(269 days)
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.
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.
The provided text describes information for the K201436 submission to the FDA for the Vortek® Single Loop Ureteral Stent. However, it does not contain specific acceptance criteria or performance results in a structured format that can be directly extracted into a table.
Instead, it lists the types of testing performed to support substantial equivalence and states that "The protocol and results of the provided performance testing to support substantial equivalence are acceptable." This implies that the device met internal acceptance criteria defined for these tests, but the document does not enumerate them or present the specific performance values.
Therefore, I cannot directly populate a table of acceptance criteria and reported device performance from the provided text.
Similarly, much of the other requested information pertains to a study design and results (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) which are typical for clinical trials or AI algorithm validation studies, rather than the biocompatibility and mechanical testing summaries presented here for a ureteral stent.
Below, I will extract what I can based on the text, with clear indications where the information is not provided in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Not provided | Not provided |
| Sensitization | Not provided | Not provided | |
| Irritation | Not provided | Not provided | |
| Acute Systemic toxicity | Not provided | Not provided | |
| Material-mediated pyrogenicity | Not provided | Not provided | |
| Subchronic toxicity | Not provided | Not provided | |
| Genotoxicity | Not provided | Not provided | |
| Implantation | Not provided | Not provided | |
| Chemical characterization | Not provided | Not provided | |
| Toxicological Risk evaluation | Not provided | Not provided | |
| Mechanical | Flow Rate | Not provided | Not provided |
| Elongation/Yield and tensile strength | Not provided | Not provided | |
| Curl (Loop) Strength | Not provided | Not provided | |
| Shelf Life/Expiration date | Not provided | Not provided | |
| Visual and dimensional testing | Not provided | Not provided | |
| Guidewire compatibility | Not provided | Not provided | |
| Radiopacity | Not provided | Not provided | |
| Magnetic resonance compatibility | Not provided | Not provided | |
| Sterilization | Ethylene oxide cycle | Sterility Assurance Level (SAL) of 10^-6 (implied standard for sterilization) | 10^-6 (The document states "demonstrating a sterility assurance level (SAL) of 10^-6.") **Correction: The document states 10^-9. ** |
| Shelf Life | Package integrity testing | Not provided | Not provided |
| Performance verification | Not provided | Not provided |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not provided. The document lists types of tests (e.g., cytotoxicity, flow rate) but does not specify the number of units/samples tested for each.
- Data Provenance: Not provided (e.g., country of origin, retrospective/prospective). The tests are laboratory-based and do not involve patient data in the typical sense for this type of medical device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number and Qualifications of Experts: Not applicable/Not provided. The "ground truth" for these types of tests (biocompatibility, mechanical performance) is typically established by recognized standards, experimental protocols, and calibrated equipment, not by expert consensus on clinical findings.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not provided. This concept is relevant for clinical or diagnostic study designs, not for the laboratory testing of a ureteral stent's physical properties or biocompatibility.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a ureteral stent, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a physical ureteral stent, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: For the biocompatibility and mechanical testing, the "ground truth" implicitly refers to the scientific and engineering principles, material standards (like ISO 10993-1), and industry-accepted test methodologies and their respective endpoints which define acceptable performance. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not provided. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. (See #8).
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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 (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 13050 Humlebaek, Denmark |
| Phone/Fax/Email: | Office: 612-422-7956Email: usaby@coloplast.com |
| Name of Contact Person: | Angela KilianHead of Regulatory Affairs, North America |
| Address/Contact: | 1601 West River Road NorthMinneapolis, 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 & PredicateDevice(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 andloop or only on the loop | Eyelet on loop andstraight part | Eyelets on straight partand loop or only on theloop |
| Coating | No | Hydrogel | No |
| Sterile | Yes | Yes | Yes |
| Shelf Life | 5 years | Unknown | 5 years |
| Guidewire | PTFE-coated stainless steel | Unknown | PTFE-coated stainlesssteel or hydro-coatedNitinol 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.
§ 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).