(228 days)
The Medical Video Endoscope is designed 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.
The image processor is used with the specified endoscope designed by SEPLOU during minimally invasive surgery.
The image processor provides power and processes the images for medical electronic endoscope.
The Medical Video Endoscope system is designed to provide image solution for endoscopy and endoscopic surgery, and perform procedures in the urinary tract and interior of the kidney using appropriate accessory devices (e.g. laser fibers, forceps baskets).
The Medical Video Endoscope is a sterile Medical Video Endoscope. The Image Processor for Endoscopy is a reusable monitor.
The Medical Video Endoscope 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 Processor processes the images from the Endoscope and outputs video signals to a display.
This document describes the FDA 510(k) clearance for the Seplou (ZHUHAI) Co., Ltd. Medical Video Endoscope System. It is important to note that this is a medical device clearance, not an AI/ML device clearance. Therefore, the information regarding AI-specific criteria like training sets, expert ground truth, and MRMC studies will not be present in this document. The provided text does not describe an AI/ML device.
Here's an analysis based on the provided document for the Medical Video Endoscope System:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a medical device and not an AI/ML system, the "acceptance criteria" discussed are related to physical, electrical, and performance standards rather than metrics like sensitivity or specificity. The "reported device performance" refers to the device's adherence to these standards.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | FDA guidance "Use of International Standard ISO 10993-1" and ISO 10993-1 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-mediated Pyrogens) | Evaluated in accordance with guidance; Complies |
| Sterilization & Shelf Life | ISO 11135:2014 (Sterilization Process Validation) | Validated |
| ISO 10993-7:2008 (EO/ECH Residual Test) | Performed (implies compliance) | |
| ASTM F1980-21 (Accelerated Aging for Shelf Life) | Shelf life determined based on optical testing and product performance after accelerated aging | |
| ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1886/F1886M-16, ASTM F88/F88M-23, ASTM F1929-23 (Package Validation) | Conducted (implies compliance) | |
| Electrical Safety & EMC | IEC 60601-1 (General Safety) | Complies |
| IEC 60601-2-18 (Endoscopic Equipment Specific Safety) | Complies | |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Complies | |
| Software Verification & Validation | FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" | Conducted, documentation provided (implies compliance) |
| Bench Performance Testing | ISO 8600 series (Optical Performance) | Complies |
| Color performance (color reproduction), geometric distortion, optical performance (resolution, depth of field and image intensity uniformity), Noise and dynamic range compared with the predicate device. | Bench tests performed (implies meeting performance comparable to predicate) | |
| Mechanical testing (use-life of bending section and control knob, connection strength, peak tensile force, corrosion resistance etc.) | Bench tests performed (implies meeting performance) |
2. Sample Sizes Used for Test Set and Data Provenance
This is not applicable as the clearance is for a physical medical device (endoscope system) and not an AI/ML algorithm that processes data. The "test set" in this context refers to the physical units and their components undergoing various engineering and performance tests, not a dataset of medical images. The data provenance would be laboratory testing data generated during the device's development and validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable for a non-AI medical device clearance. Ground truth, in the context of AI/ML, refers to definitively labeled data. For this device, "ground truth" would be established through adherence to engineering standards, validated measurement techniques, and industry best practices by qualified engineers and technicians.
4. Adjudication Method for the Test Set
Not applicable for a non-AI medical device clearance. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI ground truth labeling. For a physical device, testing outcomes are typically definitive measurements against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is an endoscope system, not an AI diagnostic tool.
6. Standalone (i.e. algorithm only without human-in-the loop performance) Study
Not applicable. This device is a physical endoscope system, not a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" for this medical device's performance is established by:
- International Standards: Adherence to ISO, ASTM, and IEC standards for biocompatibility, sterilization, electrical safety, EMC, optical performance, and packaging.
- Engineering Specifications: The device's measurable physical and optical properties meeting predefined design specifications.
- Comparison to Predicate Device: Demonstrating substantial equivalence to a legally marketed predicate device, implying similar performance characteristics.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
Summary of Device and Performance:
The Seplou (ZHUHAI) Medical Video Endoscope System aims to provide an image solution for endoscopy and endoscopic surgery within the urinary tract and interior of the kidney. It consists of multiple models of flexible endoscopes and an image processor.
The device's performance has been demonstrated through a series of non-clinical tests to meet established regulatory and industry standards. This includes:
- Biocompatibility: Evaluated according to ISO 10993-1, covering cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogens.
- Sterilization and Shelf Life: Validated via ISO 11135:2014 for sterilization, ISO 10993-7:2008 for EO/ECH residuals, and ASTM F1980-21 for accelerated aging to support a 3-year shelf life. Package validation was also done per ISO and ASTM standards.
- Electrical Safety and EMC: Complies with IEC 60601-1 (general medical electrical equipment safety), IEC 60601-2-18 (endoscopic equipment specific safety), and IEC 60601-1-2 (electromagnetic compatibility).
- Software Verification and Validation: Conducted and documented as per FDA guidance.
- Bench Performance Testing: Included optical performance (according to ISO 8600 series, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range compared to the predicate device) and mechanical tests (use-life of bending section, control knob, connection strength, tensile force, and corrosion resistance).
The conclusion states that these performance tests and compliance with voluntary standards confirm the substantial equivalence of the proposed Medical Video Endoscope system to its predicate device (K172098). No clinical studies were deemed necessary for this clearance.
§ 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.