(260 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 is described as an access catheter for delivery of contrast media and for access, advancement, or exchange of wire guides, not for treating a disease or condition.
No
The device descriptions and intended use clearly state that these are access catheters used for delivery of contrast media, navigation, and access/exchange of wire guides in the renal and urinary tracts. These are interventional tools, not diagnostic devices that provide information about the presence or absence of a disease or condition.
No
The device description clearly details physical components like tubing, connectors, and braided wire, indicating it is a hardware medical device, not software-only.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for delivery of contrast media, access, advancement, and exchange of wire guides within the renal area and urinary tract. These are all procedures performed in vivo (within the living body).
- Device Description: The description details a physical catheter designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) on biological samples. This device is clearly designed for in vivo procedures.
N/A
Intended Use / Indications for Use
Renal Access Cobra Catheter
This device is intended for delivery of contrast media as well as access, advancement, or exchange of wire guides in the renal area.
Kumpe Access Catheter
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 Renal Access Cobra Catheter is used in the delivery of contrast media as well as access, advancement, or exchange of wire guides in the renal area. The catheter consists of tubing with a proximal connector cap and a winged female Luer lock adapter. The catheter has a total length of 65 cm and an outer diameter of 6.0 French. The catheter tubing is composed of a polymer reinforced with braided wire. The distal end of the catheter has a hook shaped curve. The tubing French size and compatible wire guide size are printed on one side of the winged female Luer lock adapter; on the other side is the name of the manufacturer.
The Kumpe Access Catheter is used in the urinary tract for the delivery of contrast media, navigation of a tortuous ureter, and access, advance, or exchange of wire guides. The catheter consists of tubing with a proximal cap and female Luer lock adapter. The catheter has a total length of 65 cm and an outer diameter of 5.0 French. The catheter tubing is composed of a polymer reinforced with braided wire. The distal tubing configuration is angled at approximately 45 degrees. The tubing French size, compatible wire guide size, and manufacturer are printed on the cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
renal area; urinary tract
Indicated Patient Age Range
Not Found
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 following testing was performed in order to demonstrate that the proposed Renal Access Cobra Catheter and Kumpe Access Catheter met applicable design and performance requirements.
- Dimensional and Compatibility Testing
- Radiopacity Testing
- Kink Radius Testing
- Blockage and Leakage Testing
- Tensile Testing
- Biocompatibility Testing
- Environmental Testing
- Sterilization Testing
- Accelerated Age Testing
The results of these tests support a conclusion that the Renal Access Cobra Catheter and Kumpe Access Catheter will perform as intended. The subject devices do not raise new questions of safety or effectiveness as 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.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
February 16, 2018
Cook Incorporated Samuel Engelman Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K171600
Trade/Device Name: Renal Access Cobra Catheter, Kumpe Access Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: KOD Dated: January 10, 2018 Received: January 11, 2018
Dear Samuel Engelman:
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,
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Renal Access Cobra Catheter
Indications for Use (Describe)
This device is intended for delivery of contrast media as well as access, advancement, or exchange of wire guides in the renal area.
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: | January 31, 2017 |
| See PRA Statement below. |
3
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.
3
510(k) Number (if known)
K171600
Device Name Kumpe Access 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)
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 reqarding 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 Druq 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."
4
Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif letters at the top. Below "COOK" is a smaller rectangle, also in red, with the word "MEDICAL" written in white, sans-serif letters.
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON, IN 47404 USA
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
K171600 Page 1 of 4
2.0 510(k) Summary
Renal Access Cobra Catheter and Kumpe Access Catheter 21 CFR §807.92 Date Prepared: May 31, 2017
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Samuel Engelman |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone: | (812) 335-3575 x104340 |
| Contact Fax: | (812) 332-0281 |
| Device Information: | |
| Trade Name: | Renal Access Cobra Catheter |
| Kumpe Access Catheter | |
| Common Name: | Urological Catheter |
Classification Name: Classification Regulation: Device Class/Classification Panel:
Urological Catheter and Accessories 21 CFR §876.5130, Product Code KOD Class II, Gastroenterology/Urology
Predicate Device:
Imager™ II Catheter (K102527)
Subject Device Descriptions:
The Renal Access Cobra Catheter is used in the delivery of contrast media as well as access, advancement, or exchange of wire guides in the renal area. The catheter consists of tubing with a proximal connector cap and a winged female Luer lock adapter. The catheter has a total length of 65 cm and an outer diameter of 6.0 French. The catheter tubing is composed of a polymer reinforced with braided wire. The distal end of the catheter has a hook shaped curve. The tubing French size and compatible wire guide size are printed on one side of the winged female Luer lock adapter; on the other side is the name of the manufacturer.
The Kumpe Access Catheter is used in the urinary tract for the delivery of contrast media, navigation of a tortuous ureter, and access, advance, or exchange of wire guides. The
5
Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a red background that is slightly darker than the background for the word "COOK".
K171600 Page 2 of 4
catheter consists of tubing with a proximal cap and female Luer lock adapter. The catheter has a total length of 65 cm and an outer diameter of 5.0 French. The catheter tubing is composed of a polymer reinforced with braided wire. The distal tubing configuration is angled at approximately 45 degrees. The tubing French size, compatible wire guide size, and manufacturer are printed on the cap.
Indications for Use:
Renal Access Cobra Catheter
This device is intended for delivery of contrast media as well as access, advancement, or exchange of wire guides in the renal area.
Kumpe Access Catheter
These devices are intended for access and catheterization of the urinary tract, including the following applications:
- Delivery of contrast media
- o Navigation of a tortuous ureter
- o Access, advancement, or exchange of wire guides
Comparison to Predicate Device:
The subject devices have similar indications for use, methods of operation, and fundamental technological characteristics as the predicate device. Differences between the subject devices and the predicate device include a difference in indications, dimensional variations, and materials. Characteristics of the subject devices that differ from the predicate device are supported by testing and analysis.
| PREDICATE DEVICE | SUBJECT DEVICE | SUBJECT DEVICE | |
|---|---|---|---|
| Imager ™ II Catheter | Renal Access Cobra | ||
| Catheter | Kumpe Access | ||
| Catheter | |||
| 510(k) Number | K102527 | Subject of Submission | Subject of Submission |
| Manufacturer | Boston Scientific | Cook Incorporated | Cook Incorporated |
| Regulation | |||
| Number | 21 CFR §876.5130 | Identical | Identical |
| Product Code | KOD | Identical | Identical |
| Classification | |||
| Name | Urological Catheter | Identical | Identical |
| Device Class | Class II | Identical | Identical |
| PREDICATE DEVICE | SUBJECT DEVICE | SUBJECT DEVICE | |
| Imager ™ II Catheter | Renal Access Cobra | ||
| Catheter | Kumpe Access | ||
| Catheter | |||
| Indications for | |||
| Use | The Imager™ II Urology | ||
| Torque Catheter is | |||
| indicated for use in | |||
| facilitating access to | |||
| the urinary tract, either | |||
| through a retrograde or | |||
| antegrade route, and may | |||
| be used in | |||
| conjunction with a | |||
| guidewire or for the | |||
| infusion of radiopaque | |||
| contrast material. The | |||
| Imager™ II Urology | |||
| Torque Catheter is also | |||
| indicated for the infusion | |||
| of gels, such | |||
| as BackStop™, intended | |||
| for use in the urinary | |||
| tract. | This device is intended for | ||
| delivery of contrast media as | |||
| well as access, advancement, | |||
| or exchange of wire guides in | |||
| the renal area. | 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 | |||
| Sterilization | Unknown | Ethylene Oxide | Ethylene Oxide |
| Single Use | |||
| Device | Yes | Identical | Identical |
| Packaging | Unknown | Tyvek-Polyethylene | |
| peel-open pouch | Tyvek-Polyethylene | ||
| peel-open pouch | |||
| Shelf Life | Unknown | 3 Years | 3 Years |
| Catheter Specifications | |||
| Distal Tubing | |||
| Design | Straight, Angled, Hook | Hook | Angled |
| Radiopacity | Radiopaque | Identical | Identical |
| Proximal | |||
| Adapter | Luer Lock Hub | Identical | Identical |
| Catheter Dimensions | |||
| Catheter | |||
| Diameter (Fr) | 5.0 | 6.0 | 5.0 |
| Catheter | |||
| Length (cm) | 40, 65, 100 | 65 | 65 |
| Catheter Materials | |||
| Tubing | Polymer Reinforced with | ||
| Stainless Steel Braided | |||
| Wire | Identical | Identical |
Substantial Equivalence Table
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Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red square. Below the word "COOK" is the word "MEDICAL" in white, block letters on a smaller red rectangle.
Substantial Equivalence Table – Continued
Differences between the characteristics of the subject device sets and the predicate devices are supported by testing.
K171600 Page 3 of 4
б
7
Image /page/7/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, bold, sans-serif font in the upper portion of the logo. Below "COOK" is the word "MEDICAL" in a smaller, white, bold, sans-serif font.
Performance Data:
The following testing was performed in order to demonstrate that the proposed Renal Access Cobra Catheter and Kumpe Access Catheter met applicable design and performance requirements.
- Dimensional and Compatibility Testing ●
- Radiopacity Testing ●
- Kink Radius Testing ●
- Blockage and Leakage Testing
- Tensile Testing
- o Biocompatibility Testing
- o Environmental Testing
- o Sterilization Testing
- o Accelerated Age Testing
Conclusion:
The results of these tests support a conclusion that the Renal Access Cobra Catheter and Kumpe Access Catheter will perform as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate device.