(267 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a medical stent and its components, with no mention of AI or ML.
Yes
The device is used to establish temporary internal drainage, which is a therapeutic intervention following a renal transplant.
No
Explanation: The device description and intended use clearly state that the Greene Renal Transplant Stent Set is used to establish temporary internal drainage, which is a therapeutic function, not a diagnostic one. It does not mention analyzing or interpreting any data for diagnostic purposes.
No
The device description clearly states it is comprised of physical components like a silicone stent, ureteral catheter, stent positioner, and wire guide, and the performance studies focus on physical properties and tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish temporary internal drainage from the ureteropelvic junction to the bladder" following renal transplant. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is a stent set designed to be placed within the body to facilitate drainage. This is an invasive medical device, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical (drainage).
IVD devices are used in vitro (outside the body) to examine specimens for diagnostic purposes. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Greene Renal Transplant Stent Set is used to establish temporary internal drainage from the ureteropelvic junction to the bladder. It is indicated for use following renal transplant.
Product codes
FAD
Device Description
The Greene Renal Transplant Stent Set is sterile, single-use device. The Greene Renal Transplant Stent Set is comprised of a double pigtail multi-length silicone stent, a radiopaque polyurethane ureteral catheter, a vinyl stent positioner and a stainless steel wire guide. The stent is available in sizes, 6.0 and 7.0 Fr with multi-length 8 to 20 centimeters. The stents are constructed of radiopaque silicone elastomer. Sideports extend along the body of the stent as well as on the curled pigtail loops (pigtail) to provide drainage. The stents are secured in the urinary tract with pigtail loops on the proximal and distal ends. There are black ink markings at the proximal and distal ends, and grey ink marks on the stent body which provide visualization during stent advancement and placement. The Greene Renal Transplant Stent is labeled for a 3-month indwell time.
The set will be supplied sterilized by ethylene oxide gas in a peel-open package and intended for one-time use. The product is packaged with three-year shelf life.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteropelvic junction to the bladder
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
The following tests have been conducted to ensure reliable design and performance under the specified testing parameters. The Greene Renal Transplant Stent Set was subjected to the tests. These tests include:
- Sterility
- Packaging
- Biocompatibility
- Stent Radiopacity Test
- Stent Dimensional Test
- Stent Curl Retention Test
- Stent Kink Radius Test
- Stent Simulated Use Test
- Stent Flow Rate and Lumen Blockage Test
- Stent MRI Compatibility Test
- Stent Retention and Tensile Test
- Catheter Radiopacity Test
- Catheter Leakage and Lumen Blockage Test
- Catheter Kink Radius Test
- Catheter Tensile Strength Test
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and 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 includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 23, 2018
Cook Incorporated Yuan Zhou Regulatory Affairs Team Lead 750 Daniels Way Bloomington, Indiana 47404
Re: K180557
Trade/Device Name: Greene Renal Transplant Stent Set Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral Stent Regulatory Class: Class II Product Code: FAD Dated: October 23, 2018 Received: October 24, 2018
Dear Yuan Zhou:
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 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 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.html; 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 medical devices and radiation-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
Indications for Use
510(k) Number (if known) K180557
Device Name Greene Renal Transplant Stent Set
Indications for Use (Describe)
Greene Renal Transplant Stent Set is used to establish temporary internal drainage from the ureteropelvic junction to the bladder. It is indicated for use following renal transplant.
| 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: 06/30/2020
See PRA Statement below.
3
Image /page/3/Picture/0 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. The red background is a rectangle shape.
2.0 510(k) Summary
K180557 p. 1 of 3
Greene Renal Transplant Stent Set 21 CFR §807.92 Date Prepared: October 17, 2018
Submitted By:
Submission: Applicant: Applicant Address:
Contact:
Contact Phone Number: Contact Fax Number:
Traditional 510(k) Premarket Notification Cook Incorporated Cook Incorporated 750 Daniels Way Bloomington, IN 47404 Yuan Zhou Karthik Pillai (812) 335-3575 x102529 (812) 332-0281
Device Information:
| Trade Name: | Greene Renal Transplant Stent Set |
|---|---|
| Common Name: | Ureteral stent |
| Classification Name: | Ureteral stent |
| Classification Regulation: | 21 CFR §876.4620 |
| Product Code: | FAD |
| Device Class/Classification Panel: | Class II, Gastroenterology/Urology |
Predicate Devices:
- K961446 AQ Hydrophilic Stent (Cook Urological).
Device Description:
The Greene Renal Transplant Stent Set is sterile, single-use device. The Greene Renal Transplant Stent Set is comprised of a double pigtail multi-length silicone stent, a radiopaque polyurethane ureteral catheter, a vinyl stent positioner and a stainless steel wire guide. The stent is available in sizes, 6.0 and 7.0 Fr with multi-length 8 to 20 centimeters. The stents are constructed of radiopaque silicone elastomer. Sideports extend along the body of the stent as well as on the curled pigtail loops (pigtail) to provide drainage. The stents are secured in the urinary tract with pigtail loops on the proximal and distal ends. There are black ink markings at the proximal and distal ends, and grey ink marks on the stent body which provide visualization during stent
4
Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a smaller red background. The logo is simple and clean, with a focus on the company name.
COOK INCORP 50 DANIELS WAY, P.C MINGTON, IN 47402-04 WWW.COOKMEDICALC
K180557 p. 2 of 3
advancement and placement. The Greene Renal Transplant Stent is labeled for a 3-month indwell time.
The set will be supplied sterilized by ethylene oxide gas in a peel-open package and intended for one-time use. The product is packaged with three-year shelf life.
Intended Use:
Greene Renal Transplant Stent Set is used to establish temporary internal drainage from the ureteropelvic junction to the bladder. It is indicated for use following renal transplant.
Comparison to Predicate Devices:
The Greene Renal Transplant Stent Set and the predicate device, AQ Hydrophilic Stents (K961446) are substantially equivalent in that these devices are similar in intended use, methods of operation, designs, and fundamental technological. The differences between the subject device and the predicate device do not raise new issues of the safety and effectiveness as the subject device has undergone clinically relevant performance and biocompatibility testing to ensure the reliability of the subject device.
Performance Data:
The following tests have been conducted to ensure reliable design and performance under the specified testing parameters. The Greene Renal Transplant Stent Set was subjected to the tests. These tests include:
- Sterility ●
- Packaging ●
- Biocompatibility ●
- Stent Radiopacity Test
- Stent Dimensional Test
- Stent Curl Retention Test
- Stent Kink Radius Test ●
- Stent Simulated Use Test
- Stent Flow Rate and Lumen Blockage Test
- Stent MRI Compatibility Test
- Stent Retention and Tensile Test
- Catheter Radiopacity Test ●
- Catheter Leakage and Lumen Blockage Test ●
- Catheter Kink Radius Test ●
- Catheter Tensile Strength Test
5
Image /page/5/Picture/0 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, also 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
K180557 p. 3 of 3
Conclusion:
The results of these tests provide reasonable assurance that the Greene Renal Transplant Ureteral Stent Set met the design input requirements based on the intended use. The subject device does not raise new questions of safety or effectiveness as compared to the predicate.