This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation of kidney stones and stone dust during ureteral lithotripsy.

Device Description

The Pusen Single Use Flexible Video Ureteroscope (Model: PU3033H, PU3033AH) and Pusen Single Use Suction Access Ureteroscope (Model: PU400A, PU411A) have been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy. This product is for use in a hospital or qualified medical institution.

Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are provided sterile with the following model differences:
| Product name | Single UseUreteroscope | Suction Access | Single UseUreteroscope | Flexible Video |
|----------------|----------------------------|----------------|----------------------------|----------------|
| Model | PU400A | PU411A | PU3033H | PU3033AH |
| Suction access | Yes | Yes | Yes | Yes |
| Buttons | Yes | Yes | No | Yes |
. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope have two LEDs and CMOS imaging sensor at its distal tip. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope need to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are powered by the HD Medical Video Endoscope Image Processor PV300.
The HD Medical Video Endoscope Image Processor PV300 was cleared under 510(k) number K222602.

AI/ML Overview

The provided text describes a submission to the FDA for a medical device (Single Use Suction Access Ureteroscope and Single Use Flexible Video Ureteroscope) and its comparison to a predicate device. However, it does not contain information related to software AI performance or studies specifically designed to establish AI acceptance criteria.

The document focuses on the safety and effectiveness of the physical ureteroscope devices, including aspects like:

Biocompatibility
Electrical safety and electromagnetic compatibility (EMC)
Software verification and validation (for the device's operational software, not AI)
Mechanical and optical performance
Image quality (of the physical device's optics, not AI-enhanced image analysis)
Photobiological safety
Luer taper
Sterilization and shelf life

Therefore, I cannot provide the requested information about acceptance criteria and studies related to an AI component, as it is not present in the given text.

The closest relevant section is "Software Verification and Validation Testing," which states:
"Software verification and validation testing were conducted, and relevant software documentations were provided as recommended by FDA's Guidance for Industry and FDA staff, "Guidance for the Content of Premarket Submissions for Device Software Function" (issued on June 14, 2023)."

This refers to the software controlling the device's basic functions, not an AI component for medical diagnosis or image interpretation. Without specific details on AI functionality, performance metrics, or clinical studies involving AI, the requested table and study details cannot be generated from this document.

Summary

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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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 16, 2024

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 519000 CHINA

Re: K233778

Trade/Device Name: Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB, FED Received: June 18, 2024

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 (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.

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

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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) K233778

Device Name

Single Use Suction Access Ureteroscope (PU400A, PU411A); Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)

Indications for Use (Describe)

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: July 16, 2024

II. DEVICE

Name of Device: Pusen Single Use Flexible Video Ureteroscope (Model: PU3033H, PU3033AH) and Pusen Single Use Suction Access Ureteroscope (Model: PU400A, PU411A) Common Name: Ureteroscope and Accessories 510(k) number: K233778 Classification Name: Ureteroscope and Accessories, Flexible/Rigid (21 CFR 876.1500) Regulatory Class: Class II Product Code: FGB

III. PREDICATE DEVICE

Predicate device

Name of Device: Medical Video Endoscope system

510(k) number: K172098

Classification regulation: Ureteroscope and Accessories, Flexible/rigid

Product code: FGB

This predicate device has not been subject to a design-related recall.

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Reference device

Name of Device: ClearPetra Suction-Evacuation Sheath 510(k) number: K203119 Classification regulation: Endoscope and Accessories Product code: FED, FAJ, FGA This reference device has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are provided sterile with the following model differences:

Product name	Single UseUreteroscope	Suction Access	Single UseUreteroscope	Flexible Video
Model	PU400A	PU411A	PU3033H	PU3033AH
Suction access	Yes	Yes	Yes	Yes
Buttons	Yes	Yes	No	Yes

. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope have two LEDs and CMOS imaging sensor at its distal tip. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope need to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system. The Pusen Single Use Flexible Video Ureteroscope and 510(k) summary

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Pusen Single Use Suction Access Ureteroscope are powered by the HD Medical Video Endoscope Image Processor PV300.

The HD Medical Video Endoscope Image Processor PV300 was cleared under 510(k) number K222602.

V. INDICATIONS FOR USE

This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy.

VI. COMPARISON WITH THE PREDICATE DEVICE

a. INDICATIONS FOR USE

Item	Subject device	Predicate device	Reference device
Trade name	Single Use Flexible VideoUreteroscopeSingle Use Suction AccessUreteroscope	Medical Video EndoscopeSystem	ClearPetra Suction-Evacuation Sheath
510(K) number	K233778	K172098	K203119
Indications foruse	This instrument has beendesigned to be used withEndo-Therapy accessoriessuch as a biopsy forcepsandotherancillaryequipment for endoscopyandendoscopic surgerywithin urinary tract andinterior of the kidney. Thisinstrument is also used as asuctioncatheterthatestablishes a conduit used	This instrument has beendesigned to be used withendo-therapy accessoriessuch as a biopsy forcepsandotherancillaryequipment for endoscopyandendoscopic surgerywithin urinary tract andinterior of the kidney.	The ClearPetra Suction-Evacuation Sheath isused to establish aconduitduringendoscopicurologicalprocedures facilitatingthepassageofendoscopes and otherinstruments into theurinary tract. It isdesigned to establish aconduit for the treatment

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for irrigation and aspirationof kidney stones and stonedust during ureterallithotripsy	of urinary stones or otherurinary diseases duringendoscopic procedures.
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The subject device's indications for use is similar to that of the predicate device, the difference is only supplementary descriptions to the suction access functionality which aligns with that of the reference device, and this difference does not change the intended use of the subject device.

TECHNOLOGICAL CHARACTERISTICS b.

Item	Subject device	Predicate device
Trade name	Single Use Flexible Video UreteroscopeSingle Use Suction Access Ureteroscope	Medical Video Endoscope System
510(K) number	K233778	K172098
Scope type	Flexible	Flexible
Scope reusability	Single-use	Single-use
Energy used	Powered by chargeable battery or linepower.	Powered by chargeable battery or linepower.
Digitalvideotechnology	CMOS	CMOS
Illuminationsource	LED	Fiber
Field of view	120 °	120 °
Direction of view	0°	0°
Depth of field	3~50 mm	3~50 mm
Maximuminsertion portionwidth	PU3033AH, PU3033H: 2.7 mmPU400A, PU411A: 3.2	3.2 mm
Working length	PU3033AH, PU3033H: 650 mm	650 mm

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	PU400A: 650 mmPU411A: 680 mm
Working channelsize	PU3033AH, PU3033H: $\ge$ 1.2 mmPU400A, PU411A: $\ge$ 5.1 Fr	1.0 mm
Up/downdeflection	Up: 270°Down: 270°	Up: 270°Down: 270°
Irrigation	Provided	Provided
Suction	Provided	Not Provided
Sterility	Ethylene Oxide (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 illumination source. However, these differences do not raise different questions of safety and effectiveness.

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VII. PERFORMANCE DATA

The subject device has been verified for the safety and effectiveness based on the following performance data.

Biocompatibility testing

The biocompatibility evaluation for the Pusen Single Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope was conducted in accordance with the FDA final guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued on September 4, 2020) and international standard ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. To support the contact classification as breached/compromised or compromised surfaces, contacting tissue for a limited duration (< 24 hours), the following endpoints were evaluated:

. Cytotoxicity
Intracutaneous Irritation .
Sensitization ●
. Material-Mediated Pyrogenicity
. Acute Systemic Toxicity

The subject device passed the relevant tests and complies with ISO 10993-1.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the subject device system, and the system complies with the IEC 60601-1 and IEC 60601-2-18 standards for safety and the IEC 60601-1-2 standard and IEC TS 60601-4-2 for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted, and relevant software documentations were provided as recommended by FDA's Guidance for Industry and FDA

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staff, "Guidance for the Content of Premarket Submissions for Device Software Function" (issued on June 14, 2023).

Bench Performance Testing

Mechanical and Optical Performance

The subject device was designed to comply with applicable parts of ISO 8600. Optical measurements and physical performances tests were performed according to applicable part of ISO 8600 standard, include appearance, working length, working channel diameter, maximum insertion width, angle of deflection, field of view and direction of view. Mechanical characteristics were tested and include flow rate of water, suction rate and tensile strength testing.

lmage quality

Comparative testing related to image quality performances were performed for the subject device and the predicate device to support substantial equivalence. The tests included color reproduction performance, optical performance (such as resolution, depth of field, image intensity uniformity, signal-to-noise ratio (SNR), dynamic range and distortion).

Photobiological safety

The LEDs in the subject device were tested according to the following FDA recognized standards:

• IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems.

Luer taper

Luer taper in the subject device was tested according to ISO 80369-7: 2021, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications.

Sterilization and shelf life

A shelf life of 3 years for the Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope was supported with accelerated aging of final

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devices, followed by simulated shipping distribution, package integrity testing, and product performance testing.

The EO sterilization method has been validated to ISO 11135:2014.

Animal Study and Clinical study

No animal study or clinical study is included in this submission.

Summary of performance data

All tests were passed and all evaluation acceptance criteria were met.

VIII. CONCLUSIONS

The performance data described above demonstrate that the Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope is as safe and effective as the predicate device and supports a substantial equivalence determination.

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.