The Cook Ureteral Balloon Dilation Catheter Set is used for Dilation prior to stone manipulation or ureteroscopy, and Dilating the intramural ureter. This device is sterile And intended for one-time use.

Device Description

The Cook Ureteral Balloon Dilation Catheter Set is used for dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter. The materials used to construct the balloon and catheter is nylon with a hydrophilic coating. The Catheter is 7 French in diameter and is 65 cm's in length. The Rated Burst is 20 ATM's. The Set will include the balloon catheter and an inflation device. The product will be sold as sterile and intended for one-time use.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Cook Ureteral Balloon Dilation Catheter Set." It does not contain information about acceptance criteria or a dedicated study proving the device meets specific performance metrics in the way you've described (e.g., sensitivity, specificity, or human improvement with AI).

Instead, this document focuses on establishing substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, without needing to conduct extensive new clinical trials to prove efficacy from scratch.

Here's why the requested information cannot be extracted from this document:

Acceptance Criteria and Reported Device Performance: This document does not specify quantitative performance acceptance criteria (e.g., a certain percentage of successful dilations or a specific rate of adverse events that the device must achieve). The "Rated Burst is 20 ATM's" is a physical specification, not a clinical performance metric. The "performance" being evaluated here is primarily whether it's functionally similar to predicates, not whether it achieves a specific clinical outcome with a measurable metric.
Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Studies, Ground Truth for Test Set: These concepts are relevant for studies that assess diagnostic accuracy or clinical efficacy, often involving human readers, and are simply not present in a 510(k) substantial equivalence submission for a device like a ureteral balloon catheter. There's no test set in the sense of a collection of cases to be interpreted or diagnosed.
Training Set Sample Size and Ground Truth for Training Set: Similarly, for devices that are not AI-driven or diagnostic in nature (like this physical catheter), there is no concept of a "training set" for an algorithm.

What the document does tell us about "proof" and "acceptance":

Acceptance Criteria (Implicit): The implicit acceptance criterion is substantial equivalence to predicate devices. This means the device must be shown to be as safe and effective as devices already permitted for sale.
Study That Proves the Device Meets Acceptance Criteria: The "study" in this context is the 510(k) submission itself, which demonstrates substantial equivalence through:
- Comparison of Indications for Use: The proposed device's indications must be the same as or very similar to the predicate devices.
- Comparison of Design and Materials: The design (7 French, 65 cm, nylon with hydrophilic coating) and materials are compared to predicate devices.
- Comparison of Manufacturing and Quality Control: The document states the device "will be manufactured according to specified process controls and Quality Assurance Program" and "will undergo packaging and sterilization procedures similar to devices currently marketed."
- Performance Specifications: The "Rated Burst is 20 ATM's" is a specific performance characteristic, likely compared to predicates to ensure it's within an acceptable range for safe use.

In summary, for this particular document, the requested information (related to AI, diagnostic performance, expert review, sample sizes for test/training sets, etc.) is not applicable because the submission is based on substantial equivalence for a physical medical device, not a diagnostic or AI-driven system.

Summary

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APR = 6 2004

K040127

I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitted By:

Debbie Schmitt Cook Urological, Inc. 1100 West Morgan Street Spencer, Indiana 47460

Device:

Trade Name:

Cook Ureteral Balloon Dilation Catheter Set (Not vet determined) Dilator, Catheter, Ureteral

Proposed Classification Name:

Predicate Devices:

The Cook Ureteral Balloon Dilation Catheter Set is substantial equivalent to predicate devices in terms of indications for use and design. Predicate devices include the Balloon Ureteral Dilator Set, D.C. #K813278 manufactured by Cook Urological, Accent DGTM Balloon Ureteral Dilator Set. D.C. #K905375 manufactured by Cook Urololgical, Ascend™ Balloon Dilation Catheter, D.C. #K970041, the Balloon Dilation Catheters manufactured by Bard and the High Pressure Ureteral Dilatation Balloon Catheter manufactured by Microvasive.

Device Description:

Substantial Equivalence:

The device will be manufactured according to specified process controls and Quality Assurance Program. The device will undergo packaging and sterilization procedures to devices currently marketed and distributed by Cook Urological. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, with three curved lines forming the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 6 2004

Ms. Debbie Schmitt Regulatory Affairs Manager Cook Urological 1100 W. Morgan Street SPENCER IN 47460

Re: K040127

Trade/Device Name: Cook® Ureteral Dilation Catheter Set Regulation Number: 21 CFR §876.5470 Regulation Name: Ureteral dilator Regulatory Class: II Product Code: 78 EZN Dated: March 10, 2004 Received: March 12, 2004

Dear Ms. Schmitt:

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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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.

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Page 2 - Ms. Debbie Schmitt

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 (21 CFR Part 807); listing (21 CFR Part 807). labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation, please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Daniel A. Lynn

for
N
I

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	Not yet assigned K040127
Device Name:	Cook Ureteral Balloon Dilation Catheter
Indications for Use:	The Cook Ureteral Balloon Dilation Catheter Set is used forDilation prior to stone manipulation or ureteroscopy, andDilating the intramural ureter. This device is sterileAnd intended for one-timeuse.

Prescription Use (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Knadon

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number.

Regulation Number and Section

§ 876.5470 Ureteral dilator.

(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).