(266 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a ureteral stent, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for temporary internal drainage from the ureteropelvic junction to the bladder, which is a therapeutic intervention to address a medical condition.
No
The device is described as being used for "temporary internal drainage from the ureteropelvic junction to the bladder," which indicates a therapeutic rather than a diagnostic function.
No
The device description clearly details physical components made of silicone rubber, including a stent, wire guide, stent positioner, and T-inserter. It also describes physical properties like diameter, length, flexibility, and radiopacity, and performance testing related to these physical characteristics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary internal drainage from the ureteropelvic junction to the bladder." This describes a therapeutic or interventional procedure performed within the body, not a test performed on a sample taken from the body.
- Device Description: The device is a "flexible, tubular double pigtail stent" designed to be placed within the urinary tract. This is a medical device used for drainage, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used for drainage.
N/A
Intended Use / Indications for Use
This product is used for temporary internal drainage from the ureteropelvic junction to the bladder. They are not intended to remain indwelling more than twelve months.
Product codes
FAD
Device Description
The Black Silicone Filiform Double Pigtail Stent Set is a sterile, single-use device. The stents are available with outside diameters of 6.0, 7.0, or 8.5 Fr and specified lengths ranging from 20 to 30 centimeters. The stents are flexible, tubular double pigtail stents constructed of radiopaque silicone rubber. Sideports extend along the body of the stent as well as on the pigtails to provide drainage. The stents are secured in the urinary tract with pigtail loops on the proximal and distal ends. A braided tether for repositioning and removal of the device is located on the proximal pigtail (bladder end) of the stent. Along the stent are graduation marks to provide visualization during stent advancement and placement. The Black Silicone Filiform Double Pigtail Stent Set includes a stent, wire guide, a stent positioner with a lockable fitting, and a T-inserter. The lockable fitting on the proximal end of the stent positioner secures the position of the stent positioner on the wire guide and allows for one-pass placement of the stent. The Black Silicone Filiform Double Pigtail Stent Set is labeled for a 12-month indwell time; however, the tether should be removed after 14 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteropelvic junction to the bladder (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 Black Silicone Filiform Double Pigtail Ureteral Stent Set was subjected to the following tests to assure reliable design and performance under the specified testing parameters:
-
- Sterility
-
- Packaging
-
- Biocompatibility
-
- Flow Rate
-
- Retention Strength
-
- Tensile Strength
-
- Curl Restoration
-
- Kink Radius
-
- Radiopacity
-
- MRI Testing
The results of the testing provide reasonable assurance that the Black Silicone Filiform Double Pigtail Ureteral Stent Set has been designed such that it will function as intended. The subject device does not raise new questions of safety or effectiveness as compared to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 26, 2018
Cook Incorporated Karthik Pillai Regulatory Science Specialist 750 Daniels Wav P.O. Box 489 Bloomington, IN 47402
Re: K172017
Trade/Device Name: Black Silicone Filiform Double Pigtail Stent Set Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: FAD Dated: February 16, 2018 Received: February 20, 2018
Dear Karthik Pillai:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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 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 (OS) 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
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
510(k) Number (if known) K172017
Device Name
The Black Silicone Filiform Double Pigtail Ureteral Stent Set
Indications for Use (Describe)
This product is used for temporary internal drainage from the ureteropelvic junction to the bladder. They are not intended to remain indwelling more than twelve months.
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/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, uppercase letters, with a registered trademark symbol next to it. Below "COOK" is the word "MEDICAL" in white, uppercase letters, set against a slightly darker red background.
510(k) Summary
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 V.COOKM
Black Silicone Filiform Double Pigtail Stent Set 21 CFR §876.4620 Date Prepared: June 30, 2017
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact: | Karthik Pillai |
| Email: | RegSubmissions@CookMedical.com |
| Contact Phone Number: | 812-335-3575 x104929 |
| Contact Fax Number: | 812-332-0281 |
Device Information:
| Trade Name: | Black Silicone Filiform Double Pigtail Ureteral Stent Set |
|---|---|
| Common Name: | Ureteral Stent |
| Classification Name: | Ureteral Stent |
| Regulation: | 21 CFR §876.4620 |
| Product Code: | FAD |
| Device Class: | II |
| Classification Panel: | Gastroenterology/Urology |
Predicate Device:
The predicate device is Universa™ Firm Ureteral Stents and Stent Sets, cleared under 510(k) K161236 on January 27, 2017.
Device Description:
The Black Silicone Filiform Double Pigtail Stent Set is a sterile, single-use device. The stents are available with outside diameters of 6.0, 7.0, or 8.5 Fr and specified lengths ranging from 20 to 30 centimeters. The stents are flexible, tubular double pigtail stents constructed of radiopaque silicone rubber. Sideports extend along the body of the stent as
4
well as on the pigtails to provide drainage. The stents are secured in the urinary tract with pigtail loops on the proximal and distal ends. A braided tether for repositioning and removal of the device is located on the proximal pigtail (bladder end) of the stent. Along the stent are graduation marks to provide visualization during stent advancement and placement. The Black Silicone Filiform Double Pigtail Stent Set includes a stent, wire guide, a stent positioner with a lockable fitting, and a T-inserter. The lockable fitting on the proximal end of the stent positioner secures the position of the stent positioner on the wire guide and allows for one-pass placement of the stent. The Black Silicone Filiform Double Pigtail Stent Set is labeled for a 12-month indwell time; however, the tether should be removed after 14 days.
Intended Use:
This product is used for temporary internal drainage from the ureteropelvic junction to the bladder. They are not intended to remain indwelling more than twelve months.
Comparison to Predicate Device:
The Black Silicone Filiform Double Pigtail Ureteral Stent Set is substantially equivalent to the predicate device, the Universa™ Firm Ureteral Stents and Stent Sets, as described in K161236. The table below presents the similarities and differences between the devices for substantial equivalence purposes. The differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness. Performance data are available to support substantial equivalence and were developed using acceptable scientific methods for evaluation.
| | Universa™ Firm Ureteral Stent and
Stent Set (K161236) | Black Silicone Filiform Double Pigtail
Ureteral Stent Set (Subject of this
submission) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Used for temporary internal drainage
from the ureteropelvic junction to the
bladder. Ureteral stents have been used to
relieve obstruction in a variety of benign,
malignant, and post-traumatic conditions.
The stents may be placed using
endoscopic, percutaneous, or open
surgical techniques. | Used for temporary internal drainage
from the ureteropelvic junction to the
bladder. They are not intended to remain
indwelling more than twelve months. |
| Maximum Indwell
Time | 12 months | Identical |
| Sterilization | Ethylene oxide | |
| Maximum Shelf
Life | 3 years | Identical |
5
| | UniversaTM Firm Ureteral Stent and
Stent Set (K161236) | Black Silicone Filiform Double Pigtail
Ureteral Stent Set (Subject of this
submission) |
|-----------------------------------|-----------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Principle Operation
Components | Double pigtail stent Stent positioner Wire guide | Double pigtail stent Stent positioner with lockable fitting Wire guide T-inserter |
| Dimensions | | |
| Loop Diameter | 13 mm - 20 mm | 15 mm - 18 mm |
| Stent Outer
Diameter | 5 Fr - 8 Fr | 6 Fr - 8.5 Fr |
| Stent Length | 18 cm - 30 cm | 20 cm - 30 cm |
| Pusher/Positioner | 5 Fr and 7 Fr | 7 Fr, 8 Fr, and 9 Fr |
| Materials | | |
| Stent | Radiopaque Polycarbonate-based
Polyurethane | Radiopaque Silicone Rubber |
| Stent Markings | Black Ink | White Ink |
| Tether | Tevdek® (Polyethylene Terephthalate) | Identical |
| Pusher/Positioner | Polyethylene Non-radiopaque or Vinyl | Identical |
| Pusher/Positioner
Marker | Stainless Steel | Stainless Steel or Tungsten |
| Wire Guide | PTFE-coated Stainless Steel | Identical |
Technological Characteristics:
The Black Silicone Filiform Double Pigtail Ureteral Stent Set was subjected to the following tests to assure reliable design and performance under the specified testing parameters:
-
- Sterility
-
- Packaging
-
- Biocompatibility
-
- Flow Rate
-
- Retention Strength
-
- Tensile Strength
-
- Curl Restoration
-
- Kink Radius
-
- Radiopacity
-
- MRI Testing
6
Conclusion:
The results of the testing provide reasonable assurance that the Black Silicone Filiform Double Pigtail Ureteral Stent Set has been designed such that it will function as intended. The subject device does not raise new questions of safety or effectiveness as compared to the predicate.