(66 days)
No
The device description and performance studies focus on the physical and mechanical properties of a ureteral catheter, with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is used for diagnostic visualization, guidewire direction, and drainage, not for treating a disease or condition.
No
The device is primarily used to inject contrast medium for visualization, direct a guidewire, and for urinary drainage, which are interventional or procedural uses rather than diagnostic. While it aids in visualization, its core function is not to diagnose a condition.
No
The device description clearly outlines a physical, single-use catheter made from nylon resin with various tip configurations and a luer lock adapter. It undergoes biocompatibility and functional/mechanical testing, which are characteristic of hardware devices. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for procedures like injecting contrast, guiding wires, and drainage. This is an in vivo use.
- Device Description: The description details a physical catheter designed to be inserted into the ureter.
- Lack of IVD Characteristics: An IVD is a device used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a medical device used for interventional procedures within the urinary tract.
N/A
Intended Use / Indications for Use
The Kendall Curity Ureteral Catheter is intended to be used to inject contrast medium for fluoroscopic ureteral visualization, to direct a guidewire into the ureter and for urinary drainage.
Product codes
Not Found
Device Description
The proposed Kendall Curity Ureteral Catheter is a sterile, single use device which facilitates preliminary procedural components of ureteroscopy. The catheter is a single lumen extrusion fabricated from nylon resin. Graduated placement markers on the catheter shaft will allow the urologist to determine the extent of catheter advancement. The proximal end of the catheter has a friction fitted luer lock adapter. The distal catheter tip will be manufactured in a cone tip, open tip or whistle tip configuration. The catheter will be sold in a standard 70 cm working length in French sizes ranging from 4.0 Fr. to 7.0 Fr.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic
Anatomical Site
ureter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
urologist
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
Biocompatibility testing was performed on the catheter following ISO-10993 Biological Evaluation of Medical Devices. This testing found the material contained no toxic diffusible substances. Functional/Mechanical testing was performed to determine flow rates, shaft kink, shaft stiffness, shaft tensile, cone tip/shaft bond and shaft radiopacity. Testing showed equivalence between the proposed catheter and referenced predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Pre-Amendment Device, K923729
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
FEB - 7 1997
EXHIBIT #7
P192
510(k) Summary
Kendall Curity® Ureteral Catheter
In accordance with section 513(i) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14. 1994. this summary is submitted by:
Kendail Healthcare Products Company 15 Hampshire Street Mansfield, MA 02048 Date: November 25, 1996
-
- Contact Person
David A. Olson Manager Regulatory Affairs (508) 261-8530
- Contact Person
2. Name of Medical Device
Classification Name: Gastro-Urology Ureteral Catheter Common or Usual Name: Ureteral Catheter Proprietary Name: Curity Ureteral Catheter
3. Identification of Legally Marketed Device
The proposed Kendall Curity Ureteral Catheter is substantially equivalent in intended use, design and function to the commercially available Bard Ureteral Catheter (Pre-Amendment Device); Cook Ureteral Catheter, 510(k) No. K923729.
4. Device Description
The proposed Kendall Curity Ureteral Catheter is a sterile, single use device which facilitates preliminary procedural components of ureteroscopy. The catheter is a single lumen extrusion fabricated from nylon resin. Graduated placement markers on the catheter shaft will allow the urologist to determine the extent of catheter advancement. The proximal end of the catheter has a friction fitted luer lock adapter. The distal catheter tip will be manufactured in a cone tip, open tip or whistle tip configuration. The catheter will be sold in a standard 70 cm working length in French sizes ranging from 4.0 Fr. to 7.0 Fr.
1
11964899 02012
ട്. Device Intended Use
The Kendall Curity Ureteral Catheter is intended to be used to inject contrast medium for fluoroscopic ureteral visualization, to direct a guidewire into the ureter and for urinary drainage.
ട. Product Comparison
The Kendall Curity Ureteral Catheter is equivalent to the referenced predicate devices in that they are fabricated from similar materials have the same function, equivalent indications for use, and similar designs.
7. Nonclinical Testing
Biocompatibility testing was performed on the catheter following ISO-10993 Biological Evaluation of Medical Devices. This testing found the material contained no toxic diffusible substances.
Functional/Mechanical testing was performed to determine flow rates, shaft kink, shaft stiffness, shaft tensile, cone tip/shaft bond and shaft radiopacity. Testing showed equivalence between the proposed catheter and referenced predicate devices.