The large-bore multiple lumen catheter permits venous access to a central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, and femoral veins. The heparin coating on the catheter intended to decrease the incidence of thrombous formation associated with catheterization.

Device Description

The device is a triple-lumen polyurethane catheter, 12 French in size, with three extension lines, luer hubs, and clamps. It is essentially the same in appearance and function to the Arrow multi-lumen predicate catheters except for the larger size to accommodate rapid fluid administration in emergency critical care situations in the hospital.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Arrow-Howes™ Large Bore Multi-lumen central venous catheter:

This submission is for a device, not an AI/software product, so many of the common fields related to AI/software performance studies (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set data, etc.) are not applicable in this context. The evaluation focuses on the physical and functional characteristics of a medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (Implied)	Reported Device Performance
1. Flow rate	To accommodate rapid fluid administration in emergency critical care situations. (Implied: Faster than predicate devices, suitable for "large bore.")	Demonstrated "greater fluid flow rates" compared to predicates.
2. Tensile test	Must meet safety and effectiveness standards, comparable to predicate devices.	Contributed to the conclusion that the device is safe and effective.
3. Pressure leak test	Must meet safety and effectiveness standards, comparable to predicate devices.	Contributed to the conclusion that the device is safe and effective.
4. Positive pressure burst test	Must meet safety and effectiveness standards, comparable to predicate devices.	Contributed to the conclusion that the device is safe and effective.
5. Biocompatibility tests	Must meet biocompatibility safety standards.	Contributed to the conclusion that the device is safe and effective.
6. Flex (fatigue) test	Must meet safety and effectiveness standards, comparable to predicate devices.	Contributed to the conclusion that the device is safe and effective.
Overall	Safe and as effective as legally marketed predicate devices.	"The results of the laboratory tests demonstrated that the device is safe, and as effective as the legally marketed predicate devices."

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

Not Applicable. This is a physical device evaluation based on laboratory and bench testing, not a study involving patient data or a "test set" in the context of an AI algorithm. No patient samples or clinical data sets were used for performance evaluation. All testing was laboratory-based.

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

Not Applicable. Ground truth in the context of AI/software performance is not relevant here. The "ground truth" for a physical device like this is established by engineering standards and validated laboratory testing procedures for mechanical integrity, biocompatibility, and fluid dynamics. Experts involved would be engineers, material scientists, and toxicologists conducting the specified tests.

4. Adjudication Method for the Test Set

Not Applicable. No human adjudication of a "test set" was part of this regulatory submission, as it relates to physical device performance.

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

Not Applicable. An MRMC study is relevant for AI-assisted diagnostic or interpretative tasks. This is a physical medical device (catheter) and does not involve AI or human "readers" in its primary function or evaluation.

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

Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

Engineering Standards and Laboratory Measurements: The "ground truth" for this device's performance is based on established engineering principles, material science properties, and direct measurements from standardized laboratory tests (e.g., flow rate measurements, tensile strength measurements, pressure endurance measurements, established biocompatibility protocols). The comparison is made against the performance of legally marketed predicate devices with known safety and effectiveness profiles.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of a physical device. Design and manufacturing might involve iterations and testing of prototypes, but that doesn't align with the concept of a training set for an AI algorithm.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary of the Study:

The study was a desk-based review of laboratory and bench testing performed on the Arrow-Howes™ Large Bore Multi-lumen central venous catheter. The primary goal was to demonstrate substantial equivalence to existing legally marketed predicate devices.

Study Type: Non-clinical laboratory and bench testing.
Purpose: To demonstrate the device's safety and effectiveness are comparable to predicate devices, particularly highlighting the larger size and greater fluid flow rates while maintaining essential technological characteristics.
Key Finding: The device is "safe, and as effective as the legally marketed predicate devices" based on the performed laboratory tests.
Clinical Testing: No clinical testing was performed for this submission.

Summary

{0}------------------------------------------------

7-1-2004

510(k) SUMMARY - K970864

OCT 17 1997

Submitter:

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

Contact Person:	Thomas D. NickelVice President, Regulatory Affairs and Quality Assurance610/478-3137
Date summaryprepared -	10/16/97

Device:

Trade Name -	Arrow-Howes™ Large Bore Multi-lumen central venous catheter
Common Name -	Central venous catheter
ClassificationName -	Catheter, intravascular, 80FOZ, and 21 CFR 880.5200,Intravascular catheter

Legally marketed device to which the device is substantially equivalent:

Various Arrow central venous catheters; specifically K820648, K844080, K862056, and K895417

Description of device:

Intended use of the device:

The intended use and indications for use are comparable to the predicate devices, and appear below:

"Indications for use:

{1}------------------------------------------------

Technological characteristics:

The device has the same exact technological characteristics as the predicates, with the only difference being the larger size and accompanying greater fluid flow rates.

The performance tests included in the submission include:

1. Flow rate
1. Tensile test
1. Pressure leak test
1. Positive pressure burst test
1. Biocompatibility tests
1. Flex (fatigue) test

No clinical testing was performed.

The results of the laboratory tests demonstrated that the device is safe, and as effective as the legally marketed predicate devices.

97095

{2}------------------------------------------------

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's head and three human figures.

OCT 17 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Thomas D. Nickel Vice President, Requlatory Affairs and Quality Assurance Arrow International, Incorporated 3000 Bernville Road Readinq, Pennsylvania 19605

Re : K970864 Trade Name: Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters Requlatory Class: II Product Code: FOZ Dated: July 21, 1997 Received: July 22, 1997

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 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

{3}------------------------------------------------

Page 2 - Mr. Nickel

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 requlations.

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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

K. Clatird.

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

Enclosure

{4}------------------------------------------------

P.O. Box 12888 Reading, PA 19612

Image /page/4/Picture/1 description: The image shows the logo for Arrow International. The logo consists of the word "ARROW" in large, bold, sans-serif font, with the word "INTERNATIONAL" in a smaller, thinner, sans-serif font underneath. The logo is black and white.

TM
The S 970864 : ,

Reading, PA 19605 (610) 378-0131 FAX: (610) 374-5360

3000 Bernville Road

Section 11 - Indications

ie large bore multiple lumen catheter permits venous access to a central circulation for rapid uid administration. It may be inserted into the jugular, subclavian, or femoral veins. The heparin coating on the catheter intended to decrease the incidence of thrombus formation associated with catheterization.

Rx Prescription Use

Viola Hilbert for Patricia Cucenti

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).