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.
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.
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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"
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(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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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
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# 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) |
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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: +86-21-61117375 |
| | Fax: +86-21-61117374 |
| | ra_dept@anqing-sh.com |
# 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.
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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
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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 |
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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.
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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
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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.
