(117 days)
Not Found
No
The device description focuses on the physical construction and materials of the stents, and there is no mention of AI, ML, or related concepts in the summary.
Yes
Explanation: The device is used for "stenting the urethra during hypospadias repair and to allow postoperative drainage of the bladder," which are therapeutic interventions.
No
This device is a stent used for drainage and support after surgery, which is a therapeutic function, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions.
No
The device description clearly details physical components made of silicone and C-Flex tubing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for stenting the urethra and allowing postoperative drainage of the bladder. This is a therapeutic and drainage function performed in vivo (within the body).
- Device Description: The device is a physical stent made of silicone or C-Flex tubing, designed to be inserted into the urethra.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo for a structural and drainage purpose.
N/A
Intended Use / Indications for Use
This device is used for stenting the urethra during hypospadias repair and to allow postoperative drainage of the bladder in infants (29 days to less than 2 years old) and children (2 years old to less than 12 years old).
Product codes
GBM
Device Description
The Firlit-Kluge Urethral Stent is constructed out of silicone tubing and a silicone ball. The stent tubing comes in both 8 French (Fr) and 10 French (Fr). The ball is located between the distal and proximal end of the stent tubing. The 8 Fr stent comes in lengths of 31, 40, and 50 cm. The 10 Fr stent comes in lengths of 31 and 50 cm.
The Firlit-Kluge Urethral Stent has one variation with additional sideports. This catalogue number has 8 Fr tubing and a length of 31cm. There are a total of 40 sideports.
The Koyle Diaper Stent is constructed of C-Flex tubing and C-Flex suture funnel. The tubing is 50 cm in length and is available in diameters of 6 and 10 Fr. The tubing has four or eight distal sideports. The distal tip is open and rounded smooth; the proximal end is open. The suture funnel is bonded in between the distal and proximal tip. One version of the 6 Fr stent has ink marks from the distal tip to the suture funnel.
The Zaontz Urethral Stent is constructed from C-Flex tubing. The stent has two drainage sideports placed opposite of each other at the distal tip. The stent's proximal tip is flared and has four sideports. The stent is available in 6, 8, and 10 Fr diameter sizes and the length is 12 cm.
The devices will be supplied sterile and are intended for one-time use. The subject devices are packaged in a peel-open pouch with a three-year shelf life.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder
Indicated Patient Age Range
infants (29 days to less than 2 years old) and children (2 years old to less than 12 years old).
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 Firlit-Kluge Urethral Stent, Koyle Diaper Stent, and Zaontz Urethral Stent met applicable design and performance requirements.
- Biocompatibility
- Sterilization Testing
- Packaging Testing
- Dimensional Verification Testing
- Tensile Testing
- Flow Rate Testing
- Accelerated Age Testing
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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".
November 22, 2017
Cook Incorporated Samuel Engelman Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K172278
Trade/Device Name: Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: October 19, 2017 Received: October 20, 2017
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,
Joyce M. Whang -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)
Device Name Firlit-Kluge Urethral Stent
Indications for Use (Describe)
This device is used for stenting the urethra during hypospadias repair and to allow postoperative drainage of the bladder in infants (29 days to less than 2 years old) and children (2 years old to less than 12 years old).
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)
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 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
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172278
Device Name Koyle Diaper Stent
Indications for Use (Describe)
This device is used for stenting the urethra during hypospadias repair and to allow postoperative drainage of the bladder in infants (29 days to less than 2 years old) and children (2 years old to less than 12 years old).
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."
EF
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Zaontz Urethral Stent
Indications for Use (Describe)
This device is used for stenting the urethra during hypospadias repair and to allow postoperative drainaee of the bladder in infants (29 days to less than 2 years old) and children (2 years old to less than 12 years old).
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)
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.
5
6
Image /page/6/Picture/1 description: The image shows the Cook Medical logo, which is a red square with the word "COOK" in white letters on the top line and the word "MEDICAL" in white letters on the second line. Below the logo is the text "2.0 510(k) Summary" in bold font. The text is likely a heading or title for a document or section of a document.
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, and Zaontz Urethral Stent 21 CFR §807.92 Date Prepared: November 22, 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) 339-2235 x104340 |
| Contact Fax: | (812) 332-0281 |
| Device Information: | |
| Trade Name: | Firlit-Kluge Urethral Stent |
| Koyle Diaper Stent | |
| Zaontz Urethral Stent | |
| Common Name: | Catheter, Urethral |
| Classification Name: | Urological catheter and accessories |
| Classification Regulation: | 21 CFR §876.5130, Product Code GBM |
Predicate Device:
Device Class/Classification Panel:
The predicate devices are the VPI-Fair Urethral Stent cleared under 510(k) K820313 and the Disposable Silicone Foley Catheter cleared under K130908.
Class II, Gastroenterology/Urology
Device Description:
The Firlit-Kluge Urethral Stent is constructed out of silicone tubing and a silicone ball. The stent tubing comes in both 8 French (Fr) and 10 French (Fr). The ball is located between the distal and proximal end of the stent tubing. The 8 Fr stent comes in lengths of 31, 40, and 50 cm. The 10 Fr stent comes in lengths of 31 and 50 cm.
The Firlit-Kluge Urethral Stent has one variation with additional sideports. This catalogue number has 8 Fr tubing and a length of 31cm. There are a total of 40 sideports.
7
Image /page/7/Picture/1 description: The image is a logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font, also on a red background. The word "MEDICAL" is positioned on a diagonal red block.
COOK INCORPORATED 50 DANIELS WAY, P.O. BOX 489 MINGTON IN 47402-0489 II S 2 339 2235 TOULEREE 800 457 4500 WW.COOKMEDICAL.COM
The Koyle Diaper Stent is constructed of C-Flex tubing and C-Flex suture funnel. The tubing is 50 cm in length and is available in diameters of 6 and 10 Fr. The tubing has four or eight distal sideports. The distal tip is open and rounded smooth; the proximal end is open. The suture funnel is bonded in between the distal and proximal tip. One version of the 6 Fr stent has ink marks from the distal tip to the suture funnel.
The Zaontz Urethral Stent is constructed from C-Flex tubing. The stent has two drainage sideports placed opposite of each other at the distal tip. The stent's proximal tip is flared and has four sideports. The stent is available in 6, 8, and 10 Fr diameter sizes and the length is 12 cm.
The devices will be supplied sterile and are intended for one-time use. The subject devices are packaged in a peel-open pouch with a three-year shelf life.
Indications for Use:
This device is used for stenting the urethra during hypospadias or epispadias repair and to allow postoperative drainage of the bladder in infants (29 days to less than 2 years old) and children (2 years old to less than 12 years old).
Comparison to Predicate Device:
The subject devices have similar indications for use, methods of operation, and fundamental technological characteristics as the predicate devices. Differences between the subject devices and the predicate devices are the indications for use, dimensional variations, sideports, and materials. Characteristics of the subject devices that differ from the predicate devices are supported by testing and analysis.
Performance Data:
The following testing was performed in order to demonstrate that the Firlit-Kluge Urethral Stent, Koyle Diaper Stent, and Zaontz Urethral Stent met applicable design and performance requirements.
- . Biocompatibility
8
K172278 Page 3 of 3
Image /page/8/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.
cook incorporated 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
- Sterilization Testing '
- Packaging Testing "
- 트 Dimensional Verification Testing
- Tensile Testing ■
- Flow Rate Testing 트
- 트 Accelerated Age Testing
Conclusion:
The results of these tests provide reasonable assurance that the Firlit-Kluge Urethral Stent, Koyle Diaper Stent, and Zaontz Urethral Stent will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate devices.