(24 days)
Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.
The Single-use Video Ureterorenoscope (SVU-220US) is intended to be used with the HUGER'S Medical Video Processor (cleared in K230475). 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 provided text is a 510(k) Summary for a medical device (Single-use Video Ureterorenoscope, model SVU-220US), seeking clearance from the FDA. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (Single-use Video Ureterorenoscope, model SVU-220).
This document does not describe the specific acceptance criteria for an AI/CADe device, nor does it detail a study proving such a device meets those criteria. The information provided is for a ureteroscope, which is an optical instrument, not an AI or computer-aided detection/diagnosis (CADe) device.
Therefore, many of the requested details about acceptance criteria, AI performance metrics, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable to the information contained in this 510(k) summary.
However, I can extract information related to the device's performance testing and the comparison made for demonstrating substantial equivalence.
Here's a breakdown of the relevant information from the document, acknowledging the limitations regarding AI/CADe systems:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in the format of a table with specific thresholds for image quality or clinical performance that would be typical for an AI/CADe device. Instead, it states that the subject device (SVU-220US) and its predicate (SVU-220) comply with various standards to demonstrate performance and safety. The equivalence is primarily based on the devices being "exactly the same" in fundamental technology, optical and physical characteristics, structure, sterilization methods, and components, with one minor difference in deflection marking.
Implicit "Performance" aspects (compared to predicate or standards):
| Parameter | Acceptance/Compliance Criterion (Implicit) | Reported Device Performance (Subject Device SVU-220US) |
|---|---|---|
| Product Code | FGB (matches predicate) | FGB |
| Regulation No. | 876.1500 (matches predicate) | 876.1500 |
| Class | II (matches predicate) | II |
| Structure & Components | Same as Predicate Device Ureterorenoscope | Same as Predicate Device Ureterorenoscope |
| Indications for Use | Identical to the Single-use Video Ureterorenoscope component of the predicate device's Indications for Use. | "Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging." (Identical to predicate's SVU component use) |
| Single use/Reuse | Single use (matches predicate) | Single use |
| Sterile | Yes (matches predicate) | Yes |
| Anatomical Site | Urinary tract and interior of the kidney (matches predicate) | Urinary tract and interior of the kidney |
| Where used | Hospital (matches predicate) | Hospital |
| Label/Labeling | Conform with 21CFR Part 801 (matches predicate) | Conform with 21CFR Part 801 |
| Scope type | Flexible (matches predicate) | Flexible |
| Field of view | 120° (matches predicate) | 120° |
| Direction of view | 0° (matches predicate) | 0° |
| Depth of field | 2-100mm (matches predicate) | 2-100mm |
| Sensor type | CMOS (matches predicate) | CMOS |
| Max. outer diameter of insertion section | 2.9mm (matches predicate) | 2.9mm |
| Up/down deflection | Up: 270°, Down: 270° (matches predicate, though the labeling of up/down for clockwise/counter-clockwise rotation differs) | Up: 270°, Down: 270° |
| Work length | 700mm (matches predicate) | 700mm |
| Minimum instrument channel width | 1.2mm (matches predicate) | 1.2mm |
| Product Performance | Comply with ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 8600-7 (matches predicate) | Comply with ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 8600-7 |
| Biocompatibility | Meet ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-10 (Irritation) - applied from predicate. | Results of predicate device testing confirm no negative impacts for Cytotoxicity, Sensitization, Intracutaneous. (Subject device shares same raw materials and contact level/duration) |
| Sterilization Method | EO sterilization, SAL 10^-6 (matches predicate) | EO sterilization, SAL 10^-6 |
| Optical Performance | Passed photobiological safety test (IEC 62471:2006) on predicate; aged and unaged optical performance similar. | "Photobiological safety test was performed according to IEC 62471: 2006 on predicate device;" "The test results demonstrate that the optical performance of the aged endoscope is similar as those of the unaged endoscope." |
| Physical/Functional | Passed irrigation valve leakage test (on predicate). | "Irrigation valve leakage test was performed on the predicate device." |
2. Sample sizes used for the test set and the data provenance
- Sample Size: Not explicitly stated in terms of a "test set" for performance evaluation in a quantitative manner as would be done for an AI/CADe. The information provided heavily relies on direct comparison to the predicate device and compliance with general standards. For biocompatibility and optical/physical testing, it states tests were performed on the "predicate device" or "aged/unaged Single-use Video Ureterorenoscope (SVU-220)", implying a sample was used but the size (N) is not given.
- Data Provenance: Not specified. The manufacturer is based in Shanghai, China. The document does not indicate if the performance testing data was gathered retrospectively or prospectively, or the country of origin of the physical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the device is a direct imaging instrument, not an AI/CADe system requiring expert ground truth for classification or detection tasks. The "ground truth" for its performance is assessed through engineering and biocompatibility testing against defined industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable for the type of device and performance testing 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 MRMC study was done, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable; this is an instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device revolves around its physical characteristics, material composition, optical performance, and biocompatibility conforming to established international standards (e.g., ISO, ASTM, IEC). There is no "patient outcome" or "pathology" ground truth discussed in the context of validating the device's core functionality as an endoscope. Its function is to provide video imaging to a physician, who then uses clinical judgment.
8. The sample size for the training set
- Not applicable; this device does not involve a "training set" as it is not an AI/machine learning product.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
§ 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.