The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in coniunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of acute clot in thrombosed dialysis grafts.

Device Description

Not Found

AI/ML Overview

Here's an analysis of the provided text regarding the Arrow-Trerotola™ Percutaneous Thrombolytic Device, with the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" in the typical sense (e.g., a specific target sensitivity or specificity). Instead, it focuses on demonstrating equivalency to a predicate device, the Angiodynamics Pro™ Infusion Catheter thrombolytic procedure, across several key outcomes for the clinical study.

Acceptance Criteria (Demonstrated Equivalency To Predicate)	Reported Device Performance (Arrow-Trerotola™ PTD)
Equivalency in acute technical patency rates	Achieved equivalency to predicate device
Equivalency in acute major complication rates	Achieved equivalency to predicate device
Reduced mean procedure time	Achieved reduced mean procedure time compared to predicate device
Equivalency in rates of any complication (major or minor)	Achieved equivalency to predicate device
Equivalency in 3-month clinical patency rates	Achieved equivalency to predicate device

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

Sample Size: 122 patients
Data Provenance:
- Country of Origin: Not explicitly stated, but the FDA approval suggests it's likely a US-based study, given the approving body. However, this is an inference, not a direct statement.
- Retrospective or Prospective: Prospective (described as a "randomized study recently completed at six institutions").

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

The document does not provide information on the number of experts, their qualifications, or how the ground truth was established for the clinical study. It only states that the "results of this clinical trial support claims."

4. Adjudication Method for the Test Set

The document does not provide information on the adjudication method used for the clinical trial results.

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

MRMC Study: No, this was not an MRMC study. The device is a mechanical thrombolytic device, not an AI or imaging diagnostic tool that would typically involve human readers interpreting output.
Effect Size of Human Readers with/without AI: Not applicable, as this is not an AI-assisted diagnostic device. The study compared the device to another mechanical thrombolytic procedure.

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

Not applicable. This is a medical device (a catheter and drive unit) used directly on patients, not an algorithm. Therefore, "standalone" in the context of an algorithm's performance is not relevant. The clinical study itself demonstrates the device's performance in its intended use.

7. The Type of Ground Truth Used

The "ground truth" was established through direct clinical outcomes in a randomized controlled trial. This includes:

Acute technical patency rates (likely assessed by clinical observation or imaging post-procedure)
Acute major complication rates (clinical observation and medical records)
Procedure time (measured during the intervention)
Any complication rates (clinical observation and medical records)
3-month clinical patency rates (follow-up clinical assessment, potentially with imaging).

8. The Sample Size for the Training Set

Not applicable. This is a medical device, and the document describes a clinical trial (test set), not a machine learning model that requires a "training set."

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

Not applicable, as there is no machine learning "training set" in the context of this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

JUL 2 5 1997

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

Re: K970080 Arrow-Trerotola™ Percutaneous Thrombolytic Device Requlatory Class: II (two) Product Code: MCW Dated: July 22, 1997 Received: July 23, 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 general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labelinq, 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 such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 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,

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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) 594-4648. 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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JUL 25 -

SECTION 2 - 510(k) SUMMARY

The device is substantially equivalent to the Angiodynamics Pro™ Infusion Catheter thrombolytic procedure.

Indications for Use: The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in coniunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of acute clot in thrombosed dialysis grafts.

The device has comparable technological characteristics to the predicate device.

The nonclinical test results included in the submission are as follows:

JUL 25 .

Animal Studies

1. Evaluation of venous injury caused by a percutaneous mechanical thrombolytic device - rabbit study.
1. Pulmonary emboli from pulse-spray and mechanical thrombolysis: Evaluation with an animal Dialysis Graft Model.
1. Preclinical in-vivo testing of a rotational mechanical thrombolytic device.

Bench Testing

1. Basket durability test
1. Mechanical tests
- Destructive tensile and destructive torque testing for the following A. device joints, or bonds:
  - . Torque cable
  - Stiffness rod-to-torque cable .
  - Splined Luer hub-to-torque cable .
  - Nitinol basket wires-to-metal cap and sleeve .
  - Nitinol basket-to-torque cable .
  - Plastic tip-to-metal cap .
  - Hemostasis hub-to-sheath extension sleeve ●
  - Side arm-to-hemostasis hub ●
  - Luer hub-to-hemostasis hub side arm ●

Biocompatibility Testing

All components tested per ISO 10993.

Clinical evaluation results from IDE G950225 are included in the submission, and are summarized below.

A 122 patient randomized study comparing mechanical thrombolysis (PTD) to pulse-spray thrombolysis was recently completed at six institutions. The results of this clinical trial support claims for (1) equivalency in acute technical patency rates, (2) equivalency in acute major complication rates, and (3) reduced mean procedure time. In addition, the results support secondary claims of (1) equivalency in the rates of any complication (major or minor) and (2) equivalency in 3 month clinical patency rates.

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Image /page/3/Picture/0 description: The image shows a mailing address. The address is P.O. Box 12888 in Reading, PA 19612. The text is black and the background is white.

Image /page/3/Picture/1 description: The image shows the word "ARROW" in large, bold, sans-serif font. Below the word "ARROW" is the word "INTERNATIONAL" in a smaller, thinner, sans-serif font. The text is black against a white background.

2400 Bernville Road Reading, PA 19605 ·

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

SECTION 10 - INDICATIONS

The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of acute clot in thrombosed dialysis grafts.

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(Division Sign Oil) (Division - Catchevascurar Respiratory, and passiblogical Devices K910080 510(k) Number -

9691

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).