(190 days)
No
The document describes a standard video endoscopy system with an image processor for real-time display. There is no mention of AI, ML, or any advanced image analysis beyond basic processing for visualization.
Yes
The device is indicated for "therapeutic applications during endoscopic procedures in bile ducts."
Yes
The device is intended for "examination of the lower urinary tract" and "examination and therapeutic applications during endoscopic procedures in bile ducts," which are diagnostic activities. It provides visualization via a video processor to enable "visual examination of target site."
No
The device description explicitly states that the system includes both a "Single Use Flexible Video Cystoscope/Choledochoscope" (hardware) and an "HD Medical Video Endoscope Image Processor" (hardware with software). It is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this system is used for direct visualization and examination of the lower urinary tract and bile ducts within the body. It does not involve analyzing samples taken from the body.
- The device is an endoscope. Endoscopes are medical devices used to look inside the body, not to perform tests on biological samples.
- The image processing is for real-time visualization. The image processor is used to display the video feed from the endoscope for visual examination, not to analyze biological markers or substances in a sample.
Therefore, the Pusen Single Use Flexible Video Cystoscope/Choledochoscope System falls under the category of an endoscopic device for direct visualization and therapeutic procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System is intended to be used for endoscopic access to and examination of the lower urinary tract. This system is also indicated for the examination and therapeutic applications during endoscopic procedures in bile ducts. The Cystoscope/Choledochoscope is intended to provide visualization via video processor and can be used with endoscopic accessories.
This system is intended for use in a hospital environment or medical office environment.
Product codes
FBN, FAJ
Device Description
The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System includes a Single Use Flexible Video Cystoscope/Choledochoscope and an HD Medical Video Endoscope Image Processor.
This system is intended to be used for endoscopic access to and examination of the lower urinary tract. This system is also indicated for the examination and therapeutic applications during endoscopic procedures in bile ducts. This Cystoscope/Choledochoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment.
- The Pusen Single Use Flexible Video Cystoscope/Choledochoscope is provided sterile and has the following 4 models:
| Model | Description of difference |
|---|---|
| PC200-AS | 'A' means this model has function buttons; 'S' means standard deflection. |
| PC200-AR | 'A' means this model has function buttons; 'R' means reverse deflection. |
| PC200-S | 'S' means standard deflection. |
| PC200-R | 'R' means reverse deflection. |
- The Pusen Single Use Flexible Video Cystoscope/Choledochoscope needs to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system, and it is powered by the latter.
- The HD Medical Video Endoscope Image Processor PV300 is a reusable device, used to process the image signal from the Pusen Single Use Flexible Video Cystoscope/Choledochoscope and display the real-time video on its LCD screen, which enables visual examination of target site.
This change is to expand the indications for the currently cleared reference Pusen Single Use Flexible Video Cystoscope System (K222602) to allow it to also be marketed as a Choledochoscope used for examination and therapeutic applications during endoscopic procedures in bile ducts. No changes were made to the device design. Only the product name, indications for use and applicable labeling were updated.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower urinary tract, bile ducts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital environment or medical office environment.
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
No animal study or clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 22, 2023
Zhuhai Pusen Medical Technology Co., Ltd. Changshen Wang Regulatory Affairs Director 5/F, Building 1, No 33, Ke Ji San Road High-tech Zone, Tangjiawan Town Zhuhai, Guangdong 519085 China
Re: K223741
Trade/Device Name: Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R:HD Medical Video Endoscope Image Processor: PV300 Regulation Number: 21 CFR§ 876.1500
Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FBN, FAJ Dated: December 12, 2022 Received: May 18, 2023
Dear Changshen 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.
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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-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 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 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
510(k) Number (if known) K223741
Device Name
Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AR. PC200-S and PC200-R:HD Medical Video Endoscope Image Processor: PV300
Indications for Use (Describe)
The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System is intended to be used for endoscopic access to and examination of the lower urinary tract. This system is also indicated for the examination and therapeutic applications during endoscopic procedures in bile ducts. The Cystoscope/Choledochoscope is intended to provide visualization via video processor and can be used with endoscopic accessories.
This system is intended for use in a hospital environment or medical office environment.
| 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
I. SUBMITTER
Submitter's name: Zhuhai Pusen Medical Technology Co, Ltd. Submitter's address: 5/F, Building 1, No 33, Keji San Road, High-tech Zone, Tangjiawan Town, 519085 Zhuhai, Guangdong, People's Republic of China.
Phone: +86 756 688 0865
Contact Person: Ellen Wang Date Prepared: May 16, 2023
II. DEVICE
Name of Device: Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope: PC200-AR, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300 Classification Name: Endoscope and Accessories (21 CFR 876.1500) 510(k) number: N/A Regulatory Class: Class II Product Code: FBN, FAJ
III. PREDICATE DEVICE
Predicate device Name of Device: Flexible Video-Choledo-Cysto-Ureteroscope System 510(k) number: K211686 Classification Name: Endoscope and Accessories Product code: FGB, FBN, FET, FAJ, FGA This predicate device has not been subject to a design-related recall.
Reference device
Name of Device: Pusen Single Use Flexible Video Cystoscope System 510(k) number: K222602 Classification regulation: Endoscope and Accessories Product code: FAJ This reference device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
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The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System includes a Single Use Flexible Video Cystoscope/Choledochoscope and an HD Medical Video Endoscope Image Processor.
This system is intended to be used for endoscopic access to and examination of the lower urinary tract. This system is also indicated for the examination and therapeutic applications during endoscopic procedures in bile ducts. This Cystoscope/Choledochoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment.
- The Pusen Single Use Flexible Video Cystoscope/Choledochoscope is provided sterile and has the following 4 models:
| Model | Description of difference |
|---|---|
| PC200-AS | 'A' means this model has function buttons; 'S' means standard deflection. |
| PC200-AR | 'A' means this model has function buttons; 'R' means reverse deflection. |
| PC200-S | 'S' means standard deflection. |
| PC200-R | 'R' means reverse deflection. |
- The Pusen Single Use Flexible Video Cystoscope/Choledochoscope needs to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system, and it is powered by the latter.
- The HD Medical Video Endoscope Image Processor PV300 is a reusable device, used to process the image signal from the Pusen Single Use Flexible Video Cystoscope/Choledochoscope and display the real-time video on its LCD screen, which enables visual examination of target site.
This change is to expand the indications for the currently cleared reference Pusen Single Use Flexible Video Cystoscope System (K222602) to allow it to also be marketed as a Choledochoscope used for examination and therapeutic applications during endoscopic procedures in bile ducts. No changes were made to the device design. Only the product name, indications for use and applicable labeling were updated.
V. INDICATIONS FOR USE
The subject device: The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System is intended to be used for endoscopic access to and examination of the lower urinary tract. This system is also indicated for the examination and therapeutic applications during endoscopic procedures in bile ducts. This Cystoscope/Choledochoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment.
5
Zhuhai Pusen Medical Technology Co., Ltd.
Traditional 510(k)
The predicate device: 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.
The indications for use of the subject device fall within the intended use of the predicate device and, therefore, the two devices have the same intended use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Item | Subject device | Predicate device | Reference device |
|---|---|---|---|
| Trade name | Pusen Single Use Flexible | ||
| Video | |||
| Cystoscope/Choledochoscope | |||
| System | Flexible Video-Choledo- | ||
| Cysto-Ureteroscope | |||
| System | Pusen Single Use Flexible | ||
| Video Cystoscope System | |||
| 510(K) | |||
| number | N/A | K211686 | K222602 |
| Scope type | Flexible | Flexible | Flexible |
| Scope | |||
| reusability | Single-use | Single-use | Single-use |
| Energy used | Powered by chargeable | ||
| battery or line power. | Powered by chargeable | ||
| battery or line power. | Powered by chargeable | ||
| battery or line power. | |||
| Digital video | |||
| technology | CMOS | CMOS | CMOS |
| Illumination | |||
| source | LED | LED | LED |
| Field of view | 90 ° | 110 ° | 90 ° |
| Direction | |||
| of | |||
| view | 0° | 0° | 30° |
| Depth of field | 3~80 mm | 5~50mm | 3~80 mm |
| Maximum | |||
| insertion | |||
| portion width | 5.6mm | 5.3mm | 6.0mm |
| Working | |||
| length | 380 mm | 385 mm | 380 mm |
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Image /page/6/Picture/1 description: The image contains the word "PUSEN" in a stylized, sans-serif font. The letters are a light blue color. Below the word "PUSEN" is the text "Zhuhai Pusen Medical Technology Co." in a smaller, sans-serif font. The text is a dark gray color.
| Zhuhai Pusen Medical Technology Co., Ltd. | Traditional 510(k) | ||
|---|---|---|---|
| Working | |||
| channel size | 2.3 mm | 2.6 mm | 2.3 mm |
| Up/down | |||
| deflection | Up: 210° | ||
| Down: 210° | Up: 210° | ||
| Down: 130° | Up: 210° | ||
| Down: 210° | |||
| Suction | Provided | Not Provided | Provided |
| Sterility | Ethylene Oxide (EO) | ||
| SAL: 10-6 | EO | ||
| SAL: 10-6 | Ethylene Oxide (EO) | ||
| SAL: 10-6 |
The subject and the predicate device have different dimensions (e.g., working length, channel size) and optical specifications (e.g., depth of field, field of view). However, these differences do not raise different questions of safety and effectiveness.
VII. PERFORMANCE DATA
Non-Clinical Performance Data
The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System and reference Pusen Single Use Flexible Video Cystoscope System (K222602) share the same fundamental technology and physical characteristics except for the Direction of view and the Maximum insertion portion width, verification reports on these two performances are provided. The other performance data described in the cleared Pusen Single Use Flexible Video Cystoscope System, K222602, is also applicable to the Pusen Single Use Flexible Video Cystoscope/Choledochoscope System. The labelling was updated to reflect the new indications and new specifications.
Animal Study and Clinical study
No animal study or clinical study is included in this submission.
VIII. CONCLUSIONS
The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System is substantially equivalent to its predicate device. Performance testing and compliance with voluntary standards, demonstrate that the subject device is substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use. Therefore, the subject devices are determined to be substantially equivalent to the referenced predicate devices.