(21 days)
WiScope™ Digital Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
WiScope™ Digital Endoscope System is designed for physicians to access, visualize, and perform procedures in the urinary tract for diagnosis and treatment. This system includes a single-use digital ureteroscope and an image system. The single-use ureteroscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image system processes the images from the ureteroscope and outputs video signals to a display.
The WiScope™ Digital Endoscope System is described as substantially equivalent to a predicate device (Zhuhai Pusen Medical Technology Co., Ltd. Medical Video Endoscope System, K171076) based on non-clinical performance testing. No clinical study was performed.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provides a "General Comparison" table (Table 5A) that directly compares the proposed device to the predicate device in terms of various technological characteristics. This table implicitly sets the acceptance criteria as being "substantially equivalent" to the predicate, or demonstrating comparable or improved performance without raising new safety or effectiveness concerns.
| Item | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed Device) | Remark/Explanation |
|---|---|---|---|
| Intended Use | "to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney." | "intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site." | Note 1: Similar intended use. |
| Digital video technology | CMOS | CMOS | Note 2: Similar CMOS image sensor technology (sensor at tip, back-end processing, cable connection). |
| Illumination | Optical fiber | LED | Analysis 2: Different illumination source (LED at distal-end vs. optical fiber/LED at proximal-end). Manufacturer claims both ensure high image quality and proposed device passed distal tip temperature tests (meets IEC 60601-1). Considered substantially equivalent. |
| Field of View (Diagonal) | 120° | 100° | Note 3: Smaller FOV for proposed device. However, a comparison study by physicians demonstrated the optical parameter is similar and does not affect safety and effectiveness. |
| Outer Shaft Diameter | 9.0Fr | 8.6Fr | Note 4: Smaller diameter for proposed device. Considered improved performance as it "facilitates passage of the ureter and into the kidney," contributing to better performance. |
| Working Length (mm) | 630 | 670 | Note 4: Longer working length for proposed device. Considered improved performance as it "allows for better operating flexibility." |
| Working Channel Diameter (Fr) | 3.6Fr | 3.6Fr | SE: Substantially Equivalent. |
| Up/Down Deflection | UP: 270°, DOWN: 270° | UP: 275°, DOWN: 275° | SE: Substantially Equivalent (slightly better range for proposed device). |
| Direction of View | 0° | 0° | SE: Substantially Equivalent. |
| Brightness Control | Yes | Yes | SE: Substantially Equivalent. |
| White Balance | Yes | Yes | SE: Substantially Equivalent. |
| Output Formats | USB/AV/HDMI | USB/AV/HDMI | SE: Substantially Equivalent. |
| Image/Video Capture | Yes | No | Analysis 3: Proposed device lacks integrated capture. However, this feature can be achieved with legally marketed external video recorders/software, complying with cybersecurity. Considered substantially equivalent. |
| Sterilization | EO SAL: 10-6 | EO SAL: 10-6 | SE: Substantially Equivalent. |
| Biocompatibility | Comply with ISO 10993-5, 10993-10 | Comply with ISO 10993-5, 10993-10, and also 10993-10, 10993-10 (Sensitization) | SE: Both devices comply with relevant ISO standards. Proposed device additionally states "not an irritant" and "not a sensitizer." |
| Electrical Safety | AAMI / ANSI ES60601-1:2012, IEC 60601-1-2:2007, IEC 60601-2-18:2009 | IEC 60601-1:2012, AAMI/ANSIES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 AND IEC 60601-2-18:2009, IEC 60601-1-2:2014 | More testing than the predicate to show safety. All evaluation acceptance criteria were met. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly mention a "test set" in the context of an algorithm or AI model, as this is a traditional medical device 510(k) submission not primarily focused on AI. Performance was primarily evaluated through non-clinical testing (bench testing, engineering verification, and compliance with standards).
For "Note 3" regarding the Field of View, a "comparison study between the proposed and the predicate device by physicians" is mentioned.
- Sample size: Not specified.
- Data provenance: Not explicitly stated, but it seems to be a prospective comparison performed for the purpose of this submission using physical devices. There is no mention of country of origin, but the submitting company is based in the US (OTU Medical Inc.) and the submission correspondent in China (Shanghai CV Technology Co., Ltd.).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For the "Field of View" comparison, it states "a comparison study...by physicians."
- Number of experts: Not specified (plural "physicians" implies more than one).
- Qualifications of those experts: "Physicians" are mentioned, implying medical doctors who would typically use such a device. No specific subspecialty (e.g., urologist) or years of experience are detailed.
For other non-clinical tests, the "ground truth" is defined by established engineering and medical device standards (e.g., IEC 60601-1, ISO 10993 series, ISO 8600 series). Experts in these fields (e.g., test engineers, certified labs) perform the evaluations.
4. Adjudication Method for the Test Set
For the "Field of View" comparison study by physicians, the adjudication method is not explicitly stated. It only mentions "a comparison study...demons[strating] that the optical parameter is similar and it does not affect safety and effectiveness." This suggests a consensus or expert opinion based on their evaluation, but no formal adjudication process (like 2+1 or 3+1) is detailed.
For other non-clinical tests, compliance with standards serves as the adjudication, where the results either meet or do not meet the specified pass/fail criteria of the standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed and is not applicable here, as this device is a traditional endoscope system and not an AI-powered diagnostic/interpretive tool requiring human-in-the-loop performance evaluation against a baseline. The submission explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a hardware medical device (digital endoscope system) with an integrated camera and image processing. It is not an algorithm that operates in a standalone capacity without human interaction for diagnosis or interpretation in the way an AI model would. Its function is to provide visualization to a human physician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for most of the evaluations is based on:
- Established industry standards and regulatory requirements: For electrical safety, EMC, biocompatibility, sterilization, and physical performance characteristics (e.g., bending radius, depth of field, resolution, temperature). These standards themselves define acceptable parameters.
- Predicate device comparison: The predicate device (K171076) itself serves as a functional "ground truth" or benchmark against which the proposed device's equivalence is assessed.
- Physician comparison/assessment: For the field of view, physician evaluation served as the "ground truth" to determine if the differing FOV affected safety and effectiveness.
8. The sample size for the training set
Not applicable. As this is not an AI/Machine Learning device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.