(42 days)
No
The summary describes a physical medical device (a stent) with a hydrophilic coating. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes.
The device is used for temporary internal drainage from the ureteropelvic junction to the bladder, which is a medical intervention to manage a physiological condition.
No
The device is described as a stent used for temporary internal drainage, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description explicitly states it is made from physical materials (polyurethane, silicone, hydrophilic coating) and is a physical stent, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary internal drainage from the ureteropelvic junction to the bladder." This is a therapeutic and drainage function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical device (stent) made of materials like polyurethane and silicone, designed for placement within the urinary tract. This aligns with a medical device used for treatment or support, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, this device is a medical device used for internal drainage, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder.
Product codes
Not Found
Device Description
The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder. The hydrophilic coating will allow the stent to become 'slippery-when-wet' which will reduce friction. This device will be made from polyurethane, silicone and a hydrophilic coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteropelvic junction to the bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Slipcoat™ Stent, Hydro-Plus™, Lubri-Flex™ Ureteral Stent, K905289
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).
0
9
510(k) Premarket Notification AQ Hydrophilic Stent Cook Urological
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS L
Submitted By:
Tammy Bacon Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 April 15, 1996
Device
Trade Name:
AQ Hydrophilic Stent
Proposed Classification Name:
Splint, Ureteral
Predicate Devices:
The AQ Hydrophilic Stent is substantially equivalent to predicate devices in terms of indications for use, design, and materials of construction. Predicate devices include the Slipcoat™ Stent manufactured by Cook Urological, the Hydro-Plus™ manufactured by Microvasive and the Lubri-Flex™ Ureteral Stent, K905289, manufactured by Surgitek®
Device Description:
The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder. The hydrophilic coating will allow the stent to become 'slippery-when-wet' which will reduce friction. This device will be made from polyurethane, silicone and a hydrophilic coating.
1
4961446
10
510(k) Premarket Notification AQ Hydrophilic Stent Cook Urological
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program. The device 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 device meets the requirements for section 510(k) substantial equivalence.