(261 days)
Hydrophilic Intermittent Catheter is used to empty the bladder for patients with urinary retention or incomplete bladder emptying.
Hydrophilic intermittent catheter is a sterile, single use hollow tube inserted into the bladder to drain the urine at regular intervals. The catheter also contains a Polyvinyl Pyrrolidone hydrophilic-coating and is sterilized by irradiation. The product can be used on patients who need intermittent urine drainage. The Hydrophilic intermittent catheter is available for use in professional medical facilities and home environments.
The Hydrophilic Intermittent Catheter Ready to Use is placed in a wetting liquid, packed and sealed in a foil pouch and sterilized.
The Hydrophilic Intermittent Catheter Compact is placed in a wetting liquid inside the container, which together with screw cap, connector and plug make up the primary packaging and the sterile barrier.
The Hydrophilic Intermittent Catheter Ready to Use is available in three configurations:
- Ready to use Female (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr)
- Ready to use Standard (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr)
- Ready to use Tiemann (10Fr, 12Fr, 14Fr, 16Fr, 18Fr) .
The Hydrophilic Intermittent Catheter Compact is available in one configuration (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 16Fr).
This document is a 510(k) Summary for a medical device (Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not to present a comparative effectiveness study or a detailed algorithm performance study for an AI/ML enabled device.
Therefore, the provided text does not contain the information required to populate most of the fields in your request, such as a formal acceptance criteria table with reported performance specific to an AI device, sample sizes for test/training sets of AI models, details about expert ground truth establishment, or MRMC study results. The non-clinical performance testing described focuses on standard medical device validation (e.g., sterilization, biocompatibility, physical properties) rather than AI model performance.
Based on the provided text, here's what can be extracted:
Acceptance Criteria and Device Performance Study (Non-AI Device)
This document is a 510(k) submission for a non-AI medical device (Hydrophilic Intermittent Catheter). The "acceptance criteria" here refer to testing to ensure the device meets established standards and performs comparably to predicate devices, rather than a statistical performance threshold for an AI algorithm. The "study" refers to non-clinical bench testing, packaging tests, aging tests, and biocompatibility tests.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a physical medical device (catheter) and not an AI device, "acceptance criteria" and "reported device performance" are described in terms of compliance with relevant international standards and successful bench testing, rather than metrics like sensitivity, specificity, or AUC for an AI model. Therefore, a table structured for AI performance metrics is not directly applicable. However, we can reframe the "acceptance criteria" as the types of tests performed and the "reported device performance" as compliance with those tests and standards.
| Acceptance Criteria Category | Specific Tests/Standards Met | Reported Device Performance |
|---|---|---|
| Non-clinical Bench Testing | ISO 20696:2018 (Sterile urethral catheters for single use) | Complies with standard |
| ASTM F623-19 (Standard performance specification for Foley Catheter) | Complies with standard | |
| pH testing | (Implicitly) Passed, as no non-compliance is reported. | |
| Osmolarity testing | (Implicitly) Passed, as no non-compliance is reported. | |
| Surface drying time of coating | (Implicitly) Passed, as no non-compliance is reported. | |
| Packaging Testing | ASTM F1929 (Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration) | (Implicitly) Passed, as no non-compliance is reported. |
| ASTM F88 (Seal Strength of Flexible Barrier Materials) | (Implicitly) Passed, as no non-compliance is reported. | |
| ASTM F1886 (Determining integrity of Seals for Flexible Packaging by Visual inspection) | (Implicitly) Passed, as no non-compliance is reported. | |
| Aging Testing | ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems for Medical Devices) | Complies with standard (Accelerated aged shelf life test passed) |
| Biocompatibility | ISO 10993-1:2018 (Biological Evaluation - Risk Management) | Complies with standard |
| ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Cytotoxicity Test passed | |
| ISO 10993-6:2016 (Tests for Local Effects after Implantation) | Implantation Test passed | |
| ISO 10993-10:2021 (Tests for irritation and skin sensitization) | Sensitization Test, Intracutaneous Reactivity Test passed | |
| ISO 10993-23:2021 (Tests for irritation) | (Covered by 10993-10) | |
| ISO 10993-17:2023 (Toxicological risk assessment) | (Implicitly) Passed, as no non-compliance is reported. | |
| ISO 10993-18: 2020 (Chemical characterization) | Chemical characterization passed | |
| ISO 10993-11 (Pyrogen Test) | Pyrogen Test passed | |
| Sterilization | ISO 11137-1 and ISO 11137-2 | Complies with standard (Sterilization dose confirmation completed) |
2. Sample Size for Test Set and Data Provenance
This document describes a medical device (catheter) validation, not an AI/ML model study. Therefore, the concept of a "test set" in the AI/ML sense (a dataset used to evaluate a trained model) does not apply. The validation involves various physical, chemical, and biological tests on samples of the manufactured device. The document does not specify the exact number of units or samples used for each bench test, but it indicates the tests were performed to demonstrate compliance with relevant standards.
- Date Provenance: The manufacturing entity is Well Lead Medical Co., Ltd. in Guangzhou, China. The testing would have been conducted on devices manufactured within their facility or by contracted laboratories. The origin of the data (i.e., test results) is from these non-clinical, controlled tests. It is not "retrospective" or "prospective" in the clinical study sense for data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. For a physical medical device like a catheter, "ground truth" is established by adherence to engineering specifications, material properties, sterility, and biocompatibility. This is determined through objective testing against widely accepted standards (e.g., ISO, ASTM), rather than by expert consensus on clinical data similar to an AI diagnostic device.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies or AI algorithm validation where expert disagreement on ground truth labels needs to be resolved. For standard device testing, compliance to a defined physical, chemical, or biological specification is measured objectively.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. An MRMC study assesses the impact of an AI algorithm on human reader performance (e.g., radiologists interpreting images). This device is a physical catheter, not an AI-enabled diagnostic tool.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
Not applicable. This is not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's validation is based on:
- Compliance with international standards (e.g., ISO, ASTM for sterility, biocompatibility, physical properties).
- Objective measurements from bench testing (e.g., pH, osmolarity, strength, seal integrity).
- Established material science and biological compatibility criteria.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML algorithm.
§ 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.