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 mm in diameter.

Device Description

Each AngioJet Ultra AVX Thrombectorny Set is a sterile, single use, disposable set that includes the AngioJet AVX Thrombectomy catheter and pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is 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 vascular where the catheter is positioned.

AI/ML Overview

The provided text is a 510(k) summary for the AngioJet Ultra AVX Thrombectomy Set, indicating its substantial equivalence to a predicate device. It briefly mentions "Bench and biocompatibility testing supported using a 3-port catheter manifold and adding labeling instructions for using the AngioJet Ultra AVX Thrombectomy Set to inject contrast media and other fluids into the vascular site where the catheter is positioned." However, the document does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria, as requested.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document. The document only generally states that "Bench and biocompatibility testing supported" certain aspects.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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: This device is an embolectomy catheter, not an AI diagnostic tool, so an MRMC study is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is an embolectomy catheter, not an AI algorithm. Its performance is inherent to its physical design and function, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, beyond general "Bench and biocompatibility testing."
8. The sample size for the training set: Not applicable for this type of device, as it's not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows 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. Mark Stenoien Director Of Regulatory Affairs 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003

Re: K082382

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

Dear Mark Stenoien:

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 12, 2008. 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 regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075. Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three overlapping wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 12 2008

Possis Medical, Inc. c/o Mr. Mark D. Stenoien Director of Regulatory Affairs 9055 Evergreen Boulevard, N.W. Coon Rapids, MN 55433

Re: K082382

AngioJet® Ultra AVX® Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: November 20, 2008 Received: November 21, 2008

Dear Mr. Stenoien:

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. Mark D. Stenoien

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 (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. 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 Biometrics' (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 vours.

vuna R. Palmer

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

Enclosure

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Indications for Use

510(k) Number (if known):

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 mm 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 NEEDED) . .

Nuna R. b. humen

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko82382

Possis Medical, Inc.

CONFIDENTIAL PreMarket Notification for the AngioJet Ultra AVX Thrombectomy Set Page 15 of 48

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K0r23dz

DEC 1 2 2008

510(k) Summary 5.

Submitter:

Possis Medical, Inc. 9055 Evergreen Boulevard, N.W. Coon Rapids, MN 55433

Contact Person:

Mark D. Stenoien Director Regulatory Affairs Phone: 763.717.1092 Fax: 763.780.2227 Email: mark.stenoien@possis.com

Device Common Name:	Embolectomy Catheter
Device Trade Name:	AngioJet® Ultra AVX® Thrombectomy Set
Device Classification Name:	Embolectomy Catheter
Predicate Devices:	AngioJet Ultra AVX Thrombectomy Set (K073441)

Device Description

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 mm in diameter.

Comparison to Predicate Devices

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.

Supporting Information

Bench and biocompatibility testing supported using a 3-port catheter manifold and adding labeling instructions for using the AngioJet Ultra AVX Thrombectomy Set to inject contrast media and other fluids into the vascular site 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).