(74 days)
AMSURE® 3-Way Hydrophilic Latex Foley Catheter is intended to be used for bladder/urinary tract drainage and bladder/urinary tract irrigation for urological use only.
The AMSURE® 3-WAY Hydrophilic Latex Foley Catheter is a retention type urological catheter made of silicone coated natural latex material modified with the addition of a lubricious/hydrophilic coating to facilitate insertion of the catheter. This device is a Latex tube with three lumens: one lumen for urinary drainage which is to be connected to a urine collecting container; one lumen with two-way valve for inflation/deflation of the foley balloon and one lumen for irrigation of the bladder/urinary tract. The 3-Way Hydrophilic Latex Foley Catheter is coated with a lubricious hydrophilic coating which becomes slippery when wet. On the opposing end of the shaft are a connecting funnel and a luer activated valve. This product is available in a combination of French sizes, balloon capacities and lengths to accommodate adult male and female applications. The device will be offered in French sizes from 14Fr to 26Fr, balloon size of 5 cc and 30cc, The device is disposable, sterile (Ethylene Oxide Sterilization) and for single use only.
The AMSURE® 3-WAY Hydrophilic Latex Foley Catheter was evaluated for substantial equivalence to predicate devices, and its performance was assessed through various tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from industry standards/predicate device equivalence) | Reported Device Performance |
|---|---|---|
| Friction Test | Not explicitly stated, but expected to be comparable to predicate devices and industry standards for ease of insertion. | Performed; implies satisfactory results by meeting "performance requirements." |
| Hydrophilic Coating Distribution | Not explicitly stated, but expected to be uniform for effective lubricity. | Performed; implies satisfactory results by meeting "performance requirements." |
| Hydrophilic Coating Uniformity | Not explicitly stated, but expected to be uniform for effective lubricity. | Performed; implies satisfactory results by meeting "performance requirements." |
| Flow Rate (Drainage and Douche/Irrigation Lumens) | Not explicitly stated, but expected to meet functional requirements for effective drainage and irrigation. | Performed; implies satisfactory results by meeting "performance requirements." |
| Balloon Integrity | Not explicitly stated, but expected to ensure safe and effective retention of the catheter. | Performed; implies satisfactory results by meeting "performance requirements." |
| Balloon Volume Integrity | Not explicitly stated, but expected to maintain the intended volume for proper inflation and retention. | Performed; implies satisfactory results by meeting "performance requirements." |
| Deflation Reliability | Not explicitly stated, but expected to allow for smooth and complete deflation for safe removal. | Performed; implies satisfactory results by meeting "performance requirements." |
| Biocompatibility | Compliance with ISO 10993 (Biological Evaluation of Medical Devices Part I: Evaluation and Testing) | Met by virtue of using materials well-characterized and with a long history of safe use, similar to predicate devices. |
| Sterilization | Validation per ISO 11135-1:2007 (Sterilization of Healthcare Products - Ethylene Oxide) | Met by using the same sterilization method and materials as predicate devices. |
2. Sample Size and Data Provenance
The document does not specify a distinct "test set" in the context of device performance data from human subjects or image analysis. Instead, the performance testing described is likely in vitro or bench testing. Therefore, information about sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided in this 510(k) summary.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. The performance testing appears to be based on engineering and material standards, not expert subjective assessment of medical data.
4. Adjudication Method
Not applicable. The performance testing is based on objective measurements against engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is typically done for diagnostic or screening devices involving human interpretation of medical images. This 510(k) pertains to a urological catheter, whose performance is evaluated through physical and material properties, not human interpretation.
6. Standalone Performance Study (Algorithm only)
Not applicable. This device is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is established by engineering standards and material specifications, as well as equivalency to predicate devices. This includes:
- ASTM F-623-99 (Standard Specification for Foley Catheter)
- FDA's Guidance for Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters - February 27, 1997
- ISO 10993 (Biocompatibility)
- ISO 11135-1:2007 (Sterilization)
- The known performance and safety history of the predicate devices based on their materials and manufacturing processes.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI models that require a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set is involved.
§ 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.