The Coda LP Balloon Catheters are over-the-wire catheters that are available with an inflated balloon diameter of 32 millimeters and a balloon volume of 30 cc. The catheters are 9.0 French and are available in lengths of 100 or 120 centimeters. The Coda LP Balloon Catheter shaft contains two independent lumens within a single extrusion. The distal lumen extends the length of the catheter and is used for placement over a 0.035 inch diameter wire guide. The balloon (inflation and deflation) lumen extends from the proximal hub to the two inflation media exit ports within the balloon. The catheters are supplied sterile and are intended for one-time use.

AI/ML Overview

The provided document is a 510(k) summary for the Coda® LP Balloon Catheter, which is a medical device. This document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to predicate devices. It does not present information about a study involving an AI algorithm or human readers, but rather "Test Data" related to the physical performance of the balloon catheter.

Therefore, I will extract the available "acceptance criteria" and "device performance" for the physical device based on the provided "Test Data". I cannot provide information related to AI performance, multi-reader multi-case studies, or training/test set ground truth as these are not relevant to this type of device submission.

Here's the information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Balloon Burst Testing	Balloons burst above the maximum rated volume, with all failures non-fragmentary.	Testing showed that the balloons burst above the maximum rated volume, with all failures being non-fragmentary. The acceptance criteria were met.
Balloon Inflation/Deflation Testing	Balloons inflated to rated burst pressure within 30 seconds and fully deflated within 30 seconds.	Testing showed that the balloons inflated to rated burst pressure within 30 seconds and fully deflated within 30 seconds. The acceptance criteria were met.
Simulated Use Testing	Catheters capable of being inserted and retracted from an appropriately sized sheath without excessive resistance. Device able to expand an endovascular graft by inflating the balloon.	Testing showed that the catheters were capable of being inserted into and retracted from an appropriately sized sheath without experiencing excessive resistance. Testing showed that this device was able to expand an endovascular graft by inflating the balloon. The acceptance criteria were met.
Fatigue Testing	Balloons free from leakage and damage on inflation after withstanding 40 cycles of inflation/deflation.	Testing showed that the balloons were free from leakage and damage on inflation, withstanding 40 cycles of inflation/deflation. The acceptance criterion was met.
Occlusion and Migration Testing	Device able to occlude fluid flow without migrating.	Testing showed that this device was able to occlude fluid flow without migrating. The acceptance criteria were met.
Tensile Strength Testing	Peak load values in accordance with the acceptance criteria under proper clinical use.	Testing showed that under proper clinical use of the device, the peak load values were in accordance with the acceptance criteria.

2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of balloons for burst testing, number of catheters for simulated use). It also does not specify the provenance of the data (country of origin, retrospective/prospective), as it's a submission for a physical medical device. These tests are typically conducted in a laboratory setting by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for a physical device like a balloon catheter is determined by objective engineering and performance specifications and measurements (e.g., burst pressure, inflation time, tensile strength), not by expert consensus or interpretation of data.

4. Adjudication method for the test set:
Not applicable, as the tests involve objective physical measurements rather than subjective assessments requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human interpretation is involved. The Coda® LP Balloon Catheter is an interventional device, and the testing focuses on its mechanical and functional performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, this concept is not applicable as the submission is for a physical medical device, not an algorithm.

7. The type of ground truth used:
The "ground truth" for this device's testing is based on engineered performance specifications and objective measurements of its physical and functional properties, as described in the "Test Data" section. This includes measurements of burst pressure, inflation/deflation times, material strength, and performance during simulated use.

8. The sample size for the training set:
Not applicable. This device is not an AI algorithm; therefore, there is no "training set."

9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this physical device.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 12, 2015

Cook Incorporated Chad Schulenburg Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47404

Re: K150970

Trade/Device Name: Coda LP Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: April 10, 2015 Received: April 13, 2015

Dear Chad Schulenburg:

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. 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 (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K150970

Device Name Coda® LP Balloon Catheter

Indications for Use (Describe)

The Coda® LP Balloon Catheter is intended for the temporary occlusion of large vessels, or to expand vascular prostheses.

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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510(k) SUMMARY

Submitted By: Chad Schulenburg, MA Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47404 Phone: (812) 335-3575 x104073 Fax: (812) 332-0281 Date Prepared: May 12, 2015

Device:

Trade Name:	Coda® LP Balloon Catheter
Common Name:	Occlusion Balloon Catheter
Classification Name:	Catheter, PercutaneousDOY (21 CFR §870.1250)

Indications for Use:

The Coda® Low Profile Balloon Catheter is intended for the temporary occlusion of large vessels, or to expand vascular prostheses.

Predicate Devices:

The device subject of this submission is substantially equivalent to the predicate devices, cleared for market under 510(k) numbers K032869 on November 19, 2003 and K122917 on June 28, 2013.

Comparison to Predicate Devices:

It has been demonstrated that the Coda LP Balloon Catheters are comparable to the predicate devices. The Coda LP Balloon Catheters are identical in terms of intended use, principles of operation, materials of construction, and basic technological characteristics to the predicate devices. The device changes consist of a balloon with a smaller diameter and volume, and a smaller catheter French size. The Coda LP Balloon Catheters are also used through a smaller introducer sheath. The safety and effectiveness of the modifications are supported by testing.

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a red background. The logo is simple and clean, and the red and white color scheme is eye-catching.

Device Description:

Test Data:

The following tests were performed to demonstrate that the Coda LP Balloon Catheters met applicable design and performance requirements and support a determination of substantial equivalence.

. Balloon Burst Testing - Testing showed that the balloons burst above the maximum rated volume, with all failures being non-fragmentary. The acceptance criteria were met.
. Balloon Inflation/Deflation Testing - Testing showed that the balloons inflated to rated burst pressure within 30 seconds and fully deflated within 30 seconds. The acceptance criteria were met.
. Simulated Use Testing - Testing showed that the catheters were capable of being inserted into and retracted from an appropriately sized sheath without experiencing excessive resistance. Testing showed that this device was able to expand an endovascular graft by inflating the balloon. The acceptance criteria were met.
Fatigue Testing – Testing showed that the balloons were free from leakage and damage on inflation, withstanding 40 cycles of inflation/deflation. The acceptance criterion was met.
. Occlusion and Migration Testing – Testing showed that this device was able to occlude fluid flow without migrating. The acceptance criteria were met.
. Tensile Strength Testing – Testing showed that under proper clinical use of the device, the peak load values were in accordance with the acceptance criteria.

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Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. The logo is simple and clean, and the red and white colors are eye-catching.

cook incorporated 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

Conclusion:

In conclusion, the results of these tests support a determination of substantial equivalence to the predicate devices.

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).