(234 days)
Not Found
No
The device description and performance studies focus solely on the physical characteristics and mechanical performance of a ureteral access catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an access catheter for injection of contrast medium and/or safety wire guide placement, not for treating a disease or condition.
No
Explanation: The device is described as an access catheter intended "for injection of contrast medium and/or safety wire guide placement." Its function is interventional (providing access for other procedures), not diagnostic.
No
The device description clearly details a physical catheter made of polyurethane tubing with lumens, ink marks, and a manifold. It also mentions sterilization and packaging, indicating a tangible hardware device.
No, 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 (in vitro).
- Device Function: The description clearly states the device is a "Dual Lumen Ureteral Access Catheter" intended for "injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access." This is a device used within the body for a medical procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, reagents, or laboratory testing.
This device is a medical device used for a procedural purpose within the urinary tract.
N/A
Intended Use / Indications for Use
This device is intended for injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access. The catheters that are 24 cm in length can be used in pediatric patients 12 years and over.
Product codes
EYB
Device Description
The Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter has a working length of 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and create a 5.0 Fr tip with the other lumen. This device is manufactured both with and without a hydrophilic coating.
The Flexi-Tip® Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter is available in lengths of 24, 40, and 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and a flexible polyurethane tip is bonded to the tip of the other lumen. The Flexi-Tip® Dual Lumen Ureteral Access Catheter is available with hydrophilic coating and a radiopaque urethane tungsten marker. The Dual Lumen Ureteral Access Catheter and the Flex-Tip® Dual Lumen Ureteral Access catheters are sterilized by ethylene oxide and are packaged in peel-open pouches for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ureteral
Indicated Patient Age Range
The catheters that are 24 cm in length can be used in pediatric patients 12 years and over.
Adult, and Pediatric 12 years and over
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
The following testing was performed in order to demonstrate that the proposed Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter met applicable design and performance requirements.
- Biocompatibility
- Sterilization
- Dimensional
- Lumen Patency
- Blockage and Leakage
- Radiopacity
- Kinking
- Dynamic Friction Force
- Tensile
- Accelerated Age
The results of these tests provide reasonable assurance that the Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 14, 2018
Cook Incorporated Samuel Engelman Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K180182
Trade/Device Name: Dual Lumen Ureteral Access Catheter, Flexi-Tip® Dual Lumen Ureteral Access Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EYB Dated: August 13, 2018 Received: August 14, 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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,
Glenn B. Bell -S 2018.09.14 10:17:38 -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
2
Indications for Use
510(k) Number (if known) K180182
Device Name
Dual Lumen Ureteral Access Catheter Flexi-tip® Dual Lumen Ureteral Access Catheter
Indications for Use (Describe)
This device is intended for injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access. The catheters that are 24 cm in length can be used in pediatric patients 12 years and over.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K180182 Page 1 of 4
1
Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter 21 CFR §876.5130 Date Prepared: September 13, 2018
Submitted By:
Submission: Applicant: Primary Contact: Applicant Address:
Primary Contact Phone: Contact Fax:
Device Information:
Trade Name:
Common Name: Classification Name: Regulation Number: Product Code: Device Class: Review Panel:
Predicate Device:
Traditional 510(k) Premarket Notification Cook Incorporated Karthik Pillai, Ph.D. Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 339-2235 x104929 (812) 332-0281
Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter Catheter, Ureteral, Gastro-Urology Urological catheter and accessories 21 CFR §876.5130 EYB Class II Gastroenterology/Urology
The predicate device is ACMI Corporation's Dual Lumen Catheter cleared under 510(k) Premarket Notification number K043581.
Device Description:
The Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter has a working length of 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and create a 5.0 Fr tip with the other lumen. This device is manufactured both with and without a hydrophilic coating.
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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 in large, white, sans-serif font, and below it is the word "MEDICAL" in a smaller, white, sans-serif font.
K180182 Page 2 of 4
2
The Flexi-Tip® Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter is available in lengths of 24, 40, and 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and a flexible polyurethane tip is bonded to the tip of the other lumen. The Flexi-Tip® Dual Lumen Ureteral Access Catheter is available with hydrophilic coating and a radiopaque urethane tungsten marker. The Dual Lumen Ureteral Access Catheter and the Flex-Tip® Dual Lumen Ureteral Access catheters are sterilized by ethylene oxide and are packaged in peel-open pouches for single use.
Indications for Use:
This device is intended for injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access. The catheters that are 24 cm and 40 cm in length can be used in pediatric patients 12 years and over.
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 for use, patient population, dimensions, and materials. Characteristics of the subject devices that differ from the predicate device are supported by testing and analysis.
| Predicate Device | Subject Device | |
|---|---|---|
| Dual Lumen Catheter | Dual Lumen Ureteral Access Catheter | |
| and Flexi-Tip® Dual Lumen Ureteral | ||
| Access Catheter | ||
| 510(k) Number | K043581 | K180182 |
| Manufacturer | ACMI Corporation (acquired by | |
| Olympus) | Cook Incorporated | |
| Regulation | ||
| Number | 21 CFR §876.5130 Urological catheter | |
| and accessories. | Identical | |
| Product | ||
| Code | EYB | Identical |
| Classification | ||
| Name | Urological catheter and accessories | Identical |
| Device Class | II | II |
| Indications for | ||
| Use | The dual lumen ureteral catheter is | |
| designed for percutaneous and | This device is intended for injection of | |
| contrast medium and/or safety wire guide |
5
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA 9.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Radiopaque Polyurethane Tubing
Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font in the upper portion of the logo. Below "COOK" is the word "MEDICAL" in white, bold, sans-serif font.
| Predicate Device | Subject Device | |
|---|---|---|
| Dual Lumen Catheter | Dual Lumen Ureteral Access Catheter | |
| and Flexi-Tip® Dual Lumen Ureteral | ||
| Access Catheter | ||
| transurethral access and is indicated as a | ||
| conduit for multiple uses including, but | ||
| not limited to, ureteral dilation, stone | ||
| displacement, delivery of contrast | ||
| material/anesthetic agents and guidewire | ||
| placement. | placement during percutaneous and | |
| transurethral access. The catheters that | ||
| are 24 cm and 40 cm in length can be | ||
| used in pediatric patients 12 years and | ||
| over. | ||
| Patient | ||
| Population | Unknown | Adult, and Pediatric 12 years and over |
| Single- Use | ||
| Only | Single- Use Only | Identical |
| Sterile | Yes | Yes |
| Sterilization | ||
| Method | Not known | Ethylene Oxide |
| Flexible Tip | Yes | Available |
| Catheter Tip | ||
| Diameter (Fr) | 6.0 | 5.0, 6.0 |
| Catheter | ||
| Lumens | Two | Two |
| Lumen size | ||
| (in) | .045 | .050 |
| Catheter | ||
| Diameter (Fr) | 10.0 | 10.0 |
| Working | ||
| Length (cm) | 60 | 24, 40, 50 |
| Radiopacity | Radiopaque Catheter | Radiopaque Catheter Shaft, Flexible Tip |
| and Marker | ||
| Materials | ||
| Hydrophilic | ||
| Coating | Not known | Available (Surmodics) |
Performance Data:
Catheter
Material
The following testing was performed in order to demonstrate that the proposed Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter met applicable design and performance requirements.
Radiopaque Polyethylene Tubing
- Biocompatibility
- י Sterilization
- Dimensional
- Lumen Patency '
3
6
Image /page/6/Picture/0 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.
K180182 Page 4 of 4
- ব
- Blockage and Leakage .
- Radiopacity
- I Kinking
- Dynamic Friction Force .
- Tensile ■
- " Accelerated Age
Conclusion:
The results of these tests provide reasonable assurance that the Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate device.