The EquaFlow™ Multivalve Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents into the general vasculature. It is not intended for coronary, pediatric or neonatal use.

Device Description

The EquaFlow Multivalve Infusion Catheter (MIC) is manufactured as a 4.0 or 5.0 French catheter, available in lengths of 40, 65, 100, or 130 centimeters (cm). The EquaFlow Multivalve Infusion Catheter is manufactured with distal and proximal platinum/iridium radiopaque markers, indicating the location of the side-valves' infusion segment. The infusion segments are in lengths of 5, 10, 15, 20, 30, 40, 50, and 60 cm. The number of side-valves is directly related to the length of the infusion segment, with holes 0.10 inches apart at the distal end and 0.25 inches apart as you move toward the proximal end. The distal tip of the EquaFlow Multivalve Infusion Catheter is straight and tapered. The catheter is manufactured with a nylon hub and strain relief at the proximal end.

The EquaFlow Multivalve Infusion Catheter is a single lumen catheter intended for delivering controlled infusions of intravascular therapeutic solutions. The catheter tip is designed with a tip valve, which allows occlusion of the catheter end hole without the use of a wire guide. The EquaFlow Multivalve Infusion Catheter is designed with side-valves spiraling along the specified infusion segment length of the distal portion of the catheter, providing a more even distribution of therapeutic solutions to the targeted location.

AI/ML Overview

The provided text describes a medical device, the Cook Incorporated EquaFlow™ Multivalve Infusion Catheter, and its clearance through the FDA's 510(k) process. This process focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or determining specific acceptance criteria for performance metrics in a clinical study. Therefore, much of the requested information (regarding clinical study design, sample sizes for test/training sets, expert involvement, and comparative effectiveness) is not available in the provided text, as it describes a premarket notification for a device that is not an AI/ML powered device.

However, the text does describe the mechanical and physical performance tests conducted to ensure reliable design and performance, equating these to the "acceptance criteria" for product release.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (Tests Conducted) and Reported Device Performance:

Acceptance Criteria (Test)	Reported Device Performance
Tensile	Supports substantial equivalence to predicate devices
Flow Restriction	Supports substantial equivalence to predicate devices
Flow Rate	Supports substantial equivalence to predicate devices
Burst Pressure	Supports substantial equivalence to predicate devices
Liquid/Air Leakage	Supports substantial equivalence to predicate devices
Biocompatibility	Supports substantial equivalence to predicate devices

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

Sample Size: Not specified in the provided document. The document refers to "applicable testing" and does not detail the number of units tested for each criterion.
Data Provenance: The tests were conducted internally by Cook Incorporated as part of their specified process controls and procedures, likely in a laboratory setting. There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical context, as these are technical performance tests, not clinical efficacy studies.

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 these tests would be the established engineering standards and specifications for the device's physical and mechanical properties. These are measured objectively by testing equipment, not by expert consensus from clinicians.

4. Adjudication method for the test set:

Not applicable. The results of the mechanical and physical tests are objective measurements against defined specifications. There is no mention of adjudication, as that is typically relevant for subjective assessments in clinical studies or image interpretation.

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:

No. This is a medical device (infusion catheter), not an AI/ML powered device. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted or is relevant for this device.

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

No. This is a medical device, not an AI/ML algorithm.

7. The type of ground truth used:

The ground truth for these tests would be objective engineering specifications and standards for material strength, flow characteristics, pressure resistance, leakage, and biological compatibility. The device was tested to ensure it met these predetermined physical and performance requirements.

8. The sample size for the training set:

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. As this is not an AI/ML device, there is no "training set."

Summary of Study:

The "study" referenced for this device is a series of in-vitro engineering and biocompatibility tests. These tests were conducted by Cook Incorporated to demonstrate that the EquaFlow™ Multivalve Infusion Catheter met its design specifications and performed reliably. The results of these tests supported the conclusion of substantial equivalence to existing predicate devices (Cragg-McNamara™ Valved Infusion Catheters and Pulse*Spray® Infusion System) under the FDA's 510(k) pathway. The purpose of these tests was to ensure the device's physical integrity and functional performance in a lab setting, not its clinical efficacy or AI performance.

Summary

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Cook Incorporated EquaFlow™ MultiValve Infusion Catheter 11 January 2013

5. 510(k) Summary

K123235 Poge 2 of

FEB 1 4 2013

EquaFlow™ Multivalve Infusion Catheter 510(k) Summary 21 CFR §807.92

1. Submitter Information:

Applicant: Address:

Phone Number: Fax Number:

Contact: Contact Address:

Email Contact Phone Number: Contact Fax Number:

2. Device Information:

Trade name: Common name: Classification: Regulation: Product Code:

Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (800) 468-1379 (812) 332-0281

Amber Brown Cook Incorporated 750 Daniels Way Bloomington, IN 47404 amber.brown@cookmedical.com 812-339-2235 Ext. 2234 812-332-0281

EquaFlow™ Multivalve Infusion Catheter Continuous flush catheter Class II 21 CFR 870.1210 KRA

3. Predicate Device:

The EquaFlow Multivalve Infusion Catheter is substantially equivalent to the Cragg-McNamara" Valved Infusion Catheters, manufactured by Micro Therapeutics Incorporated, which are cleared under 510(k) number K964868. The EquaFlow Multivalve Infusion Catheter is also substantially equivalent to the Pulse*Spray® Infusion System, manufactured by AngioDynamics Incorporated, which is cleared under 510(k) number K961763.

4. Comparison to Predicates:

The proposed device is substantially equivalent to the predicates in terms of intended use, duration of use, principles of operation, technological characteristics, insertion method, anatomical location, and method of sterilization. The proposed devices will be manufactured

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Cook Incorporated EquaFlow™ MultiValve Infusion Catheter 11 January 2013

according to Cook Incorporated's specified process controls, sterilization, and packaging procedures.

K12323

5. Device Description:

6. Intended Use:

The EquaFlow Multivalve Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents into the general vasculature. It is not intended for coronary, pediatric or neonatal use.

7. Technological Characteristics:

The proposed EquaFlow Multivalve Infusion Catheter was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:

Tensile
Flow Restriction
Flow Rate
Burst Pressure .
Liquid/Air Leakage
Biocompatibility

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Cook Incorporated
EquaFlow™ MultiValve Infusion Catheter
11 January 2013

The results of these tests support a conclusion that the proposed Equaflow Multivalve Infusion Catheter and the predicate devices are substantially equivalent.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

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

FEB 1 4 2013

Cook Incorporated Amber Brown, Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K123235

Trade/Device Name: EquaFlow Multivalve Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: DYB Dated: January 11, 2013 Received: January 14, 2013

Dear Ms. Brown:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

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

Enclosure

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Cook Incorporated EquaFlow™ MultiValve Infusion Catheter 11 January 2013

4. Indications for Use Statement

510(k) Number (if known):

K123235

Device Name:

EquaFlow™ Multivalve Infusion Catheter

Intended Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/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	MAWTex
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K123235

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).