(58 days)
No
The description focuses on the physical construction and intended use of a standard ureteral catheter and wire guide, with no mention of AI/ML capabilities or related performance metrics.
No.
The device description and intended use indicate it is an access and delivery tool for the urinary tract, not for treating a condition or disease itself.
No
The device description and intended use indicate it is an access and catheterization device for the urinary tract, used for delivery, navigation, and exchange of wire guides, not for diagnosing conditions.
No
The device description clearly outlines physical components such as polyurethane tubing, a Luer lock adapter, and a stainless steel wire guide, indicating it is a hardware 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 clearly describes a device used for accessing and manipulating the urinary tract within the body (in vivo). This involves procedures like delivering contrast media, navigating the ureter, and guiding wires.
- Device Description: The description details a physical catheter and wire guide designed for insertion into the urinary tract.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro), such as blood, urine, or tissue samples, to provide information about a patient's health status.
IVD devices are specifically designed for testing samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device's function is procedural and interventional, not diagnostic based on in vitro analysis.
N/A
Intended Use / Indications for Use
These devices are intended for access and catheterization of the urinary tract, including the following applications:
- Delivery of contrast media
- Navigation of a tortuous ureter
- Access, advancement, or exchange of wire guides
Product codes (comma separated list FDA assigned to the subject device)
KOD
Device Description
The Angled Tip Ureteral Catheter is constructed from polyurethane tubing and is designed with a female Luer lock adapter. The catheter is available in 5 and 6 French diameters and a length of 70 centimeters. The distal tip of the catheter has an angle of 20°, sideports, and a taper. The female Luer lock adapter is constructed from polyamide. The subject device also includes a stainless steel wire guide coated with PTFE. The wire guide diameter is 0.035 inches and the length is 145 centimeters
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was performed at time-zero and following accelerated aging in order to demonstrate that the subject device Angled Tip Ureteral Catheter met applicable design and performance requirements.
- Biocompatibility
- Sterilization
- Dimensional and Compatibility
- Radiopacity
- Kink Radius
- Tensile
- Blockage and leakage
The results of these tests support a conclusion that the Angled Tip Ureteral Catheter will perform as intended. The subject device does not raise new questions of safety and/or effectiveness when compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Kumpe Access Catheter (K171600)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Imager™ II Catheter (K102527), Renal Access Cobra Catheter (K171600), Ureteral Catheter (K171662)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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June 28, 2018
Cook Incorporated Chelsea Woods Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404
Re: K181144
Trade/Device Name: Angled Tip Ureteral Catheter Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: KOD Dated: April 30, 2018 Received: May 1, 2018
Dear Chelsea Woods:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark R. Kreitz -S 2018.06.28 11:28:42 -04'00'
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. HONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Number (if known)
K181144
Device Name Angled Tip Ureteral Catheter
Indications for Use (Describe)
These devices are intended for access and catheterization of the urinary tract, including the following applications:
- Delivery of contrast media ●
- Navigation of a tortuous ureter
- . Access, advancement, or exchange of wire guides
Type of Use (Select one or both, as applicable)
V Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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750 DANIELS WAY, P.O. LOOMINGTON, IN 47402
2.0 510(k) Summary
Angled Tip Ureteral Catheter 21 CFR §807.92 Date Prepared: April 30, 2018
Submitted By:
Submission: Applicant: Primary Contact: Secondary Contact: Applicant Address:
Traditional 510(k) Premarket Notification Cook Incorporated Chelsea Woods Karthik Pillai Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x104707 (812) 332-0281
Contact Phone: Contact Fax:
Device Information:
Trade Name: Angled Tip Ureteral Catheter Common Name: Urological Catheter Classification Name: Urological Catheter and Accessories Classification Regulation: 21 CFR §876.5130, Product Code KOD Device Class/Classification Panel: Class II, Gastroenterology/Urology
Predicate Device:
- Kumpe Access Catheter (K171600)
Reference Device:
Device Description:
The Angled Tip Ureteral Catheter is constructed from polyurethane tubing and is designed with a female Luer lock adapter. The catheter is available in 5 and 6 French diameters and a length of 70 centimeters. The distal tip of the catheter has an angle of 20°, sideports, and a taper. The female Luer lock adapter is constructed from polyamide. The subject device
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also includes a stainless steel wire guide coated with PTFE. The wire guide diameter is 0.035 inches and the length is 145 centimeters
Indications for Use:
These devices are intended for access and catheterization of the urinary tract, including the following applications:
- Delivery of contrast media ●
- Navigation of a tortuous ureter ●
- . Access, advancement, or exchange of wire guides
Comparison to Predicate Device:
The subject device has the same indications for use, methods of operation, and fundamental technological characteristics as the predicate device. Differences between the subject device and the predicate device include design and materials. Characteristics of the subject device that differ from the predicate device are supported by testing and analysis.
Performance Data:
The following testing was performed at time-zero and following accelerated aging in order to demonstrate that the subject device Angled Tip Ureteral Catheter met applicable design and performance requirements.
- . Biocompatibility
- o Sterilization
- Dimensional and Compatibility ●
- Radiopacity ●
- Kink Radius ●
- Tensile
- Blockage and leakage ●
Conclusion:
The results of these tests support a conclusion that the Angled Tip Ureteral Catheter will perform as intended. The subject device does not raise new questions of safety and/or effectiveness when compared to the predicate device.