The Arrow Central Venous Access Product permits venous access and catheter introduction to the central circulation. The ARROWg+ard Blue® antimicrobial surface is intended to help provide protection against access device-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.

Device Description

The Arrow MAC™ with ARROWg+ard Blue® is a venous access catheter with the functionality of three segregated internal pathways. The hemostasis valve and distal lumen can accommodate a thermodilution catheter, or similar device, 7 to 8 Fr in size while the remaining space is utilized as a flow lumen through the distal port.

AI/ML Overview

The provided 510(k) summary for the MAC™ 3 Lumen Central Venous Access Kit with ARROWg+ard Blue® Antimicrobial Surface (K032962) indicates that the device's acceptance criteria and the study proving it meets these criteria are based on performance tests demonstrating substantial equivalence to legally marketed predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Tests)	Reported Device Performance (Conclusion)
Flow rate	The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.
Leak test	The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.
Tensile test	The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.
Fatigue test	The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.
Flex modulus test	The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.

Note: The document only lists the types of tests performed and a general conclusion of substantial equivalence. Specific quantitative acceptance criteria (e.g., "flow rate must be > X mL/min") and the exact results achieved for each test are not detailed in this 510(k) summary. The "reported device performance" is essentially that it met the unspecified criteria for substantial equivalence to the predicate devices in these areas.

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

The document does not specify the sample size used for the performance tests.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in the sense that it's a submission of lab test results to demonstrate equivalence, rather than a prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the study described is a series of laboratory performance tests rather than an evaluation of a diagnostic device requiring expert interpretation of results. The "ground truth" for these engineering tests would be the established scientific and engineering principles for evaluating medical device performance.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., reading medical images) to resolve discrepancies among experts.

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

An MRMC comparative effectiveness study was not done. This type of study is entirely irrelevant for the device described, which is a physical catheter and not an AI-powered diagnostic or assistive tool.

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

A standalone performance test in the context of an algorithm or AI was not done. This device is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used for these performance tests would be established engineering and material science standards and specifications for intravascular catheters and introducers. These are objective measurements against defined physical properties and functionalities (e.g., material strength requirements, acceptable leak rates, flow rate specifications).

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of a physical medical device undergoing performance testing. Training sets are relevant for machine learning algorithms.

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

This information is not applicable for the same reasons as point 8.

Summary

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K032962

OCT 2 9 2003

510(k) Summary
Submitter:	ARROW International, Inc.2400 Bernville RoadReading, PA 19605-9607 USA
Contact person:	Elizabeth Price, Regulatory AssociatePhone: 610-378-0131, ext. 3220Fax: 610-374-5360Email: elizabeth.price@arrowintl.com
Date summary prepared:	9/22/03
Device trade name:	MAC™ 3 Lumen Central Venous Access Kit with ARROWg+ardBlue® Antimicrobial Surface.
Device common name:	Catheter introducer; intravascular catheter
Device classificationname:	DYB, Class II, 21 CFR 870.1340, Catheter, introducer, short term.FOZ, Class II, 21 CFR 880.5200, Catheter, Intravascular, short term
Legally marketeddevices to which thedevice is substantiallyequivalent:	Arrow MAC™ 2 Lumen Central Venous Access Kit withARROWg+ard Blue® Antimicrobial Surface (K011761).Baxter Multiple-Lumen Access Products (K981909).
Description of thedevice:	The Arrow MAC™ with ARROWg+ard Blue® is a venous accesscatheter with the functionality of three segregated internalpathways. The hemostasis valve and distal lumen canaccommodate a thermodilution catheter, or similar device, 7 to 8 Frin size while the remaining space is utilized as a flow lumen throughthe distal port.
Intended use of thedevice:	The Arrow Three-Lumen Central Venous Access device permitsvenous access and catheter introduction to the central circulation.The ARROWg+ard antimicrobial surface is intended to help provideprotection against access device-related infections. It is notintended to be used as a treatment for existing infections nor is itindicated for long-term use.
Technologicalcharacteristics:	The proposed device has the same technological characteristics asthe predicate device(s).
Performance tests:	Tests were performed to demonstrate substantial equivalence in thefollowing areas:- Flow rate- Leak test- Tensile test- Fatigue test- Flex modulus test
Conclusions:	The results of the laboratory tests demonstrate that the device is assafe and effective as the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2003

Ms. Elizabeth Price Regulatory Affairs ARROW International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605

Re: K032962

Trade/Device Name: MAC™ 3 Lumen Central Venous Access Kit with ARROWg ard Blue® antimicrobial surface Regulation Number: 880.5200, 870.1340 Regulation Name: Intravascular Catheter, Catheter Introducer Regulatory Class: II Product Code: FOZ, DYB Dated: September 22, 2003 Received: September 29, 2003

Dear Ms. Price:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Price

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); good manufacturing practice requirements as set 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

Indications for Use:

K, 032962

MAC™ 3 Lumen Central Venous Access Kit with ARROWg*ard Blue® antimicrobial surface

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrica Cuenite

(Division Sian-Off) Division of Anesthesiology. General Hospital. Infection Control, Dental Devices

510(k) Number. K032962

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).