(266 days)
Not Found
No
The description focuses on standard optical imaging and signal processing, with no mention of AI or ML algorithms for image analysis or other functions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in diagnostic and therapeutic applications".
Yes.
The "Intended Use / Indications for Use" section explicitly states: "The Flexible Video-Choledochoscope System is indicated for use in diagnostic and therapeutic applications..." and "The Flexible Video-Choledochoscope is indicated for use in diagnostic applications..." The "Device Description" also mentions it is used for "observation and diagnosis" and "display images on its monitor output for doctor observation and diagnosis."
No
The device description clearly outlines hardware components including a flexible video-choledochoscope with mechanical parts, a camera system, a lighting system, and an imaging processor system with a light source and image processing board. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Flexible Video-Choledochoscope System is used for direct visualization and therapeutic interventions within the pancreatico-biliary system. It uses an optical camera to capture images inside the body.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It is an endoscopic imaging system used for direct observation and potentially therapeutic procedures.
The device is an endoscopic system used for internal examination and treatment, not for testing samples in a laboratory setting, which is the core function of an IVD.
N/A
Intended Use / Indications 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 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.
Product codes
FBN, KQM, NTN, FET
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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. No Clinical Study is included in this submission.
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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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image 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 | |
| District, Shanghai, China | |
| Contact Person: | Yihua Ma |
| RA Supervisor | |
| Shanghai SeeGen Photoelectric Technology Co., Ltd. | |
| Address: 3 Floor, Building No.1, 4299 JinDu Road, Minhang | |
| District, Shanghai, China | |
| Phone: 0086-18616909737 | |
| 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; |
| 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
System, K183636 |
|--------------------|-----------------------------------------------------------------------------------------------------------|
| Common Name: | Choledochoscope and Accessories, Flexible/Rigid;
Camera, Surgical and Accessories;
LED light Source |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 876.1 00 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | FBN, KQM, NTN |
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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-
Choledochoscope System
(Proposed Device) | SpyGlass DS and DS II Direct
Visualization System,
K183636 | Comment |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| 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 SpyGlass DS and DS II
Direct Visualization System
is indicated for use in
diagnostic and therapeutic
applications during
endoscopic procedures in the
pancreatico-biliary system
including the hepatic ducts. | Almost the
same. |
| | The Flexible Video-
Choledochoscope System
comprises two
components: the Flexible
Video- Choledochoscope
and Imaging Processor
System (Including Light
Source). | The SpyGlass DS and DS II
Direct Visualization System
comprises two components:
the SpyScope DS Access and
Delivery Catheter or
SpyScope DS II Access and
Delivery Catheter, and the
SpyGlass DS Digital | |
| | 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. | Controller.
The SpyScope DS Access and
Delivery Catheter and
SpyScope DS II Access and
Deliver Catheter are intended
to provide direct visualization
and to guide both optical and
accessory devices for | |
| | 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 | diagnostic and therapeutic
applications during
endoscopic procedures in the
pancreatico-biliary system
including the hepatic ducts.
The SpyGlass DS Digital
Controller is intended to | |
| | | Section 5 510(k) Summary | |
| | it on the examination
monitor. | provide illumination and
receive, process, and output
images from the SpyScope
DS Access and Delivery
Catheter or SpyScope DS II
Access and Delivery Catheter
for diagnostic and therapeutic
applications during
endoscopic procedures in the
pancreaticobiliary system
including the hepatic ducts. | |
| Imaging
Technology | CMOS chips at distal end | CMOS chips at distal end | Same. |
| Illumination
Source | LED | LED | Same. |
| Distal
End(mm)
Outer
Diameter | CHV-US100J-U (OD:3.3mm)
CHV-US110J-U
(OD:3.4mm) | 3.5 | Similar |
| Working
Length
(mm) | CHV-US100J-U (Working
Length:2000mm)
CHV-US110J-U (Working
Length: 2000mm) | 2140 | Similar |
| bending
angle (°) | CHV-US100J-U
(UP/DOWN:120°/120°,
LEFT/RIGHT: N/A)
CHV-US110J-U
(UP/DOWN:120°/120°,
LEFT/RIGHT:
120°/120° ) | SpyGlass DS AND SpyGlass DS
II (UP/DOWN:90°/90°,
LEFT/RIGHT:
90°/90° ) | Similar |
| Field of
View | $110°±10°$ | 120° | Almost the
same. |
| Sterilization
Method | ETO Sterilization | ETO Sterilization | Same. |
| Suction
Channel | Connect the suction pump
to the suction port and turn
on the suction. pump to
generate suction. | Suction holes are used for
extracting liquid through
intervention channels. | Same. |
| Water Jet
Channel | Connect the irrigation
pump to the water
injection, and inject the
irrigation solution through
the irrigation channel. | Irrigation holes are used to
inject irrigation solution
through two dedicated
irrigation channels to release
vision and stretch the pipeline. | Almost the
same. |
| Item | Flexible Video-Choledochoscope
System (Proposed Device)
The following type:
PL-1000 | SpyGlass DS Digital
Controller,
K183636(Primary
Predicate Device) | Comment |
| Indicati
on for
Use | 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. | The SpyGlass DS Digital
Controller is intended to
provide illumination and
receive, process, and
output images from the
SpyScope DS Access and
Delivery Catheter or
SpyScope DS II Access
and Delivery Catheter for
diagnostic and therapeutic
applications during
endoscopic procedures in
the pancreaticobiliary
system including the
hepatic ducts.and Delivery
Catheter and SpyScope
DS II Access and Delivery
Catheter are intended to
provide direct
visualization and to guide
both optical and accessory | Almost the
same. |
| input
voltage | 100 - 240V | 100 – 240V | Same |
| frequenc
y | 50/60 Hz | 50/60 Hz | Same |
| Operatin
g
temperat
ure | 5-40°C | 10-35°C | Similar |
| Storage
temperat
ure | -20-50°C | -40-70°C | Similar |
| Type of
protectio
n against
electric
shock | Class I | Class I | Same |
| Protectio
n class of
applicati | BF | BF | Same |
| on parts | | | |
| light
source | Have | Have | Same |
| Light
control | Have | Have | Same |
| Light
source
brightnes
s
indicatio
n | Have | Have | Same |
| image
processin
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
equalizat
ion
terminal | Have | Have | Same |
| Heat
dissipati
on
design | Cooling fan | Cooling fan | Same |
| electrom
agnetic
radiation | Group 1 Class A | Group 1 Class A | Same |
| electrom
agnetic
immunit
y | Compliance with EMC standards | Compliance with EMC standards | Same |
5.6 Substantial Equivalence and Technological Characteristics
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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.
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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.
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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.