(140 days)
No reference devices were used in this submission.
No
The document describes a physical medical device (ureteral stent) and its accessories. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on physical and material properties, not algorithmic performance.
Yes
The device is intended for the drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter, which directly contributes to the treatment or palliation of a disease or condition.
No
The device is an implantable ureteral stent intended for drainage and healing of the urinary tract, not for diagnosing conditions.
No
The device description clearly states it is an implantable ureteral stent, which is a physical medical device, not software. The performance studies also focus on physical properties and biocompatibility.
Based on the provided information, the NovoFlow Reinforced ureteral stent is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for drainage and healing of the upper urinary tract by being implanted within the body. This is a therapeutic and structural function, not a diagnostic one performed on samples outside the body.
- Device Description: The device is an implantable stent designed to maintain urine flow. This is a physical intervention, not a test or analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, mechanical properties, sterilization, and packaging – all relevant to an implantable medical device, but not to an IVD.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The NovoFlow Reinforced ureteral stent does not fit this description.
N/A
Intended Use / Indications for Use
The NovoFlow™ Reinforced ureteral stents are intended for patients 12 years of age (40 kg) and over for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 6 months.
Product codes
FAD
Device Description
NovoFlow Reinforced Ureteral Stents are implantable ureteral stents used to maintain urine drainage and allow healing of the ureter. They are inserted into the ureter during a surgical procedure using mainly a retrograde technique, although an antegrade approach is also possible.
The stents are supplied in 7 Fr or 8 Fr diameters and lengths from 26 cm through 30 cm, with both tips open (O/O). NovoFlow Reinforced Ureteral Stents are supplied in kits which contain the following components:
- A double loop ureteral stent
- A steerable pusher, packed separately
Also contained in some kits: - -An Orchestra® Hydrophilic guidewire, packed separately
The NovoFlow Reinforced Ureteral Stents and accessories included in the kits are supplied sterile via ethylene oxide. The ureteral stent and each accessory are packaged and sterilized separately prior to being combined in the kit.
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
patients 12 years of age (40 kg) and over
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
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility testing was conducted based upon ISO 10993-1 (2018): 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.
Mechanical Testing
Mechanical testing was completed using the FDA guidance document "Guidance for the content of premarket notifications for ureteral stents" for reference. The following tests were performed:
- Visual Inspection
- Dimensional Testing
- o Diameter
- o Length
- Flow Rate ●
- Elongation/Yield and Tensile Strength ●
- Loop/Curl strength ●
- Guidewire compatibility
- Radiopacity
- Magnetic resonance compatibility ●
- Shelf Life/Expiration Date ●
Sterilization
The NovoFlow Reinforced Ureteral Stents and accessories are sterilized using ethylene oxide in a validated cycle, demonstrating a sterility assurance level of 10-6.
Packaging and Distribution
The NovoFlow Reinforced Ureteral Stents were subjected to distribution testing and verification testing to demonstrate that the product and package would be undamaged throughout the product life and maintain the device sterility.
No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 16, 2022
Coloplast Corp Gayatri Ghadge Principal Regulatory Affairs Specialist 1601 West River Road North Minneapolis. MN 55411
Re: K213186
Trade/Device Name: NovoFlow™ Reinforced Ureteral Stent Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: January 19, 2022 Received: January 20, 2022
Dear Gayatri Ghadge:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.
1
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.
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) 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 (OS) 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 medical devices and radiation-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,
Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213186
Device Name
NovoFlow™ Reinforced Ureteral Stent
Indications for Use (Describe)
The NovoFlow Reinforced ureteral stents are intended for patients 12 years of age (40 kg) and over for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 6 months.
| 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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| information unless it displays a currently valid OMB number." |
Page 1 of 1
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
3
Image /page/3/Picture/0 description: The image shows the Coloplast logo, which is a blue circle with white lines inside. Next to the logo is the word "Coloplast" in blue, bold letters. Below the logo and word is the address "1601 West River Road North, Minneapolis, MN 55411".
K213186 Page 1 of 3
5. 510(k) SUMMARY
| I. SUBMITTER INFORMATION | |
|---|---|
| 510(K) Owner's Name: | Coloplast A/S |
| Legal Manufacturer Address: | Holtedam 1 |
| 3050 Humlebaek, Denmark | |
| Phone/Fax/Email: | Phone: 612-422-3206 |
| Email: usggh@coloplast.com | |
| Name of Contact Person: | Gayatri Ghadge |
| Principal Regulatory Affairs Specialist | |
| Address/Contact: | 1601 West River Road |
| Minneapolis, MN 55411 | |
| Date Prepared: | January 19, 2022 |
| II. DEVICE | |
| Trade or Proprietary Name: | NovoFlow™ Reinforced Ureteral Stent |
| Common or Usual Name: | Ureteral Stents |
| Classification Name: | Stent, Ureteral |
| (21 CFR section 876.4620) | |
| Product Code: FAD | |
| Device Class: II |
PREDICATE DEVICE IDENTIFICATION III.
Vortek® Double Loop Ureteral Stents (K180057). Predicate device:
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
NovoFlow Reinforced Ureteral Stents are implantable ureteral stents used to maintain urine drainage and allow healing of the ureter. They are inserted into the ureter during a surgical procedure using mainly a retrograde technique, although an antegrade approach is also possible.
The stents are supplied in 7 Fr or 8 Fr diameters and lengths from 26 cm through 30 cm, with both tips open (O/O). NovoFlow Reinforced Ureteral Stents are supplied in kits which contain the following components:
- A double loop ureteral stent
Page 5-1
4
1601 West River Road North Minneapolis, MN 55411
-
A steerable pusher, packed separately
Also contained in some kits: -
-An Orchestra® Hydrophilic guidewire, packed separately
The NovoFlow Reinforced Ureteral Stents and accessories included in the kits are supplied sterile via ethylene oxide. The ureteral stent and each accessory are packaged and sterilized separately prior to being combined in the kit.
V. INDICATIONS FOR USE
The NovoFlow Reinforced ureteral stents are intended for patients 12 years of age (40 kg) and over for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 6 months.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
NovoFlow Reinforced Ureteral Stents are substantially equivalent in performance, design and materials to the Vortek® Double Loop Ureteral Stents, cleared under premarket notification number K180057. All devices are tubes made from the same radiopaque, polymeric materials with loops at both the renal and vesical ends to hold the stent in place. Both devices use guidewires and pushers and are intended to be implanted for up to six months. All the devices are sold as kits with the same accessories intended to facilitate implantation. The main differences between the NovoFlow Reinforced Ureteral Stents and the predicate device are that the subject device is available in only 7 and 8 Fr sizes while the predicate device is available in 4.8 -8 Fr. In addition, some models of the predicate device contain a suture, while the NovoFlow Reinforced Ureteral Stents do not contain a suture.
VII. PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility testing was conducted based upon ISO 10993-1 (2018): 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.
5
1601 West River Road North Minneapolis. MN 55411
Mechanical Testing
Mechanical testing was completed using the FDA guidance document "Guidance for the content of premarket notifications for ureteral stents" for reference. The following tests were performed:
- Visual Inspection
- Dimensional Testing
- o Diameter
- o Length
- Flow Rate ●
- Elongation/Yield and Tensile Strength ●
- Loop/Curl strength ●
- Guidewire compatibility
- Radiopacity
- Magnetic resonance compatibility ●
- Shelf Life/Expiration Date ●
Sterilization
The NovoFlow Reinforced Ureteral Stents and accessories are sterilized using ethylene oxide in a validated cycle, demonstrating a sterility assurance level of 10-6.
Packaging and Distribution
The NovoFlow Reinforced Ureteral Stents were subjected to distribution testing and verification testing to demonstrate that the product and package would be undamaged throughout the product life and maintain the device sterility.
No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices.
VIII. CONCLUSIONS
The NovoFlow Reinforced Ureteral Stents and related accessories have been demonstrated to be substantially equivalent to the predicate device, Vortek Double Loop Ureteral Stents based on the non-clinical data provided, similar intended use, patient population, materials, biocompatibility, kit composition, and technological characteristics. The differences in technological characteristics do not raise new questions of safety or effectiveness.