(254 days)
Medical Video Endoscope System has been designed to be used with endo-therapy accessories such as a biopsy forcens and other ancillary equipment for endoscopic surgery within urinary tract and interior of the kidney.
Medical Video Processor is intended to be used in conjunction with the endoscopes to enhance and display the image of the field of view of the endoscope on the monitor, and also provides functional supply for the endoscope.
Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.
Medical Video Endoscope System is consist of a Single-use Video Ureterorenoscope and a Medical Video Processor. The proposed device has been 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 Single-use Video Ureterorenoscope is a single use device. The Single-use Video Ureterorenoscope is consist of distal end, bending section, insertion portion, operational portion and connection portion. The Single-use Video Ureterorenoscope is a single-channel endoscope. Only one instrument channel is in the distal end of the endoscope.
The Medical Video Processor is a reusable device. The Medical Video Processor is composed of a power circuit, an image processing circuit and software.
The provided text describes the Huger Medical Instrument Co., Ltd.'s "Medical Video Endoscope System" and its substantial equivalence to a predicate device (K172098). However, it does not contain acceptance criteria for specific device performance metrics or the details of a study proving the device meets said criteria in the format requested.
The document primarily focuses on:
- Indications for Use: What the device is intended for (endoscopic surgery within the urinary tract and kidney).
- Device Description: Components of the system (Single-use Video Ureterorenoscope and Medical Video Processor).
- Non-Clinical Test Conclusions: A list of standards and types of tests performed (biocompatibility, software, bench performance including optical and physical/functional, and use-life testing). These tests demonstrate compliance with relevant standards and similarity to the predicate device in certain aspects.
- Substantial Equivalence (SE) Comparison: A detailed comparison table between the proposed device and the predicate device, highlighting similarities and differences in various specifications (e.g., field of view, depth of field, dimensions, materials).
- SE Conclusion: A statement that the proposed device is as safe, effective, and performs as well as or better than the predicate.
Missing Information (from the provided text):
The input document does not detail specific acceptance criteria values (e.g., "resolution must be X lp/mm") and corresponding quantitative results from a study that explicitly demonstrates the device "meets the acceptance criteria." Instead, it states that tests were conducted according to standards and that performance is "similar to the predicate device" or "meets the requirements of ISO 8600-1, ISO 8600-4 and ISO 8600-7."
Therefore, I cannot populate the table or answer most of the specific questions about the study's methodology, sample sizes, expert involvement, or comparative effectiveness with human readers as this information is not present in the provided text.
Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
As the document does not explicitly state acceptance criteria in a quantitative format for most parameters, and often refers to "similarity" to the predicate or "compliance with standards" without specific numerical targets, a comprehensive table cannot be precisely generated from the given information.
However, based on the comparative effectiveness section (Table 2 and subsequent analysis), here's an attempt to infer or describe reported performance relative to the predicate:
| Acceptance Criteria (Inferred from comparison to predicate/standards) | Reported Device Performance (from "Similar Analysis" and "Bench performance testing") |
|---|---|
| Optical Performance | |
| Photobiological Safety | Complies with IEC 62471: 2006 |
| Color reproduction | Similar to predicate device (K172098) |
| Resolution | Similar to predicate device (K172098) |
| Depth of Field of view (Target: wider range than predicate) | 2-100mm (Predicate: 3-50mm – proposed device has wider range) |
| Noise | Similar to predicate device (K172098) |
| Geometric distortion | Similar to predicate device (K172098) |
| Intensity uniformity | Similar to predicate device (K172098) |
| Image frame frequency and system delay | Similar to predicate device (K172098) |
| Video Signal Output Image Quality | No difference in image quality compared to predicate (despite DVI vs HDMI) |
| Physical/Functional Performance | |
| Irrigation valve leakage | Test performed (result implied acceptable) |
| Maximum outer diameter of insertion section | 2.9mm (Predicate: 3.2mm – similar, lower value) |
| Work length | 700mm (Predicate: 650mm – similar) |
| Minimum instrument channel width | 1.2mm (Predicate: 1.0mm – similar, larger value) |
| Biocompatibility | |
| Cytotoxicity | Test performed (ISO 10993-5); no negative impacts |
| Sensitization | Test performed (ISO 10993-10); no negative impacts |
| Intracutaneous irritation | Test performed (ISO 10993-10); no negative impacts |
| Sterilization | |
| Sterility Assurance Level (SAL) | 10^-6 (Same as predicate) |
| Software | |
| Verification and Validation | Conducted per FDA Guidance; documentation provided |
| Use-Life | |
| Single-use Video Ureterorenoscope Optical Performance (after aging) | Similar to un-aged endoscope |
| Medical Video Processor Optical Performance (after aging) | Similar to new processor; use-life of six years accepted |
2. Sample size used for the test set and the data provenance:
The document does not specify sample sizes (number of devices, images, or data points) for any of the non-clinical tests or comparisons. Data provenance information (country of origin, retrospective/prospective) is also not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The study appears to be non-clinical bench testing and comparisons to a predicate device, not involving expert interpretation or ground truth establishment in a clinical context.
4. Adjudication method for the test set:
Not applicable, as there's no indication of a clinical study or expert adjudication process described.
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, the document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study or AI assistance effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not explicitly stated or described. The document refers to "Software verification and validation testing," but does not detail a standalone algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" would be established by physical measurements, adherence to standards, and direct comparison of specifications and optical properties between the proposed and predicate devices, rather than clinical ground truth types.
8. The sample size for the training set:
Not applicable/not provided. This device description pertains to hardware and its performance, not an AI/ML component with a training set.
9. How the ground truth for the training set was established:
Not applicable/not provided, as there's no mention of a training set for an AI/ML component.
§ 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.