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.

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.

AI/ML Overview

The document provided is a 510(k) summary for the NovoFlow™ Reinforced Ureteral Stent, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The 510(k) summary does not include information about AI/ML device performance, ground truth, or human reader studies. The "study" mentioned refers to non-clinical bench testing to demonstrate physical properties and biocompatibility.

Here's a breakdown based on the information provided, and where information is not provided:

1. A table of acceptance criteria and the reported device performance

The document lists mechanical tests that were performed, but does not provide a table with specific acceptance criteria (e.g., minimum flow rate, tensile strength) or the reported values for the NovoFlow™ Reinforced Ureteral Stent for each test. It states that "Mechanical testing was completed using the FDA guidance document 'Guidance for the content of premarket notifications for ureteral stents' for reference." This implies that the tests and criteria were based on FDA recommendations for ureteral stents in general. The document also mentions "Biocompatibility testing was conducted based upon ISO 10993-1 (2018)" and sterilization and packaging tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The "test set" in this context would refer to the physical devices tested for mechanical properties, biocompatibility, etc. The document does not specify the number of stents or accessories tested for each category. Data provenance (country of origin, retrospective/prospective) is not applicable or provided for physical device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is a physical ureteral stent, not an AI/ML algorithm that requires expert ground truth for classification or diagnosis. The "ground truth" for the performance of this device would be its adherence to established engineering and biocompatibility standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable, as it pertains to AI/ML performance evaluation through expert review, which is not relevant for this device.

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

No such study was done. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No such study was done. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this medical device's performance is compliance with established physical, mechanical, chemical (biocompatibility), and sterility standards derived from FDA guidance documents and international standards (like ISO 10993-1). No expert consensus, pathology, or outcomes data were used to establish "ground truth" for the performance tests conducted for this 510(k). The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices."

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device, so there is no training set in that context.

9. How the ground truth for the training set was established

This information is not applicable. This is not an AI/ML device.

Summary of "Acceptance Criteria" and "Study" for the NovoFlow™ Reinforced Ureteral Stent (based on the provided document):

Study: The substantial equivalence determination for the NovoFlow™ Reinforced Ureteral Stent was supported by non-clinical performance data, including:

Biocompatibility Testing: Conducted based on ISO 10993-1 (2018) and relevant FDA guidance.
Mechanical Testing: Based on FDA's "Guidance for the content of premarket notifications for ureteral stents." Specific tests included:
- Visual Inspection
- Dimensional Testing (Diameter, Length)
- Flow Rate
- Elongation/Yield and Tensile Strength
- Loop/Curl strength
- Guidewire compatibility
- Radiopacity
- Magnetic resonance compatibility
- Shelf Life/Expiration Date
Sterilization Testing: Validated using ethylene oxide to achieve a sterility assurance level of 10-6.
Packaging and Distribution Testing: To ensure product integrity and sterility throughout its life.

Acceptance Criteria & Reported Performance:

Acceptance Criteria Category	Reported Device Performance (Summary from Document)
Biocompatibility	Compliant with ISO 10993-1 (2018) and FDA Guidance. (Specific test results and acceptance limits not provided, but the statement implies successful completion based on established standards for medical devices with prolonged tissue contact.)
Mechanical Performance	Tests were completed for Visual Inspection, Dimensional (Diameter, Length), Flow Rate, Elongation/Yield and Tensile Strength, Loop/Curl strength, Guidewire compatibility, Radiopacity, Magnetic Resonance Compatibility, and Shelf Life/Expiration Date as referenced in FDA guidance. (Specific numerical acceptance criteria and results are not detailed in this summary, but the conclusion states "substantial equivalence... based on the non-clinical data provided," implying the device met the criteria set forth in the referenced FDA guidance and standards.)
Sterilization	Validated ethylene oxide cycle achieved a sterility assurance level (SAL) of 10-6. (Acceptance criterion: SAL of 10-6 achieved.)
Packaging & Distribution	Subjected to distribution and verification testing to demonstrate product and package remain undamaged and maintain device sterility throughout product life. (Acceptance criterion: Product and package integrity maintained, sterility maintained. Specific tests and results not detailed, but implied successful completion.)
Overall Conclusion	The document concludes that "The NovoFlow Reinforced Ureteral Stents and related accessories have been demonstrated to be substantially equivalent to the predicate device... 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." This implies all performed tests met their respective acceptance criteria to support the substantial equivalence claim.

Summary

{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)

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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW
The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:
Food and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff(@fda.hhs.gov	Department of Health and Human Services
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation 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 13050 Humlebaek, Denmark
Phone/Fax/Email:	Phone: 612-422-3206Email: usggh@coloplast.com
Name of Contact Person:	Gayatri GhadgePrincipal Regulatory Affairs Specialist
Address/Contact:	1601 West River RoadMinneapolis, 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: FADDevice 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.

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

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.

Regulation Number and Section

§ 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).