The Advance CS Coronary Sinus Infusion Catheter is intended for temporary occlusion of the coronary sinus for infusion of contrast media, drugs, or therapeutic agents; or possible introduction of devices into the coronary venous system.

Device Description

The Advance® CS Coronary Sinus Infusion Catheter is an over-the-wire catheter. The 5.0 Fr balloon catheter is compatible with a 0.035 inch diameter wire guide. The device will be supplied sterile and intended for one-time use.

AI/ML Overview

The Cook Advance® CS Coronary Sinus Infusion Catheter underwent a series of non-clinical bench and animal tests to establish its safety and performance. The primary goal of these tests was to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Balloon Minimum Burst Strength	Balloons burst at or above the minimum rated burst pressure, with all failure modes being linear tears.	Predetermined acceptance criteria met; balloons burst at or above minimum rated burst pressure, linear tears.
Sheath Compatibility	Qualitative and quantitative evaluations show compatibility with a 5, 6, or 7 Fr sheath.	Predetermined acceptance criteria met; compatible with 5, 6, or 7 Fr sheath.
Balloon Profile	Measurement of catheter shaft, bonds, and folded balloon diameter shows compatibility with a 5, 6, or 7 Fr sheath (0.074, 0.087, or 0.100 inch profile).	Predetermined acceptance criteria met; compatible with 5, 6, or 7 Fr sheath.
Balloon Compliance	Balloon inflates to the stated balloon size.	Predetermined acceptance criteria met; balloon inflates to stated size.
Dynamic Burst of the Distal Lumen	All test articles withstand at least pressures in excess of 300 psig, regardless of injection media type (saline and contrast agent).	Predetermined acceptance criteria met; all test articles withstood >300 psig.
Static Burst of the Distal Lumen	Similar test articles fail at or above 100 psig.	Predetermined acceptance criteria met; similar test articles fail at or above 100 psig.
Freedom from Leakage	Balloon catheter withstands pressurization to 200 psi for 15 seconds without leaking or significantly increasing in outside diameter.	Predetermined acceptance criteria met; withstood 200 psi for 15 seconds without leak/significant OD increase.
Balloon Fatigue	Balloons are free from leakage and damage on inflation, withstanding 10 cycles of inflation.	Predetermined acceptance criteria met; free from leakage and damage after 10 inflation cycles.
Bond and Materials Strength	The tensile force during normal use does not fracture or rupture the balloon catheter bonds or materials.	Predetermined acceptance criteria met; tensile force during normal use does not fracture/rupture bonds/materials.
Inflation / Deflation Time	Balloon inflates within 60 seconds and fully deflates within 60 seconds.	Predetermined acceptance criteria met; inflates/deflates within 60 seconds.
Torque Strength	Catheter withstands two full rotations without failure.	Predetermined acceptance criteria met; withstood two full rotations without failure.
Kink and Flexibility	Catheter does not kink at a radius equal to or greater than 13mm.	Predetermined acceptance criteria met; no kinking at radius ≥ 13mm.
Particulate	Balloon does not create particulates that exceed reference limits.	Predetermined acceptance criteria met; particulates do not exceed reference limits.
Dimensional Verification	Devices meet dimensional specifications.	Predetermined acceptance criteria met; devices meet dimensional specifications.
Animal Evaluation	Acute safety and biologic response characterized approximately 48 hours following acute inflation of the balloon in the porcine coronary sinus.	Safety and biologic response characterized; no specific acceptance quantifiable criteria are provided beyond characterization.
Biocompatibility Testing	In conformance with applicable sections of ISO 10993-1, device is biocompatible (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility).	Predetermined acceptance criteria met; device is biocompatible per ISO 10993-1.

Study Details:

2. Sample Size and Data Provenance:
- The document does not explicitly state the specific number of devices or samples used for each individual test. However, the phrasing "all test articles" and "similar test articles" suggests that multiple units were tested for each criterion.
- The testing was performed by Cook Medical, a U.S.-based company. The animal evaluation was conducted in vivo, likely in a controlled laboratory setting (indicated by "acute inflation of the balloon in the porcine coronary sinus"). This suggests prospective testing for device validation.
3. Number of Experts and Qualifications for Ground Truth:
- This section is not applicable as the study involves non-clinical bench testing and animal evaluations, not studies requiring human expert assessment of images or data for ground truth establishment.
4. Adjudication Method:
- This section is not applicable for non-clinical bench and animal testing. The results are typically objectively measured and evaluated against predefined engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices interpreting medical images, not for the performance testing of a catheter.
6. Standalone Performance (Algorithm Only):
- This section is not applicable as the device is a physical medical catheter, not a software algorithm.
7. Type of Ground Truth Used:
- The ground truth for these tests was established through:
  - Engineering Specifications/Standards: Predetermined acceptance criteria based on product design specifications, recognized industry standards (e.g., ISO 10993-1 for biocompatibility), and regulatory requirements for medical devices.
  - Physical Measurements: Direct measurements of device attributes (e.g., burst pressure, dimensions, inflation/deflation times, force resistance).
  - Qualitative Observations: Visual inspection for leaks, damage, and compatibility.
  - Biological Response Assessment: In the animal study, the safety and biological response were characterized, implying observation and evaluation by veterinarians or researchers.
8. Sample Size for the Training Set:
- This section is not applicable. There is no "training set" in the context of physical medical device performance testing, as these are not machine learning or AI models. The testing described focuses on verifying the device's adherence to specifications.
9. How the Ground Truth for the Training Set was Established:
- This section is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below "COOK" is the word "MEDICAL" in smaller, white letters. The logo is simple and modern.

COOK INCORPORATED
750 DANIELS WAY, P.O, BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
612.339,2235 10 : 800.457.4500
WWW.COOKMEDICAL.COM

JAN 2 9 2014

510(k) SUMMARY

Submitted By:

Jennifer Richardson, MA Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (812) 335-3575 x102370 Fax: (812) 332-0281 Date Prepared: December 20, 2013

Device:

Advance® CS Coronary Sinus Infusion Catheter Trade Name: Common Name: Percutaneous Catheter Class II, Product Code: DQY, (21 CFR §870.1250) Classification:

Indications for Use:

The Advance® CS Coronary Sinus Infusion Catheter is intended for temporary occlusion of the coronary sinus for infusion of contrast media, drugs, or therapeutic agents; or possible introduction of devices into the coronary venous system.

Device Description:

Comparison to Predicate Device:

The proposed device is substantially equivalent to the predicate in terms of intended use, duration of use, principles of operation, and technological characteristics.

Discussion of Tests and Test Results:

The device 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 Testing shows the balloons will burst at or above the 1. minimum rated burst pressure, with all failure modes being linear tears. The predetermined acceptance criteria were met.
Sheath Compatibility Qualitative and quantitative evaluations show that the balloons 2. are compatible with a 5, 6, or 7 Fr sheath. The predetermined acceptance criteria were met.
1. Balloon Profile Measurement of the diameter of catheter shaft, bonds, and folded balloon shows that the device profile is compatible with a 5, 6. or 7 Fr sheath (0.074. 0.087, or 0.100 inch profile). The predetermined acceptance criteria were met.

K131204 Page 1 of 2

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Image /page/1/Picture/0 description: The image shows the logo for Cook Medical. The logo is black and white and features the word "COOK" in large, bold letters on the top line. Below that, the word "MEDICAL" is written in smaller letters. The logo is simple and professional.

COOK
INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
HONE: 812.339.2235 TOLL FREE: 800.457.4500
•WWW.COOKMEDICAL.COM

1. Balloon Compliance Testing shows that the balloon will inflate to the stated balloon size. The predetermined acceptance criteria were met.
1. Dynamic Burst of the Distal Lumen Testing characterized saline and contrast agent flow rate vs. pressure curves. Testing shows that all test articles withstood at least pressures in excess of 300 psig regardless of injection media type. The predetermined acceptance criteria were met.
1. Static Burst of the Distal Lumen Testing shows that similar test articles can be expected to fail at or above 100 psig. The predetermined acceptance criteria were met.
1. Freedom from Leakage Testing shows that the balloon catheter will withstand pressurization to 200 psi for a time period of 15 seconds without leaking or significantly increasing in outside diameter. The predetermined acceptance criteria were met.
Balloon Fatigue Testing shows that balloons are free from leakage and damage on 8. inflation, withstanding 10 cycles of inflation. The predetermined acceptance criteria were met.
1. Bond and Materials Strength Testing shows the tensile force during normal use should not fracture or rupture the balloon catheter bonds or materials. The predetermined acceptance criteria were met.
1. Inflation / Deflation Time Testing shows that the balloon will inflate within 60 seconds and fully deflate within 60 seconds. The predetermined acceptance criteria were met.
1. Torque Strength Testing shows that the catheter will withstand two full rotations without failure.
1. Kink and Flexibility The testing shows that the catheter will not kink at a radius equal to or greater than 13mm.
1. Particulate The testing shows that the balloon will not create particulates that exceed that of the reference limits.
1. Dimensional Verification The testing shows that the devices will meet dimensional specifications.
1. Animal Evaluation In vivo testing characterized the safety and biologic response approximately 48 hours following the acute inflation of the balloon in the porcine coronary sinus.
1. Biocompatibility Testing (i.e., cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility) shows the device is biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.

Conclusions Drawn from the Tests:

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.

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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

January 29, 2014

Cook Incorporated c/o Ms. Jennifer Richardson, MA 750 Daniels Way . P.O. Box 489 Bloomington, IN 47402

Re: K131204

Trade/Device Name: Advance® CS Coronary Sinus Infusion Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Advance® CS Coronary Sinus Infusion Catheter Regulatory Class: Class II Product Code: DQY Dated: December 30, 2013 Received: December 31, 2013

Dear Ms. Richardson:

We have reviewed vour 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

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Page 2 - Ms. Jennifer Richardson

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-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/ResourcesforYou/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/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 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/ResourcesforYou/Industry/default.htm.

.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm141.htm

Sincerely yours,

M.A. Hilleman

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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Cook Incorporated Advance® CS Coronary Sinus Infusion Catheter Traditional 510(k) 26 April 2013

Indications for Use Statement

510(k) Number (if known): _K131204

Device Name: Advance CS Coronary Sinus Infusion Catheter

Indications for Use:

Over-The-Counter Use X Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Hillerman

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).