. Upper and Lower extremity peripheral arteries > 3 mm in diameter
. Upper extremity peripheral veins > 3 mm in diameter
Ileofemoral and lower extremity veins ≥ 3 mm in diameter .
. AV access conduits > 3 mm in diameter and
. For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

The AngioJet Ultra Xpeedior Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from

Upper and Lower extremity peripheral arteries ≥ 3 mm in diameter .
Upper extremity peripheral veins > 3 mm in diameter .
lleofemoral and lower extremity veins > 3 mm in diameter .
. A V access conduits > 3 mm in diameter and
For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of ● physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Device Description

AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include the AngioJet DVX and Xpeedior Thrombectomy catheters and a pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console. A 3-port catheter manifold is used, so that contrast media and other fluids can be injected into the bloodstream where the catheter is positioned.

AI/ML Overview

The provided text is a 510(k) summary for the AngioJet Ultra DVX and Xpeedior Thrombectomy Sets. This document outlines the device's intended use and demonstrates its substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria as typically found in clinical trials for new medical device approvals or AI/CAD performance assessment.

Instead, the provided text describes an administrative change to a previous 510(k) clearance and the original 510(k) submission which focuses on demonstrating substantial equivalence to predicate devices based on similarities in functional design, materials, indications for use, and principles of operation, supported by bench and biocompatibility testing.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from the provided text. The document focuses on regulatory clearance through substantial equivalence, not on novel performance evaluation against specific metrics like sensitivity, specificity, etc., usually associated with acceptance criteria for new or AI-powered devices.

Here's a breakdown of what can be extracted or inferred, and what cannot:

1. A table of acceptance criteria and the reported device performance:

Cannot be provided: The document does not define specific acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or similar quantitative metrics) for the device's performance in breaking apart and removing thrombus. It also does not report specific device performance statistics against such criteria. The "Supporting Information" section mentions "Bench and biocompatibility testing supported using a 3-port catheter manifold and adding labeling instructions," but it doesn't detail performance metrics or acceptance criteria for these tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Cannot be provided: The document does not describe a clinical "test set" in the context of diagnostic or AI performance evaluation. The testing mentioned is "Bench and biocompatibility testing," which are typically laboratory-based and do not involve patient data in the same way as a clinical test set for AI/CAD. Therefore, data provenance (country, retrospective/prospective) for such a test set is not applicable or provided.

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

Cannot be provided: No "ground truth" establishment by experts for a clinical test set is mentioned. This is a 510(k) submission focusing on substantial equivalence, not a clinical trial evaluating diagnostic accuracy against a gold standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Cannot be provided: No clinical test set or adjudication process is described.

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:

Cannot be provided: This device is a mechanical thrombectomy set, not an AI or imaging diagnostic aid for which an MRMC study comparing human readers with and without AI assistance would be relevant. The document does not mention any AI component.

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

Cannot be provided: This device is a physical medical device (catheter) used by a medical professional. It is not an algorithm, so the concept of "standalone performance" for an algorithm is not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Cannot be provided: As no clinical test set for diagnostic accuracy is described, no ground truth type is specified. The assessment here is about the device's physical properties and intended function (breaking apart and removing thrombus), likely evaluated through engineered performance tests and simulations, rather than diagnostic "ground truth."

8. The sample size for the training set:

Cannot be provided: This device is not an AI algorithm, so there is no "training set."

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

Cannot be provided: Not applicable as there is no AI algorithm or training set discussed.

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 USA logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

May 20, 2021

MEDRAD Interventional/Possis Doug Atkins Sr Regulator Affairs Specialist 9055 Evergreen Blvd., NW Minneapolis, Minnesota 55433-8003

Re: K090253

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

Dear Doug Atkins:

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 April 8, 2009. Specifically, FDA is updating this SE Letter 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 this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075. Gregory. Oconnell(a)FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -O'connell -S Date: 2021.05.20 09:37:08 -04'00'

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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Public Health Service

Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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MEDRAD Interventional/Possis c/o Mr. Doug Atkins Senior Regulatory Affairs Associate 9055 Evergreen Blvd. NW Minneapolis, MN 55433-8003

APR - 8 2009

Re: K090253

Trade/Device Name: AngioJet Ultra DVX Thrombectomy Set and AngioJet Xpeedior Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulatory Class: Class II Product Code: DXE, KRA Dated: January 30, 2009 Received: February 2, 2009

Dear Mr. Atkins;

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 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 (reporting of medical device-related 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.

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Page 2 - Mr. Doug Atkins

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M. S. Allehenne

Bram D. 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

510(k) Number (if known): K0610253

Device Name: AngioJet® Ultra DVX® Thrombectomy Set

Indications for Use:

The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from

. Upper and Lower extremity peripheral arteries > 3 mm in diameter
. Upper extremity peripheral veins > 3 mm in diameter
Ileofemoral and lower extremity veins ≥ 3 mm in diameter .
. AV access conduits > 3 mm in diameter and
. For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Hillier
(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K090253
---------------	---------

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Indications for Use

510(k) Number (if known): K0910353

Device Name: AngioJet® Ultra Xpeedior® Thrombectomy Set

Indications for Use:

The AngioJet Ultra Xpeedior Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from

Upper and Lower extremity peripheral arteries ≥ 3 mm in diameter .
Upper extremity peripheral veins > 3 mm in diameter .
lleofemoral and lower extremity veins > 3 mm in diameter .
. A V access conduits > 3 mm in diameter and
For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of ● physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) 91 Hillelie M

(Division Sign-Off) Division of Cardiovascular Devi

510(k) number K090253

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K090253 page 1 of 2

APR - 8 2009

5. 510(k) Summary	APR - 8 2009
Submitter:	MEDRAD Interventional / Possis(MIP)9055 Evergreen Boulevard, N.W.Coon Rapids, MN 55433
Contact Person:	Doug AtkinsSr. Regulatory Affairs AssociatePhone: 763.450-8060Fax: 763.780.2227Email: doug.atkins@possis.com
Device Common Name:	Embolectomy Catheter
Device Trade Name:	AngioJet® Ultra DVX® Thrombectomy Set andAngioJet® Ultra Xpeedior® Thrombectomy Set
Device Classification Name:	Embolectomy Catheter
Predicate Devices:	AngioJet AVX Thrombectomy Set with injection (K082382)AngioJet Ultra DVX Thrombectomy Set (K072269)AngioJet Ultra Xpeedior Thrombectomy Set (K071342)AngioJet Xpeedior Rheolytic Thrombectomy Catheter(K071336)AngioJet Xpeedior Rheolytic Thrombectomy Catheter(K071514)AngioJet Xpeedior Catheter (K993564)AngioJet LF140 Catheter (K960970)
Device Description

Device Description

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Indications for Use

The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from the:

Upper and Lower extremity peripheral arteries > 3 mm in diameter .
. Upper extremity peripheral veins > 3 mm in diameter
Ileofemoral and lower extremity veins > 3 mm in diameter .
A V access conduits > 3 mm in diameter and .
For use with the AngioJet Ultra Power Pulse Kit for the control and selective . infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system

Comparison to Predicate Devices

MEDRAD Interventional / Possis (MIP) considers the AngioJet Ultra DVX and Xpeedior Thrombectomy Sets to 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.

Supporting Information

Bench and biocompatibility testing supported using a 3-port catheter manifold and adding labeling instructions for using the AngioJet Ultra DVX and Xpeedior Thrombectomy Set to inject contrast media and other fluids into the bloodstream where the catheter is positioned.

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).