(267 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a standard Foley catheter with a micro-patterned surface, with no mention of AI or ML.
No.
The device description and intended use clearly state that the device is for 'providing drainage of urine from the urinary tract', which is a supportive function, not a therapeutic one that treats a disease or condition.
No
This device is a Foley catheter, intended for providing drainage of urine. Its function is to facilitate the flow of urine out of the body, which is a therapeutic function, not a diagnostic one. While it can be used to monitor urine output (which might inform diagnosis), its primary role is drainage.
No
The device description clearly outlines a physical, hardware-based medical device (a Foley catheter) with specific dimensions, materials, and lumens for drainage and balloon inflation. The performance studies also focus on physical characteristics and biological interactions, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "providing drainage of urine from the urinary tract." This is a direct therapeutic or supportive function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical device (a catheter) designed for insertion into the urinary tract to facilitate drainage. It does not describe a test kit, reagent, instrument for analyzing samples, or anything used to diagnose a condition.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the catheter (flow rate, balloon integrity, friction, biocompatibility, etc.) and its interaction with the body (ovine study). They do not involve analyzing biological samples for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
This device is intended for providing drainage of urine from the urinary tract.
Product codes (comma separated list FDA assigned to the subject device)
EZL
Device Description
The Radiance™ Clear Sharklet® Silicone Foley is identified as a balloon retention type catheter and is supplied sterile for single-use. It is a two-way silicone Foley catheter manufactured in 14.0. 16.0 and 18.0 French sizes with an effective working length of 34 centimeters. One lumen is used for drainage and the other lumen for inflation and deflation of the balloon. Sterile media is used to inflate and deflate the balloon. The proximal end of the drainage lumen has a funnel for connection to a drainage collection device. The proximal end of the inflation lumen has a check valve for connection to a syringe for inflation. The distal end has two drainage eyes placed opposite each other which allow drainage. The shaft has the Sharklet® micro-pattern molded into the outer surface.
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
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 Radiance™ Clear Sharklet® Silicone Foley Catheter met applicable design and performance requirements in accordance with FDA recognized consensus standard ASTM F623-99, Standard Specification for Foley Catheters: Flow Rate through Drainage Lumen, Balloon Integrity, Inflated Balloon Response to Traction, Balloon Volume Maintenance, Dimensional Verification, Balloon Deflation Reliability.
The following testing, in addition to those in ASTM F623-99, was performed in order to support the safety of the catheter's micropattern:
- Friction Testing: Devices were pulled horizontally across a silicone surface and frictional forces were recorded to calculate a coefficient of kinetic friction. This was performed on a 2-way silicone Foley catheter control device as well as the Radiance Clear Sharklet® Silicone Foley Catheter and the results were compared. The coefficient of kinetic friction for the Radiance™ Clear Sharklet® Silicone Foley Catheter was less than the control.
- Ovine Study: The Radiance™ Clear Sharklet® Silicone Foley Catheter and a 2-way silicone Foley catheter control device were each placed in six sheep for an indwell time of one month. The sheep were subsequently euthanized, a necropsy performed, and tissues excised for gross evaluation and histological processing. A comparison of the data revealed similar responses between the tested devices. Additional accelerated aged performance testing, biocompatibility, and sterility testing were performed to demonstrate the subject device is appropriate for its intended use.
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
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August 23, 2018
Cook Incorporated Chelsea Woods Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47402
Re: K173657
Trade/Device Name: Radiance™ Clear Sharklet® Silicone Foley Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZL Dated: July 23, 2018 Received: July 24, 2018
Dear Chelsea Woods:
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. Although this letter refers to your product as a device, please be aware 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. 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
1
801); 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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173657
Device Name Radiance™ Clear Sharklet® Silicone Foley Catheter
Indications for Use (Describe)
This device is intended for providing drainage of urine from the urinary tract.
Type of Use (Select one or both, as applicable)
V Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the Cook Medical logo, which is a red square with the word "COOK" in white letters at the top and the word "MEDICAL" in white letters below. Below the logo is the text "2.0 510(k) Summary". The text is in black and is in a larger font size than the text in the logo.
COOK INCORPORATED DANIELS WAY, P.O.
Radiance™ Clear Sharklet® Silicone Foley Catheter 21 CFR §807.92 Date Prepared: August 23, 2018
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Primary Contact: | Chelsea Woods |
| Secondary Contact: | Andrew Breidenbach |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Primary Contact Phone: | (812) 339-2235 x104707 |
| Secondary Contact Phone: | (812) 339-2235 x105147 |
| Contact Fax: | (812) 332-0281 |
| Device Information: | |
| Trade Name: | Radiance™ Clear Sharklet® Silicone Foley |
| Catheter |
Common Name: Catheter, Retention Type, Balloon Classification Name: Urological Catheter and accessories Classification Regulation: 21 CFR 876.5130, Product Code EZL Device Class/Classification Panel: Class II, Gastroenterology/Urology
Predicate Device:
The predicate device is the Well Lead Silicone and Latex Foley Catheters cleared under 510(k) Premarket Notification number K082815.
Device Description:
The Radiance™ Clear Sharklet® Silicone Foley is identified as a balloon retention type catheter and is supplied sterile for single-use. It is a two-way silicone Foley catheter manufactured in 14.0. 16.0 and 18.0 French sizes with an effective working length of 34 centimeters. One lumen is used for drainage and the other lumen for inflation and deflation of the balloon. Sterile media is used to inflate and deflate the balloon. The proximal end of the drainage lumen has a funnel for connection to a drainage collection
4
Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif letters. Below "COOK" is the word "MEDICAL" in smaller, white letters, set on a red banner.
COOK INCORPORATED DANIELS WAY, P.O. BOX NGTON, IN 47402-0 WW.COOKMEDICAL.CO
device. The proximal end of the inflation lumen has a check valve for connection to a syringe for inflation. The distal end has two drainage eyes placed opposite each other which allow drainage. The shaft has the Sharklet® micro-pattern molded into the outer surface.
Indications for Use:
This device is intended for providing drainage of urine from the urinary tract.
Comparison to Predicate Device:
The subject device has similar indications for use, methods of operation, and fundamental technological characteristics as the predicate devices. Differences between the subject device and the predicate device include a difference in indications for use, surface modifications, and dimensions. Characteristics of the subject device that differ from the predicate device are supported by testing and analysis.
Performance Data:
The following testing was performed in order to demonstrate that the proposed Radiance™ Clear Sharklet® Silicone Foley Catheter met applicable design and performance requirements in accordance with FDA recognized consensus standard ASTM F623-99, Standard Specification for Foley Catheters.
- 트 Flow Rate through Drainage Lumen
- . Balloon Integrity
- Inflated Balloon Response to Traction ■
- 트 Balloon Volume Maintenance
- . Dimensional Verification
- 트 Balloon Deflation Reliability
The following testing, in addition to those in ASTM F623-99, was performed in order to support the safety of the catheter's micropattern:
- 트 Friction Testing: Devices were pulled horizontally across a silicone surface and frictional forces were recorded to calculate a coefficient of kinetic friction. This was performed on a 2-way silicone Foley catheter control device as well as the Radiance " Clear Sharklet® Silicone Foley Catheter and the results were
5
Image /page/5/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 the word "MEDICAL" is in a smaller, white, sans-serif font below the word "COOK".
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 OOMINGTON, IN 47402-0489 U.S.A. 12.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
compared. The coefficient of kinetic friction for the Radiance™ Clear Sharklet® Silicone Foley Catheter was less than the control.
- Ovine Study: The Radiance™ Clear Sharklet® Silicone Foley Catheter and a 2-. way silicone Foley catheter control device were each placed in six sheep for an indwell time of one month. The sheep were subsequently euthanized, a necropsy performed, and tissues excised for gross evaluation and histological processing.
A comparison of the data revealed similar responses between the tested devices. Additional accelerated aged performance testing, biocompatibility, and sterility testing were performed to demonstrate the subject device is appropriate for its intended use.
Conclusion:
The results of these tests provide reasonable assurance that the Radiance™ Clear Sharklet® Silicone Foley Catheter will function as intended. The subject device does not raise new questions of safety or effectiveness as compared to the predicate device.