upper and lower extremity peripheral arteries > 3.0 mm in diameter and
upper extremity and infrainguinal lower extremity peripheral veins > 3.0 mm in diameter.

Device Description

When used with the AngioJet System, the XPEEDIOR Rheolytic Thrombectorny Catheter uses high velocity saline jets to percutaneously break-up and remove thrombus. These saline jets are contained within the Catheter and provide the suction that produces this effect.

AI/ML Overview

This document is a 510(k) premarket notification for the AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter, seeking to expand its indications for use. It outlines the device, its function, and the justification for the expanded indications. However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial report would.

Here's an analysis based on the provided text, addressing your points where possible, and highlighting what is not present:

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

The document does not provide a table of acceptance criteria and reported device performance in the typical sense of a clinical study. This 510(k) is focused on expanding the indications for use of an already cleared device. The "Supporting Information" section states: "Applicable preclinical and clinical experience supports the expanded indications for use." This implies that data exists, but it is not detailed within this document.

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

This information is not explicitly stated in the provided text. While "preclinical and clinical experience" are mentioned, no specifics on sample size, study design (retrospective/prospective), or data provenance are given.

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)

This information is not provided. Since this is a 510(k) for an expanded indication of an existing device, a formal "ground truth establishment" process for a new diagnostic algorithm's test set is not described.

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

This information is 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 is not an AI device. The AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter is a mechanical device used to remove thrombus. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and not mentioned.

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

This is not an AI device. Standalone algorithm performance is not applicable.

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

This information is not explicitly stated. The supporting information mentions "preclinical and clinical experience," which could involve various types of data and endpoints related to thrombus removal and patient outcomes, but the specific "ground truth" used is not defined in this document.

8. The sample size for the training set

This is not an AI device, so there is no "training set" in the context of machine learning.

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

This is not an AI device, so there is no "training set" or establishment of ground truth for a training set in this context.

Summary of what the document does provide regarding the device and its expansion:

Device Name: AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter
Intended Use (Expanded): For use with the AngioJet System in breaking apart and removing thrombus from:
- Upper and lower extremity peripheral arteries > 3.0 mm in diameter
- Upper extremity and infrainguinal lower extremity peripheral veins > 3.0 mm in diameter
Comparison to Predicate Devices: No design, packaging, sterilization, or other device change was required to expand the indications for use. The predicate devices are listed as AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter (K040013, K052256, and K061951).
Basis for Expansion: "Applicable preclinical and clinical experience supports the expanded indications for use."

Conclusion:

The provided document is a 510(k) summary for an expanded indication of a mechanical medical device, not a report on an AI-powered diagnostic tool. Therefore, many of the requested details related to acceptance criteria, sample sizes, ground truth establishment, and AI study methodologies are not present in this type of regulatory submission. The FDA grants substantial equivalence based on the provided "preclinical and clinical experience" and the comparison to legally marketed predicate devices, rather than a detailed report of a specific study meeting predefined acceptance criteria for a novel device or AI algorithm.

Summary

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September 15, 2021

Possis Medical, Inc. Frank Freedman Senior Regulatory Affairs Associate 9055 Evergreen Blvd., NW Minneapolis, Minnesota 55433-8003

Re: K071514

Trade/Device Name: AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Frank Freedman:

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 July 31, 2007. 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,

Image /page/0/Picture/9 description: The image shows a digital signature. The signature is from Gregory W. O'connell. The signature was signed on September 15, 2021 at 10:18:17 -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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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the top of the logo. The word "DEPAR" is at the bottom of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2007

Possis Medical, Inc. c/o Dr. Frank Freedman Senior Regulatory Affairs Associate 9055 Evergreen Blvd. NW Minneapolis, MN 55433

Re: K071514

Trade/Device Name: AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE, KRA Dated: June 1, 2007 Received: June 4, 2007

Dear Dr. Freedman:

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 - Dr. Frank Freedman

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 Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding 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,

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

KO71514 510(k) Number (if known):

Device Name: Traditional 510(k) Notification AngioJet® XPEEDIOR® Rheolytic Thrombectomy Catheter

Indications For Use: The AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from:

upper and lower extremity peripheral arteries > 3.0 mm in diameter and ●
upper extremity and infrainguinal lower extremity peripheral veins > 3.0 mm in diameter. .

Prescription Use 2 (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)

(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number Koz 15 / 4

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క. 510(k) Summary

Submitter:	Frank B. Freedman, Ph.D.Possis Medical, Inc.9055 Evergreen Boulevard, N.W.Coon Rapids, MN 55433Phone: 763.780.4555Fax: 763.780.2227	JUL 31 200
Contact Person:	Primary ContactFrank B. FreedmanPossis Medical, Inc.	Secondary ContactMark D. StenoienPossis Medical, Inc.
Device Common Name:	Thrombectomy Catheter
Device Trade Name:	AngioJet® XPEEDIOR® Rheolytic ThrombectomyCatheter
Device Classification Name:	Embolectomy Catheter
Predicate Devices:	AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter(K040013, K052256 and K061951)

Device Description

Indications for Use

The currently cleared indications for use were expanded to include breaking apart and removing thrombus from:

. upper and lower peripheral extremity arteries > 3.0 mm in diameter and
upper extremity and infrainguinal lower extremity peripheral veins > 3.0 mm in diameter. .

Comparison to Predicate Devices

No design, packaging, sterilization or other device change was required to expand the AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter indications for use (K040013, K052556 and K061951).

Supporting Information

Applicable preclinical and clinical experience supports the expanded indications for use.

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).