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510(k) Data Aggregation
(345 days)
Wellead Ureteral Catheter
The Ureteral Catheter is used for temporary urine drainage, delivery of irrigation fluids, injection of contrast agent to the urinary tract, navigation of a tortuous ureter, access, advancement or exchange of wire guides (open-ended catheters only).
Ureteral Catheters are single-use and sterile devices, which consist of catheter, adapter and guide wire. Ureteral Catheters are available in a variety of French sizes and distal tip configurations. Ureteral Catheters have 5 different distal tip configurations, which are closed round tip, open tapered tip, open tip, open soft tip and open cone tip. The adapter and guide wire are optional and the choice of Ureteral Catheter, adapter and guide wire should be based on the physician's preference and clinical situation. The catheter tube is made of Polyvinylchloride (PVC). The catheter is uncoated. Recommend duration of use: less than 24 hours.
The document describes a 510(k) premarket notification for a medical device, the Wellead® Ureteral Catheter (K220036). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. While it includes "Test Summary" and "Comparison to predicate device and conclusion" sections, it does not present acceptance criteria or a study design in the way typically expected for assessing AI/ML-based device performance.
This document focuses on the physical and material properties of a non-AI/ML medical device (a ureteral catheter) and its equivalence to a predicate device. Therefore, many of the requested items related to AI/ML device performance (like expert adjudication, MRMC studies, standalone performance, training sets) are not applicable.
Here's an interpretation of the available information in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail performance metric for the device's intended use. Instead, it relies on demonstrating that the subject device's various characteristics are equivalent to a predicate device and meet relevant industry standards.
| Acceptance Criteria Category | Reported Device Performance (as demonstrated by testing and comparison to predicate) |
|---|---|
| Mechanical Properties | |
| Seal Leaks | Meets ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. (Implied acceptance: no leaks detected per standard) |
| Seal Strength | Meets ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials. (Implied acceptance: sufficient seal strength per standard) |
| Seal Integrity (Visual) | Meets ASTM F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection. (Implied acceptance: acceptable visual seal integrity per standard) |
| Tensile Strength | "Identical to predicate device." Predicate's performance: "Testing shows that there should be no fracture of catheter tips or shafts during proper clinical use." (Implied acceptance: No fracture during proper clinical use, and equivalent to predicate performance). |
| Leakage and Lumen Blockage | "Identical to predicate device." Predicate's performance: "Testing evaluated lumen blockage and leakage in a pressurized flow test. Lumen patency, dimensional length, inner diameter, and outer diameter were determined." (Implied acceptance: Maintenance of lumen patency, no leakage, and dimensions comparable to predicate under pressurized flow). |
| Kink Radius | "Identical to predicate device." Predicate's performance: "Testing determined the kink radius of the Ureteral Catheter tubing." (Implied acceptance: Kink radius equivalent to predicate, maintaining functionality without kinking under typical use). |
| Catheter-Hub Bond | "Does not contain a Catheter Hub" (for this specific device configuration). Predicate's performance (for devices with a hub): "Testing determined the tensile strength of the hub-to-shaft bond." (Implied acceptance: Not applicable to subject device without a hub, and for predicate, sufficient bond strength). |
| Biocompatibility | |
| Cytotoxicity | Meets ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. (Implied acceptance: Non-toxic per standard) |
| Skin Sensitization | Meets ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization. (Implied acceptance: No skin sensitization per standard) |
| Irritation | Meets ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation. (Implied acceptance: Non-irritating per standard) |
| Material/Design Properties | |
| Accelerated Aging | Meets ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. (Implied acceptance: Maintains integrity after accelerated aging, supporting shelf-life) |
| Radiopacity | Meets ASTM F640-20 Standard Test Methods for Determining Radiopacity for Medical Use. (Implied acceptance: Sufficiently radiopaque for medical visualization). |
| Small-bore Connectors (if applicable) | Meets ISO 80369-7:2016 (intravascular/hypodermic) and ISO 80369-20:2015 (common test methods). (Implied acceptance: Connectors function safely and effectively per standards). |
| Other Catheter Properties | Meets EN 1618:1997 Catheters other than intravascular catheters Test methods for common properties. (Implied acceptance: General catheter common properties meet standard). |
| Kink Testing | Meets ISO EN ISO 20697:2018 Sterile drainage catheters and accessory devices for single use for kink testing. (Implied acceptance: Resists kinking per standard). |
| Intended Use | The device is used for temporary urine drainage, delivery of irrigation fluids, injection of contrast agent, navigation of a tortuous ureter, access/advancement/exchange of wire guides (open-ended). This is considered "substantially equivalent" to the predicate device's indications for use. Testing supports this equivalence. (Implied acceptance: Serves the described indications for use safely and effectively, comparable to the predicate). |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to various "lab bench testing" (e.g., for ASTM, ISO standards) but does not provide specific sample sizes for these tests. It indicates that the tests were performed on the "Ureteral Catheter," implying testing was done on samples of the subject device. The provenance of these test results is from the manufacturer, Well Lead Medical Co., Ltd. in China.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable as the device is a physical medical instrument, not an AI/ML system that requires expert interpretation for a "ground truth" test set. The "ground truth" here is the physical and biological performance as measured by objective engineering and biocompatibility tests against established standards.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as above. Testing involved objective measurements against standards, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This is not applicable as the device is not an AI-assisted diagnostic or imaging device. There is no human-in-the-loop component for which an MRMC study would be performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This is not applicable as the device is a physical ureteral catheter, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used in this submission is based on:
- Compliance with international and national standards (e.g., ISO 10993, ASTM F1929, EN 1618).
- Objective physical and chemical measurements (e.g., tensile strength, leakage, radiopacity, cytotoxicity, sensitization, irritation).
- Demonstrated equivalence to a predicate device (Cook Incorporated's Ureteral Catheters, K171662) which itself was previously cleared based on similar principles.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical medical instrument, not an AI/ML system requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as above. There is no training set for this type of device.
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