The ARROWg ard Blue Plus™ antimicrobial catheter is indicated in the short-term (<30 day) The ARROWN are Blue Frice - Blue Frice - and access, including, but not limited to the following:

multiple peripheral sites for IV access ●
lack of usable peripheral IV sites ●
central venous pressure monitoring ●
total parenternal nutrition (TPN)
incompatible medications ●
multiple infusions of fluids, medications, or chemotherapy .
frequent blood sampling or receiving blood transfusions/blood products .
infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values

Device Description

The device is a triple-lumen, polyurethane catheter, 7 French in size, with three independent non-communicating lumens, extension lines, Luer hubs and slide clamps. It is identical in appearance and function to the ARROW predicate catheter except for the increased amount of chlorhexidine acetate and silver sulfadiazine on the external surface and the addition of the internal lumen chlorhexidine and chlorhexidine acetate impregnation.

AI/ML Overview

This document is a 510(k) Premarket Notification for the ARROWg†ard Blue Plus™ Antimicrobial Central Venous Catheter. It describes the device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission outlines performance tests and states that the device is "as safe as and is more effective than the legally marketed predicate device." However, specific numerical acceptance criteria (e.g., "X% reduction in infections") and corresponding quantitative performance metrics are not explicitly stated in the provided text. The evaluation is based on a comparison to a predicate device and the results of various in vitro and in vivo studies.

Acceptance Criteria (Implied)	Reported Device Performance
In vitro efficacy: Sufficient antimicrobial activity (zone of inhibition)	Demonstrated efficacy
In vitro efficacy: Reduced internal lumen adherence of microorganisms	Demonstrated efficacy
In vitro performance: Adequate release rate of antimicrobial agents	Demonstrated efficacy
Mechanical Integrity (Tensile strength, Fatigue life): Comparable to or better than a predicate device	Met, device is "as safe as" predicate
Stability: Maintained over time	Demonstrated
Biocompatibility: Safe for biological contact	Demonstrated
In vivo safety (swine): No unacceptable adverse reactions	Demonstrated safety
In vivo half-life: Maintained antimicrobial activity over time in vivo	Demonstrated
In vivo delayed inoculum: Protection against infection in a living system	Demonstrated efficacy and "more effective than" predicate

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

The provided text does not explicitly state the sample sizes used for the in vitro or in vivo tests. It only lists the types of tests performed.

Data Provenance: The studies are described as "in vitro" (laboratory-based) and "in vivo" (using swine). No information on the country of origin or whether the studies were retrospective or prospective is detailed. However, animal studies are inherently prospective.

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

The document does not mention the use of experts to establish "ground truth" in the context of human interpretation or diagnosis. The studies are laboratory and animal-based performance tests where "ground truth" would be determined by scientific measurements and observations, not expert consensus on medical images or clinical cases.

4. Adjudication Method for the Test Set

As the test set primarily consists of laboratory and animal studies, and not human-interpreted data requiring consensus, an adjudication method (like 2+1, 3+1) is not applicable and therefore not mentioned in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not indicate that an MRMC comparative effectiveness study was done. The studies mentioned are focused on the device's inherent performance and safety characteristics, not on how human readers' performance might improve with the device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to a physical medical device like a central venous catheter. The device itself is the "standalone" component being evaluated for its physical, chemical, and biological performance. There is no algorithm or human-in-the-loop component in its function.

7. Type of Ground Truth Used

The ground truth for the performance studies would be based on:

In vitro measurements: e.g., zone of inhibition diameters, release rates, tensile strength values, microbial adherence counts.
In vivo observations: e.g., absence/presence of infection in animal models, measured half-life of antimicrobial agents in tissue, safety endpoints (adverse reactions).

8. Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning algorithms. For a physical medical device, there isn't a "training set" in this sense. The device's design and manufacturing processes are refined through engineering, material science, and iterative testing, not through training data in an AI context. Therefore, a sample size for a training set is not applicable or provided.

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

Given that there is no "training set" in the AI sense for this device, the question of how its ground truth was established is not applicable. The "ground truth" for the device's design and production would be established through established engineering principles, material specifications, and quality control processes.

Summary

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K993691

510(k) Premarket Notification ARROWg†ard Blue Plus™ Antimicrobial Central Venous Catheter Page 52 of 70

Section 13 - 510(k) Summary

a) Submitter

ARROW International. Inc. 2400 Bernville Road Reading, PA 19605

Contact Person: Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Direct phone: 610-478-3137 Fax: 610-478-3172 e-mail: tom nickel@arrowintl.com

October 28, 1999 Date summary prepared:

b) Device

ARROWg ard Blue Plus™ Multi-Lumen Central Venous Catheter Trade Name:

Antimicrobial Central Venous Catheter and Antimicrobial CVC Common Name:

Classification Name: Class II at 21 CFR 880.5200, Intravascular Catheter

c) Legally marketed device to which the device is substantially equivalent

ARROWq*ard Blue® Antimicrobial Multi-Lumen Central Venous Catheter

d) Description of the device

e} Intended use of the device

The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg ard Blue Plus™ antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.

Technological characteristics f)

The device has the same exact technological characteristics as the predicate, with the only differences being the increased concentration of chlorhexidine acetate and silver sulfadiazine to the catheter body outer surface and the impregnation of chlorhexidine and chlorhexidine acetate to the catheter body, extension line, and extension line hubs internal lumens.

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510(k) Premarket Notification ARROWg*ard Blue Plus™ Antimicrobial Central Venous Catheter Page 53 of 70

The performance tests included in the submission include:

In vitro efficacy -- zone of inhibition 1)
In vitro efficacy internal lumen adherence 2)
1. In vitro performance release rate test
1. Tensile tests
- a) blue tip to catheter body
- b) catheter body tensile
- c) catheter body to juncture hub
- d) extension line to juncture hub
- e) extension line tensile
- extension line to extension line hub f) f f f f f f f f f f f
1. Fatigue life testing
1. Stability tests
1. Biocompatibility tests

The in vivo performance tests included in the submission include:

1. In vivo swine safety study
1. In vivo half-life study
In vivo delayed inoculum study 3)

The results of the laboratory tests demonstrate that the device is as safe as and is more effective than the legally marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 2000

Mr. Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Arrow International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605

K993691 Re:

Trade Name: ARROWg+ard Blue Plus™ Antimicrobial Multi-Lumen Central Venous Catheter Kit Regulatory Class: II Product Code: FOZ Dated: January 3, 2000 Received: January 4, 2000

Dear Mr. Nickel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 (the You may, therefore, market the device, subject to the Act). general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Please note: If you purchase your device Device Amendments. components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal

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Page 2 - Mr. Nickel

Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

In addition, we have determined that your device kit contains the following: three swabstick foil pack 10% povidone-iodine and one 5 mL ampule HCL, 1% Lidocaine solution which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Druq Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101

This letter will allow you to begin marketing your device as described in your 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 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the

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Page 3 - Mr. Nickel

regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on nour responsibilities under the Act, may be obtained from the your reopeners as Manufacturers Assistance at its toll free bivieror (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/qsma/dsmamain.html".

Sincerely,

Timothy A. Ulatowski

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

Enclosure

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P.O. Box 12888 Reading, PA 19612

Image /page/5/Picture/1 description: The image shows the logo for Arrow International. The word "ARROW" is in large, bold, sans-serif font. Below it, in a smaller font, is the word "INTERNATIONAL". The logo is in black and white.

2400 Bernville Road Reading, PA 19605

(610) 378-0131 FAX: (610) 374-5360

Section 14 -- Indications for Use

The ARROWg ard Blue Plus™ antimicrobial catheter is indicated in the short-term (<30 day) The ARROWN are Blue Frice - Blue Frice - and access, including, but not limited to the following:

multiple peripheral sites for IV access ●
lack of usable peripheral IV sites ●
central venous pressure monitoring ●
total parenternal nutrition (TPN) �
incompatible medications ●

11 993691

multiple infusions of fluids, medications, or chemotherapy .
frequent blood sampling or receiving blood transfusions/blood products .
infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values

There are no specific CDC guidelines for maximum indwelling times or catheter exchanges. There are the Spoolite Ober guing or should be exchanged per hospital protocol.

Vick Hilliard for Pat Ciarrocchi

(Division Sign-0 Division of Dental, Infection Control, and General Hospital D . Olk) Number K

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).