Ureteric catheters are intended for endourological procedures, to restore or maintain drainage of the upper urinary tract and to inject contrast medium or saline.

Duration of use: Ureteric catheters are intended for temporary use during surgical procedure.

Device Description

Ureteric catheters are ethylene oxide sterilized, single use devices intended to restore or maintain drainage of the upper urinary tract and to flush or inject contrast medium or saline during an endoscopic procedure. All ureteric catheters include a connector nut with a Luer fitting. The connector nut is inserted into the proximal end of the catheter allowing the Luer fitting to connect to collecting or injection devices. Ureteric catheters are open at the distal end (farthest away from the surgeon) to allow use over a guidewire.

Flush Ureteric Catheters and Ureteric Catheters come in three different tip configurations (straight, open coudé with side eyes, open coudé without side eyes). A stylet in included with the catheters to aid during the catheter insertion. The Flush Ureteric Catheters and Ureteric Catheters are supplied in a 74 cm length and diameters range from 3 Fr. to 8 Fr. The Floppy Tip Hydro-coated Ureteric catheters are 70 cm long and have 5,6, and 7 Fr. diameters.

The Flush Ureteric Catheters and Ureteric Catheters are made from polyether block amide materials. The Floppy Tip Hydro-coated Ureteric catheters are made from polyvinyl chloride (PVC), have a hydrophilic coating over the distal tip (farthest away from the surgeon), and a soft tip which allows for easier insertion and advancement of the catheter. The materials have a radiopaque filler to allow for fluoroscopic visibility.

AI/ML Overview

This document describes the performance testing and acceptance criteria for Ureteric catheters, Flush Ureteric catheters, and Floppy Tip Hydro-Coated Ureteric Catheters.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing	In accordance with ISO 10993-1 and FDA guidance for "Biological Evaluation of Medical Devices part I: Evaluation and Testing within a risk management system". Devices categorized as surface contacting devices in contact with mucous membrane for a limited (<24 hours) duration.	Passed all tests for: Cytotoxicity, Sensitization, Irritation, Systemic toxicity (Floppy Tip Hydro-Coated Ureteric Catheter only), Sub-chronic toxicity (Floppy Tip Hydro-Coated Ureteric Catheter only), Implantation (Floppy Tip Hydro-Coated Ureteric Catheter only).
Performance Testing	Maintain safety and effectiveness for intended use throughout product shelf life (including after 5 years accelerated aging).	Passed all tests for: Visual, Compatibility, Dimensional, Viscous Fluid Test / Injection of contrast liquid, Flow Rate, Tensile, Friction Strength Test (distal tip), Radiopacity.

2. Sample size used for the test set and the data provenance:

Sample Size: Samples were tested at T=0 (initial state) and after 5 years of accelerated aging. The specific number of samples tested for each performance test is not explicitly stated in the provided document.
Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective. It implies the performance data was generated as part of the 510(k) submission to demonstrate substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This document describes performance testing of a physical medical device (catheter) rather than an AI/software device that requires expert review for ground truth establishment. The ground truth for these tests is based on objective measurements and established standards.

4. Adjudication method for the test set:

Not Applicable. As mentioned above, this is not an AI/software device requiring human adjudication of results. The performance tests yield objective data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This is not an AI/software device. MRMC studies are typically used to evaluate the performance of diagnostic imaging aids where human readers interpret images with and without AI assistance.

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

Not Applicable. This is a physical medical device. The "standalone" performance refers to the device's inherent functionality against specified criteria.

7. The type of ground truth used:

The ground truth for the performance tests is based on objective measurements against predefined specifications and industry standards. For example, dimensional measurements are compared to design specifications, flow rates are measured against expected values, and biocompatibility is assessed against ISO 10993-1.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device that requires a training set.

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

Not Applicable. As this is not an AI/machine learning device, there is no training set and therefore no ground truth establishment for a training set.

Summary

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December 21, 2017

Coloplast Corp. Cori L. Ragan Regulatory Affairs Manager 1601 West River Road North Minneapolis, MN 55411

Re: K171043

Trade/Device Name: Ureteric catheters, Flush Ureteric catheters, Floppy Tip Hydro-Coated Ureteric Catheters Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EYB Dated: November 22, 2017 Received: November 28, 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)

K171043

Device Name

Ureteric catheters / Flush Ureteric catheters / Floppy Tip Hydro-Coated Ureteric Catheters

Indications for Use (Describe)

Ureteric catheters are intended for endourological procedures, to restore or maintain drainage of the upper urinary tract and to inject contrast medium or saline.

Duration of use: Ureteric catheters are intended for temporary use during surgical procedure.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

I.	Submitter510(k) Owner:	Coloplast A/SHoltedam 13050 Humlebaek, Denmark
	Contact Person:	Cori RaganRegulatory Affairs Manager1601 West River RoadMinneapolis, MN 55411Phone: 612.597.5106Email: usclr@coloplast.com
	Date Prepared:	22 November 2017
II.	DeviceTrade or Proprietary Name:	Ureteric CathetersFlush Ureteric CathetersFloppy Tip Hydro-Coated Ureteric Catheters
	Common or Usual Name:	Ureteric Catheters
	Classification name:	Urological catheter and accessories(21CFR section 876.5130)
	Regulatory Class:	II
	Product Code:	EYB
III.	Predicate DeviceTrade Name:	Pigtail Ureteral Catheter set (K962004)
	Common / Usual Name:	Catheter, Ureteral, Gastro-Urology
	Classification Name:	Urological catheter and accessories(21CFR section 876.5130)
	Reference Device:	Porges Ureteral Catheters (K021856)
	Common / Usual Name:	Ureteral Catheters
	Classification Name:	Urological catheter and accessories(21CFR section 876.5130)

IV. Device Description

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the Luer fitting to connect to collecting or injection devices. Ureteric catheters are open at the distal end (farthest away from the surgeon) to allow use over a guidewire.

V. Indications for Use / Intended Use

Ureteric catheters are intended for endourological procedures, to restore or maintain drainage of the upper urinary tract and to inject contrast medium or saline.

Duration of use: Ureteric catheters are intended for temporary use during surgical procedure.

VI. Comparison of Technological Characteristics with the Predicate Device

The Ureteric Catheters, Flush Ureteric Catheters, and Floppy Tip Hydro-Coated Ureteric Catheters are similar to the predicate and reference device in that the following parameters:

All devices are hollow, polymeric tubes for urological drainage .
The devices are supplied sterile and intended for single use. ●
The predicate device and Floppy Tip Hydro-Coated Ureteric Catheter both have a ● hydrophilic coating to minimize friction.
. The reference device and the Ureteric catheters included devices which are uncoated and made from the same polyether block amide materials.
. The predicate device is supplied in 5.0 – 8.0 Fr diameters and 70 cm lengths and the reference device is available in 3 .0 - 10.0 Fr diameters and 70 cm lengths. These available configurations are essentially equivalent to the subject devices.
. The subject, predicate, and reference devices have side eyes (sideports) on some models.
The subject and reference devices both include stylets for ease of insertion.
. The subject and reference devices both include a connector nut with a Luer connector to allow for connection to a drainage device or syringe.

The following technological differences exist between the subject and predicate devices:

The predicate device is supplied with a round, pigtail end while the subject ● devices are supplied with straight and coudé tips.

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VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the Ureteric Catheters device was conducted in accordance with ISO 10993-1 and FDA guidance document for Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices part I: Evaluation and Testing within a risk management system". The Ureteric Catheters, Flush Ureteric Catheters, and Floppy Tip Hydro-coated Ureteric catheters are categorized as surface contacting devices in contact with mucous membrane for a limited (<24 hours) duration. The time of contact is assessed based on the total accumulated use time, when the device is used as intended.

The battery of biocompatibility testing included the following tests:

Cytotoxicity ●
Sensitization ●
Irritation ●
Systemic toxicity (Floppy Tip Hydro-Coated Ureteric Catheter only) ●
Sub-chronic toxicity (Subacute toxicity) (Floppy Tip Hydro-Coated Ureteric ● Catheter only)
Implantation (Floppy Tip Hydro-Coated Ureteric Catheter only) ●

Performance Testing

Performance testing was conducted with samples at T=0 and after 5 years accelerated aging. The battery of performance testing included the following tests:

Visual ●
Compatibility ●
Dimensional ●
Viscous Fluid Test / Injection of contrast liquid ●
Flow Rate ●
Tensile
Friction Strength Test (distal tip)
Radiopacity ●

The results of the performance testing demonstrate that the Ureteric Catheters, Flush Ureteric Catheters, and Floppy Tip Hydro-coated Ureteric catheters are safe and effective for their intended use throughout the product shelf life.

VIII. Conclusion

Substantial equivalence is supported by bench testing comparing the design, materials, intended use, technological characteristics, biocompatibility, and performance of the Ureteric Catheters, Flush Ureteric Catheters, and Floppy Tip Hydro-Coated Ureteric Catheters to the predicate and reference devices. Based on the entire comparison, the Ureteric Catheters, Flush Ureteric Catheters, and Floppy Tip Hydro-Coated Ureteric Catheters are substantially equivalent to products currently on the market.

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.