The Ureteric Catheters for retrograde ureteropyelography are flexible tubular devices designed with open proximal and distal ends. The bulb shaped distal end permits the catheter to enter the lowest part of the ureter maintaining water tightness when injecting contrast or saline. The Ureteric Catheters are made from a polyvinyl chloride (PVC) material and have soft bulbous tip to help position the device in the ureter meatus. The devices are provided sterile and are intended for single use. The Ureteric Catheters have a Chevassu open tip, do not have side eyes, and range in diameter from 3 Fr to 7 Fr for the catheter body and 4 Fr to 10 FR for the Chevassu bulb. They are supplied with a metal stylet to facilitate insertion and a Luer-lock syringe connector. They are provided in two lengths, 69.5 and 73 cm. The longer version is intended to be compatible with a 0.035" guidewire. The shaft is marked at one centimeter increments along the length to aid in advancement and is radiopaque for fluoroscopic visualization.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Ureteric catheter) and does NOT contain information about acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, I cannot extract the requested information from this document. The document details:

Device Name: Ureteric catheter
Regulation Number: 21 CFR § 876.5130 (Urological Catheter and Accessories)
Product Code: EYB
Predicate Devices: PORGES™ Ureteral Catheters (K021856) and Floppy Tip Hydro-Coated Ureteric Catheter (K171043)
Non-Clinical Performance Data: Biocompatibility testing (Cytotoxicity, Sensitization, Irritation), Performance testing (Visual Evaluation, Compatibility with Guidewire or Stylet, Compatibility with Connector, Compatibility with Liquid, Tensile Strength on Catheter Bulb, Tensile Strength on Catheter Tube, Flow Rate, Simulation of Use, Radiopacity), Sterilization, and Packaging and Distribution testing.
Absence of Clinical Studies: Explicitly states "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices."

No AI/ML software is mentioned, nor are any acceptance criteria or studies related to AI/ML performance.

Summary

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October 4, 2018

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

Re: K182122

Trade/Device Name: Ureteric catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EYB Dated: August 3, 2018 Received: August 6, 2018

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 mav, 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 avare 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Glenn B. Bell -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices

Center for Devices and Radiological Health

Office of Device Evaluation

Enclosure

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Indications for Use

510(k) Number (if known)

K182122

Device Name Ureteric catheter

Indications for Use (Describe)

Ureteric catheters for retrograde ureteropyelography are intended for injection of contrast medium or saline during endourological procedures.

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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7. 510(k) SUMMARY

SUBMITTER I.

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:	August 3, 2018
II.DEVICE
Trade or Proprietary Name:	Ureteric Catheter
Common or Usual Name:	Ureteric catheter
Classification Name:	Urological catheter and accessories(21CFR section 876.5130)Product Code: EYBDevice Class: 2

III. PREDICATE DEVICE

The Ureteric Catheters are substantially equivalent in performance, indication, and design to the primary predicate, PORGESTM Ureteral Catheters, cleared under premarket notification number K021856.

In addition to the primary predicate, the Floppy Tip Hydro-Coated Ureteric Catheter, cleared under premarket notification number K171043, is a secondary predicate for this submission. The Floppy Tip Hydro-Coated Ureteric Catheters are made from similar materials as the subject device and have similar performance requirements.

IV. DEVICE DESCRIPTION

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Ureteric Catheters are made from a polyvinyl chloride (PVC) material and have soft bulbous tip to help position the device in the ureter meatus. The devices are provided sterile and are intended for single use.

The Ureteric Catheters have a Chevassu open tip, do not have side eyes, and range in diameter from 3 Fr to 7 Fr for the catheter body and 4 Fr to 10 FR for the Chevassu bulb. They are supplied with a metal stylet to facilitate insertion and a Luer-lock syringe connector. They are provided in two lengths, 69.5 and 73 cm. The longer version is intended to be compatible with a 0.035" guidewire. The shaft is marked at one centimeter increments along the length to aid in advancement and is radiopaque for fluoroscopic visualization

V. INDICATIONS FOR USE

The Ureteric Catheters in this submission and the predicate PORGES ™ Ureteral Catheters have the same general intended use:

Ureteric catheters for retrograde ureteropyelography are intended for injection of contrast ● medium or saline during endourological procedures.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The subject devices, Ureteric Catheters, are substantially equivalent in performance, and design to PORGES Ureteral Catheters, cleared under premarket notification number K021856 and the Floppy Tip Hydro-Coated Ureteric Catheters, cleared under premarket notification number K171043. The Ureteric Catheters are similar to the predicates in the following parameters:

All devices are hollow, polymeric tubes for injection of saline or contrast media.
The devices are supplied sterile and intended for single use.
The subject and predicate devices both include stylets for ease of insertion.
The primary predicate device was supplied in 7.0 12.0 Fr bulb diameters and 69 cm ● lengths and the secondary predicate is available in 5 - 7 Fr diameters and 70 cm lengths.
Both the Ureteric Catheters and its predicate device. PORGES Ureteral Catheters, are ● made from Neoplex® with a Chevassu open tip.
All of the catheters are intended for transient use during the surgical procedure.
All of the catheters allow for connection with a syringe.
. The Floppy Tip Hydro-Coated Ureteric Catheters are made from similar materials without the Chavassu bulb and conform to similar performance requirements.

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

The Floppy Tip Hydro-Coated Ureteric Catheter has a hydrophilic coating and the subject ● device does not.

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VII. PERFORMANCE DATA

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

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 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

Performance Testing

Performance testing was conducted with samples immediately after production and after five years accelerated aging. The battery of performance testing included the following tests:

Visual Evaluation
Compatibility with Guidewire or Stylet ●
Compatibility with Connector ●
Compatibility with Liquid ●
. Tensile Strength on Catheter Bulb
Tensile Strength on Catheter Tube
Flow Rate
Simulation of Use
Radiopacity

The results of the performance testing demonstrate equivalence of the Ureteric Catheters to the predicate device. The Ureteric Catheters are considered safe and effective for their intended use.

Sterilization

The Ureteric Catheters are sterilized using ethylene oxide in a validated cycle demonstrating a sterility assurance level of 10-6.

Packaging and Distribution

The Ureteric Catheters 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.

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No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices.

VIII. CONCLUSIONS

The Ureteric Catheters have been demonstrated to be substantially equivalent to the two predicates, PORGES Ureteral Catheters, and the Floppy Tip Hydro-Coated Ureteric Catheters based on the nonclinical data provided, the same intended use, patient population, transient use duration, biocompatibility, and technological characteristics. Based on the comparisons, the 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.