(261 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the catheters, with no mention of AI or ML.
No.
The device descriptions and intended use indicate that these catheters are diagnostic tools used for retrograde pyelogram, which is an imaging procedure to examine the urinary tract. They are not designed to treat a medical condition.
Yes
The device is intended for "retrograde pyelogram," which is a diagnostic imaging procedure to visualize the ureters and renal pelvis.
No
The device description clearly details physical components made of materials like polyvinyl chloride and nylon, with specific dimensions and features like tips, shafts, adapters, and side ports. This indicates a hardware medical device, not a software-only one.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "retrograde pyelogram." This is a medical imaging procedure performed on a patient, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description details a catheter designed to be inserted into the ureter to facilitate the retrograde pyelogram procedure. This is a medical device used in vivo (within the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a tool used in a medical procedure.
N/A
Intended Use / Indications for Use
- The Cone Tip Ureteral Catheter is intended for retrograde pyelogram.
- The Rutner Universal Wedge Catheter is intended for retrograde pyelogram. The 4.0 Fr Rutner Universal Wedge Catheter is indicated for pediatric population 2 years and older.
Product codes (comma separated list FDA assigned to the subject device)
KOD
Device Description
Cone Tip Ureteral Catheter
The Cone Tip Ureteral Catheter is used for retrograde pyelogram. The product consists of a straight, tipped catheter. The distal tip is in a cone formation and intended to temporarily occlude the ureteral orifice. The catheter tip and tubing shaft are made of radiopaque polyvinyl chloride material. The catheter is available in outer diameters of 4.8 and 6.0 French with corresponding tip diameters of 8.0 and 10.0 French respectively. The total working length of the device measures 70 centimeters. All French sizes are available with a closed distal end, except the 4.8 French catheters which are also available with an open end. Catheters with closed distal ends include one side port near the tip, whereas catheters with open distal ends do not include a side port. The radiopaque vinyl tubing shaft has an adapter on the proximal end and incremental graduation marks placed along the distal 50 centimeters of the catheter surface.
Rutner Universal Wedge Catheter
The Rutner Universal Wedge Catheter is used for retrograde pyelogram. The distal tip is made of polyvinyl chloride radiopaque material and its configuration is designed to occlude the ureteral orifice and stabilize the catheter by temporarily wedging the orifice. The catheter tubing shaft is manufactured from non-radiopaque nylon with an adapter located at the proximal end. The catheter is available in outer diameters of 4.0 or 5.0 French and a total device length of 70 centimeters. The outer diameter of the tip is available in 8.0 and 14.0 French. Based upon the device size, the distal tip may occlude an opening of 3.0 to 8.0 French or 4.0 to 14.0 French, respectively. A single sideport is located in the distal end of the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteral orifice
Indicated Patient Age Range
The 4.0 Fr Rutner Universal Wedge Catheter is indicated for pediatric population 2 years and older.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Cone Tip Ureteral Catheter and the Rutner Universal Wedge Catheter were subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters:
- Biocompatibility
- Dimensional Verification
- Blockage And Leakage Testing
- Kink Radius Testing
- Tensile Testing
- Shelf Life (3 Years Accelerated Age)
Conclusion: The results of testing support a conclusion that the Cone Tip Ureteral Catheter and the Rutner Universal Wedge Catheter meet the design input requirements based on their intended uses. The testing also demonstrates that the minor differences in the subject devices do not raise new issues of safety or effectiveness and therefore support a determination of substantially equivalence to the predicate devices, the Rutner Universal Wedge Catheter (K760858) and Van-Tec Open Ended Cone Tip Ureteral Catheter (K870694).
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.
Not Found
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 7, 2018
Cook Incorporated Yan Li Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
Re: K171810
Trade/Device Name: Cone Tip Ureteral Catheter, Rutnersal Wedge Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: KOD Dated: January 31, 2018 Received: February 1, 2018
Dear Yan Li:
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.
1
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,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.
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) K171810
Device Name Cone Tip Ureteral Catheter
| Indications for Use (Describe) |
|---|
| The Cone Tip Ureteral Catheter is intended for retrograde pyelogram. |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information 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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K171810
Device Name Rutner Universal Wedge Catheter
Indications for Use (Describe)
The Rutner Universal Wedge Catheter is intended for retrograde pyelogram. The 4.0 Fr Rutner Universal Wedge Catheter is indicated for pediatric population 2 years and older.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information 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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
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Image /page/4/Picture/0 description: The image shows the Cook Medical logo, which is a red square with the word "COOK" in white letters. Below the logo, the words "MEDICAL" are written in white letters. Below the logo, the text "2.0 510(k) SUMMARY" is written in black letters. The logo is simple and professional, and the text is clear and easy to read.
Cone Tip Ureteral Catheter Rutner Universal Wedge Catheter 21 CFR §807.92 Date Prepared: March 5, 2018
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Yan Li |
| Karthik Pillai | |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812)335-3575x104987 |
| Contact Fax Number: | (812)332-0281 |
Device Information:
| Trade Names: | Cone Tip Ureteral Catheter
Rutner Universal Wedge Catheter |
|----------------------------|---------------------------------------------------------------|
| Common Name: | Urological Catheter |
| Classification Name: | Urological catheter and accessories |
| Device Class/Review Panel: | Class II, Gastroenterology/Urology |
| Regulation: | 21 CFR §876.5130 |
| Product Code: | KOD |
Predicate Devices:
Cone Tip Ureteral Catheter
- . Rutner Universal Wedge Catheter - Cook Incorporated, K760858
- Van-Tec Open Ended Cone Tip Ureteral Catheter (Boston Scientific Cone Tip Ureteral Catheter), K870694*
Rutner Universal Wedge Catheter
- Rutner Universal Wedge Catheter Cook Incorporated, K760858 .
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Image /page/5/Picture/1 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is written in white, sans-serif, capital letters in the top portion of the logo. Below that, the word "MEDICAL" is written in white, sans-serif, capital letters in a smaller font size.
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
- Van-Tec Open Ended Cone Tip Ureteral Catheter (Boston Scientific Cone Tip Ureteral ● Catheter). K870694*
- Note: Boston Scientific is the current owner of K870694 Van-Tec Open Ended Cone Tip Ureteral Catheter.
Device Description:
Cone Tip Ureteral Catheter ●
The Cone Tip Ureteral Catheter is used for retrograde pyelogram. The product consists of a straight, tipped catheter. The distal tip is in a cone formation and intended to temporarily occlude the ureteral orifice. The catheter tip and tubing shaft are made of radiopaque polyvinyl chloride material. The catheter is available in outer diameters of 4.8 and 6.0 French with corresponding tip diameters of 8.0 and 10.0 French respectively. The total working length of the device measures 70 centimeters. All French sizes are available with a closed distal end, except the 4.8 French catheters which are also available with an open end. Catheters with closed distal ends include one side port near the tip, whereas catheters with open distal ends do not include a side port. The radiopaque vinyl tubing shaft has an adapter on the proximal end and incremental graduation marks placed along the distal 50 centimeters of the catheter surface.
Rutner Universal Wedge Catheter ●
The Rutner Universal Wedge Catheter is used for retrograde pyelogram. The distal tip is made of polyvinyl chloride radiopaque material and its configuration is designed to occlude the ureteral orifice and stabilize the catheter by temporarily wedging the orifice. The catheter tubing shaft is manufactured from non-radiopaque nylon with an adapter located at the proximal end. The catheter is available in outer diameters of 4.0 or 5.0 French and a total device length of 70 centimeters. The outer diameter of the tip is available in 8.0 and 14.0 French. Based upon the device size, the distal tip may occlude an opening of 3.0 to 8.0 French or 4.0 to 14.0 French, respectively. A single sideport is located in the distal end of the catheter.
Indications for Use:
- . The Cone Tip Ureteral Catheter is intended for retrograde pyelogram.
- The Rutner Universal Wedge Catheter is intended for retrograde pyelogram. The 4.0 Fr . Rutner Universal Wedge Catheter is indicated for pediatric population 2 years and older.
6
Image /page/6/Picture/1 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background that is shaped like a banner.
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Comparison to Predicates:
The Cone Tip Ureteral Catheter and the predicate devices, the Rutner Universal Wedge Catheter (K760858) and Van-Tec Open Ended Cone Tip Ureteral Catheter (K870694) are substantially equivalent in that these devices share similar indications for use, materials, dimensions, designs, and technological characteristics.
The Rutner Universal Wedge Catheter and the predicate devices, the Rutner Universal Wedge Catheter (K760858) and Van-Tec Open Ended Cone Tip Ureteral Catheter (K870694), are substantially equivalent in that these devices share similar indications for use, materials, dimensions, designs, and technological characteristics.
While many characteristics are similar, there are minor differences between the subject devices and the predicate devices. These differences include updates to the indications for use, materials, and dimensions of the subject devices. The device modifications are supported by testing and do not raise new issues of safety or effectiveness of the subject device.
Performance Data:
The Cone Tip Ureteral Catheter and the Rutner Universal Wedge Catheter were subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters:
-
- Biocompatibility
-
- Dimensional Verification
-
- Blockage And Leakage Testing
-
- Kink Radius Testing
-
- Tensile Testing
-
- Shelf Life (3 Years Accelerated Age)
Conclusion:
The results of testing support a conclusion that the Cone Tip Ureteral Catheter and the Rutner Universal Wedge Catheter meet the design input requirements based on their intended uses. The testing also demonstrates that the minor differences in the subject devices do not raise new issues of safety or effectiveness and therefore support a determination of substantially equivalence to the predicate devices, the Rutner Universal Wedge Catheter (K760858) and Van-Tec Open Ended Cone Tip Ureteral Catheter (K870694).