(181 days)
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.
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.
The provided document is a 510(k) Premarket Notification from the FDA, specifically concerning a Flexible Choledochoscope. This type of document is for a medical device that does not rely on complex algorithms or AI for its primary function. Therefore, the concepts of "AI algorithm," "acceptance criteria for an AI model," "training dataset," "test set," "ground truth establishment," "MRMC studies," and "standalone performance" as they relate to AI are not applicable to this submission.
The acceptance criteria and performance data provided in this document are entirely related to the physical and functional characteristics of the choledochoscope itself, not an AI component.
Here's an analysis of the document in relation to the questions asked, noting where the questions are not applicable due to the nature of the device:
Acceptance Criteria and Device Performance (Non-AI Device)
Since this is a physical medical device (a choledochoscope), the "acceptance criteria" are related to its physical properties, safety standards, and functional performance compared to a predicate device.
1. A table of acceptance criteria and the reported device performance
The document presents a comparison table between the subject device (Flexible Choledochoscope, Models CS50H-20EU, CS50H-20US) and its predicate device (Olympus CHF TYPE V), showing "acceptance criteria" as functional and physical similarities and differences. The "reported device performance" is essentially that the subject device meets or is comparable to the predicate device in these aspects, and where there are differences, non-clinical tests were conducted to demonstrate equivalence without raising new safety/effectiveness concerns.
| Feature / Criteria | Subject Device (CS50H-20EU, CS50H-20US) | Predicate Device (CHF TYPE V) (K081456) | Comparison / Performance Outcome |
|---|---|---|---|
| Indications for Use | Diagnosis & treatment within bile duct, for adults. Used with video processor, monitor, endotherapy accessories. | Diagnosis & treatment within bile duct. Used with Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories. | Equivalent (Note 1: Wording differences do not alter intended use or raise new safety/effectiveness questions). |
| Physical Characteristics | |||
| Type of Scope | Flexible | Flexible | Same |
| Outer diameter (mm) | Max. 5.0 mm | Max. 5.85 mm | Similar (Subject is smaller; Note 2: Differences evaluated via performance testing). |
| Inner diameter (mm) | Min. 2.0 mm | Min. 2.0 mm | Same |
| Working length | 380 mm | 380 mm | Same |
| Deflection | 210° up, 180° down | 160° up, 130° down | Similar (Subject has greater deflection; Note 2: Differences evaluated via performance testing). |
| Optical Characteristics | |||
| Type of Image sensor | CMOS | Color CCD | Different (Note 2: Differences evaluated via performance testing). |
| Field of View | 110° | 120° | Similar (Note 2: Differences evaluated via performance testing). |
| Direction of View | 0° | 0° | Same |
| Depth of Field | 5mm~100mm | 3mm~50mm | Similar (Note 2: Differences evaluated via performance testing). |
| Light Source | Internal LEDs | External light source | Different (Note 2: Differences evaluated via performance testing). |
| Patient Contacting Materials | |||
| General material type | Compliance with ISO10993-1 | Compliance with ISO10993-1 | Similar (Note 2: Differences evaluated via performance testing). |
| Duration and type of contact | "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.