characteristics
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| Item | Flexible Video-Choledochoscope (Proposed Device)
The following type:
For Flexible Video-Choledochoscope:
CHV-110J-U/CHV-US120J-U | Flexible Video-Choledochoscope System
(Predicate Device),K222261
The following type:
For Flexible Video-Choledochoscope:
CHV-US100J-U/CHV-US110J-U | Comment |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Indication for Use | The Flexible Video-Choledochoscope 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 is indicated for use in
diagnostic and therapeutic applications during endoscopic
procedures in the pancreatico - biliary system including the
hepatic ducts. | Same |
| Imaging
Technology | CMOS chips at distal end | CMOS chips at distal end | Same |
| Illumination
Source | LED | LED | Same |
| Distal
End(mm)
Outer
Diameter | CHV-110J-U (OD:3.8mm)
CHV-US120J-U (OD:2.6mm) | CHV-US100J-U (OD:3.3mm)
CHV-US110J-U (OD:3.4mm) | Similar |
| Working
Length(mm) | CHV-110J-U(Working Length:2000mm)
CHV-US120J-U (Working Length:2150mm) | CHV-US100J-U (Working Length:2000mm)
CHV-US110J-U (Working Length:2000mm) | Similar |
| Bending Angle(°) | CHV-110J-U (UP/DOWN:120°/120°, LEFT/RIGHT:
120°/120°)
CHV-US120J-U (UP/DOWN:120°/120°, LEFT/RIGHT:
120°/120°) | CHV-US100J-U (UP/DOWN:120°/120°, LEFT/RIGHT:
N/A)
CHV-US110J-U (UP/DOWN:120°/120°,
LEFT/RIGHT:120°/120°) | Same |
| Field of View | 110° | 110° | Same |
| Sterilization
Method | EO
SAL:10-6 | EO
SAL:10-6 | Same |
| Image: SEEGEN vision borderless logo | | 510(k) Summary | K243535 |
| Suction
Channel | Connect the suction pump to the suction port and turn on the suction pump to generate suction. | Connect the suction pump to the suction port and turn on the suction pump to generate suction. | Same |
| Water Jet
Channel | Connect the irrigation pump to the water injection, and inject the irrigation solution through the irrigation channel. | Connect the irrigation pump to the water injection, and inject the irrigation solution through the irrigation channel. | Same |
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5.7 Substantial Equivalence
Flexible Video-Choledochoscope System, K222261 are used as predicate device Flexible Video-Choledochoscope manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.
5.8 Non-clinical Performance Data
The following performance tests were conducted to substantial equivalence: mechanical performance: duodenosoone compatibility testing and flexible surgical instrument compatibility testing and comparison performance testing.
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, Section 5 510(k) Summary based on the information provided in this premarket notification, Shanghai SeeGen Photoeler Co., Ltd has demonstrated that proposed device Flexible Video-Choledochosope is substantially equivalent to Shanghai SeeGen Photoelectic Technology Co., Ltd's currently marketed Flexible Video-Choledochosope System, K22261.
1/01/0000