(45 days)
The URO Pro is an irrigation roller pump intended for the infusion of sterile solutions into the ureter and upper urinary tract during diagnostic and/or therapeutic endoscopic urologic procedures. It is indicated for the infusion of sterile solutions through an endoscope into the urogenital tract to irrigate the ureter and upper urinary tract in a controlled manner and to improve visibility of the surgical field during urologic procedures.
The URO Pro is a microprocessor controlled pump which functions according to the peristaltic principle and incorporates the following major components and features: a power supply, a main cable, a roller wheel, a pump head, various setting keys and display elements. The pump head is designed with two pressure sensors to perform redundant pressure measurement. A software controlled active sensor monitoring ensures the conformity of the preset nominal pressure value with the actual measured pressure. In addition, the URO Pro is designed with several alarms to inform the operator in case of an overpressure.
The provided text is a 510(k) summary for the URO Pro device, which is an irrigation roller pump. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to electrical safety and electromagnetic compatibility standards. It does not contain information about specific acceptance criteria related to device performance in a clinical or simulated clinical setting, nor does it describe a study that proves the device meets such criteria in terms of efficacy or diagnostic accuracy.
Therefore, many of the requested sections about acceptance criteria, sample sizes, expert involvement, and ground truth cannot be answered from the provided document.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from this document) | Reported Device Performance (from this document) |
|---|---|
| Compliance with electrical safety standards | The device complies with the International Standard IEC 60601-1 (Electrical Safety). |
| Compliance with electromagnetic compatibility standards | The device complies with IEC 60601-1-2 (Electromagnetic Compatibility). |
| Substantial equivalence in design and characteristics to predicate devices | The URO Pro is substantially equivalent to the Hysteroscopy Pump HM4 in regards to its design and characteristics, using the same basic principles of operation, technological characteristics, and tubing sets. |
| Substantial equivalence in intended use to predicate devices | The URO Pro is substantially equivalent to the Karl Storz Uromat and ENDO FMS Urology in its intended use for the infusion of sterile solutions into the ureter and upper urinary tract during diagnostic and/or therapeutic endoscopic urological procedures. |
| Technological characteristics and principles of operation similar to predicate devices | The URO Pro has similar technological characteristics and principles of operation as the Karl Storz Uromat and ENDO FMS Urology. |
The following information is NOT available in the provided text:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information about a test set or its provenance is given. The "Performance Data" section refers to compliance with safety standards, not clinical performance.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No information about experts or ground truth establishment for a test set is provided.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set performance 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: This device is an irrigation pump, not an AI-assisted diagnostic device, so an MRMC study is not relevant and not mentioned.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical performance study requiring ground truth is described.
- 8. The sample size for the training set: Not applicable as no training set for an algorithm is mentioned.
- 9. How the ground truth for the training set was established: Not applicable.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.