(233 days)
The Balloon Ureteral Dilator and Balloon Ureteral Dilator Set is intended for ureteral dilation prior to ureteral stone manipulation or ureteroscopy and dilation of the intramural ureter.
The Balloon Ureteral Dilator Set includes the balloon ureteral dilator, a wire guide, a 10 mL syringe, an endoscopic cap and a pin-vise handle. Balloon ureteral dilators can be purchased separately. The balloon ureteral dilator is composed of a radiopaque dilator fitted with a polyethylene balloon. The balloon ureteral dilator is available in 5.0 or 7.0 French and is 65 centimeters in length. The balloon is located on the distal end of the dilator and has diameters of 5 or 6 millimeters with lengths of 4 or 10 centimeters when inflated. The balloon has a maximum inflation pressure of 40 or 60 psi, depending on the diameter and length of the balloon. Additionally, radiopaque marker bands are placed at the proximal and distal ends of the balloon to provide fluoroscopic visibility. Additional set components in the Balloon Ureteral Dilator Set include a straight safety wire guide, endoscopic cap, pin-vise handle, and syringe. The wire guide has a diameter of 0.028 or 0.038 inches and a length of 145 centimeters. The endoscopic cap and a pin-vise handle are provided to stabilize the wire guide during introduction. The syringe is a 10 mL luer-lock syringe provided for balloon inflation. The Balloon Ureteral Dilator and Balloon Ureteral Dilator Set is provided sterile for one-time use.
This document is a 510(k) Premarket Notification for a medical device called the "Balloon Ureteral Dilator and Balloon Ureteral Dilator Set." It is not an AI/ML medical device, clinical study, or imaging study, but rather a submission for a physical medical instrument. Therefore, most of the requested information regarding acceptance criteria, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Ascend™ Balloon Dilation Catheter (K970041)) through comparison of technical characteristics and performance testing of the physical device.
However, I can extract the closest equivalent information where available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests conducted, implying that the device was considered to "meet the design input requirements" based on these tests. It doesn't present a table with specific numeric acceptance criteria and reported numeric performance values for each test, but rather states that it met the requirements.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Radiopacity (Demonstrates visibility under fluoroscopy) | Tested and confirmed to ensure reliable design and performance. |
| Pressure Resistance for Dilatation Balloons (Ability to withstand inflation pressure) | Tested and confirmed to ensure reliable design and performance. |
| Kink Radius Testing (Resists kinking) | Tested and confirmed to ensure reliable design and performance. |
| Balloon Rated Burst Pressure (RBP) (Withstands specified pressure without bursting) | Tested and confirmed to ensure reliable design and performance. |
| Dimensional Verification of Balloon upon inflation (Inflates to specified dimensions) | Tested and confirmed to ensure reliable design and performance. |
| Balloon Deflation Testing (Ability to deflate properly) | Tested and confirmed to ensure reliable design and performance. |
| Tensile Testing (Strength and integrity of materials) | Tested and confirmed to ensure reliable design and performance. |
| Dimensional Verification (Overall device dimensions meet specs) | Tested and confirmed to ensure reliable design and performance. |
| Biocompatibility (Cytotoxicity, Sensitization, and Irritation/Intracutaneous) | Tested and confirmed to ensure reliable design and performance (implies passing relevant ISO standards for biocompatibility). |
2. Sample Sizes Used for the Test Set and the Data Provenance:
- Sample Size: Not explicitly stated for each test. For physical device testing, sample sizes are typically determined by relevant ISO standards or internal quality procedures, but are not detailed in this summary.
- Data Provenance: The testing was conducted internally by Cook Incorporated as part of their design verification and validation process for the 510(k) submission. No external clinical data or patient data is mentioned; it's laboratory-based performance testing of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This is not applicable. Ground truth establishment by experts (e.g., radiologists) is relevant for diagnostic or AI/ML devices that interpret data. This document describes a physical medical instrument (dilator). Its "ground truth" is its physical and functional performance as measured by engineering and material science tests.
4. Adjudication Method for the Test Set:
This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving disagreements among multiple human readers in studies, typically in diagnostic imaging. The performance testing of this device is based on objective, quantifiable engineering measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
This is not applicable. MRMC studies are used to evaluate the impact of a diagnostic tool (often AI-assisted) on human reader performance. This device is a therapeutic instrument, not a diagnostic one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This document is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by engineering specifications and established test methods (e.g., ISO standards for medical devices, internal design requirements) that define acceptable physical and functional characteristics (e.g., burst pressure, tensile strength, dimensions).
8. The Sample Size for the Training Set:
This is not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable. As it's not an AI/ML device, there is no training set or its associated ground truth establishment.
In summary, this 510(k) submission demonstrates the substantial equivalence of a physical medical device. The "acceptance criteria" and "proof" relate to standard engineering and biocompatibility performance testing, rather than clinical study designs typically associated with AI/ML or diagnostic devices.
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).