(138 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a ureteral catheter, with no mention of AI or ML capabilities.
No
The device is described as an access and catheterization tool for the urinary tract, used for delivery of fluids, drainage, and navigation, rather than for treating a disease or condition itself.
No
The device is described as a ureteral catheter used for access, catheterization, fluid delivery/drainage, and wire guide access/exchange within the urinary tract. These are interventional and facilitative actions, not diagnostic ones.
No
The device description clearly describes a physical catheter made of thermoplastic elastomer, designed for insertion into the urinary tract. It includes details about its size, material, and physical components like a Touhy-Borst adapter. This is a hardware medical device, not software-only.
Based on the provided information, the Dornier MINNOW Ureteral Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, in order to provide information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The description clearly states the Dornier MINNOW Ureteral Catheter is used for access and catheterization of the urinary tract for purposes like delivering contrast media, draining fluids, delivering irrigation fluids, navigating the ureter, and accessing/exchanging guidewires. These are all in vivo procedures, meaning they are performed within the living body.
- No Specimen Examination: The device does not involve the examination of specimens derived from the human body outside of the body.
Therefore, the Dornier MINNOW Ureteral Catheter is a medical device used for interventional procedures within the urinary tract, not an In Vitro Diagnostic device.
N/A
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 quides
Product codes
EYB
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
Indicated Patient Age Range
adults only (at least 22 years old)
Intended User / Care Setting
physicians
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
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
1
(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 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).
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 Catheter
5F x 70cm Open Tip Ureteral Catheter - MIOTO570R
6F 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).
4
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). 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.