The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits > 3.0mm in diameter.

Device Description

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

AI/ML Overview

The provided text is a 510(k) summary for the AngioJet Ultra AVX Thrombectomy Set. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on functional and safety testing. However, it does not detail specific acceptance criteria or a dedicated study with performance metrics in the format requested.

Therefore, I cannot provide the information in the requested table format regarding acceptance criteria and device performance based solely on the provided text. The document refers generally to "bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing to demonstrate appropriate functional and performance characteristics." This is a broad statement and does not specify the quantitative criteria or the results of such tests.

Furthermore, the document does not contain information about:

Sample sizes used for test sets.
Data provenance (country of origin, retrospective/prospective).
Number and qualifications of experts for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set (as this is not an AI/ML device per the document).
How ground truth for the training set was established.

This document is a regulatory submission for a medical device (thrombectomy set) based on substantial equivalence to predicate devices, not an AI/ML-based device requiring detailed performance metrics and ground truth establishment in the way the prompt implies.

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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 20, 2021

Possis Medical, Inc. Mike Burnside Sr. Regulatory Affairs Associate 9055 Evergreen Blvd., NW Minneapolis, Minnesota 55433-8003

Re: K073441

Trade/Device Name: Angiojet Ultra AVX Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

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 January 24. 2008. 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. O'connell -S O'connell -S Date: 2021.05.20

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/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing or protecting another, conveying a sense of care and support. The overall design is simple and professional, reflecting the department's role in public health and human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

JAN 2 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Possis Medical, Inc. c/o Mr. Mike Burnside Sr. Regulatory Affairs Associate 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003

Re: K073441

AngioJet Ultra AVX Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: December 6, 2007 Received: December 7, 2007

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Mike 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): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Duna R. Vahmer

1 Bram D. Zuckerman, M.D. Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

2

Enclosure

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Indications for Use

510(k) Number (if known): K073441

Device Name: AngioJet® Ultra AVX® Thrombectomy Set

Indications for Use:

The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits > 3.0mm in diameter.

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)

pornasa le Division Sign-Off) on of Cardiovascular Devices

· number Ko 7344

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Section 5 – 510(k) Summary

Submitter:	Possis Medical, Inc.9055 Evergreen Boulevard NWMinneapolis, MN 55433-8003 USA
Contact Person:	Mike BurnsideSr. Regulatory Affairs AssociatePhone: (763) 780-4555Fax: (763) 780-2227Email: mike.burnside@possis.com
Date Prepared:	December 6, 2007
Trade Name:	AngioJet® Ultra AVX® Thrombectomy Set
Classification:	870.5150
Product Code:	DXE
Predicate Device(s):	The subject devices are equivalent to the following devices:K960970 AngioJet Rapid Thrombectomy System - Pump Set K972610 AngioJet LF140 Catheter K993564 AngioJet XPEEDIOR® 60 Rheolytic Thrombectomy Catheter K071342 AngioJet XPEEDIOR® Thrombectomy Set (reference device-design only) K072269 AngioJet DVX® Thrombectomy Set (reference device-design only) K072769 AngioJet XMI®, XVG®, & Spiroflex® Thrombectomy Sets (reference device-design only)
Device Description:	Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.
Intended Use:	The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits > 3.0mm in diameter.
Functional andSafety Testing:	Representative samples of the devices underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing to demonstrate appropriate functional and performance characteristics.
Conclusion:	Possis Medical, Inc. considers the AngioJet Ultra AVX Thrombectomy Set 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.

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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).