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.

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: PC200-AS, PC200-AR, PC200-S, and PC200-R.
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.

AI/ML Overview

This document is a 510(k) premarket notification for the "Pusen Single Use Flexible Video Cystoscope/Choledochoscope System." It seeks to establish substantial equivalence to a predicate device for an expanded indication (examination of bile ducts) from a previously cleared device (Pusen Single Use Flexible Video Cystoscope System K222602) which only covered the lower urinary tract.

The information provided does not contain acceptance criteria for device performance measured against the indicated use for the "Pusen Single Use Flexible Video Cystoscope/Choledochoscope System," nor does it describe a study to prove its performance in meeting such criteria. Instead, it relies on non-clinical performance data (bench testing) and substantial equivalence to a predicate device.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document presents a comparison of technological characteristics between the subject device, a predicate device (Flexible Video-Choledo-Cysto-Ureteroscope System, K211686), and a reference device (Pusen Single Use Flexible Video Cystoscope System, K222602). This comparison (found on pages 5 and 6) lists specifications such as field of view, depth of field, working length, etc., but these are not presented as acceptance criteria for performance related to clinical outcomes or diagnostic accuracy.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document states, "No animal study or clinical study is included in this submission." This means there was no "test set" of patient data in the context of a clinical performance study. The "non-clinical performance data" mentioned refers to bench testing, for which sample sizes of tested units are not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/provided. Since no clinical or animal studies were conducted, there was no need for experts to establish ground truth based on patient or animal data.

4. Adjudication Method

This information is not applicable/provided. No clinical studies with expert adjudication were performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable/provided. No such study was performed, as explicitly stated by "No animal study or clinical study is included in this submission." Therefore, no effect size of human readers improving with or without AI assistance can be reported.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable/provided. The device described is an endoscope system, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. Type of Ground Truth Used

This information is not applicable/provided for clinical performance. As stated, no clinical studies were performed. The "ground truth" for the non-clinical performance data would be based on engineering specifications and measurements (e.g., measuring angles of deflection, illumination intensity, image resolution in a lab setting).

8. Sample Size for the Training Set

This information is not applicable/provided. Since no AI or machine learning component is described for clinical decision-making, there is no "training set" in that context.

9. How Ground Truth for the Training Set Was Established

This information is not applicable/provided. As above, there is no training set for an AI algorithm.

Summary of what the document does provide regarding performance:

The document relies on the following points to support the substantial equivalence:

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." This indicates that specific bench tests were performed to verify these two differences. The document asserts that "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." This implies that prior bench testing for the K222602 device is considered sufficient for this new expanded indication, with only the differences verified.
Substantial Equivalence Argument: The core of the submission is that the device is substantially equivalent to existing legally marketed devices, primarily the predicate device (K211686), which already has indications for both urinary tract and bile duct examination. The subject device is a modification of a previously cleared device (K222602), with the only change being an expanded "Indications for Use" to include bile ducts, matching the predicate. "No changes were made to the device design. Only the product name, indications for use and applicable labeling were updated."
Conclusion: "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."

In essence, the device's "performance" for its intended use, particularly the newly added choledochoscope indication, is justified by its similarity in design and technology to a predicate device that already holds that indication, combined with non-clinical (bench) testing to confirm that minor physical differences do not raise new questions of safety or effectiveness. No clinical studies directly demonstrating performance for the bile duct indication were submitted or required for this 510(k) clearance based on substantial equivalence.

Summary

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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)

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.

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.

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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 FlexibleVideoCystoscope/CholedochoscopeSystem	Flexible Video-Choledo-Cysto-UreteroscopeSystem	Pusen Single Use FlexibleVideo Cystoscope System
510(K)number	N/A	K211686	K222602
Scope type	Flexible	Flexible	Flexible
Scopereusability	Single-use	Single-use	Single-use
Energy used	Powered by chargeablebattery or line power.	Powered by chargeablebattery or line power.	Powered by chargeablebattery or line power.
Digital videotechnology	CMOS	CMOS	CMOS
Illuminationsource	LED	LED	LED
Field of view	90 °	110 °	90 °
Directionofview	0°	0°	30°
Depth of field	3~80 mm	5~50mm	3~80 mm
Maximuminsertionportion width	5.6mm	5.3mm	6.0mm
Workinglength	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)
Workingchannel size	2.3 mm	2.6 mm	2.3 mm
Up/downdeflection	Up: 210°Down: 210°	Up: 210°Down: 130°	Up: 210°Down: 210°
Suction	Provided	Not Provided	Provided
Sterility	Ethylene Oxide (EO)SAL: 10-6	EOSAL: 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.

Regulation Number and Section

§ 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.