← Product Code [FAJ](/productcode/FAJ) · K231118
# Cystoscope System (K231118)
_Shenzhen HugeMed Medical Technical Development Co., Ltd. · FAJ · Nov 13, 2023 · Gastroenterology, Urology · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K231118
## Device Facts
- **Applicant:** Shenzhen HugeMed Medical Technical Development Co., Ltd.
- **Product Code:** [FAJ](/productcode/FAJ.md)
- **Decision Date:** Nov 13, 2023
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
## Indications 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.
## Device Story
System comprises sterile, single-use flexible cystoscope and reusable image processor. Cystoscope features control body with articulation controls, accessory ports, insertion tube with on-tip CMOS camera, and LED illumination. Device provides visualization of lower urinary tract; used in hospital or medical office settings by clinicians. Image processor receives video signals from cystoscope, processes images, and outputs to display. Used for diagnostic and management procedures; compatible with endoscopic accessories. Benefits include sterile, single-use design eliminating reprocessing requirements and reducing cross-contamination risk.
## Clinical Evidence
No clinical data. Bench testing only. Performance supported by biocompatibility (ISO 10993), sterilization validation (ISO 11135), electrical safety/EMC (IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2), and bench performance testing (optical performance per ISO 8600, mechanical stress, irrigation flow, and accessory compatibility).
## Technological Characteristics
Single-use flexible cystoscope; reusable image processor. CMOS imaging sensor; LED illumination. Working length 350mm; shaft diameters 3.1mm-5.0mm; working channels 1.1mm-2.8mm. Up/down deflection 210°/210°. Sterilization: Ethylene Oxide (SAL 10^-6). Compliance: ISO 10993 (biocompatibility), ISO 11135 (sterilization), IEC 60601-1/2-18 (safety), IEC 60601-1-2 (EMC).
## Regulatory 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.
## Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
## Predicate Devices
- Ambu aScope 4 Cysto ([K193095](/device/K193095.md))
## Submission Summary (Full Text)
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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 & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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)
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.
| 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-M32 image 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
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
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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 4 Cysto | / |
| 510(K) Submitter | Shenzhen HugeMed Medical Technical Development Co., Ltd. | Ambu Inc. | / |
| K number | - | K193095 | / |
| Classification Regulation | 21CRF 876.1500 | 21CRF 876.1500 | Same |
| Classification and Code | Class II, FAJ | Class II, FAJ | Same |
| Common name | Cystoscope and Accessories,, Flexible/rigid | Cystoscope and Accessories,, Flexible/rigid | Same |
| Cystoscope | Single-Use | Single-Use | Same |
| 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 | Ambu® aScopeTM 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the | Same |
| Features | Subject Device | Predicate Device | Comparison |
| | 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. | lower urinary tract. The Ambu® aScope™ 4 Cysto is intended to provide visualization via Ambu® displaying unit and can be used with endoscopic accessories. Ambu® aScope™ 4 Cysto is intended for use in a hospital environment or medical office environment. Ambu® aScope™ 4 Cysto is designed for use in adults. | |
| Digital video technology | CMOS | CMOS | Same |
| Illumination | LED | LED | Same |
| Field of view (degree) | 120° | 120° | Same |
| Working length (mm) | 350 mm±10% | 390mm | Different |
| Outer Shaft Diameter | CY-M52: $Φ$ 5.0 CY-M50: $Φ$ 5.0 CY-M40: $Φ$ 4.2 CY-M32: $Φ$ 3.1 | 16.2Fr(5.4mm) | Different |
| Working Channel Diameter | CY-M52: $Φ$ ≥2.10 mm CY-M50: $Φ$ 2.8±10%mm CY-M40: $Φ$ ≥1.1 mm CY-M32: $Φ$ 1.2±10%mm | 6.6Fr(2.2mm) | Different |
| Up/Down Deflection | 210° upward and 210° downward | UP: 210° DOWN: 120° | Different |
| Sterilization | EO SAL: 10-6 | EO SAL: 10-6 | Same |
| Packaging | Cystoscope is packaged in a tray which is sealed by sterile barrier. | Cystoscope is packaged by paper-plastic bag. | Same |
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | 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.
2. 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.
3. 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.
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**Source:** [https://fda-staging.innolitics.com/device/K231118](https://fda-staging.innolitics.com/device/K231118)
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