(181 days)
Not Found
No
The summary describes a standard flexible endoscope and video processor with no mention of AI or ML capabilities. The image processing mentioned is standard video signal processing.
Yes
The device is specifically designed for "diagnosis and treatment within the bile duct," indicating a therapeutic purpose in addition to diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is designed for "endoscopic diagnosis and treatment within the bile duct." The "Device Description" also mentions it's for "providing endoscopic imaging within the bile duct for the purpose of diagnosis and treatment." Both indicate a diagnostic purpose.
No
The device description clearly details physical hardware components including a handle, insertion section, distal tip, endoscope connector, CMOS sensor, LEDs, and a working channel. It also mentions being a sterile single-use endoscope.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for endoscopic diagnosis and treatment within the bile duct." This describes a procedure performed inside the body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description details an endoscope, which is a device inserted into the body for visualization and intervention. This is characteristic of an in vivo diagnostic/therapeutic device.
- Anatomical Site: The device is used in the "bile duct," which is an internal anatomical structure.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that definition.
N/A
Intended Use / 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.
Product codes
FBN
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS sensor for capturing image
Anatomical Site
bile duct
Indicated Patient Age Range
adults
Intended User / Care Setting
Healthcare facility/hospital
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: Compliance with 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.
- Photobiological safety: LEDs tested according to IEC 62471:2006.
- Mechanical and Optical Performance: The Flexible Choledochoscope was designed to comply with applicable parts of ISO 8600 standard. Optical measurements performed according to applicable part of ISO 8600. Mechanical characteristics tested include leakage tightness, bending, deflection endurance, withstand of channel. Comparative testing related to image quality parameters was performed for submitted Flexible Choledochoscope and the predicate device to support substantial equivalence.
- Biocompatibility Summary: Evaluation performed according to ISO 10993-1 and FDA Guidance based on contact category of "External communication medical device -Tissue" with a contact duration of "Limited (
§ 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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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 (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
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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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. |
| 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 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
(CS50H-20EU,
CS50H-20US) | Predicate Device,
(CHF TYPE V)
(K081456) | Comparison |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Indications For Use | | | |
| 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. | This instrument has
been designed to be
used with an Olympus
video system center,
light source,
documentation
equipment, monitor,
EndoTherapy
accessories, and other
ancillary equipment
for endoscopic
diagnosis and
treatment within the
bile duct. | Equivalent
See Note1. |
| Physical Characteristics | | | |
| Type of
Scope | Flexible | Flexible | Same |
| Outer
diameter
(mm) | Max. 5.0 mm | Max. 5.85 mm | Similar
See Note2. |
| Inner
diameter | Min. 2.0 mm | Min. 2.0 mm | Same |
| | Subject Device
(CS50H-20EU,
CS50H-20US) | Predicate Device,
(CHF TYPE V)
(K081456) | Comparison |
| (mm)
Working length | 380 mm | 380mm | Same |
| Deflection | 210°up, 180°down | 160° up, 130° down | Similar
See Note2. |
| Optical Characteristics | | | |
| Type of
Image sensor | CMOS | Color CCD | Different
See Note2. |
| Field of View | 110° | 120° | Similar
See Note2. |
| Direction of
View | 0° | 0° | Same |
| Depth of
Field | 5mm100mm | 3mm50mm | Similar
See Note2. |
| Light Source | Internal LEDs | External light source | Different
See Note2. |
| 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 | "External communication
medical device-Tissue"
with a contact duration of
"Limited (