(282 days)
The double loop ureteral stents are used for:
- drainage of the upper urinary tract over fistulas or ureteral obstacles
- healing of the ureter
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
This FDA 510(k) summary provides information on the Vortek® Hydro-Coated Double Loop Ureteral Stents. Unfortunately, the document does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a dedicated performance evaluation section that would answer your specific questions about device performance against acceptance criteria.
The document primarily focuses on establishing "substantial equivalence" of the new Vortek Hydro-Coated device to previously cleared predicate devices (Vortek Ureteral Double Loop Stents, K881744 and K981591) based on performance, indication, design, and materials.
Here's what can be inferred and what is explicitly missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Missing. This document does not provide a table of specific acceptance criteria (e.g., specific measurable thresholds for attributes like lubricity, friction, degradation rates, etc.) and the reported performance of the device against those criteria. It summarily states that "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." This indicates that bench tests were performed, but the detailed results and criteria are not provided here.
2. Sample Size Used for the Test Set and Data Provenance:
- Missing. The document does not specify any sample sizes used for bench testing. It only mentions "bench testing," which implies laboratory-based tests rather than human subject testing for this part of the submission. Therefore, data provenance relevant to human subjects (country of origin, retrospective/prospective) is not applicable or provided for this type of testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. Since the described testing is bench testing (e.g., comparing physical properties or biocompatibility), the concept of "ground truth" established by human experts in the context of diagnostic accuracy (like radiologists) does not apply.
4. Adjudication Method:
- Not applicable. As above, adjudication methods are relevant to expert consensus on diagnostic or clinical outcomes, not to bench testing of physical device properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This document explicitly states that substantial equivalence is supported by "bench testing" and "biocompatibility testing." There is no mention of an MRMC comparative effectiveness study, which is typically for AI/diagnostic imaging devices where human readers' performance is evaluated with and without AI assistance. This device is a physical medical device (a ureteral stent), not a diagnostic algorithm.
6. Standalone Performance Study (Algorithm Only):
- No. This is not an algorithm or AI device, so the concept of standalone performance does not apply.
7. Type of Ground Truth Used:
- For the bench testing, the "ground truth" would likely be objective, measurable physical properties (e.g., friction coefficients, tensile strength, degradation rates) determined by validated laboratory methods, and comparisons to the predicate device's measured properties or defined standards. For biocompatibility, it would be based on ISO standards for medical devices. The document does not detail how these specific ground truths were established, only that tests were performed.
8. Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. As this is not an AI/ML algorithm, there is no training set or associated ground truth.
In summary, the provided document is a 510(k) clearance letter and executive summary for a physical medical device (a ureteral stent). It confirms the device's substantial equivalence based on bench and biocompatibility testing but does not offer the granular detail about acceptance criteria, specific performance metrics, sample sizes, or clinical study designs that would be typical for an AI/ML diagnostic device or a more complex clinical trial.
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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.
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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 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
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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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510(k) SUMMARY
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Legal Manufacturer Address: | Holtedam 13050 Humlebaek, Denmark |
| Phone/Fax/Email: | Phone: (612) 597-5106Email: usclr@coloplast.com |
| Name of Contact Person: | Cori L. RaganRegulatory Affairs Manager |
| Address/Contact: | 1601 West River RoadMinneapolis, 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: FADDevice 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.
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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.
§ 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).