(111 days)
No
The summary describes a standard flexible cystoscope and video processor for visualization. There is no mention of AI/ML in the device description, intended use, or performance studies. The image processing mentioned is standard video signal processing, not AI/ML-based analysis.
Yes
The device is used for both diagnostic and therapeutic endoscopic procedures of the lower urinary tract, meaning it can be used for treatment purposes.
Yes
The device provides "visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract." The description explicitly states its purpose is "for the purpose of diagnosis and treatment," indicating it is used to identify conditions.
No
The device description clearly outlines physical components such as a handle, insertion section, distal tip, endoscope connector, CMOS sensor, and LEDs, indicating it is a hardware device with integrated software for image processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract. This is a direct examination of the body's internal structures using an optical instrument.
- Device Description: The device is a flexible cystoscope, which is an endoscope used for imaging the lower urinary tract. It captures images internally.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform tests on samples in vitro (outside the body).
The device is a medical device used for direct visualization and intervention within the body, not for analyzing samples taken from the body.
N/A
Intended Use / 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.
Product codes
FAJ
Device Description
The Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) is a sterile single-use endoscope which is used with the video 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS image sensor
Anatomical Site
lower urinary tract, including the bladder and urethra
Indicated Patient Age Range
adults
Intended User / Care Setting
hospital environment or medical office environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 ANSI/AAMI ES:60601-1:2005/A2:2010, IEC 60601-2-18:2009, and IEC 60601-1-2:2014.
Bench Testing Summary:
Photobiological safety: The LEDs in the submitted Cystoscope were tested according to IEC 62471:2006.
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 the submitted Flexible Cystoscope and the predicate device to support substantial equivalence.
Biocompatibility Summary: The biocompatibility evaluation for the patient contacting components of the Flexible Cystoscope was performed according to ISO 10993-1 and FDA Guidance. Tests conducted include Cytotoxicity (ISO 10993-5:2009/(R) 2014), Sensitization, Intracutaneous reactivity/irritation (ISO 10993-10:2010), Material-mediated pyrogenicity (ISO 10993-11:2017), and Acute systemic toxicity (ISO 10993-11:2017).
Sterilization and shelf life testing: The sterilization method has been validated to ISO 11135:2014. EO/ECH residual test was performed according to ISO 10993-7:2008. The shelf life is determined based on stability study including ageing test according to ASTM F1980-16.
Package Validation: Package validation was conducted according to ISO 11607-1:2019, ISO 11607-2:2019, F88/F88M-15, ASTM F 1929-15, and 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.
Key Results: The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Flexible Cystoscope is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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. |
| 3 & 4 Floor, No.2 Building, 366 Huiqing Rd, East | |
| Zhangjiang High-Tech Park, 201201 | |
| Shanghai, China | |
| Contact Person: | Shuwen Fan |
| RA Manager | |
| Shanghai AnQing Medical Instrument Co., Ltd. | |
| Tel: +86-21-61117375 | |
| Fax: +86-21-61117374 | |
| ra_dept@anqing-sh.com | |
| Identification of the Device: | |
| Proprietary/Trade Name: | Flexible Cystoscope |
| Model: | CY50H-20EU, CY50H-20US, CY55H-24EU, |
| 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
(CY50H-20EU,
CY50H-20US,
CY55H-24EU,
CY55H-24US) | Predicate Device,
Ambu aScope 4 Cysto
(K193095) | Comparison |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Indications For Use | | | |
| 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. | Ambu® aScope™ 4
Cysto is a sterile,
single-use, flexible
cystoscope intended to
be used for endoscopic
access to and
examination of the
lower urinary tract.
The Ambu® aScope™
4 Cysto is intended to
provide visualization
via Ambu®
displaying unit and
can be used with
endoscopic | Equivalent
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
(CY50H-20EU,
CY50H-20US,
CY55H-24EU,
CY55H-24US)
The Flexible Cystoscope is
designed for use in adults. | Predicate Device,
Ambu aScope 4 Cysto
(K193095)
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. | Comparison | |
|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------|
| Physical Characteristics | | | |
| Type of
Scope | Flexible | Flexible | Same |
| Outer
diameter
(mm) | Max. 5.0 mm
(CY50H-20EU,
CY50H-20US)
Max. 5.5 mm
(CY55H-24EU,
CY55H-24US) | Max. 6.0 mm | Similar
See Note2. |
| Inner
diameter
(mm) | Min. 2.0 mm
(CY50H-20EU,
CY50H-20US)
Min. 2.4 mm
(CY55H-24EU,
CY55H-24US) | Min. 2.2 mm | Similar
See Note2. |
| Working
length | 380 mm | 390 mm (15.4") | Similar
See Note2. |
| Deflection | 210°up, 180°down | 210° up, 120° down | Similar
See Note2. |
| Optical Characteristics | | | |
| Type of
Imager | CMOS | CMOS | Same |
| Field of View | 110° | 120° | Similar
See Note2. |
| Direction of | 0° | 0° | Same |
| | Subject Device
(CY50H-20EU,
CY50H-20US,
CY55H-24EU,
CY55H-24US) | Predicate Device,
Ambu aScope 4 Cysto
(K193095) | Comparison |
| View | | | |
| Depth of Field | 5mm100mm | 3mm100mm | Similar
See Note2. |
| Light Source | Internal LED | Internal LED | Same |
| Patient Contacting Materials | | | |
| General material type of main patient-contact part | Compliance with
ISO10993-1 | Compliance with
ISO10993-1 | Similar
See Note2. |
| Duration and type of contact | "Surface –Mucosal Membrane" with a contact duration of “Limited (