(241 days)
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
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.
The provided text describes a 510(k) premarket notification for a family of ureteral catheters. It focuses on demonstrating substantial equivalence to predicate devices, primarily through performance and biocompatibility testing. However, it does not contain the information required to answer your specific questions regarding an AI/algorithm-based device and its acceptance criteria, such as a table of accuracy metrics, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance.
The document is for a traditional medical device (catheters) and not an AI/ML-driven diagnostic or assistive system. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering performance tests and biocompatibility, not AI performance metrics.
Specifically, the document states:
- Performance Testing: "Performance - Testing shows that the subject device conforms to the performance testing requirements based on intended use. All predetermined acceptance criteria were met." (Page 6)
- Biocompatibility Testing: "Biocompatibility – Testing shows that the subject device conforms to the biocompatibility requirements based on its intended use. All predetermined acceptance criteria were met." (Page 6)
The tests performed are typical for a physical medical device: Tensile Strength, Leakage and Lumen Blockage, Radiopacity, Kink Radius, Catheter-Hub Bond, Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity.
To directly answer your request based on the provided text, the following information is NOT available:
- A table of acceptance criteria and the reported device performance (for an AI/ML device): The document lists performance tests for a physical device, not AI performance metrics like sensitivity, specificity, or AUC.
- Sample size used for the test set and the data provenance: No information on test data, as it's a physical device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this type of device.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for physical ureteral catheters and does not contain any information about AI/ML device performance or the study design for such a device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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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
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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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Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, block letters, with the registered trademark symbol next to it. Below "COOK" is the word "MEDICAL" in white, block letters, set against a black background.
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.
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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 PREDICATEDEVICE | SECONDARYPREDICATE DEVICE | SUBJECT DEVICE | |
|---|---|---|---|
| Bard - TigerTail UreteralCatheter | 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 |
| ClassificationName | Catheter, Urological | Catheter, Ureteral, Gastro-Urology | Identical to primary predicate |
| Classification | II | Identical | Identical |
| Indicationsfor Use | The Bard TigerTail UreteralCatheter is intended tofacilitate drainage andretrograde pyelogram of the | Ureteral catheterization:-Drainage catheters-Catheters for retrogradeureteropyelography | Ureteral catheters are indicated foraccess and catheterization of theurinary tract, including the followingapplications: |
Substantial Equivalence Comparison
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| PRIMARY PREDICATEDEVICE | SECONDARYPREDICATE DEVICE | SUBJECT DEVICE | |
|---|---|---|---|
| Bard - TigerTail UreteralCatheter | Porges Ureteral Catheters | Ureteral Catheters | |
| upper urinary tract. Thiscatheter will allow access toand navigation of a tortuousureter using standardendoscopic techniques. | -Interventional catheters | • Delivery of contrast media• Drainage of fluids from the urinarytract• Delivery of irrigation fluids to theurinary tract• Navigation of a tortuous ureter• Access, advancement, or exchangeof wire guides (open-ended cathetersonly)The Pediatric Ureteral Catheter isindicated for access andcatheterization of the urinary tract inpediatric patients, including thefollowing applications:• Delivery of contrast media• Drainage of fluids from the urinarytract• Delivery of irrigation fluids to theurinary tract• Navigation of a tortuous ureter | |
| Catheter OD(Fr size) | 4-6 Fr | 3-12 Fr | 3-9 Fr |
| CatheterLength (cm) | 70 cm | Unknown | 10, 15, 70, 85, 120 |
| Materials | |||
| CatheterMaterial | Radiopaque Polyurethane | Radiopaque polymer-polyvinyl chloride andpolyamide mixture | Radiopaque Polyvinyl chloride orPolyurethane Radiopaque tubing orPolytetrafluoroethylene |
| Components | The following componentsmay be included:AdapterStylet/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
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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 orshafts during proper clinical use. | |
| Leakage and Lumen Blockage – Testing evaluated lumen blockage and leakage in apressurized flow test. Lumen patency, dimensional length, inner diameter, and outerdiameter were determined. | |
| Radiopacity – Testing shows that the mean radiopacity met the acceptance criteria andevaluated radiopacity by subjecting the ureteral catheters to a comparative fluoroscopicevaluation. | |
| 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 StandardISO 10993-1, "Biologicalevaluation of medical devices- Part 1: Evaluation and testingwithin a risk managementprocess" |
| 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.
§ 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.