Vortek Single Loop Ureteral Stent

K201436 · Coloplast Corp. · FAD · Feb 25, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K201436
• Device Name: Vortek Single Loop Ureteral Stent
• Applicant: Coloplast Corp.
• Product Code: FAD · Gastroenterology, Urology
• Decision Date: Feb 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4620
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Vortek Single Loop Ureteral Stent is a self-retaining, radiopaque catheter for short-term (<30 days) upper urinary tract drainage. Device inputs: inserted into ureter/bladder via guidewire to bypass obstacles (calculi/stenosis) or maintain drainage post-intervention. Principle: passive urine drainage from kidney to bladder or external collection bag. Used in clinical settings by physicians; kit includes 90cm stent (6-8 Fr), PTFE-coated guidewire, immobilization clamp, and connectors. Output: physical drainage path. Clinical benefit: maintains patency of ureter, prevents obstruction, facilitates urine flow, reduces risk of hydronephrosis. Provider uses visual markings on stent to guide insertion; output confirms successful placement via radiopacity.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-1), mechanical performance (flow rate, tensile strength, curl strength, radiopacity, guidewire compatibility), and shelf-life/sterilization validation (EO, SAL 10^-9).

Technological Characteristics

Materials: Vortek material. Form factor: 90cm length, 6-8 Fr diameter, single loop configuration. Radiopaque. Energy source: None (passive). Connectivity: None. Sterilization: Ethylene oxide (SAL 10^-9). Accessories: PTFE-coated stainless steel guidewire, luer/latex connectors.

Indications for Use

Indicated for adult and pediatric patients (infants, children, adolescents) requiring endourological procedures, ureterostomy, vesical replacement, or short-term (<30 days) upper urinary tract drainage due to fistulas or ureteral obstacles.

Regulatory Classification

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.

Predicate Devices

• Hydrogel Coated Percuflex® Drainage Catheters (K924608)
• Vortek® Double Loop Ureteral Stents (K180057)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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<br>3050 Humlebaek, Denmark |
| Phone/Fax/Email: | Office: 612-422-7956<br>Email: [e-mail] |
| Name of Contact Person: | Angela Kilian<br>Head of Regulatory Affairs, North America |
| Address/Contact: | 1601 West River Road North<br>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.

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#### 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 (<30 day) drainage and can be connected to a urine bag for collection. It is a prescription only device. Vortek® Single Loop Ureteral Stents are supplied as a kit containing:

- . A 90 cm, radiopaque Single Loop Ureteral Stent with diameters from 6 to 8 Fr. The stents come either with an open or closed distal end. The eyelets or holes for drainage are along the entire loop and length of the device for some models or only on the loop for other models. There are markings along the length of the stent to facilitate insertion of the stent. The stents are made of Vortek Material.
- A Polytetrafluoroethylene (PTFE) coated radiopaque guidewire (Seldinger) with a fixed core and flexible end.
- A clamp for immobilizing the guidewire inserted in the stent during the procedure.
- . Luer connector to connect the Single Loop Stent to the latex connector.
- . A latex connector, for connection to a urine bag conical connector.

#### V. 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) patients 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.

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### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

| Device & Predicate<br>Device(s): | K201436 | K924608 | K180057 |
|----------------------------------|----------------------------------------------------------|-------------------------------------|---------------------------------------------------------------------|
| Materials | Vortek Material | copolymer | Vortek Material |
| Configuration | Image: One loop | Image: One loop | Image: Two loops |
| Indwelling duration | Less than 30 days | Up to 90 days | Up to 180 days |
| Size (Fr) | 6 to 8 Fr | 6 to 8 Fr | 4.8 to 8.0 Fr |
| Length (cm) | 90 cm | 80 cm | 12- 30 cm |
| Eyes | Eyelets on straight part and<br>loop or only on the loop | Eyelet on loop and<br>straight part | Eyelets on straight part<br>and loop or only on the<br>loop |
| Coating | No | Hydrogel | No |
| Sterile | Yes | Yes | Yes |
| Shelf Life | 5 years | Unknown | 5 years |
| Guidewire | PTFE-coated stainless steel | Unknown | PTFE-coated stainless<br>steel or hydro-coated<br>Nitinol guidewire |

As evidenced by the above table, the subject and predicate devices have different technological characteristics. However, the differences in technological characteristics do not raise different questions of safety or effectiveness.

#### SUMMARY OF TESTING PERFORMED VII.

The sponsor provided the following performance testing to support substantial equivalence:

# Biocompatibility Testing

Biocompatibility testing was conducted based upon ISO 10993-1 (2009): Biological evaluation of medical devices – Part 1: "Evaluation and testing within a risk management process" and FDA Guidance for Use of International Standard ISO 10993-1, "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff - June 16, 2016. The biocompatibility of the Vortek Single Loop Ureteral Stent included:

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- Cytotoxicity ●
- Sensitization ●
- Irritation ●
- . Acute Systemic toxicity
- Material-mediated pyrogenicity
- Subchronic toxicity
- Genotoxicity
- Implantation ●
- Chemical characterization
- Toxicological Risk evaluation

# Mechanical Testing

The following mechanical testing was completed using the FDA guidance document "Guidance for the content of premarket notifications for ureteral stents" February 1993.

- Flow Rate
- Elongation/Yield and tensile strength ●
- Curl (Loop) Strength ●
- Shelf Life/Expiration date
- Visual and dimensional testing ●
- Guidewire compatibility
- Radiopacity
- Magnetic resonance compatibility ●

## Sterilization

The Vortek Single Loop Ureteral Stents and accessories are sterilized using ethylene oxide in a validated cycle demonstrating a sterility assurance level (SAL) of 10-9.

# Shelf Life

The Vortek Single Loop Ureteral Stent was subjected to package integrity testing and performance verification testing to support the proposed shelf life.

The protocol and results of the provided performance testing to support substantial equivalence are acceptable.

#### VIII. CONCLUSION

The subject device is substantially equivalent to the predicate device.