Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)

K222162 · Shanghai AnQing Medical Instrument Co., Ltd. · FAJ · Nov 9, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K222162
• Device Name: Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
• Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Nov 9, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AnQing Medical Single Use Flexible Cystoscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra. The Flexible Cystoscope is intended for use in a hospital environment or medical office environment. The Flexible Cystoscope is designed for use in adults.

Device Story

Single-use flexible cystoscope for lower urinary tract visualization and operative access; hospital or medical office use. Device comprises handle with deflection lever, insertion section, distal tip, and connector. Distal tip contains CMOS sensor and LED illumination. User operates deflection lever to maneuver tip; inputs include visual data from body cavity. CMOS captures images; RGB video signals transmitted to external video processor (EOS-H-01) via wiring. Processor outputs video to monitor and controls LED brightness. Luer port on handle allows accessory insertion and irrigation. Physician uses real-time visualization to guide diagnostic or therapeutic interventions. Benefits include sterile, single-use design eliminating reprocessing requirements.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety (ANSI/AAMI ES:60601-1, IEC 60601-2-18, IEC 60601-1-2), photobiological safety (IEC 62471), mechanical/optical performance (ISO 8600), biocompatibility (ISO 10993), and sterilization validation (ISO 11135).

Technological Characteristics

Sterile, single-use flexible endoscope. CMOS imaging sensor; LED illumination. Materials compliant with ISO 10993-1. Sterilized via Ethylene Oxide (EO) per ISO 11135. Dimensions: 5.0-5.5mm outer diameter; 2.0-2.4mm working channel. Connectivity: Wired connection to external video processor. Energy source: Electricity.

Indications for Use

Indicated for adult patients undergoing diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra.

Regulatory Classification

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.

Predicate Devices

• Ambu aScope 4 Cysto (K193095)

Reference Devices

• Video Processor (EOS-H-01) (K211169)

Submission Summary (Full Text)

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November 9, 2022

Shanghai AnQing Medical Instrument Co., Ltd Shuwen Fan RA Manager 3 & 4 Floor, No.2 Building, 366 Huiging Road, East Zhangjiang High-Tech Park Shanghai, 201201 China

Re: K222162

> Trade/Device Name: Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: October 11, 2022 Received: October 11, 2022

Dear Shuwen Fan:

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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Mark J. Antonino -S

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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K222162

Device Name

Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)

Indications for Use (Describe)

AnQing Medical Single Use Flexible Cystoscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra.

The Flexible Cystoscope is intended for use in a hospital environment or medical office environment. The Flexible Cystoscope is designed for use in adults.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <span style="font-size: large;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: large;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image contains the logo for Innovex Anqing Medical. The logo features a purple graphic on the left side, with the word "INNOVEX" in a sans-serif font to the right of the graphic. Below "INNOVEX" is the text "Anqing Medical" in a larger, bolder font. A curved line is above the word "INNOVEX".

Device Class:

Review Panel:

510(k) Premarket Notification Submission Flexible Cystoscope

| | 510(k) Summary |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 8, 2022 |
| Manufacturer: | Shanghai AnQing Medical Instrument Co., Ltd.<br>3 & 4 Floor, No.2 Building, 366 Huiqing Rd, East<br>Zhangjiang High-Tech Park, 201201<br>Shanghai, China |
| Contact Person: | Shuwen Fan<br>RA Manager<br>Shanghai AnQing Medical Instrument Co., Ltd.<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Identification of the Device: | |
| Proprietary/Trade Name: | Flexible Cystoscope |
| Model: | CY50H-20EU, CY50H-20US, CY55H-24EU,<br>CY55H-24US |
| Common name: | Flexible Cystoscope |
| Classification Name: | Endoscope and Accessories |
| Regulatory Number: | 21 CFR Part 876.1500 |
| Product Code: | FAJ |

# rketed Predicate Devic

| Identification of the Legally Marketed Predicate Device: | | | | |
|-----------------------------------------------------------------|--------------------------------------------|--|--|--|
| Trade Name: | Ambu aScope 4 Cysto | | | |
| Common name | Flexible Cystoscope | | | |
| Classification Name: | Cystoscope And Accessories, Flexible/Rigid | | | |
| Regulatory Number: | 21 CFR Part 876.1500 | | | |
| Product Code: | FAJ | | | |
| Device Class: | Class II | | | |
| Review Panel: | Gastroenterology/Urology | | | |
| Submitter/510(k) Holder: | Ambu A/S. | | | |
| Clearance: | K193095 (cleared April 2, 2020) | | | |
| This predicate has not been subject to a design-related recall. | | | | |

Class II

Gastroenterology/Urology

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Image /page/4/Picture/1 description: The image contains a logo for Innovex Anqing Medical. The logo features the word "INNOVEX" in a bold, sans-serif font, with the registered trademark symbol to the right. Below that is the text "ANQING MEDICAL" in a slightly smaller, bold font. To the left of the text is a purple graphic with a white leaf design.

## Device Description:

The Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, is a sterile single-use endoscope which is used with the video CY55H-24US) processor (Model: EOS-H-01, FDA cleared #K211169) produced by AnQing for providing endoscopic imaging of the lower urinary tract, including the bladder and urethra for the purpose of diagnosis and treatment.

The CY50H-20 and CY55H-24 difference is the size of Distal End Outer Diameter and Working Channel Inner Diameter. The US and EU model are identical except the deflection versions, which is opposite from each other (EU version or US version).

The Flexible Cystoscope is a single-use endoscope, which consists of Handle, Insertion Section, Distal Tip, and Endoscope Connector.

The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion contains one working channel and wiring to transmit the image signals to the Video Processor. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the Video Processor, LEDs for illumination, and the distal opening of the working channel. The endoscope connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope.

# Mechanism of action:

The light emitted by the LED cold light source at the distal tip of the disposable Flexible Cystoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LEDs on the endoscope.

Flexible Cystoscope has the following physical and performance characteristics:

- O Maneuverable tip controlled by the user
- Flexible insertion cord
- Camera and LED light source at the distal tip
- O Sterilized by Ethylene Oxide
- For single use O

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Image /page/5/Picture/1 description: The image contains a logo for a company called "Innovex Anqing Medical". The logo features a stylized purple graphic on the left, with the text "Innovex" in a larger font size and "Anqing Medical" in a smaller font size below it. There is a curved line above the text "Innovex".

## Indications for Use:

AnQing Medical Single Use Flexible Cystoscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra.

The Flexible Cystoscope is intended for use in a hospital environment or medical office environment.

The Flexible Cystoscope is designed for use in adults.

# Comparison with Predicate Device:

The Flexible Cystoscope and its predicate device, the Ambu aScope 4 Cysto (K193095), have the same intended use, sterilization Methods and similar physical characteristics, optical characteristics.

# Substantial Equivalence:

The Flexible Cystoscope employs the same fundamental scientific technology as its predicate device, as below table:

| | Subject Device<br>(CY50H-20EU,<br>CY50H-20US,<br>CY55H-24EU,<br>CY55H-24US) | Predicate Device,<br>Ambu aScope 4 Cysto<br>(K193095) | Comparison |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Indications For Use | | | |
| Indications<br>For Use: | AnQing Medical Single<br>Use Flexible Cystoscope is<br>used to provide<br>visualization and operative<br>access during diagnostic<br>and therapeutic endoscopic<br>procedures of the lower<br>urinary tract, including the<br>bladder and urethra.<br><br>The Flexible Cystoscope is<br>intended for use in a<br>hospital environment or<br>medical office<br>environment. | Ambu® aScope™ 4<br>Cysto is a sterile,<br>single-use, flexible<br>cystoscope intended to<br>be used for endoscopic<br>access to and<br>examination of the<br>lower urinary tract.<br><br>The Ambu® aScope™<br>4 Cysto is intended to<br>provide visualization<br>via Ambu®<br>displaying unit and<br>can be used with<br>endoscopic | Equivalent<br>See Note1. |

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Image /page/6/Picture/1 description: The image shows the logo for Innovex Anqing Medical. The logo consists of a purple square with a white leaf design on the left, and the word "INNOVEX" in purple on the right. Below the word "INNOVEX" is the phrase "Anqing Medical" also in purple. There is a registered trademark symbol next to the word Innovex.

| 510(k) Premarket Notification Submission |
|------------------------------------------|
| Flexible Cystoscope |

| Subject Device<br>(CY50H-20EU,<br>CY50H-20US,<br>CY55H-24EU,<br>CY55H-24US)<br>The Flexible Cystoscope is<br>designed for use in adults. | Predicate Device,<br>Ambu aScope 4 Cysto<br>(K193095)<br>accessories.<br>Ambu® aScope™ 4<br>Cysto is intended for<br>use in a hospital<br>environment or<br>medical office<br>environment.<br>Ambu® aScope™ 4<br>Cysto is designed for<br>use in adults. | Comparison | |
|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------|
| Physical Characteristics | | | |
| Type of<br>Scope | Flexible | Flexible | Same |
| Outer<br>diameter<br>(mm) | Max. 5.0 mm<br>(CY50H-20EU,<br>CY50H-20US)<br>Max. 5.5 mm<br>(CY55H-24EU,<br>CY55H-24US) | Max. 6.0 mm | Similar<br>See Note2. |
| Inner<br>diameter<br>(mm) | Min. 2.0 mm<br>(CY50H-20EU,<br>CY50H-20US)<br>Min. 2.4 mm<br>(CY55H-24EU,<br>CY55H-24US) | Min. 2.2 mm | Similar<br>See Note2. |
| Working<br>length | 380 mm | 390 mm (15.4") | Similar<br>See Note2. |
| Deflection | 210°up, 180°down | 210° up, 120° down | Similar<br>See Note2. |
| Optical Characteristics | | | |
| Type of<br>Imager | CMOS | CMOS | Same |
| Field of View | 110° | 120° | Similar<br>See Note2. |
| Direction of | 0° | 0° | Same |
| | Subject Device<br>(CY50H-20EU,<br>CY50H-20US,<br>CY55H-24EU,<br>CY55H-24US) | Predicate Device,<br>Ambu aScope 4 Cysto<br>(K193095) | Comparison |
| View | | | |
| Depth of Field | 5mm~100mm | 3mm~100mm | Similar<br>See Note2. |
| Light Source | Internal LED | Internal LED | Same |
| Patient Contacting Materials | | | |
| General material type of main patient-contact part | Compliance with<br>ISO10993-1 | Compliance with<br>ISO10993-1 | Similar<br>See Note2. |
| Duration and type of contact | "Surface –Mucosal Membrane" with a contact duration of “Limited (< 24 hours)” | "Surface -Mucosal Membrane" with a contact duration of “Limited (< 24 hours)” | Same |
| Sterilization Methods | | | |
| Number of Users | Single-Use | Single-Use | Same |
| Sterilization | EO Sterilized,<br>SAL 10-6 | EO Sterilized,<br>SAL 10-6 | Same |
| Technological Characteristics | | | |
| Environment of use | Healthcare facility/hospital | Healthcare facility/hospital | Same |
| Energy source | Electricity | Electricity | Same |

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Image /page/7/Picture/1 description: The image shows the logo for Innovex Anqing Medical. The logo is purple and white. The logo has a stylized image on the left and the words "INNOVEX" and "ANQING MEDICAL" on the right.

#### 510(k) Premarket Notification Submission Flexible Cystoscope

Note:

1. The indications for use statement for the subject Cystoscope is very similar to that of the predicate device. A slightly different is wording description. The differences do not alter the intended use of the device nor do they raise different questions of safety and effectiveness of the device relative to the predicate.

2. The subject and predicate device have the same fundamental technology,

type of scope, type of imager, light source, Sterilization method, number of users and environment.

The subject Cystoscope differs from the predicate in Outer diameter, Inner diameter,

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Image /page/8/Picture/1 description: The image contains the logo for Anqing Medical. The logo features a purple square with a white leaf design inside. To the right of the square, the word "INNOVEX" is written in a sans-serif font, with a registered trademark symbol next to it. Below the logo, the words "Anqing Medical" are written in a larger, bolder font.

510(k) Premarket Notification Submission Flexible Cystoscope

| Subject Device | Predicate Device, | |
|-----------------------------------------------------------|----------------------------------|------------|
| (CY50H-20EU,<br>CY50H-20US,<br>CY55H-24EU,<br>CY55H-24US) | Ambu aScope 4 Cysto<br>(K193095) | Comparison |

Working length, Deflection, Field of View, Depth of Field, and patient-contacting materials. These differences do not raise different questions of safety and effectiveness as compared to the predicate, and can be evaluated through performance testing.

# Summary of Testing:

# Summary of Non-Clinical Tests:

Electrical Safety and Electromagnetic Compatibility Summary The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards:

- •ANSI/AAMI ES:60601-1:2005/A2:2010
- ·IEC 60601-2-18:2009: Part 2-18
- •IEC 60601-1-2:2014

# Bench Testing Summary

Photobiological safety

The LEDs in submitted Cystoscope were tested according to the following FDA recognized standards:

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

#### Mechanical and Optical Performance

The Flexible Cystoscope was designed to comply with applicable parts of ISO 8600. Optical measurements were performed according to applicable part of ISO 8600 standard.

Mechanical characteristics were tested and include leakage tightness, bending, deflection endurance, withstand of channel.

In addition, comparative testing related to image quality parameters was performed for submitted Flexible Cystoscope and the predicate device to support substantial equivalence.

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Image /page/9/Picture/0 description: The image contains the logo for "Innovax Anqing Medical". The logo is purple and features a stylized leaf design on the left. The text "ANQING MEDICAL" is written in a larger, bolder font below the logo.

#### Biocompatibility Summary

The biocompatibility evaluation for the patient contacting components of the Flexible Cystoscope was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted based contact category of "Surface -Mucosal Membrane" with a contact duration of "Limited (< 24 hours):

- · Cytotoxicity: ISO 10993-5:2009/(R) 2014
- · Sensitization, Intracutaneous reactivity/irritation: ISO 10993-10:2010
- · Material-mediated pyrogenicity: ISO 10993-11:2017
- · Acute systemic toxicity: ISO 10993-11:2017

#### Sterilization and shelf life testing

The sterilization method has been validated to ISO 11135:2014. which has thereby determined the routine control and monitoring parameters.

EO/ECH residual test was performed according to ISO 10993-7:2008.

The shelf life of the Flexible Cystoscope is determined based on stability study which includes ageing test according to ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier.

#### Package Validation

Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and F88/F88M-15, ASTM F 1929-15 Transport and shipping testing as per ASTM D4169-16.

#### Summary of Clinical Tests:

The subject of this premarket submission, did not require clinical studies to support substantial equivalence.

#### Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Flexible Cystoscope is substantially equivalent to the predicate device.