Search Results
Found 1 results
510(k) Data Aggregation
(217 days)
The Uro-G flexible cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.
The Uro-G cystoscope is a handheld, battery-operated portable cystoscope consisting of a sterile, disposable steerable endoscopic cannula and a reusable handle with a video monitor. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and one channel for infusion of irrigating fluid. The handle is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the disposable cannula. The handle contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or to start/stop video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.
The provided text describes the 510(k) summary for the Uro-G Cystoscope. This document primarily focuses on establishing substantial equivalence to a predicate device (Uro-V Cystoscope) rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for an AI/ML device.
The "acceptance criteria" for a medical device like a cystoscope typically refer to the performance standards and safety requirements it must meet to be considered safe and effective, often demonstrated through engineering bench testing, biocompatibility, and electrical safety. The "study that proves the device meets the acceptance criteria" in this context refers to these non-clinical tests.
There is no mention of AI/ML components in the Uro-G Cystoscope from the provided text, nor are there any acceptance criteria, sample sizes, or ground truth establishment relevant to AI/ML or comparative effectiveness studies with human readers. The device is a physical endoscope.
Therefore, I will interpret "acceptance criteria" and "study" in the context of a medical device submission focused on equivalence for a non-AI physical device.
Here's the breakdown based on the provided document:
Acceptance Criteria and Study for Uro-G Cystoscope (Non-AI Device)
The Uro-G Cystoscope is a physical medical device. The "acceptance criteria" are based on demonstrating substantial equivalence to a legally marketed predicate device (Uro-V Cystoscope) and compliance with relevant safety and performance standards through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion (Implicit/Explicit) | Reported Device Performance/Comparison |
|---|---|---|
| Predicate Equivalence | Intended Use: "The Uro-G flexible cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra." | EXACTLY THE SAME as predicate (Uro-V Cystoscope). |
| Indications for Use: Symptomatic voiding dysfunction, Hematuria, Bladder tumor surveillance, Recurrent lower urinary tract infection, Pelvic pain syndromes. | EXACTLY THE SAME as predicate. | |
| Route of Advancement: Advanced to the bladder via the urethra. | SAME as predicate. | |
| Site of Use: Hospitals and physician offices. | SAME as predicate. | |
| Components: Reusable handle with video screen; Attachable cannula with working channel, illumination source, and camera at tip. | **SAME** as predicate (handle is identical, cannula has modifications but core components are the same). | |
| Image Transmission/Display: Image transmitted from video camera at tip to video monitor on handle; 3.5-inch LCD Display. | SAME as predicate. | |
| Field of View: 140 degrees. | SAME as predicate. | |
| Direction of View: 0 degrees (forward viewing). | SAME as predicate. | |
| Operational Characteristics: Adjustable illumination brightness, capture still images/video, cleaning/disinfection protocol, frequency/duration of use. | SAME as predicate for these operational aspects. | |
| Tissue Contact Materials: Compliant with ISO 10993. | SAME as predicate, and cannula materials passed all applicable biocompatibility tests (see details below). | |
| Differences and Rationale: Changes in Outer Diameter (5.5mm vs 4.2mm); Working Length (380mm vs 254mm); Working Channel ID (2.2mm); Flexible Tip Deflection (up to 210° up and 130° down); Focal Length (5-50mm vs 3-50mm). Rationale provided for each difference to demonstrate no new safety/effectiveness issues. | Acceptable; Differences are addressed and do not raise new issues of safety or effectiveness. For example, increased OD is still within anatomical limits for patients, increased working length allows better access, improved tip deflection enhances ease of use without compromising safety due to continuous imaging. | |
| Performance Data (Bench/Non-Clinical) | Design Verification & Validation: Ensure device performs as intended and meets specifications. | Conducted with successful results. |
| Packaging & Shelf-Life: Maintain sterility and integrity over time. | Conducted for the sterile cannula, confirming labeled shelf life compliance. | |
| Biocompatibility: Meet ISO 10993 Part 1 requirements for short-duration (<24 hours) indwelling device concerning Cytotoxicity, Irritation, Sensitization, and Systemic Toxicity (acute). | Device passed all tests. | |
| Sterilization Procedure Validation: Compliance with ISO 11135-1 (Ethylene Oxide), ISO 11607 (Packaging), AAMI TIR12 (Reusable device reprocessing), AAMI TIR30 (Cleaning reusable devices). | Conducted for the sterile cannula; compliance confirmed. | |
| Software Verification & Validation: Ensure firmware and software function correctly and safely. | Conducted with successful results. | |
| Electrical Safety & Electromagnetic Compatibility (EMC): Compliance with ISO 60601-1, ISO 60601-1-2 (EMC), and IEC 60601-2-18 (Endoscopic equipment, including thermal safety). | Device found to meet compliance requirements. (Note: The handle component's electrical safety and EMC testing from the U-Scope 8000 submission K132384 was applicable). | |
| Mechanical Characteristics: Proper functioning of mechanical components (e.g., deflection mechanism). | Tested with successful results. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of an AI/ML test set. For physical device testing, sample sizes would refer to the number of units tested for each specific bench test (e.g., number of cannulas tested for biocompatibility, sterility, or mechanical deflection). These specific numbers are not provided in this summary, but the document states "All necessary performance testing was conducted with bench testing."
- Data Provenance: The data comes from the manufacturer's (UroViu Corporation) internal bench testing and verification/validation activities. The document does not specify the country of origin for the data or whether any retrospective/prospective studies (which are clinical by nature) were performed. Since no clinical studies were deemed necessary, the data is entirely from non-clinical (benchtop) sources.
3. Number of Experts and Qualifications for Ground Truth Establishment
- Not Applicable: This pertains to AI/ML model ground truth, which is not relevant for this physical device. The "ground truth" for this device's performance is established by direct physical measurements, chemical tests, electrical tests, and adherence to engineering specifications and international standards (e.g., ISO, IEC).
4. Adjudication Method for the Test Set
- Not Applicable: This pertains to expert review and consensus for AI/ML ground truth. For this physical device, "adjudication" is not needed in the same sense; rather, test results are assessed against predefined engineering and regulatory specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: An MRMC comparative effectiveness study was not performed. This type of study is relevant for AI/ML diagnostic aids to assess human reader improvement, which is not applicable to a physical endoscope.
6. Standalone Performance (Algorithm Only)
- Not Applicable: There is no AI/ML algorithm in this device. Its performance is entirely dependent on its physical and electrical characteristics.
7. Type of Ground Truth Used
- Engineering Specifications and Standard Compliance: The "ground truth" for the device's performance relies on meeting pre-defined engineering specifications, international safety and performance standards (e.g., ISO 10993 for biocompatibility, ISO 60601-1 for electrical safety, ISO 11135-1 for sterilization), and demonstrating physical functionality (e.g., image quality, fluid infusion, tip deflection).
8. Sample Size for the Training Set
- Not Applicable: This device does not use an AI/ML training set. Its design and manufacturing process are based on engineering principles and established medical device production.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no AI/ML training set, this question is not relevant.
Summary for this specific product (Uro-G Cystoscope):
The FDA 510(k) clearance process for the Uro-G Cystoscope primarily relied on demonstrating substantial equivalence to a predicate device (Uro-V Cystoscope) and meeting general safety and performance requirements through a series of benchtop engineering tests. Questions related to AI/ML-specific validation (e.g., "AI acceptance criteria," "sample sizes for test/training sets," "expert ground truth," "MRMC studies") are not relevant for this particular device as described in the provided document, as it is a physical, non-AI medical instrument.
Ask a specific question about this device
Page 1 of 1