upper and lower extremity peripheral arteries ≥ 3.0mm in diameter, .
. upper extremity peripheral veins ≥ 3.0mm in diameter,
ileofemoral and lower extremity veins ≥ 3.0mm in diameter, .
A-V access conduits > 3.0mm in diameter and o
for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of e physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Device Description

AngioJet Ultra DVX Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX Thrombectomy Set is used with the AngioJet Ultra Console.

AI/ML Overview

This document (K113428) is a 510(k) premarket notification for a medical device called the AngioJet Ultra DVX Thrombectomy Set. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through extensive clinical studies like those for novel AI/ML devices or entirely new technologies.

Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable or not provided in this type of regulatory submission as it relates to a device with limited design changes from its predicate.

Here's an analysis based on the provided document, addressing what is present and noting what is absent:

Acceptance Criteria and Study for AngioJet Ultra DVX Thrombectomy Set (K113428)

The device is a PIVOTAL device in so much that it is a modified version of an existing device. The acceptance is based on equivalency to a device that has already established safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are not framed as specific performance metrics against an outcome (e.g., disease detection accuracy), but rather as a demonstration of equivalent performance and safety compared to its predicate devices despite a minor design change. The design change involved making the distal section more robust for guide wire use.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary from Submission)
Functional Equivalence (after design modification)	Bench testing was performed to support a determination of substantial equivalence. The device maintains similar functional design, materials, indications for use, and principles of operation to the predicate.
Safety - Catheter Operational Characteristics	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary).
Safety - Leakage	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary).
Safety - Guide Wire Compatibility	Testing performed (directly related to the design modification); results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). This is a key test given the design change.
Safety - Tracking	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary).
Safety - Extended Use	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary).
Safety - Hemolysis Ratio	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary).
Safety - Distal Emboli	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). This is a critical safety consideration for thrombectomy devices.
Safety - Catheter Tip Temperature	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary).
Safety - Mechanical Integrity (tensile, compression, torque)	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). This confirms the new design's mechanical robustness.

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

Sample Size: Not explicitly stated in this 510(k) summary. The testing refers to "bench testing" which typically involves a set number of units or iterations of the device in a laboratory setting. This is not a clinical study involving patient data.
Data Provenance: N/A. The data comes from internal bench testing (laboratory experiments) conducted by the manufacturer, MEDRAD, Inc. It is not patient data from a specific country, nor is it retrospective or prospective clinical data.

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

N/A. Since this involves bench testing of a device rather than interpretation of medical images or patient outcomes, there are no "experts" establishing a "ground truth" in the clinical sense. The ground truth for bench tests is typically established by engineering specifications, validated test methods, and measurement against known standards.

4. Adjudication Method for the Test Set

N/A. No adjudication method is applicable as this is bench testing, not an assessment requiring consensus among human interpreters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study was not done. This type of study is relevant for diagnostic imaging AI devices where human performance with and without AI assistance is compared. This device is a mechanical thrombectomy device, and its performance is evaluated through engineering bench tests, not comparative reading studies.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This device is a physical medical device (catheter and pump set), not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. Its performance is inherent to its mechanical and hydraulic functions.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the bench testing is defined by engineering specifications, physical measurements, and compliance with industry standards relevant to catheter performance, mechanical integrity, and biological interactions (e.g., hemolysis). It is not clinical "ground truth" derived from expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

N/A. There is no "training set" as this is not an AI/ML algorithm that learns from data.

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

N/A. Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

February 8, 2021

MEDRAD, Inc. Mike Burnside Manager 9055 Evergreen Blvd NW Minneapolis, Minnesota 55433-8003

Re: K113428

Trade/Device Name: AngioJet Ultra DVX Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Mike Burnside:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 02, 2011. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075. Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2021.02.08

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC - 2 2011

MEDRAD. Inc. c/o Mike Burnside Manager, Regulatory Affairs 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003

Re: K113428

Trade/Device Name: Angiojet Ultra DVX Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE, KRA Dated: November 18, 2011 Received: November 21, 2011

Dear Mr. Burnside:

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. Please note: CDRH does not evaluate information related to contract liability warranties. However, we remind you that device labeling must be truthful and not misleading.

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

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); medical device reporting of medical devicerelated adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

W. H. Hillen

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

2113428 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: AngioJet® Ultra DVX® Thrombectomy Set

Indications for Use:

The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from :

upper and lower extremity peripheral arteries ≥ 3.0mm in diameter, .
. upper extremity peripheral veins ≥ 3.0mm in diameter,
ileofemoral and lower extremity veins ≥ 3.0mm in diameter, .
A-V access conduits > 3.0mm in diameter and o
for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of e physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Prescription Use X (Part 21 CFR 801 Subpart D)

ﺮ

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Office of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number	K113428
---------------	---------

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·K113428

DEC - 2 2011

ﭩﺮ

Section 5 – 510(k) Summary

Submitter:	MEDRAD, Inc.9055 Evergreen Boulevard NWMinneapolis, MN 55433-8003 USA
Contact Person:	Mike BurnsideManager, Regulatory AffairsPhone: (763) 717.1077Fax: (763) 780.2227Email: XXXX
Date Prepared:	November 18, 2011
Trade Name:	AngioJet® Ultra DVX® Thrombectomy Set
Classification:	870.5150 and 870.1210
Product Code:	DXE and KRA
Predicate Device(s):	The subject device is equivalent to the following devices:• K091593 AngioJet Ultra DVX Thrombectomy Set• K101406 AngioJet Solent Proxi Thrombectomy Set
Device Description:	AngioJet Ultra DVX Thrombectomy Set is a sterile, single use,disposable set that includes a Thrombectomy Catheter and Pump inone combined unit. The AngioJet Ultra DVX Thrombectomy Set isused with the AngioJet Ultra Console.
Intended Use:	The AngioJet Ultra DVX Thrombectomy Set is intended for use withthe AngioJet Ultra Console to break apart and remove thrombus from:• upper and lower extremity peripheral arteries ≥ 3.0mm indiameter,• upper extremity peripheral veins ≥ 3.0mm in diameter,• ileofemoral and lower extremity veins ≥ 3.0mm in diameter,• A-V access conduits ≥ 3.0mm in diameter and• for use with the AngioJet Ultra Power Pulse Kit for the controland selective infusion of physician specified fluids, includingthrombolytic agents, into the peripheral vascular system.
Comparison topredicate:	Design changes were made to the distal section of the AngioJet UltraDVX device to make the device more robust to guide wire use.
Performance Data:	Bench testing was performed to support a determination of substantialequivalence to the predicate device. Results from the testing provideassurance that the proposed device conforms to the requirements forits intended use. This included the following testing:• Catheter operational characteristics• Leak testing

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Guide wire compatibility tests ●
Tracking .
Extended use .
Hemolysis ratio .
Distal emboli 0
Catheter tip temperature o
Mechanical integrity (tensile strengths, compression / . buckling, torque testing)

MEDRAD considers the AngioJet Ultra DVX Thrombectomy Set to Conclusion: be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and principles of operation.

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).