Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

K231105 · Shanghai AnQing Medical Instrument Co., Ltd. · FBN · Oct 17, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K231105
• Device Name: Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
• Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
• Product Code: FBN · Gastroenterology, Urology
• Decision Date: Oct 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AnQing Medical Flexible Choledochoscope has been designed to be used with the video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct. The Flexible Choledochoscope is designed for use in adults.

Device Story

Flexible Choledochoscope (single-use) provides endoscopic visualization of bile duct. Device comprises handle with deflection lever, insertion section with working channel, distal tip with CMOS sensor and LED illumination. Operates by transmitting light from distal LEDs into body cavity; reflected light captured by CMOS sensor; RGB video signals sent to external video processor (K211169) for display on monitor. Used in hospital/healthcare facility by clinicians. Deflection lever controls distal tip bending. Working channel allows insertion of endotherapy accessories and irrigation. Single-use design eliminates reprocessing requirements. Benefits include reduced risk of cross-contamination compared to reusable endoscopes.

Clinical Evidence

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

Technological Characteristics

Single-use flexible endoscope. CMOS image sensor; internal LED illumination. Working length 380mm; outer diameter max 5.0mm; working channel min 2.0mm. Deflection 210° up/180° down. Sterilized via Ethylene Oxide (ISO 11135). Patient-contacting materials compliant with ISO 10993-1. Powered by external video processor (K211169).

Indications for Use

Indicated for endoscopic diagnosis and treatment within the bile duct in adult patients.

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

• CHF-V Choledocho Videoscope (K081456)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

October 17, 2023

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

Re: K231105

Trade/Device Name: Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FBN Dated: September 15, 2023 Received: September 15, 2023

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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

{1}------------------------------------------------

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the 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).

{2}------------------------------------------------

Sincerely,

# Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known) K231105

Device Name

Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

Indications for Use (Describe)

AnQing Medical Flexible Choledochoscope has been designed to be used with the video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct. The Flexible Choledochoscope is designed for use in adults.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image contains the logo for Innovax Anqing Medical. The logo is purple and white. The word "Innovax" is in large, bold, purple letters, and the words "Anqing Medical" are in smaller, purple letters below the word "Innovax".

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

# 510(k) Summary

| Date Prepared: | Apr./17/2023 |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Shanghai AnQing Medical Instrument Co., Ltd.<br>3 & 4 Floor, No.2 Building, 366 Huiqing Rd,<br>East Zhangjiang High-Tech Park, 201201<br>Shanghai, China |

| Contact Person: | Shuwen Fan |
|-----------------|----------------------------------------------|
| | RA Manager |
| | Shanghai AnQing Medical Instrument Co., Ltd. |
| | Tel: [phone] |
| | Fax: [phone] |
| | [e-mail] |

# Identification of the Device:

| Proprietary/Trade Name: | Flexible Choledochoscope |
|-------------------------|-------------------------------------------------|
| Model: | CS50H-20EU, CS50H-20US |
| Common name: | Choledochoscope And Accessories, Flexible/Rigid |
| Classification Name: | Endoscope and accessories |
| Regulatory Number: | 21 CFR Part 876.1500 |
| Product Code: | FBN |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |

# Identification of the Legally Marketed Predicate Device:

| Trade Name: | CHF-V Choledocho Videoscope |
|--------------------------|-------------------------------------------------|
| Common name: | Choledochoscope And Accessories, Flexible/Rigid |
| Classification Name: | Endoscope and accessories |
| Regulatory Number: | 21 CFR Part 876.1500 |
| Product Code: | FBN |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
| Submitter/510(k) Holder: | OLYMPUS MEDICAL SYSTEMS CORP. |
| Clearance: | K081456 (cleared November 6, 2008) |

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

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Innovax Anqing Medical. The logo is purple and features a stylized wave-like design above the word "INNOVEX" with a registered trademark symbol. Below "INNOVEX" is the text "ANQING MEDICAL" in a larger, bolder font.

# Device Description:

The Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) 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 within the bile duct for the purpose of diagnosis and treatment.

The 2 proposed models are identical except the deflection versions, which is opposite from each other (EU version or US version).

The Flexible Choledochoscope 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, an aspiration button, an aspiration connector, 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 Choledochoscope 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 Choledochoscope has the following physical and performance characteristics:

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

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Anqing Medical. The logo is purple and features the word "INNOVEX" in a sans-serif font with a curved line above it. Below the word "INNOVEX" is the text "ANQING MEDICAL" in a larger, bolder font. To the left of the word "INNOVEX" is a stylized image of a leaf.

## Indications for Use:

AnQing Medical Flexible Choledochoscope has been designed to be used with the video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct.

The Flexible Choledochoscope is designed for use in adults.

# Comparison with Predicate Device:

The Flexible Choledochoscope and its predicate device, the Olympus CHF TYPE V(K081456), have the same intended use, and similar physical characteristics, optical characteristics.

## Substantial Equivalence:

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

| | Subject Device<br>(CS50H-20EU,<br>CS50H-20US) | Predicate Device,<br>(CHF TYPE V)<br>(K081456) | Comparison |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Indications For Use | | | |
| Indications<br>For Use: | AnQing Medical Flexible<br>Choledochoscope has been<br>designed to be used with<br>the video processor,<br>monitor, endotherapy<br>accessories and other<br>ancillary equipment for<br>endoscopic diagnosis and<br>treatment within the bile<br>duct.<br>The Flexible<br>Choledochoscope is<br>designed for use in adults. | This instrument has<br>been designed to be<br>used with an Olympus<br>video system center,<br>light source,<br>documentation<br>equipment, monitor,<br>EndoTherapy<br>accessories, and other<br>ancillary equipment<br>for endoscopic<br>diagnosis and<br>treatment within the<br>bile duct. | Equivalent<br>See Note1. |
| Physical Characteristics | | | |
| Type of<br>Scope | Flexible | Flexible | Same |
| Outer<br>diameter<br>(mm) | Max. 5.0 mm | Max. 5.85 mm | Similar<br>See Note2. |
| Inner<br>diameter | Min. 2.0 mm | Min. 2.0 mm | Same |
| | Subject Device<br>(CS50H-20EU,<br>CS50H-20US) | Predicate Device,<br>(CHF TYPE V)<br>(K081456) | Comparison |
| (mm)<br>Working length | 380 mm | 380mm | Same |
| Deflection | 210°up, 180°down | 160° up, 130° down | Similar<br>See Note2. |
| Optical Characteristics | | | |
| Type of<br>Image sensor | CMOS | Color CCD | Different<br>See Note2. |
| Field of View | 110° | 120° | Similar<br>See Note2. |
| Direction of<br>View | 0° | 0° | Same |
| Depth of<br>Field | 5mm~100mm | 3mm~50mm | Similar<br>See Note2. |
| Light Source | Internal LEDs | External light source | Different<br>See Note2. |
| Patient Contacting Materials | | | |
| General<br>material type<br>of main<br>patient-contact part | Compliance with<br>ISO10993-1 | Compliance with<br>ISO10993-1 | Similar<br>See Note2. |
| Duration and<br>type of<br>contact | "External communication<br>medical device-Tissue"<br>with a contact duration of<br>"Limited (< 24 hours)" | "External communication<br>medical device-Tissue" with a<br>contact duration of<br>"Limited (< 24 hours)" | Same |
| Sterilization Methods | | | |
| Number of<br>Users | Single-Use | Reusable | Different<br>See Note2 |
| Sterilization | EO Sterilized,<br>SAL 10-6 | Not provided sterile<br>but intended for<br>sterilization at the<br>Medical Facility. | Different<br>See Note2 |
| Technological Characteristics | | | |
| Environment | Healthcare facility/hospital | Healthcare | Same |
| | Subject Device<br>(CS50H-20EU,<br>CS50H-20US) | Predicate Device,<br>(CHF TYPE V)<br>(K081456) | Comparison |
| of use | | facility/hospital | |
| Energy<br>source | Electricity | Electricity | Same |

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image contains the logo for Innovex Medical. The logo is purple and features a stylized leaf design above the word "INNOVEX" with a registered trademark symbol. Below "INNOVEX" is the text "Anqing Medical" in a larger font.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image contains a logo for a medical company. The logo consists of a purple square with a white abstract design on the left, and the word "INNOVEX" in purple on the right. Below the word "INNOVEX" is the text "ANQING MEDICAL" also in purple. The logo has a clean and professional design.

Note:

1. The indications for use statement for the subject Choledochoscope 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, Working length, Direction of View, Inner diameter, contact duration and contact type, and environment of use.

The subject Choledochoscope differs from the predicate in Outer diameter, Type of Image Sensor, Light source, Deflection, Field of View, Depth of Field, Sterilization method, Number of uses 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 and EO Sterilization validation.

# 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 ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & . A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
- ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] ●
- IEC 60601-2-18 Edition 3.0 2009-08
- IEC/TR 60601-4-2 Edition 1.0 2016-05 .

# Bench Testing Summary

Photobiological safety

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

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

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Innovax Anqing Medical. The logo is purple and features a stylized wave-like design above the word "INNOVEX" with a registered trademark symbol. Below "INNOVEX" is the text "ANQING MEDICAL" in a larger, bolder font.

# Mechanical and Optical Performance

The Flexible Choledochoscope was designed to comply with applicable parts of ISO Optical measurements were performed according to applicable part of ISO 8600. 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 Choledochoscope and the predicate device to support substantial equivalence.

# Biocompatibility Summary

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

- · Cytotoxicity: ISO 10993-5:2009
- · 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 Choledochoscope is determined based on stability study which includes ageing test according to ASTM F1980-21, 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 ASTM F88/F88M-21, ASTM F1929-15. Transport and shipping testing as per ASTM D4169-22.

### 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 Choledochoscope is substantially equivalent to the predicate device.