The Dornier MINNOW Ureteral catheter is indicated for access and catheterization of the urinary tract, including the following applications: Delivery of contrast media Drainage of fluids from the urinary tract Delivery of irrigation fluids to the urinary tract Navigation of a tortuous ureter Access, advancement, or exchange of wire quides

The target population is for adults only (at least 22 years old).

Device Description

The MINNOW Ureteral Catheter is a sterile single lumen medical grade thermoplastic elastomer (Pebax®) catheter. It is designed to assist in access to the upper urinary tract using standard endoscopic technique for drainage and delivery of gels or fluids. The device is offered without side holes and is available in 5 and 6 Fr. Sizes, which are common to the industry. The catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a quidewire or for the injection of gels or fluids into the urinary tract. The catheter tip is radiused and has a .041" ID that allows for a smooth transition and passage when placed over a guidewire of up to 0.038" inches in diameter that is pre-positioned through the urological tract. The MINNOW Ureteral Catheters are packaged with a standard Touhy-Borst adapter that allows for injection or aspiration of fluids, but removable to allow for scope exchange without having to remove the catheter. The MINNOW Ureteral Catheters are available in 5 and 6 French (Fr) diameter, with a catheter length of 70 centimeters (cm).

AI/ML Overview

This document describes a 510(k) submission for the Dornier MINNOW Ureteral Catheter, aiming to demonstrate its substantial equivalence to a predicate device. The information provided outlines the performance testing conducted to support this claim, rather than a clinical study evaluating the device's diagnostic performance or effectiveness in a "with AI vs without AI" scenario.

Therefore, many of the requested categories regarding acceptance criteria, study details, human reader performance, ground truth, and training sets are not applicable to this type of regulatory submission, as it focuses on demonstrating equivalence through engineering and biocompatibility testing for a physical medical device, not a diagnostic AI system.

Here's an analysis based on the provided text, addressing the applicable points and indicating when information is not relevant to this type of device and submission:

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

The document does not explicitly provide a table of acceptance criteria with specific numerical targets and matching reported performance values. Instead, it lists the types of tests performed and states that "All testing was found to be acceptable and substantially equivalent to those of the predicate device."

Test Category	Reported Device Performance
Sterility	Found to be acceptable and substantially equivalent to predicate device.
Packaging	Found to be acceptable and substantially equivalent to predicate device.
Biocompatibility	Found to be acceptable and substantially equivalent to predicate device.
Radiopacity	Found to be acceptable and substantially equivalent to predicate device.
Effective Working Length	Found to be acceptable and substantially equivalent to predicate device.
Catheter Shaft ID	Found to be acceptable and substantially equivalent to predicate device.
Catheter Tensile Strength	Found to be acceptable and substantially equivalent to predicate device.
Catheter Stiffness	Found to be acceptable and substantially equivalent to predicate device.

Note: Specific numerical acceptance criteria and performance values are not detailed in this summary. The "acceptable" status implies compliance with relevant standards and/or equivalence to the predicate device's performance within acceptable ranges.

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 in the document. The testing described (sterility, biocompatibility, mechanical properties) would typically involve specific sample sizes for each test according to established standards. Data provenance (country, retrospective/prospective) is not applicable, as this is laboratory testing of a manufactured physical device.

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. For this type of physical medical device (catheter), "ground truth" as it pertains to expert consensus on diagnostic images or clinical outcomes is not relevant. The "ground truth" for the performance tests would be defined by the specifications and standards for each physical or chemical property being measured. Expert involvement for physical/chemical testing is usually in the form of qualified laboratory personnel conducting the tests and engineers/scientists reviewing the results against specifications.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, often for diagnostic devices. The testing described here involves objective physical and chemical property measurements.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices where human performance with and without AI assistance is being evaluated. The Dornier MINNOW Ureteral Catheter is a physical medical device (catheter) for access and fluid management in the urinary tract, not a diagnostic AI system.

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

This information is not applicable. The device is a physical ureteral catheter, not an algorithm or AI system.

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

For the physical and material integrity tests conducted (Sterility, Packaging, Biocompatibility, Radiopacity, Effective Working Length, Catheter Shaft ID, Catheter Tensile Strength, Catheter Stiffness), the "ground truth" is defined by established engineering specifications, material standards (e.g., USP Class VI for biocompatibility), and relevant ISO/ASTM testing standards. There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense for these types of tests in this context. The aim is to meet predefined technical requirements and demonstrate equivalence to the predicate device's performance.

8. The sample size for the training set

This information is not applicable. The Dornier MINNOW Ureteral Catheter is a physical medical device, not an AI model or software algorithm that requires a training set.

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

This information is not applicable. As stated above, this device does not involve a training set.

Summary

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September 18, 2019

Dornier MedTech America Inc John Hoffer Vice President Quality, Regulatory, Clinical 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144

Re: K191187 Trade/Device Name: Dornier MINNOW Ureteral Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EYB Dated: July 17, 2019 Received: July 19, 2019

Dear John Hoffer:

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. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling

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(21 CFR Part 801); medical device reporting (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-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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,

Sharon M. Andrews Acting Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K191187

Device Name

Dornier MINNOW Ureteral Catheter

Indications for Use (Describe)

The target population is for adults only (at least 22 years old).

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801

Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

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510(k) SUMMARY

Dornier MINNOW Ureteral Catheter

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Dornier MedTech America, Inc. 1155 Roberts Blvd., Suite 100 Kennesaw, GA 30144

Date Prepared: 4/30/19

Contact Person: John Hoffer Phone: 770-514- 6163 Name/Address of Sponsor and Name of Device

Dornier MedTech America, Inc. 1155 Roberts Blvd. Kennesaw, GA 30144

Device Name -	Dornier MINNOW Ureteral Catheter5F x 70cm Open Tip Ureteral Catheter - MIOTO570R6F x 70cm Open Tip Ureteral Catheter - MIOTO670L
Common Name -	Ureteral Catheter
Classification Number -	876.1530
Classification Name -	Urological catheter and accessories
Product Code -	EYB
Product Code Name -	Catheter, ureteral, gastro-urology [GU]
Regulatory Class -	II

Predicate Device Cook Open End Ureteral Catheter (K171662).

Purpose of the 510(k) Notice

The purpose of this submission is to obtain marketing clearance for the Dornier MINNOW Ureteral Catheter product line.

Intended Use/Indications for Use

The Dornier MINNOW Ureteral catheter is indicated for access and catheterization of the urinary tract, including the following applications:

Delivery of contrast media

Drainage of fluids from the urinary tract Delivery of irrigation fluids to the urinary tract Navigation of a tortuous ureter

Access, advancement, or exchange of wire guides

The target population is for adults only (at least 22 years old).

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Device Description

or for the injection of gels or fluids into the urinary tract. The catheter tip is radiused and has a .041" ID that allows for a smooth transition and passage when placed over a guidewire of up to 0.038" inches in diameter that is pre-positioned through the urological tract. The MINNOW Ureteral Catheters are packaged with a standard Touhy-Borst adapter that allows for injection or aspiration of fluids, but removable to allow for scope exchange without having to remove the catheter. The MINNOW Ureteral Catheters are available in 5 and 6 French (Fr) diameter, with a catheter length of 70 centimeters (cm). Dimensional details are below.

Catheter Size	OD	ID	Tip ID	Length
5FR	.065" +/- .002"	.041" +/-.002"	.041" +/- .001"	70cm +/- 2cm
6FR	.078" +/- .002"	.049" +/- .002"	.041" +/- .001"	70cm +/- 2cm

The MINNOW Ureteral Catheters are constructed of a medical grade thermoplastic elastomer (Pebax®). This material has been USP Class VI tested and has passed all applicable biocompatibility testing. The base material is compounded with BaSO4 to render the MINNOW Ureteral Catheter radiopaque under x-ray fluoroscopy. All material colorants used are compliant with FDA standards.

Technological Characteristics

The basic characteristics of the Dornier MINNOW Ureteral Catheter are substantially equivalent to the predicate device. They are both made from medical grade material and are a single lumen design with an open tip. Both are radiopaque and can be visualized under fluoroscopy. They are able to be passed over a 0.038 guidewire during clinical use.

Performance Data

The MINNOW Ureteral Catheter was subjected to the following tests to assure design and performance under the specified testing parameters:

Sterility Packaging Biocompatibility Radiopacity Effective Working Length Catheter Shaft ID Catheter Tensile Strength Catheter Stiffness
All testing was found to be acceptable and substantially equivalent to those of the predicate device.

Substantial Equivalence

A comparison of design characteristics has been performed and demonstrates that the proposed MINNOW Ureteral Catheter is substantially equivalent to the predicate device in terms of intended use, technological characteristics, type of materials and performance characteristics. Therefore, the proposed MINNOW Ureteral Catheter is as safe, as effective, and performs as well as the predicate device.

Conclusion

Based on the data and information comparing the MINNOW Ureteral Catheter and the predicate device we conclude they are substantially equivalent as they have the same intended use, basic design, principle of operation, technology, materials, and performance to the predicate. Any minor differences between the subject and predicate devices do not raise any concerns regarding the overall safety or effectiveness. Thus, the MINNOW Ureteral Catheter is substantially equivalent to its predicate device.

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.