The COOK CODA™ BALLOON CATHETER is a 2-lumen catheter. The distal lumen extends the length of the catheter for use over a ,035 wire quide. The other lumen communicates with the balloon and is used to expand and deflate it. Radiopaque bands are placed at both the distal and proximal aspects of the balloon to assist with positioning of the device under fluoroscopy. The balloon will be provided in diameters ranging from 30 to 40 mm, and in lengths ranging from 100 to 120 cm. The device is packaged in sterile, sealed double pouches.

AI/ML Overview

The provided 510(k) summary for the COOK CODA™ BALLOON CATHETER does not contain detailed information regarding acceptance criteria, specific study designs, or performance metrics in a way that allows for the completion of all requested fields. This document focuses on demonstrating substantial equivalence to predicate devices based on general performance, biocompatibility, and mechanical property testing rather than a detailed clinical or comparative effectiveness study as would be seen for AI/ML-driven devices.

Here's the information that can be extracted from the provided text, and an explanation for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Not specified	Met test criteria
Mechanical Properties	Not specified	Met test criteria
Performance Characteristics	Not specified	Met test criteria
Safety	Not specified	Met test criteria

Explanation for Missing Information:
The 510(k) summary only states that "The device met the test criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence." It does not provide the specific quantitative or qualitative acceptance criteria for these tests, nor does it present the detailed results of these tests.

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

Sample size: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "testing to assess biocompatibility, mechanical properties, performance characteristics, and safety," which implies laboratory-based testing rather than clinical data from a specific population.

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

Number of experts: Not applicable.
Qualifications of experts: Not applicable.

Explanation for Missing Information:
This section is not applicable because the provided 510(k) summary describes a traditional medical device (balloon catheter) undergoing engineering and biocompatibility testing, not an AI/ML device requiring human expert ground truth for image or data interpretation.

4. Adjudication method for the test set

Adjudication method: Not applicable.

Explanation for Missing Information:
As mentioned above, this type of adjudication is typically relevant for studies involving human interpretation or machine learning models, which is not the case for this device's reported testing.

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

MRMC study: No.
Effect size: Not applicable.

Explanation for Missing Information:
An MRMC comparative effectiveness study is not relevant for this type of traditional medical device. This is a common study type for AI-powered diagnostic devices, where the goal is to show the benefit of AI assistance for human readers.

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

Standalone study: No.

Explanation for Missing Information:
This concept is specific to AI/ML algorithms. The COOK CODA™ BALLOON CATHETER is a physical device, and its performance is evaluated in terms of its physical and material properties, not as a standalone algorithm.

7. The type of ground truth used

Type of ground truth: Laboratory and engineering test results (e.g., measurements of mechanical properties, results of biocompatibility assays).

Explanation for Missing Information:
The term "ground truth" as typically used in AI/ML studies (expert consensus, pathology, outcome data) does not apply directly here. The "ground truth" for this device's testing would be established by validated test methodologies comparing the device's characteristics against predefined engineering specifications.

8. The sample size for the training set

Training set sample size: Not applicable.

Explanation for Missing Information:
This device does not involve machine learning; therefore, there is no "training set."

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

Ground truth establishment: Not applicable.

Explanation for Missing Information:
Since there is no training set, there is no ground truth for a training set to be established.

Summary

{0}------------------------------------------------

510(k) Summary	NOV 1 9 2003
Submitted By:	Theodore Heise, PhD, RACDirector of Regulatory Scientific AffairsCook Incorporated750 N. Daniels WayBloomington, IN 47404(812) 339-2235September 12, 2003
Names of Device:

COOK CODA™ BALLOON CATHETER Trade Name: Common/Usual Name: Balloon catheter Classification Name: Percutaneous catheter

Intended Use:

The COOK CODA™ BALLOON CATHETER is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

Predicate Devices:

Predicate devices are the LDOB BALLOON CATHETER (K002286) manufactured by Cook Incorporated (vessel occlusion), and the ILIAC BALLOON CATHETER (K003495) manufactured by Guidant Corporation (prosthesis expansion).

Device Description:

Substantial Equivalence:

The COOK CODA™ BALLOON CATHETER is comparable with respect to technical characteristics and intended use to predicate devices in terms of 510(k) substantial equivalence.

Discussion of Tests and Test Results:

The COOK CODA™ BALLOON CATHETER underwent testing to assess biocompatibility, mechanical properties, performance characteristics, and safety, The device met the test criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.

Conclusions Drawn from Tests:

The COOK CODA™ BALLOON CATHETER met the test criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, black line drawing.

NOV 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Theodore Heise Director of Regulatory Scientific Affairs c/o Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489

Re: K032869 CODA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 12, 2003 Received: September 15, 2003

Dear Dr. Heise:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 801); 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.

{2}------------------------------------------------

Page 2 – Dr. Theodore Heise

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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

Arlile B. Boam

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known) __ K03 2869

COOK CODA BALLOON CATHETER

Indications for Use:

Device Name:

The COOK CODA BALLOON CATHETER is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashley B. Boane

Division Sign-Off
Division of Cardiovascular Devices

510(k) Number K032869

Image /page/3/Picture/10 description: The image shows the text "Prescription Use" followed by the text "(Per 21 CFR 801.109)". There is a check mark above the line after the word "Use". The text is black and the background is white.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).