(282 days)
Not Found
No
The device description and intended use focus on the physical characteristics and function of a ureteral stent and associated insertion tools. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for drainage and healing of the ureter, which directly addresses medical conditions.
No
The device is a ureteral stent, which is used for drainage and healing of the urinary tract, not for diagnosing conditions.
No
The device description clearly outlines physical components such as flexible tubular devices, pushers, guidewires, and catheters, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Vortek® Hydro-Coated Double loop ureteral stents are flexible tubular devices used for drainage and healing within the upper urinary tract. They are physically inserted into the body.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. Its function is mechanical and therapeutic (facilitating drainage and healing).
- Imaging Modality: The mention of fluoroscopic visualization is for guiding the placement of the device within the body, not for analyzing an in vitro sample.
Therefore, the device's intended use and mechanism of action are entirely focused on direct intervention within the patient's body, which is characteristic of a medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The double loop ureteral stents are used for:
- drainage of the upper urinary tract over fistulas or ureteral obstacles
- healing of the ureter
Product codes (comma separated list FDA assigned to the subject device)
FAD
Device Description
The Vortek Hydro-Coated Double loop ureteral stents are flexible tubular devices supplied with a hydrogel coating. They are designed with open renal and open vesical ends to be inserted with a guidewire using a pusher. The stents are radiopaque for fluoroscopic visualization. They have eyes on the straight part. Stent diameters and length vary to accommodate the patient's anatomy. For some models, a withdrawal thread is attached on the proximal end to allow removal. Non-steerable pushers are simple tubes, the clamp can be used to immobilize the pusher onto the guidewire. Steerable pushers are equipped with a blue handle/Luer Lock female connector and made of an inner tube that can move forward and backward inside an external tube, to allow connection/disconnection of the stent.
The ureteric catheter supplied with a connector fitted with a Luer tip can be used for inserting the guidewire or injecting contrast medium.
Vortek Hydro-Coated Double Loop Ureteral Stents in this submission and the predicate Vortek Double Loop Ureteral Stents are supplied in kits which are comprised of the following components:
- An open/open double loop ureteral stent with a hydrogel coating
- A non-steerable pusher provided with a clamp, or a steerable pusher
- Available in certain kits:
- A withdrawal thread attached to the stent
- A radiopaque 0.035-inch (0.89mm) diameter guidewire: PTFE-coated stainless steel guidewire or fully hydrophilic nitinol guidewire
- A ureteric (also called ureteral) catheter
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper urinary tract, ureter
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)
Substantial equivalence is supported by bench testing comparing Vortek Hydro-Coated Double Loop Ureteral Stents to the predicate device and biocompatibility testing performed on the Vortek Hydro-Coated Double Loop Ureteral Stents.
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
§ 876.4620 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 FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA acronym and full name are written in blue.
November 15, 2017
Coloplast Corp. Cori L. Ragan Regulatory Affairs Manager 1601 West River Road North Minneapolis, MN 55411
Re: K170362
Trade/Device Name: Vortek® Hydro-Coated Double Loop Ureteral Stents Regulation Number: 21 CFR$ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: November 7, 2017 Received: November 8, 2017
Dear Cori L. Ragan:
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,
Charles Viviano -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)
Device Name Vortek® Hydro-Coated Double Loop Ureteral Stents
Indications for Use (Describe)
The double loop ureteral stents are used for:
-
drainage of the upper urinary tract over fistulas or ureteral obstacles
-
healing of the ureter
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| ☑ Deposition (Part 21 CFR 601.2, Subpart D) ☐ Source Tissue Collection (21 CFR 601.2, Subpart E) | ☑ | Deposition (Part 21 CFR 601.2, Subpart D) | ☐ | Source Tissue Collection (21 CFR 601.2, Subpart E) |
| ☑ | Deposition (Part 21 CFR 601.2, Subpart D) | |||
| ☐ | Source Tissue Collection (21 CFR 601.2, Subpart E) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Legal Manufacturer Address: | Holtedam 1 |
| 3050 Humlebaek, Denmark | |
| Phone/Fax/Email: | Phone: (612) 597-5106 |
| Email: usclr@coloplast.com | |
| Name of Contact Person: | Cori L. Ragan |
| Regulatory Affairs Manager | |
| Address/Contact: | 1601 West River Road |
| Minneapolis, MN 55411 | |
| Date Prepared: | 12 September 2017 |
| Trade or Proprietary Name: | Vortek® Hydro-Coated Double Loop Ureteral Stents |
| Common or Usual Name: | Vortek Hydro-Coated Double Loop Ureteral Stents |
| Classification Name: | Stent, Ureteral |
| (21CFR section 876.4620) | |
| Product Code: FAD | |
| Device Class: 2 |
Legally Marketed Device to Which Your Firm Is Claiming Equivalence:
Vortek Hydro-Coated Double Loop Ureteral Stents and its accessories are substantially equivalent in performance, indication, design and materials to Vortek Ureteral Double Loop Stents, cleared under premarket notification numbers K881744 and K981591.
Device Description:
The Vortek Hydro-Coated Double loop ureteral stents are flexible tubular devices supplied with a hydrogel coating. They are designed with open renal and open vesical ends to be inserted with a guidewire using a pusher. The stents are radiopaque for fluoroscopic visualization. They have eyes on the straight part. Stent diameters and length vary to accommodate the patient's anatomy. For some models, a withdrawal thread is attached on the proximal end to allow removal. Non-steerable pushers are simple tubes, the clamp can be used to immobilize the pusher onto the guidewire. Steerable pushers are equipped with a blue handle/Luer Lock female connector and made of an inner tube that can move forward and backward inside an external tube, to allow connection/disconnection of the stent.
The ureteric catheter supplied with a connector fitted with a Luer tip can be used for inserting the guidewire or injecting contrast medium.
4
Vortek Hydro-Coated Double Loop Ureteral Stents in this submission and the predicate Vortek Double Loop Ureteral Stents are supplied in kits which are comprised of the following components:
- । An open/open double loop ureteral stent with a hydrogel coating
- A non-steerable pusher provided with a clamp, or a steerable pusher ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- Available in certain kits: --
- A withdrawal thread attached to the stent |
- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A radiopaque 0.035-inch (0.89mm) diameter guidewire: PTFE-coated stainless steel guidewire or fully hydrophilic nitinol guidewire
- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A ureteric (also called ureteral) catheter
Intended Use of the device:
Vortek Hydro-Coated Double Loop Ureteral Stents in this submission and the predicate Vortek Double Loop Ureteral Stents have the same intended use:
- Drainage of the upper urinary tract over fistulas or ureteral obstacles ●
- Healing of the ureter ●
Technological Characteristics Compared to Predicate Device:
Vortek Hydro-Coated Double Loop Ureteral Stents are substantially equivalent in performance, design and materials to Vortek Double Loop Ureteral Stents, cleared under premarket notification number K981591.
Summary and Conclusions from the Nonclinical Tests Submitted:
Substantial equivalence is supported by bench testing comparing Vortek Hydro-Coated Double Loop Ureteral Stents to the predicate device and biocompatibility testing performed on the Vortek Hydro-Coated Double Loop Ureteral Stents.