(20 days)
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Not Found
No
The summary describes a physical medical device (catheter) with a hydrophilic coating for lubrication. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is described as being for "drainage, irrigation and/or retrograde pyelogram," which are diagnostic or procedural uses, not explicitly therapeutic.
No
Explanation: The device is intended for drainage, irrigation, and retrograde pyelogram, which are procedural and interventional uses, not diagnostic. It does not analyze patient data to provide insights into a medical condition.
No
The device description explicitly lists physical materials (polyurethane, polyethylene, vinyl) and a hydrophilic coating, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "drainage, irrigation and/or retrograde pyelogram." These are procedures performed directly on the patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics and function of the catheter for insertion and fluid management within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely procedural and therapeutic/diagnostic in a different sense (imaging via retrograde pyelogram, but not in vitro).
N/A
Intended Use / Indications for Use
The AQ Hydrophilic Urological Catheters are intended for drainage, irrigation and/or retrograde pyelogram.
Product codes
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Device Description
The AQ Hydrophilic Urological Catheters are intended for drainage, irrigation and/or retrograde pyelogram. Materials that comprise these devices are polurethane, polyethylene, vinyl and hydrophilic coating. The hydrophilic coating will allow the catheters to become lubricious which will reduce friction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Slip-Coat™ Catheters, uncoated urological catheters
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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JUN 11 1996
510(k) Premarket Notification AQ Hydrophilic Catheters Cook Urological
I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted By:
Tammy Bacon Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 May 21, 1996
Device
Trade Name:
Proposed Classification Name:
AQ Hydrophilic Urological Catheters Catheter, Urological
Catheter, Ureteral, Gastro-Urology
Predicate Devices:
The AQ Hydrophilic Urological Catheters are substantially equivalent to predicate devices in terms of indications for use, design, and materials of construction. Predicate devices include the Slip-Coat™ Catheters manufactured by Cook Incorporated and uncoated urological catheters manufactured by Cook Urological.
Device Description:
The AQ Hydrophilic Urological Catheters are intended for drainage, irrigation and/or retrograde pyelogram. Materials that comprise these devices are polurethane, polyethylene, vinyl and hydrophilic coating. The hydrophilic coating will allow the catheters to become lubricious which will reduce friction.
Substantial Equivalence:
These devices will be manufactured according to specified process controls and a Quality Assurance Program. These devices will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Urological. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meet the requirements for section 510(k) substantial equivalence.