The Coda Balloon Catheter is a 10.0 French device measuring 120 or 140 cm in usable length. The Coda Balloon Catheter shaft contains two independent lumens. 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 inflation ports within the balloon. The maximum inflation diameter is 46 mm, with a corresponding maximum balloon inflation volume of 60 mL. The device will be supplied sterile, intended for one-time use.

AI/ML Overview

Here's an analysis of the provided text regarding the Coda Balloon Catheter, organized according to your requested information:

Coda Balloon Catheter Acceptance Criteria and Study Details

The provided document describes a Special 510(k) Premarket Notification, which typically focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel clinical effectiveness. Therefore, the "study" described is a series of engineering and performance tests, not a clinical trial involving human subjects or AI algorithms.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Balloon Minimum Burst Strength & Compliance	Minimum rated burst volume, calculated for 99% coverage and 95% confidence, is greater than the 60 mL inflation volume corresponding to a 46 mm balloon diameter.	The predetermined acceptance criteria were met (specifically, the minimum rated burst volume was greater than 60 mL at 46 mm diameter).
Occlusion and Migration	At the 95% confidence level and with 90% minimum coverage, ability to occlude a mock vessel when pressurized without any evidence of liquid leakage or migration.	The predetermined acceptance criteria were met (demonstrated ability to occlude a mock vessel without leakage or migration).
Balloon Fatigue	Balloons are free from leakage and damage on inflation, withstanding 40 cycles of inflation/deflation (20 unconstrained/20 constrained).	The predetermined acceptance criteria were met (balloons were free from leakage and damage after 40 cycles).
Inflation/Deflation Time	90% of the overall population from which test articles were sampled have an inflation and deflation time (independently evaluated) below 30 seconds with a 95% confidence level.	The predetermined acceptance criteria were met (90% of the population had inflation/deflation times below 30 seconds with 95% confidence).
Simulated Use	Device compatibility with recommended sheath and wire guide, and performance according to the instructions for use in a vascular prosthesis and anatomical model.	The predetermined acceptance criteria were met (devices showed compatibility with sheath/wire guide and performed according to IFU in simulated use).
Catheter Usable Length	Usable catheter length verifies to the specified length ± 2 cm.	The predetermined acceptance criterion was met (usable catheter length verified to the specified length ± 2 cm).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes for each test in terms of the number of individual catheters or components tested. However, it mentions statistical confidence levels and coverage, implying that a statistically significant number of samples were used for tests like "Balloon Minimum Burst Strength and Compliance," "Occlusion and Migration," and "Inflation/Deflation Time."

Sample Size: Not explicitly stated as a specific number for each test. Phrases like "99% coverage and 95% confidence," "95% confidence level and with 90% minimum coverage," and "90% of the overall population from which test articles were sampled... with a 95% confidence level" indicate a statistically sound approach was taken to determine the number of samples needed.
Data Provenance: The tests are described as pre-clinical bench testing and simulated use testing. This is not human clinical data. The location of the testing is not specified, but it can be inferred to be from the manufacturer (Cook Incorporated) or its contracted testing facilities. This is prospective testing conducted to evaluate the modified device before seeking market clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of testing does not involve "experts" establishing a "ground truth" in the clinical sense (e.g., radiologists interpreting images). The ground truth is defined by the objective physical and mechanical properties and performance standards of the device itself. The "experts" involved would be the engineering and quality assurance personnel who designed, executed, and analyzed these tests, following established engineering standards and protocols. Their qualifications would be in engineering, materials science, and quality assurance, not clinical practice.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where there is subjective assessment (e.g., by human readers). Since these are objective engineering and performance tests, there is no need for such adjudication. The results are quantitative measurements or observations against predefined pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This document pertains to the clearance of a medical device (a balloon catheter) based on its physical characteristics and engineering performance, not the interpretative accuracy of an AI algorithm or human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not applicable. This document describes a physical medical device, not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The ground truth used for these tests is objective, measurable engineering and performance specifications. For example:

Burst Strength: The maximum pressure the balloon can withstand before rupturing.
Occlusion: The ability to form a complete seal in a mock vessel without leakage.
Fatigue: The ability to withstand inflation/deflation cycles without structural damage.
Inflation/Deflation Time: The time taken to reach full inflation/deflation.
Usable Length: A precise measurement of the catheter's length.

These are not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on physical science and engineering principles.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device clearance. This is not an AI/machine learning device. The design and manufacturing processes are established based on engineering principles and regulatory standards, not on "training data."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it. The performance standards and acceptance criteria for the physical device are based on established engineering principles, industry standards, and the performance of the predicate device (K032869).

Summary

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

Special 510(K) Premarket Notification Coda Balloon Catheter Cook Incorporated November 27, 2012

510(k) Summary

Submitted By:

Submitted By:

Elysia Easton Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 812-339-2235

Device:

Trade Name: Common/Usual Name: Proposed Classification:

Coda Balloon Catheter Occlusion Balloon Catheter Catheter, Percutaneous (74 DQY)

Indications for Use:

Intended for temporary occlusion of large vessels, or to expand vascular prostheses.

Predicate Devices:

Coda Balloon Catheter cleared under the following 510(k) Premarket Notification:

K032869, November 19, 2003 .

Device Description:

Substantial Equivalence:

The identical indications for use and technological characteristics of the Coda Balloon Catheter as compared to the predicate device support a determination of substantial equivalence.

Comparison to Predicate Device:

The Coda Balloon Catheter has been modified from the predicate Coda Balloon Catheter to include a balloon diameter of 46 mm and an additional catheter length of 140 cm. It has been demonstrated that the Coda Balloon Catheter is comparable to the predicate device in terms of design, intended use, materials, fundamental technology, and principle of operation.

K 122917

JUN 2 8 2013

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

Special 510(K) Premarket Notification Coda Balloon Catheter Cook Incorporated November 27, 2012

Test Data:

The Coda Balloon Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

Balloon Minimum Burst Strength and Compliance Testing demonstrates the 1. minimum rated burst volume of the test article, calculated for 99% coverage and 95% confidence, is greater than the 60 mL inflation volume corresponding to a 46 mm balloon diameter. The predetermined acceptance criteria were met.
Occlusion and Migration Testing demonstrates, at the 95% confidence level and 2. with 90% minimum coverage, the ability to occlude a mock vessel when pressurized without any evidence of liquid leakage or migration. The predetermined acceptance criteria were met.
Balloon Fatigue Testing shows that balloons are free from leakage and damage on 3. inflation, withstanding 40 cycles of inflation/deflation (20 unconstrained/20 constrained). The predetermined acceptance criteria were met.
Inflation/Deflation Time Testing statistically demonstrates that 90% of the overall 4. population from which test articles were sampled have an inflation and deflation time (independently evaluated) below 30 seconds with a 95% confidence level. The predetermined acceptance criteria were met.
Simulated Use Simulated use testing in a vascular prosthesis and anatomical model న. shows both devices are compatible with the recommended sheath and wire guide and perform according to the instructions for use. The predetermined acceptance criteria were met.
Catheter Usable Length Testing verifies usable catheter length to the specified 6. length ± 2 cm. The predetermined acceptance criterion was met.

In conclusion, the results of these tests provide reasonable assurance that the device is as safe and effective as the predicate device and support a determination of substantial equivalence.

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 28, 2013

Cook Incorporated C/O Elysia Easton Regulatory Affair Specialist 750 Daniels Way Bloomington, IN 47404

Re: K122917

Trade/Device Name: Coda® Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DOY Dated: May 30, 2013 Received: May 31, 2013

Dear Ms Easton:

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

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

device-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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Maik Jellon
for

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

Enclosure

{4}------------------------------------------------

Special 510(K) Premarket Notification Coda Balloon Catheter Cook Incorporated September 21, 2012

K122917 510(k) Number (if known):

Device Name: Coda Balloon Catheter

Indications for Use:

Intended for temporary occlusion of large vessels, or to expand vascular prostheses.

Prescription Use X (Per 21 CFR 801 Subpart D) OR

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

1 .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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).