(269 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a ureteral stent, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for short-term drainage of the upper urinary tract to relieve obstructions or manage fistulas, which are therapeutic interventions.
No
This device is a ureteral stent, which is used for drainage of the upper urinary tract. Its intended use and description explain its function in maintaining drainage and collecting urine, not in diagnosing medical conditions.
No
The device description clearly outlines physical components such as a radiopaque stent, guidewire, clamp, and connectors, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for drainage of the urinary tract. This is a therapeutic and diagnostic procedure performed directly on the patient, not a test performed on a sample in vitro (outside the body).
- Device Description: The description details a physical catheter, guidewire, and connectors used for insertion into the urinary tract. This aligns with a medical device used for intervention and drainage, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like urine, blood, etc.), reagents, or any process that would be performed in vitro to diagnose a condition.
- Performance Studies: The performance studies focus on biocompatibility, mechanical properties, sterilization, and shelf life, which are typical for implantable or indwelling medical devices, not IVDs.
In summary, the Vortek® Single Loop Ureteral Stent is a medical device used for drainage within the body, not an in vitro diagnostic device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
Surgical indication: The Vortek® Single Loop Ureteral Stent is intended for use in ureterostomy or vesical replacement in adult and pediatric (adolescents, children, and infants requiring endourological procedure and /or short-term (less than 30 days) drainage of the upper urinary tract.
Endoscopic indication: The Vortek® Single Loop Ureteral Stent is intended for short-term (less than 30 days) drainage of urine from the upper urinary tract over fistulas or ureteral obstacles in adult and pediatric (adolescents, children, and infants) patients.
The subject and predicate device have the same intended use.
Product codes (comma separated list FDA assigned to the subject device)
FAD
Device Description
Vortek Single Loop Ureteral Stents are self-retaining catheters used to maintain drainage of the upper urinary tract following an intervention on the ureter/bladder or in the case of an obstacle such as calculi or stenosis. The devices collect urine from the kidney for short-term (
§ 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). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
February 25, 2021
Coloplast Corp. Angela Kilian Head of Regulatory Affairs, North America 1601 West River Road North Minneapolis, MN 55411
Re: K201436
Trade/Device Name: Vortek® Single Loop Ureteral Stent Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: February 22, 2021 Received: January 25, 2021
Dear Angela Kilian:
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. 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.
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 801and Part 809); 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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201436
Device Name
Vortek® Single Loop Ureteral Stent
Indications for Use (Describe)
Surgical indication:
The Vortek® Single Loop Ureteral Stent is intended for use in ureterostomy or vesical replacement in adult and pediatric (adolescents, children, and infants requiring endourological procedure and /or short-term (less than 30 days) drainage of the upper urinary tract.
Endoscopic indication:
The Vortek® Single Loop Ureteral Stent is intended for short-term (less than 30 days) drainage of urine from the upper urinary tract over fistulas or ureteral obstacles in adult and pediatric (adolescents, children, and infants) patients.
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)
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510(k) SUMMARY - K201436
I. SUBMITTER INFORMATION:
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Address: | Holtedam 1 |
| 3050 Humlebaek, Denmark | |
| Phone/Fax/Email: | Office: 612-422-7956 |
| Email: usaby@coloplast.com | |
| Name of Contact Person: | Angela Kilian |
| Head of Regulatory Affairs, North America | |
| Address/Contact: | 1601 West River Road North |
| Minneapolis, MN 55411 | |
| Date Prepared: | February 18, 2021 |
II. DEVICE CLASSIFICATION:
| Trade or Proprietary Name: | Vortek® Single Loop Ureteral Stent |
|---|---|
| Common or Usual Name: | Ureteral Stent |
| Classification Name: | Stent, Ureteral |
| Classification Number: | 876.4620 |
| Regulatory Class: | II |
| Product Code: | FAD (stent, ureteral) |
| Advisory Panel: | Gastroenterology/Urology |
PREDICATE DEVICE III.
Primary predicate: Hydrogel Coated Percuflex® Drainage Catheters (K924608) Secondary predicate: Vortek® Double Loop Ureteral Stents (K180057)
These predicates have not been subject to a design-related recall.
4
DEVICE DESCRIPTION IV.
Vortek Single Loop Ureteral Stents are self-retaining catheters used to maintain drainage of the upper urinary tract following an intervention on the ureter/bladder or in the case of an obstacle such as calculi or stenosis. The devices collect urine from the kidney for short-term (