This device is intended to be used only as (and only indicated as) an accessory to our Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device. It is intended to be used on patients who are experiencing hemodialysis graft malfunction, due to thrombosis. This device is to be used to pull the arterial plug, located at the arterial anastamosis, into the arterial limb of the graft so it can be macerated by using the Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device and removed.

The Arrow Balloon Embolectomy Catheter is indicated for use as an accessory to the Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device. It is intended to be used to remove the arterial plug from the arterial anastamosis of a thrombosed hemodialysis access graft.

Device Description

The proposed device is identical to the legally marketed Arrow Single-Lumen 5F x 60 cm Balloon Wedge Pressure Catheter with regards to materials, construction, and manufacturing processes. Minor modifications have been made to the catheter tip and the latex balloon to enhance performance.

The functions and indications for use of the new device are substantially equivalent to those of the Baxter Fogarty® Thru-Lumen Embolectomy Catheter, K892410.

The device has the same technological characteristics as the predicates, with the only difference being the longer catheter tip and heavier wall latex balloon to enhance performance.

AI/ML Overview

The acceptance criteria and study proving the device meets these criteria are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Safety	Demonstrated through laboratory tests (Biocompatibility tests, Catheter Integrity tests).
Effectiveness	Demonstrated through laboratory tests (Latex balloon tensile test, Biocompatibility tests, Catheter Integrity tests), showing it is "safe, and as effective, if not more effective, as the legally marketed predicate devices." Also, the device's functions and indications for use are "substantially equivalent" to a legally marketed predicate device (Baxter 4 Fr Fogarty® Thru-Lumen Embolectomy Catheter, K892410).
Performance	Minor modifications to the catheter tip and latex balloon were made "to enhance performance." Performance tests included: Latex balloon tensile test, Biocompatibility tests, and Catheter Integrity tests. The results of these tests demonstrated safety and effectiveness.
Substantial Equivalence	The device was found substantially equivalent to predicate devices: Arrow 5 Fr Balloon Wedge Pressure Catheter (pre-amendment) and Baxter 4 Fr Fogarty® Thru-Lumen Embolectomy Catheter (K892410). This equivalence applies to materials, construction, manufacturing processes (compared to Arrow predicate), and functions/indications for use (compared to Baxter predicate).

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

Sample size: Not applicable. No clinical testing was performed. The evaluation relied on laboratory testing and comparison to predicate devices.
Data provenance: Not applicable. The "study" was based on device description, material characteristics, manufacturing processes, and laboratory performance tests, not patient data.

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

Not applicable. No clinical test set or ground truth established by experts for a test set was mentioned. The evaluation was based on engineering and laboratory data.

4. Adjudication method for the test set:

Not applicable. No clinical test set required adjudication.

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. This device is a mechanical catheter and not an AI-powered diagnostic tool. No MRMC study was performed.

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

Not applicable. This device is a mechanical catheter and not an algorithm.

7. The type of ground truth used:

The "ground truth" for the device's performance was established through laboratory testing (Latex balloon tensile test, Biocompatibility tests, Catheter Integrity tests) and comparison to the established performance and safety profiles of legally marketed predicate devices. The regulatory body (FDA) determined substantial equivalence based on these comparisons and test results.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device; therefore, there is no concept of a training set.

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

Not applicable. There is no training set for this mechanical device.

Summary

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AUG 3 | 1998

Arrow International, Inc.

KG82141

ARROW Balloon Embolectomy Ca Page 6

SECTION 2. 510(k) SUMMARY

510(k) Summary

Submitter:

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

Contact Person:	Thomas D. Nickel
	Vice President, Regulatory Affairs and Quality Assurance
	(610) 478-3137

Date summary prepared: June 15, 1998

Device:

Arrow Balloon Embolectomy Catheter Trade Name:

Embolectomy Catheter Common Name:

Classification Catheter embolectomy, 74DXE, and 21 CFR 870.5150, Name: Embolectomy catheter

Legally marketed device to which the device is substantially equivalent:

1. Arrow 5 Fr Balloon Wedge Pressure Catheter, Al-07123, a pre-amendment device. (Arrow Balloon Wedge Pressure Catheter)
1. Baxter 4 Fr Fogarty® Thru-Lumen Embolectomy Catheter, 12TLW804F, Premarket notification number: K892410. (Baxter Catheter)

Description of device:

The functions and indications for use of the new device are substantially equivalent to those of the Baxter Fogarty® Thru-Lumen Embolectomy Catheter, K892410.

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Intended use of the device:

Technological characteristics:

The device has the same technological characteristics as the predicates, with the only difference being the longer catheter tip and heavier wall latex balloon to enhance performance.

The performance tests included in the submission include:

Latex balloon tensile test 1.
1. Biocompatibility tests
1. Catheter Integrity tests

No clinical testing was performed.

The results of the laboratory tests demonstrated that the device is safe, and as effective, if not more effective, as the legally marketed predicate devices.

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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 the department's name encircling a stylized image of three human profiles. The profiles are arranged in a way that they appear to be emerging from a single point. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 1998

Mr. Thomas D. Nickel Arrow International, Inc. 2400 Bernville Road Reading, PA 19605

Re: K982141 Arrow Balloon Embolectomy Catheter Regulatory Class: II (two) Product Code: DXE Dated: June 15, 1998 Received: June 17, 1998

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 (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Drug 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 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.

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Page 2 - Mr. Thomas D. Nickel

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) 594-4648. 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 requlation 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical 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/4/Picture/2 description: The image shows the word "ARROW" in large, bold, black letters. Below the word "ARROW" is the word "INTERNATIONAL" in smaller, thinner, black letters. The text is centered in the image. The background is white.

INTERNATIONAL

2400 Bernville Road Reading, PA 19605

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

SECTION 10. INDICATIONS

Tu A.R.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

11982141 510(k) Number_

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).