The single-use cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The single-use is intended to provide visualization via image processor and can be used with endoscopic accessories. The cystoscope system is intended for use in a hospital environment or medical office environment. The cystoscope system is designed for use for adult patients requiring cystoscopy.

Device Description

The Cystoscope System consists of a single-use Cystoscope to provide illumination and intuitive images in endoscopic surgery of the lower urinary tract and serves as a guide to diagnosis and management with accessories and an image processor for clinical image processing. The single-use Cystoscope is a sterile single-use flexible Cystoscope. The image processor is a reusable monitor. The single-use Cystoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the Cystoscope and outputs video signals to a display.

AI/ML Overview

This FDA 510(k) summary (K231118) describes the substantial equivalence of the "Cystoscope System" to a predicate device, the "Ambu aScope 4 Cysto." The submission primarily relies on bench performance testing and compliance with voluntary standards rather than clinical or AI performance studies to establish substantial equivalence.

Therefore, the requested information about acceptance criteria and study data for an AI/device performance assessment is largely not applicable to this specific submission, as it concerns a physical medical device (cystoscope) and its image processing unit, not an AI-driven diagnostic or treatment algorithm.

However, I can extract and present the types of performance data that were provided, framed in a way that attempts to answer your questions where possible, though direct "acceptance criteria" for AI performance or "effect size of human readers with AI" are not present.

Here's a breakdown based on the provided text, indicating "N/A" where the requested information is not relevant to this traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Implied / Standard)	Reported Device Performance
Biocompatibility	Compliance with FDA guidance "Use of International Standard ISO 10993-1" and ISO 10993-1.	Evaluated in accordance with referenced guidance and standards.
Sterilization & Shelf Life	Sterile (SAL 10-6), 3-year shelf life, compliance with ISO 11135:2014, ISO 10993-7:2008 (EO/ECH residual), ASTM F1980-16 (accelerated aging), ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1886/F1886M-16, ASTM F88/F88M-15, ASTM F1929-15 (packaging).	Single-use Cystoscope is provided sterile and its shelf-life is 3 years. Sterilization Process validated accordance with ISO 11135:2014. EO/ECH residual test performed according to ISO 10993-7:2008. Shelf life determined based on optical testing and product performance testing after accelerated aging test. Package validation conducted according to ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1886/F1886M-16, ASTM F88/F88M-15, ASTM F1929-15.
Electrical Safety & EMC	Compliance with IEC 60601-1, IEC 60601-2-18 (safety), and IEC 60601-1-2 (EMC).	The system complies with IEC 60601-1 and IEC60601-2-18 for safety and IEC 60601-1-2 for EMC.
Software Verification & Validation	Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for "moderate" level of concern.	Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance. The software was considered a "moderate" level of concern.
Bench Performance - Optical	Compliance with ISO 8600 series; comparable to predicate device for color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, SNR, dynamic range, image frame frequency, system delay.	Optical performance testing conducted according to ISO 8600 series. Color performance, geometric distortion, optical performance (resolution, depth of field and image intensity uniformity), SNR and dynamic range, image frame frequency and system delay test compared with the predicate device. (Specific comparison results not detailed but implied to be acceptable for substantial equivalence)
Bench Performance - Mechanical	Demonstrated functionality and integrity for force/bending/tensile stress, electrical cable connection, irrigation flow, valve functionality, suction joint functionality, image capture/video recording, and compatibility with accessories.	Force/bending/tensile stress testing of the insertion portion, force testing of the electrical cable, irrigation flow testing, functionality of Type T valve, functionality of the suction joint, functionality of the image capture and video recording functions, and compatibility with endoscopic accessories without damage to the cystoscope were performed. (Specific results not detailed but implied to be acceptable for substantial equivalence)

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

Test Set Sample Size: Not applicable. The submission focuses on verification and validation of engineering performance and regulatory compliance, not clinical or image-based diagnostic accuracy. Bench tests would use a sample of manufactured devices.
Data Provenance: Not applicable for a clinical test set. The data originates from laboratory testing, engineering assessments, and quality control processes conducted by the manufacturer (Shenzhen HugeMed Medical Technical Development Co., Ltd. in China).

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

Number of Experts: Not applicable. This is not an AI/diagnostic algorithm submission requiring expert-established ground truth on medical images.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. This submission does not involve an AI component that would necessitate an MRMC study comparing human readers with and without AI assistance. The device is a direct visualization tool.
Effect Size of Human Readers with AI: Not applicable.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Standalone Study: No. There is no AI algorithm being submitted for standalone performance evaluation in this context. The "software" mentioned relates to the image processor's operational software, not a diagnostic AI.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable for clinical ground truth. The "ground truth" for this device's performance is established by engineering specifications, international consensus standards (ISO, IEC, ASTM), and comparison to the predicate device's characteristics. For example, optical performance is measured against ISO 8600 series standards.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This product is a medical device (cystoscope system), not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable.

Summary

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November 13, 2023

Shenzhen HugeMed Medical Technical Development Co., Ltd. % Yang Jie Consultant Shenzhen Chonconn Medical Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China

Re: K231118

Trade/Device Name: Cystoscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: October 13, 2023 Received: October 13, 2023

Dear Yang Jie:

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.

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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" (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 QS 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.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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)

K231118

Device Name

Cystoscope System

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2023/10/13

1. Submission sponsor

Name: Shenzhen HugeMed Medical Technical Development Co., Ltd. Address: 415,416-1,516-1, Building 2, No. 1, Mawu Road, Baoan Community, Yuanshan Street, Longgang District, Shenzhen, Guangdong, 518115, China Contact person: Jiang Yuanning Title: Regulatory engineer E-mail: jiangyuanning(@hugemed.net Tel: +86-755-22275833

2. Submission correspondent

Name: Shenzhen Chonconn Medical Device Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China Contact person: Yang Jie E-mail: yangjie@chonconn.com Tel: +86-755 33941160

Trade/Device Name	Cystoscope System
Model	single-use Cystoscope: CY-M52, CY-M50, CY-M40, CY-M32image processor: HUV-01
Common Name	Cystoscope System
Regulatory Class	Class II
Classification	21CFR 876.1500 / Endoscope and Accessories / FAJ
Submission type	Traditional 510(K)

3. Subject Device Information

4. Predicate Device

510(k) number: K193095 Product name: Ambu aScope 4 Cysto Submitter: Ambu Inc.

5. Device Description

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processing.

The single-use Cystoscope is a sterile single-use flexible Cystoscope. The image processor is a reusable monitor.

The single-use Cystoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the Cystoscope and outputs video signals to a display.

6. Intended use & Indication for use

The single-use cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The single-use cystoscope is intended to provide visualization via image processor and can be used with endoscopic accessories. The cystoscope system is intended for use in a hospital environment or medical office environment. The cystoscope system is designed for use for adult patients requiring cystoscopy.

Features	Subject Device	Predicate Device	Comparison
Trade name	Cystoscope System	Ambu® aScopeTM 4Cysto	/
510(K) Submitter	Shenzhen HugeMedMedical TechnicalDevelopment Co., Ltd.	Ambu Inc.	/
K number	-	K193095	/
ClassificationRegulation	21CRF 876.1500	21CRF 876.1500	Same
Classificationand Code	Class II,FAJ	Class II,FAJ	Same
Common name	Cystoscope andAccessories,,Flexible/rigid	Cystoscope andAccessories,,Flexible/rigid	Same
Cystoscope	Single-Use	Single-Use	Same
Indication for use	The single-usecystoscope is a sterile,single-use, flexiblecystoscope intended to beused for endoscopicaccess to andexamination of the lower	Ambu® aScopeTM 4Cysto is a sterile,single-use, flexiblecystoscope intended tobe used for endoscopicaccess to andexamination of the	Same
Features	Subject Device	Predicate Device	Comparison
	urinary tract. The single-use cystoscope isintended to providevisualization via imageprocessor and can beused with endoscopicaccessories. Thecystoscope system isintended for use in ahospital environment ormedical officeenvironment. Thecystoscope system isdesigned for use for adultpatients requiringcystoscopy.	lower urinary tract. TheAmbu® aScope™ 4Cysto is intended toprovide visualizationvia Ambu® displayingunit and can be usedwith endoscopicaccessories.Ambu® aScope™ 4Cysto is intended foruse in a hospitalenvironment or medicaloffice environment.Ambu® aScope™ 4Cysto is designed foruse in adults.
Digital videotechnology	CMOS	CMOS	Same
Illumination	LED	LED	Same
Field of view(degree)	120°	120°	Same
Working length(mm)	350 mm±10%	390mm	Different
Outer ShaftDiameter	CY-M52: $Φ$ 5.0CY-M50: $Φ$ 5.0CY-M40: $Φ$ 4.2CY-M32: $Φ$ 3.1	16.2Fr(5.4mm)	Different
Working ChannelDiameter	CY-M52: $Φ$ ≥2.10 mmCY-M50: $Φ$ 2.8±10%mmCY-M40: $Φ$ ≥1.1 mmCY-M32: $Φ$ 1.2±10%mm	6.6Fr(2.2mm)	Different
Up/DownDeflection	210° upward and 210°downward	UP: 210°DOWN: 120°	Different
Sterilization	EOSAL: 10-6	EOSAL: 10-6	Same
Packaging	Cystoscope is packagedin a tray which is sealedby sterile barrier.	Cystoscope is packagedby paper-plastic bag.	Same
Label andLabeling	Meet FDA'sRequirements	Meet FDA'sRequirements	Same
Features	Subject Device	Predicate Device	Comparison
Cytotoxicity	Comply with ISO 10993-5,No cytotoxicity effect	Comply with ISO 10993-5,No cytotoxicity effect	Same
Irritation	Comply with ISO 10993-10,not an irritant	Comply with ISO 10993-10,not an irritant	Same
Sensitization	Comply with ISO 10993-10,not a sensitizer.	Comply with ISO 10993-10,not a sensitizer.	Same

Comparison to the Predicate Device 7.

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8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

Biocompatibility of the single-use Cystoscope was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

Sterilization and shelf life testing

The Single-use Cystoscope is provided sterile and its shelf-life is 3 years. Sterilization Process has been validated accordance with ISO 11135:2014. EO/ECH residual test was performed according to ISO 10993-7:2008. The shelf life is determined based on optical testing and product performance testing affer accelerated aging test according to ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and ASTM F1886/F1886M-16. ASTM F88/F88M-15. ASTM F 1929-15.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Bronchoscope System. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

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The software for this device was considered as a "moderate" level of concern.

Bench performance testing

The following bench tests were performed:

1. Optical performance testing according to ISO 8600 series.

Color performance (color reproduction), geometric distortion, optical performance (resolution, depth of field and image intensity uniformity), SNR and dynamic range, image frame frequency and system delay test compared with the predicate device.
Mechanical testing including the following:

· Force/bending/tensile stress testing of the insertion portion
· Force testing of the electrical cable to determine resistance to disconnection from the cystoscope handle and image system
· Irrigation flow testing through the working channel
· Functionality of Type T valve, including sealing
· Functionality of the suction joint
· Functionality of the image capture and video recording functions
· Compatibility with endoscopic accessories without damage to the cystoscope

Clinical study 9.

No clinical study is included in this submission

10. Conclusion

Performance testing and compliance with voluntary standards demonstrate that the proposed Cystoscope system is substantially equivalent to the predicate device.

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.