(185 days)
Two-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage for urological use only; the indwell time of the proposed device is no more than 30 days.
Three-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage and bladder irrigation for urological use only; the indwell time of the proposed device is no more than 30 days.
The Disposable Silicone Foley Catheter is available in two types, two-way disposable silicone Foley catheter and three-way disposable silicone Foley catheter.
The two-way disposable silicone Foley catheter is composed of a double lumen tube, a double lumen hub, one balloon and a tip.
The three-way disposable silicone Foley catheter is composed of a triple lumen tube, a triple lumen hub, one balloon and a tip.
The proposed device is supplied in French size ranging from 6 to 26. It is available in 310mm and 400mm length with various balloon sizes. The devices are applied for male and female; the 6Fr, 8Fr and 10Fr catheters are for pediatric, and others are for adult.
The Disposable Silicone Foley Catheter is provided EO sterilized as a single used device.
The provided text describes a 510(k) summary for a Disposable Silicone Foley Catheter, which primarily relies on substantial equivalence to a predicate device and bench testing against recognized standards. It is not a study focused on AI or human-in-the-loop performance, so many of the requested categories are not applicable.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| ASTM F88-09 (Seal Strength) | Device met design specifications and standard requirements |
| ASTM F1140-07 (Internal Pressurization Failure) | Device met design specifications and standard requirements |
| ASTM F1929-98(2004) (Detecting Seal Leaks) | Device met design specifications and standard requirements |
| ISO 11135-1:2007 (Ethylene Oxide Sterilization) | Device complies with standards (EO sterilized) |
| USP (Bacterial Endotoxin Limit) | Device complies with standards |
| ASTM F623-99 (2006) Performance Requirements | Device meets performance requirements |
| * Flow Rate | Met |
| * Balloon Integrity | Met |
| * Balloon Response to Pullout | Met |
| * Balloon Volume Maintenance | Met |
| * Manufacturing Tolerances | Met |
| * Balloon Deflation Reliability | Met |
| ISO 10993-5:2009 (Cytotoxicity) | Device complies with standards |
| ISO 10993-10:2010 (Irritation/Sensitization) | Device complies with standards |
| ISO 10993-11:2006 (Systemic Toxicity) | Device complies with standards |
| ISO 10993-6:2007 (Local Effects After Implantation) | Device complies with standards |
Study Details:
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Sample size used for the test set and the data provenance: The document does not specify a "test set" in the context of clinical data for performance evaluation. The "tests" mentioned are non-clinical bench tests (e.g., mechanical, biocompatibility, sterilization) that compare the device's physical properties and performance against established international and ASTM standards. No patient data is involved. The data provenance is laboratory testing conducted by the manufacturer, Guangdong Baihe Medical Technology Co., Ltd., in China.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the non-clinical tests is defined by the requirements of the recognized standards themselves (e.g., a specific flow rate value, a certain seal strength). No human experts were used to establish a "ground truth" for these engineering and biological performance metrics.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or subjective assessments. These were objective bench tests.
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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: Not applicable. This submission is for a medical device (Foley Catheter), not an AI-powered diagnostic or assistive technology.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document pertains to a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests is represented by the specific performance thresholds and methodologies detailed within the referenced international and ASTM standards (e.g., ISO 11135-1, ASTM F623-99).
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The sample size for the training set: Not applicable. This is not an AI/machine learning study.
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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.