(313 days)
Not Found
No
The description focuses on the physical components, materials, and performance characteristics of a ureteral stent set. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are related to material properties and physical function, not algorithmic performance.
No
The device is used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent post-E.S.W.L.. It is a delivery and retention device, rather than a device that provides therapy.
No
The device is primarily used for therapeutic purposes (retrograde injection and ureteral stenting) and does not inherently provide diagnostic information. While "fluoroscopic evaluation" is mentioned for placement, the device itself is not a diagnostic tool.
No
The device description clearly outlines multiple physical components made of materials like polyurethane and polyvinylchloride, and the performance studies focus on physical properties like retention strength, frictional force, radiopacity, and flow rate. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent. This is a therapeutic and procedural use within the body, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a physical implantable stent and associated insertion tools. It does not involve reagents, calibrators, control materials, or other components typically associated with IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is a medical device used in a surgical/procedural setting for treatment and drainage, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent post-E.S.W.L.
Product codes
FAD
Device Description
The Kwart Retro-Inject™ Stent Set is intended to be marketed as a set with multiple components. The set is comprised of a double pigtail ureteral stent with tether, inserter, release sleeve, wire guide, and an adapter. The stent is available as a specified length or a multi-length stent with or without hydrophilic coating. The specified lengths are 22, 24, 26, and 28 centimeters with outer diameters of 4.7, 6, and 7 French. The multi-length stent offers a range of 22-32 centimeters with outer diameters of 4.7, 6, 7, and 8.2 French. Both specified and multi-length stents have drainage holes along the kidney loop, and continuing along the stent body extending from the kidney. However, the bladder pigtail and 15 centimeters of the stent body extending from the bladder loop do not have drainage holes. The bladder pigtail has a polyethylene terephthalate tether attached. In addition, both stent types are constructed of radiopaque polyurethane elastomer and have radiopaque ink marks to aid in stent placement. The stents accept either a 0.035 or a 0.038 inch wire guide.
The inserter is made of radiopaque polyurethane and has radiopaque ink markers. The inserter is available in outer diameters of 4.5, 5, or 6 French with a 70 centimeter working length. The inserter accepts a 0.038 inch wire guide. A female luer lock to connector cap adapter may be attached on the inserter to provide injection. The release sleeve is made of radiopaque plasticized polyvinylchloride. The release sleeve has an 8 or 10 French outer diameter and a 38 centimeter working length.
The set will be supplied sterile and is intended for one-time use. The set is 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
ureteral
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
- Retention Strength and Break Strength
- Dynamic Frictional Force Testing
- Radiopacity - Testing assessed the radiopacity of the Kwart Retro-Inject Stent" by subjecting it to a comparative fluoroscopic evaluation.
- Gravity Flow Rate - Testing characterized the gravity flow rate of the Kwart Retro-Inject™ Stents.
- Magnetic Resonance (MR) – Testing shows that the proposed device is MR conditional based on defined, tested conditions.
- Biocompatibility - Testing shows that the proposed device conforms with the biocompatibility requirements based on its intended use.
All predetermined acceptance criteria for Retention Strength and Break Strength, Magnetic Resonance (MR), and Biocompatibility testing were met.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. In the center of the seal is an abstract image of an eagle with three heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2017
Cook Incorporated Carly Powell Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K162109
Trade/Device Name: Kwart Retro-Inject™ Stent Set Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: Mav 24, 2017 Received: May 25, 2017
Dear Carly Powell:
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Kwart Retro-Inject™ Stent Set
Indications for Use (Describe)
Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent post-E.S.W.L.
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)
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
Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, block letters. Below the word "COOK" is the word "MEDICAL" in smaller, white letters.
2.0 510(k) Summary
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA NE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Kwart Retro-Inject™ Stent Set 21 CFR §807.92 Date Prepared: June 6, 2017
Submitted By:
Submission: Applicant: Registration Number: Contact: Applicant Address:
Contact Phone: Contact Fax:
Device Information:
Trade Name: Common Name: Classification Name: Classification Regulation: Device Class/Classification Panel:
Predicate Device:
Traditional 510(k) Premarket Notification Cook Incorporated 1820334 Carly Powell Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 339-2235 x104913 (812) 332-0281
Kwart Retro-Inject™ Stent Set
Stent, Ureteral Ureteral Stent 21 CFR §876.4620, Product Code FAD Class II, Gastroenterology/Urology
The primary predicate device is the Contour™ and Contour VL™ Injection Ureteral Stent Set cleared under 510(k) K010002. The secondary predicate device is the Boston Scientific Hydrogel Coated Percuflex Drainage Catheter cleared under K924608.
Device Description:
The Kwart Retro-Inject™ Stent Set is intended to be marketed as a set with multiple components. The set is comprised of a double pigtail ureteral stent with tether, inserter, release sleeve, wire guide, and an adapter. The stent is available as a specified length or a multi-length stent with or without hydrophilic coating. The specified lengths are 22, 24, 26, and 28 centimeters with outer diameters of 4.7, 6, and 7 French. The multi-length stent offers a range of 22-32 centimeters with outer diameters of 4.7, 6, 7, and 8.2 French. Both specified and multi-length stents have drainage holes along the kidney loop, and continuing along the stent body extending from the kidney. However, the bladder pigtail and 15 centimeters of the stent body extending from the bladder loop do not have drainage holes. The bladder pigtail has a polyethylene terephthalate tether attached. In addition, both stent types are constructed of radiopaque polyurethane elastomer and
4
Image /page/4/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, sans-serif font, stacked on top of the word "MEDICAL" in a smaller, sans-serif font, also in white. The words are set against a red background, with the word "MEDICAL" appearing on a diagonal banner.
have radiopaque ink marks to aid in stent placement. The stents accept either a 0.035 or a 0.038 inch wire guide.
The inserter is made of radiopaque polyurethane and has radiopaque ink markers. The inserter is available in outer diameters of 4.5, 5, or 6 French with a 70 centimeter working length. The inserter accepts a 0.038 inch wire guide. A female luer lock to connector cap adapter may be attached on the inserter to provide injection. The release sleeve is made of radiopaque plasticized polyvinylchloride. The release sleeve has an 8 or 10 French outer diameter and a 38 centimeter working length.
The set will be supplied sterile and is intended for one-time use. The set is packaged in a peelopen pouch with a three-year shelf-life.
Indications for Use:
The device is used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent post- E.S.W.L.
Comparison to Predicate Device:
The proposed device has similar indications for use, methods of operation, and fundamental technological characteristics as the predicate device. Differences between the proposed device and the predicate devices include indwell time, design specifications, and materials. Characteristics of the proposed device that differ from the predicate devices are supported by testing.
Performance Data:
The following testing was performed in order to demonstrate that the proposed Kwart Retro-Inject™ Stent Set met applicable design and performance requirements.
- Retention Strength and Break Strength Retention strength testing shows the curl 트 retention during proper clinical use should retain the Kwart Retro-Inject™ Stents within the intended anatomy. Testing also shows the curl retention strength must allow for removal of the Kwart Retro-Inject™ Stents from the intended anatomy. Break strength testing evaluates the tensile forces to break the curl and shaft of the Kwart Retro-Inject™ Stents. Additional retention strength and break strength testing was conducted following a 30-day artificial urine soak and after accelerated aging to the real-time equivalent of three years both with and without a 30-day urine soak. All predetermined acceptance criteria were met.
- Dynamic Frictional Force Testing characterized the dynamic frictional force acting on ■ the outer surface of the Kwart Retro-Inject" Stents. The evaluation included the dynamic
5
Image /page/5/Picture/1 description: The image shows the 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 on a dark red background.
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
frictional force testing of both the hydrophilically coated stents and the uncoated stents at time zero and after accelerated aging to the real-time equivalent of three years.
- . Radiopacity- Testing assessed the radiopacity of the Kwart Retro-Inject Stent" by subjecting it to a comparative fluoroscopic evaluation. Testing was conducted on the stents at time zero.
- Gravity Flow Rate - Testing characterized the gravity flow rate of the Kwart Retro-Inject™ Stents. The evaluation was conducted on the stents at time zero.
- 트 Magnetic Resonance (MR) – Testing shows that the proposed device is MR conditional based on defined, tested conditions. All predetermined acceptance criteria were met.
- 트 Biocompatibility - Testing shows that the proposed device conforms with the biocompatibility requirements based on its intended use. All predetermined acceptance criteria were met.
Conclusion:
The results of these tests provide reasonable assurance that the Kwart Retro-Inject™ Stent Set will perform as intended. The proposed device does not raise new questions of safety or effectiveness as compared to the predicate devices.