The Occlusion Balloon Catheter is a triple lumen balloon catheter designed to temporarily occlude large vessels. The "Infusion" lumen is used to infuse contrast material through the catheter. The "Distal .035" lumen extends the length of the catheter and is used for placement over wire guides. The "Balloon" lumen is used to inflate and deflate the balloon. The Occlusion Balloon Catheter is available in one configuration. The catheter has two radiopaque marker bands on the shaft, enclosed within the balloon bonds, to help identify the location of the balloon under fluoroscopy. The balloon has a variable diameter up to a maximum of 40 mm when inflated and a catheter length of 75 cm.

AI/ML Overview

Acceptance Criteria and Device Performance for Occlusion Balloon Catheter (K101877)

This document describes the acceptance criteria and the study that proves the Occlusion Balloon Catheter meets these criteria, based on the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) submission for the Occlusion Balloon Catheter (K101877) focuses on establishing substantial equivalence to a predicate device (CODA Balloon Catheter, K032869) through design and performance testing. The document lists several tests conducted but does not explicitly state numerical acceptance criteria or specific quantitative performance values for each test within the document. Instead, it concludes that the "results of these tests provide reasonable assurance that the device has been designed and tested to ensure conformance to the requirements for its intended use."

However, based on the nature of the tests listed and general device safety and effectiveness principles, we can infer the common acceptance criteria for such a device and assume the reported performance met these underlying standards.

Test Category	Implicit Acceptance Criteria (Inferred)	Reported Device Performance
Burst Pressure Testing	The balloon catheter must withstand specified maximum internal pressures without bursting, maintaining integrity during clinical use.	"The proposed Occlusion Balloon Catheter was subjected to... Burst Pressure Testing." (Implied: device met predefined non-bursting pressure limits)
Bond Strength Testing	All catheter bonds (e.g., balloon to shaft) must withstand specified forces without delamination or failure.	"The proposed Occlusion Balloon Catheter was subjected to... Bond Strength Testing." (Implied: bonds met predefined strength requirements)
Tensile Testing	The catheter shaft and its components must withstand specified tensile forces without breaking or permanent deformation.	"The proposed Occlusion Balloon Catheter was subjected to... Tensile Testing." (Implied: device met predefined tensile strength requirements)
Fatigue Testing	The device must withstand repeated inflation/deflation cycles or other relevant mechanical stresses without failure, demonstrating durability.	"The proposed Occlusion Balloon Catheter was subjected to... Fatigue Testing." (Implied: device demonstrated durability over specified cycles)
Sheath Compatibility Testing	The catheter must be able to be introduced and withdrawn smoothly through compatible introducer sheaths without damage to the catheter or sheath.	"The proposed Occlusion Balloon Catheter was subjected to... Sheath Compatibility Testing." (Implied: demonstrated compatibility and smooth passage)
Inflation/Deflation Time	The balloon must inflate and deflate within clinically acceptable timeframes for efficient temporary occlusion.	"The proposed Occlusion Balloon Catheter was subjected to... Inflation/Deflation Time." (Implied: met predefined time limits for inflation/deflation)
Occlusion Testing	The inflated balloon must effectively occlude the intended vessel lumen, preventing flow past the balloon.	"The proposed Occlusion Balloon Catheter was subjected to... Occlusion Testing." (Implied: successfully demonstrated effective vessel occlusion)
Accelerated Aged Testing	The device must maintain its functional and mechanical properties after simulating a specified shelf-life period.	"The proposed Occlusion Balloon Catheter was subjected to... Accelerated Aged Testing." (Implied: demonstrated stability over simulated shelf-life)
Biocompatibility Testing	The device materials must be biocompatible, not eliciting adverse biological responses (e.g., cytotoxicity, sensitization, irritation).	"The proposed Occlusion Balloon Catheter was subjected to... Biocompatibility Testing." (Implied: materials met ISO 10993 standards for biocompatibility)

Overall Reported Performance: The document states: "The results of these tests provide reasonable assurance that the device has been designed and tested to ensure conformance to the requirements for its intended use." This indicates that all acceptance criteria were met.

2. Sample Size for Test Set and Data Provenance

The provided 510(k) submission does not explicitly state the sample sizes used for each of the performance tests (Burst Pressure, Bond Strength, Tensile, Fatigue, Sheath Compatibility, Inflation/Deflation Time, Occlusion, Accelerated Aged, and Biocompatibility Testing).

The data provenance is from Cook Incorporated, USA, as the submitter is located in Bloomington, IN, USA. The studies are described as prospective device performance tests conducted on the manufactured device.

3. Number of Experts and Qualifications for Ground Truth

This type of device submission (mechanical medical device) does not typically involve human expert adjudication for establishing "ground truth" in the same way an AI/ML-based diagnostic device would.

For mechanical performance testing, the "ground truth" is based on engineering specifications and scientific principles, verified through objective measurements and validated test methods. The "experts" involved would be the design engineers, quality control personnel, and test laboratory technicians conducting and interpreting the results according to established international and internal standards (e.g., ISO, ASTM, internal Cook specifications). Their qualifications would include engineering degrees, relevant certifications, and experience in medical device testing.

4. Adjudication Method for Test Set

As explained in point 3, no human adjudication method (like 2+1 or 3+1) was used or is applicable for this type of mechanical device performance testing. The "adjudication" is inherent in the objective measurement and comparison of test results against predefined engineering specifications and criteria.

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 (especially imaging-based AI) where human readers interpret data, and the AI's impact on their performance is evaluated. The Occlusion Balloon Catheter is a mechanical therapeutic device, not a diagnostic one.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Occlusion Balloon Catheter is a physical medical device, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this submission.

7. Type of Ground Truth Used

The ground truth used for the device's performance testing is based on:

Engineering Specifications: Predefined performance metrics (e.g., minimum burst pressure, maximum inflation time, required tensile strength) derived from design requirements, risk analysis, and relevant standards.
Physical Measurements: Objective data obtained from laboratory testing using calibrated equipment.
Biocompatibility Standards: Compliance with recognized international standards for biological evaluation of medical devices (e.g., ISO 10993 series).

8. Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" in the context of device development refers to iterative design, prototyping, and testing phases to refine the device, but not in the sense of a machine learning algorithm's training data.

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

Not applicable. As stated in point 8, there is no training set for this type of device submission.

Summary

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K101877 page 1 of 2

AUG 0 6 2010

Special 510(k): Device Modification Occlusion Balloon Catheter Cook Incorporated 2 July 2010

510(k) SUMMARY

Submitted By:

Lisa Webb, MBA, RAC Cook Incorporated 750 Daniels Way Bloomington, IN 47404

Device:

Trade Name: Proposed Classification:

Occlusion Balloon Catheter Catheter, Percutaneous DQY (21 CFR §870.1250)

Indications for Use:

The Occlusion Balloon Catheter is intended for temporary occlusion of large vessels.

Predicate Device:

The Occlusion Balloon Catheter is similar in terms of intended use, method of operation, materials of construction, and technological characteristics to the predicate device which was cleared as the CODA Balloon Catheter (K032869).

Device Description:

_ '

The Occlusion Balloon Catheter is available in one configuration. The catheter has two radiopaque marker bands on the shaft, enclosed within the balloon bonds, to help identify the location of the balloon under fluoroscopy. The balloon has a variable diameter up to a maximum of 40 mm when inflated and a catheter length of 75 cm.

Substantial Equivalence:

Cook Incorporated currently markets the predicate CODA Balloon Catheter, which was Cook moorporated Carrences 19, 2003 (K032869). The similar indications for use, enethod of operation, and technological characteristics of the Occlusion Balloon Catheter as compared to the predicate device support a determination of substantial equivalence.

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K101877 page. 2 of 2

Special 510(k): Device Modification Occlusion Balloon Catheter Cook Incorporated 2 July 2010

Test Data:

The proposed Occlusion Balloon Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters.

Burst Pressure Testing
트 Bond Strength Testing
트 Tensile Testing
Fatigue Testing 트
트 Sheath Compatibility Testing
Inflation/Deflation Time
트 Occlusion Testing
프 Accelerated Aged Testing
트 Biocompatibility Testing

The results of these tests provide reasonable assurance that the device has been designed and tested to ensure conformance to the requirements for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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, bold line drawing.

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

Cook, Inc. c/o Ms. Lisa Webb Regulatory Affairs Manager 750 Daniels Way Bloomington, IN 47402

Re: K101877

Trade/Device Name: Occlusion Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: July 2, 2010 Received: July 6, 2010

Dear Ms. Webb:

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.

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Page 2 - Ms. Lisa Webb

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours.

R. Valner

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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Special 510(k): Device Modification Occlusion Balloon Catheter Cook Incorporated 2 July 2010

Indications for Use

510(k) Number (if known):

1/10/877

Device Name: Occlusion Balloon Catheter

Indications for Use for the Occlusion Balloon Catheter:

The Occlusion Balloon Catheter is intended for temporary occlusion of large vessels.

AUG 0 6 2010

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

Over-the-Counter Use (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)

hummer R.S. humel

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K101872

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).