(241 days)
No
The summary describes a family of physical catheters used for accessing and manipulating the urinary tract. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No.
The device facilitates diagnostic and access procedures (delivery of contrast, drainage, navigation, wire guide exchange) and does not directly provide therapy.
No.
The listed uses ("Delivery of contrast media," "Drainage of fluids," "Delivery of irrigation fluids," "Navigation," and "Access, advancement, or exchange of wire guides") are interventional or delivery functions, not diagnostic ones. While contrast media delivery can be used for diagnostic imaging, the device itself is a delivery tool, not an imaging or diagnostic analysis tool.
No
The device description clearly states that the device is a family of physical ureteral catheters, which are hardware devices used for accessing and catheterizing the urinary tract.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that these ureteral catheters are used for procedures within the urinary tract (access, catheterization, delivery of fluids, drainage, navigation). These are interventional procedures performed inside the body.
- Intended Use: The intended uses listed (delivery of contrast, drainage, irrigation, navigation, wire guide access) are all related to manipulating or interacting with the urinary tract directly, not analyzing samples taken from it.
Therefore, the function and intended use of these ureteral catheters align with a medical device used for treatment or diagnosis in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ureteral catheters are indicated for access and catheterization of the urinary tract, including applications:
- Delivery of contrast media
- Drainage of fluids from the urinary tract
- · Delivery of irrigation fluids to the urinary tract
- · Navigation of a tortuous ureter
- · Access, advancement, or exchange of wire guides (open-ended catheters only)
The Pediatric Ureteral Catheter is indicated for access and catheterization of the urinary tract in pediatric patients, including the following applications:
- Delivery of contrast media
- Drainage of fluids from the urinary tract
- · Delivery of irrigation fluids to the urinary tract
- · Navigation of a tortuous ureter
Product codes (comma separated list FDA assigned to the subject device)
KOD
Device Description
The Ureteral Catheter family is comprised of nine different types of Ureteral Catheters. The types of catheters include: Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, and Pediatric Ureteral Catheter. The Ureteral Catheters range in length from 10 to 125 cm. The catheters may be closed or open-ended. The Ureteral Catheters are sterile, single-use devices.
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 (Pediatric patients explicitly mentioned for one type of catheter)
Intended User / Care Setting
Prescription Use
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)
Performance - Testing shows that the subject device conforms to the performance testing requirements based on intended use. All predetermined acceptance criteria were met.
Tests Performed:
- Tensile Strength – Testing shows that there should be no fracture of catheter tips or shafts during proper clinical use.
- Leakage and Lumen Blockage – Testing evaluated lumen blockage and leakage in a pressurized flow test. Lumen patency, dimensional length, inner diameter, and outer diameter were determined.
- Radiopacity – Testing shows that the mean radiopacity met the acceptance criteria and evaluated radiopacity by subjecting the ureteral catheters to a comparative fluoroscopic evaluation.
- Kink Radius – Testing determined the kink radius of the ureteral catheter tubing.
- Catheter-Hub Bond – Testing determined the tensile strength of the hub-to-shaft bond.
Biocompatibility – Testing shows that the subject device conforms to the biocompatibility requirements based on its intended use. All predetermined acceptance criteria were met.
Tests Performed:
- Cytotoxicity – ISO MEM Elution
- Sensitization – Guinea Pig Maximization
- Irritation/Intracutaneous Reactivity – Intracutaneous Study
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.
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.
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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February 1, 2018
Cook Incorporated Carly Powell Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
Re: K171662
Trade/Device Name: Open-End Ureteral Catheter, Open-End Ureter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: KOD Dated: December 19, 2017 Received: December 20, 2017
Dear Carly Powell:
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.
1
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.
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Benjamin R. Fisher -S
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
2
Indications for Use
510(k) Number (if known) K171662
Device Name
Open-End Ureteral Catheter, Open-End Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter
Indications for Use (Describe)
Ureteral catheters are indicated for access and catheterization of the urinary tract, including applications:
- Delivery of contrast media
- Drainage of fluids from the urinary tract
- · Delivery of irrigation fluids to the urinary tract
- · Navigation of a tortuous ureter
- · Access, advancement, or exchange of wire guides (open-ended catheters only)
The Pediatric Ureteral Catheter is indicated for access and catheterization of the urinary tract in pediatric patients, including the following applications:
- Delivery of contrast media
- Drainage of fluids from the urinary tract
- · Delivery of irrigation fluids to the urinary tract
- · Navigation of a tortuous ureter
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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2.0 510(k) Summary
50 DANIFIS WAY, P.O.
Ureteral Catheters As required by 21 CFR 807.92 Date Prepared: January 31, 2018
| Submitted By: | |
|---|---|
| Submission: | Traditional 510(k) Premarket Notification |
| Applicant: | Cook Incorporated |
| Contact: | Carly Powell |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone: | (812) 339-2235 x104913 |
| Contact Fax: | (812) 332-0281 |
| Device Information: | |
| Trade Name: | Open-End Ureteral Catheter, |
| Open-End Ureteral Catheter Sof-Flex, | |
| EchoTip Open-End Ureteral Catheter, | |
| Open-End Flexi-Tip Ureteral Catheter, | |
| Flexi-Tip Ureteral Catheter (Closed End), | |
| Whistle Tip Ureteral Catheter, | |
| Round Tip Ureteral Catheter, | |
| Spiral Tip Ureteral Access Catheter, | |
| Pediatric Ureteral Catheter | |
| Common Name: | Catheter, Urological |
| Classification Name: | Urological catheter and accessories |
| Regulation, Class: | 21 CFR §876.5130, Class II |
| Product Code, Panel: | KOD, Gastroenterology/Urology |
Predicate Devices:
- Primary predicate device: Bard TigerTail Ureteral Catheter (K033719)
- Secondary predicate device: Porges Ureteral Catheters (K021856)
Device Description:
The Ureteral Catheter family is comprised of nine different types of Ureteral Catheters. The types of catheters include: Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, and Pediatric Ureteral Catheter.
4
The Ureteral Catheters range in length from 10 to 125 cm. The catheters may be closed or open-ended. The Ureteral Catheters are sterile, single-use devices.
Indications for Use:
Ureteral catheters are indicated for access and catheterization of the urinary tract, including the following applications:
- · Delivery of contrast media
- · Drainage of fluids from the urinary tract
- · Delivery of irrigation fluids to the urinary tract
- Navigation of a tortuous ureter
- · Access, advancement, or exchange of wire guides (open-ended catheters only)
The Pediatric Ureteral Catheter is indicated for access and catheterization of the urinary tract in pediatric patients, including the following applications:
- Delivery of contrast media
- · Drainage of fluids from the urinary tract
- · Delivery of irrigation fluids to the urinary tract
- · Navigation of a tortuous ureter
Comparison to Predicate Devices:
The subject devices have similar indications for use, methods of operation, and fundamental technological characteristics as the predicate devices due to the similarities with their intended uses. Differences between the subject device and the predicate devices include dimensional variations and slight variations in materials. Characteristics of the subject device that differ from the predicate devices are supported by testing. These differences do not raise any new questions of safety and/or effectiveness. The substantial equivalence comparison of the subject device to the predicates is provided in the following table.
| | PRIMARY PREDICATE
DEVICE | SECONDARY
PREDICATE DEVICE | SUBJECT DEVICE |
|------------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | Bard - TigerTail Ureteral
Catheter | Porges Ureteral Catheters | Ureteral Catheters |
| 510(k)
Number | K033719 | K021856 | Subject of Submission |
| Manufacturer | C.R. Bard Inc. | Porges S.A. | Cook Incorporated |
| Regulation | 21 CFR §876.5130 | 21 CFR §876.5130 | Identical |
| Product Code | KOD | EYB | Identical to primary predicate |
| Classification
Name | Catheter, Urological | Catheter, Ureteral, Gastro-
Urology | Identical to primary predicate |
| Classification | II | Identical | Identical |
| Indications
for Use | The Bard TigerTail Ureteral
Catheter is intended to
facilitate drainage and
retrograde pyelogram of the | Ureteral catheterization:
-Drainage catheters
-Catheters for retrograde
ureteropyelography | Ureteral catheters are indicated for
access and catheterization of the
urinary tract, including the following
applications: |
Substantial Equivalence Comparison
5
| | PRIMARY PREDICATE
DEVICE | SECONDARY
PREDICATE DEVICE | SUBJECT DEVICE |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Bard - TigerTail Ureteral
Catheter | Porges Ureteral Catheters | Ureteral Catheters |
| | upper urinary tract. This
catheter will allow access to
and navigation of a tortuous
ureter using standard
endoscopic techniques. | -Interventional catheters | • Delivery of contrast media
• Drainage of fluids from the urinary
tract
• Delivery of irrigation fluids to the
urinary tract
• Navigation of a tortuous ureter
• Access, advancement, or exchange
of wire guides (open-ended catheters
only)
The Pediatric Ureteral Catheter is
indicated for access and
catheterization of the urinary tract in
pediatric patients, including the
following applications:
• Delivery of contrast media
• Drainage of fluids from the urinary
tract
• Delivery of irrigation fluids to the
urinary tract
• Navigation of a tortuous ureter |
| Catheter OD
(Fr size) | 4-6 Fr | 3-12 Fr | 3-9 Fr |
| Catheter
Length (cm) | 70 cm | Unknown | 10, 15, 70, 85, 120 |
| | Materials | | |
| Catheter
Material | Radiopaque Polyurethane | Radiopaque polymer-
polyvinyl chloride and
polyamide mixture | Radiopaque Polyvinyl chloride or
Polyurethane Radiopaque tubing or
Polytetrafluoroethylene |
| Components | The following components
may be included:
Adapter
Stylet/Wire | Unknown | Identical to primary predicate |
Reference Devices:
In addition to the predicate devices, the following reference devices are used to help make a determination of substantial equivalence:
- The Rutner Universal Wedge Catheter (Cook Inc., K760858) .
- The C-Flex Ureteral Stent Set (Cook Inc., K162104) ●
Performance Data:
The subject devices underwent the applicable testing listed below to ensure reliable design and performance under the testing parameters. Performance and biocompatibility
6
testing were conducted in accordance with the following applicable FDA guidance documents to confirm the reliable performance of critical device characteristics.
Performance - Testing shows that the subject device conforms to the performance testing requirements based on intended use. All predetermined acceptance criteria were met.
| Test Performed | Guidance Document |
|---|---|
| Tensile Strength – Testing shows that there should be no fracture of catheter tips or | |
| shafts during proper clinical use. | |
| Leakage and Lumen Blockage – Testing evaluated lumen blockage and leakage in a | |
| pressurized flow test. Lumen patency, dimensional length, inner diameter, and outer | |
| diameter were determined. | |
| Radiopacity – Testing shows that the mean radiopacity met the acceptance criteria and | |
| evaluated radiopacity by subjecting the ureteral catheters to a comparative fluoroscopic | |
| evaluation. | |
| Kink Radius – Testing determined the kink radius of the ureteral catheter tubing. | |
| Catheter-Hub Bond – Testing determined the tensile strength of the hub-to-shaft bond. |
Biocompatibility – Testing shows that the subject device conforms to the biocompatibility requirements based on its intended use. All predetermined acceptance criteria were met.
| Testing Performed | Guidance Document |
|---|---|
| Cytotoxicity – ISO MEM Elution | Use of International Standard |
| ISO 10993-1, "Biological | |
| evaluation of medical devices |
- Part 1: Evaluation and testing
within a risk management
process" |
| Sensitization – Guinea Pig Maximization | |
| Irritation/Intracutaneous Reactivity – Intracutaneous Study | |
All predetermined acceptance criteria were met.
Conclusion:
The data included in this submission indicate that the subject devices do not raise new questions of safety or effectiveness compared to the predicate device. This supports a determination of substantial equivalence.