(203 days)
As a disposable medical device, the product is used along with the company's image processor, to enter human body through the urethra and provide images via video monitor, and realize endoscopy inspection or operation to the patient's ureter and renal pelvis.
The Single-Use Digital Flexible Ureteroscope (Model: PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) is an endoscope which is used with the Monitor for Single-Use Endoscopy (Model:P1-D) produced by ENDOSO LIFE TECHNOLOGY for providing endoscopic imaging of the ureter and the renal pelvis for the purpose of diagnosis and treatment. The Single-Use Digital Flexible Ureteroscope is integrated with a working channel which allowing the use of flexible endoscopic accessories (e.g. stone basket, forceps, laser fibers for lithotripsy, etc.). The insertion portion of the endoscope is flexible, and the shape changes corresponding to the shape of the cavity. Anatomical images are captured by a CMOS chip at the distal end of the endoscope and the electronic signals are transmitted to the Monitor. Then, the resulting picture images are sent to and shown on a visual display.
The provided document is a 510(k) Summary for a medical device called "Single-Use Digital Flexible Ureteroscope". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria via clinical performance data (like sensitivity, specificity, or reader improvement with AI).
The document details the device's technical specifications and compares them to a predicate device. It also outlines the non-clinical testing performed to ensure safety and performance, which is typical for 510(k) submissions seeking substantial equivalence.
Therefore, many of the requested items related to clinical performance studies, such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, and ground truth establishment for training sets, are not applicable or not explicitly stated in this type of submission.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device, the "acceptance criteria" are primarily related to meeting performance standards and showing similarity to the predicate device, rather than specific clinical performance metrics. The "reported device performance" is largely based on non-clinical tests.
| Acceptance Criteria (based on standards/comparison) | Reported Device Performance (Non-Clinical Tests) |
|---|---|
| Optical Characteristics: | |
| Field of View (similar to predicate) | Subject Device: 120° ± 10% (Predicate: 110°) - deemed similar |
| Direction of View (same as predicate) | Subject Device: 0° (Predicate: 0°) |
| Mechanical Characteristics: | |
| Bending Angle (similar to predicate) | Subject Device: 260° - 300° (Predicate: Up: 285°, Down: 285°) - deemed similar |
| Maximum Insertion Portion Width (similar to predicate) | Subject Device: ≤ 2.6mm (7.7Fr) (Predicate: 3.15mm) - deemed similar (thinner) |
| Minimum Insertion Channel Width (same as predicate) | Subject Device: 1.2mm (Predicate: 1.2mm) |
| Working Length (similar to predicate) | Subject Device: 670 ± 3% (Predicate: 700mm) - deemed similar |
| Image Acquisition: | |
| Sensor Type (same as predicate) | Subject Device: CMOS (Predicate: CMOS) |
| Illumination Source (same as predicate) | Subject Device: LED (Predicate: LED) |
| Color performance (color reproduction) | Tested (results met) |
| Optical performance (resolution, depth of field, image intensity uniformity, distortion) | Tested (results met ISO 8600 series) |
| Dynamic Range | Tested (results met) |
| Leakage tightness | Tested (results met) |
| Bending/deflection endurance | Tested (results met) |
| Withstand of channel | Tested (results met) |
| Photobiological safety of lamps | Tested (according to IEC 62471) |
| Biocompatibility (ISO 10993-1, FDA Guidance): | |
| Cytotoxicity | Tested (results met) |
| Sensitization, Intracutaneous reactivity/irritation | Tested (results met) |
| Material-mediated pyrogenicity | Tested (results met) |
| Acute systemic toxicity | Tested (results met) |
| Sterilization (ISO 11135:2014, ISO 10993-7:2008): | |
| Validation of sterilization method | Validated (EO) |
| EO/ECH residual test | Tested (results met) |
| Shelf Life (ASTM F1980-16): | |
| Product performance after aging | Tested (results met) |
| Sterile testing after aging | Tested (results met) |
| Package Integrity (ISO 11607-1:2019, ISO 11607-2:2019, ASTM F88/F88M-15, ASTM F1929-15): | |
| Package validation | Conducted |
| Transport and shipping testing (ASTM D4169-16) | Conducted |
| Package integrity after aging | Tested (results met) |
| Electrical Safety and EMC (ANSI/AAMI ES:60601-1:2005/A2:2010, IEC 60601-2-18:2009, IEC 60601-1-2:2014): | |
| Compliance with standards | Compliant |
Study Proving Device Meets Acceptance Criteria:
The document states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." This means the "study" proving the device meets acceptance criteria is primarily a series of non-clinical (benchtop) tests and comparisons to a predicate device, demonstrating that the new device is as safe and effective as the legally marketed predicate.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The document describes non-clinical tests. For example, for biocompatibility, specific tests were performed on "patient contacting components," but no sample size for a clinical "test set" is mentioned as clinical studies were not required.
- Data Provenance: The tests appear to be conducted by the manufacturer or their designated testing facilities, likely in China (Hunan, where the manufacturer is located). The data is generated retrospectively as part of the device development and submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no clinical test set with corresponding ground truth established by experts is described. The "ground truth" for this submission are the established engineering standards, biocompatibility standards, and the performance characteristics of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test set requiring adjudication of findings is 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
- Not applicable. This device is a ureteroscope (an
endoscope), not an AI diagnostic/assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical instrument, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is based on:
- Validated engineering and medical device standards (e.g., ISO 8600, IEC 62471, ISO 10993, ISO 11135, ASTM F1980, ISO 11607, ASTM D4169, IEC 60601 series).
- Performance characteristics of the legally marketed predicate device (K230200).
- Pass/fail criteria for the various non-clinical tests performed.
8. The sample size for the training set
- Not applicable. There is no mention of a training set for an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. There is no mention of a training set for an AI algorithm within this document.
§ 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.