ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120

K061951 · Possis Medical, Inc. · QEZ · Nov 22, 2006 · Cardiovascular

Device Facts

• Record ID: K061951
• Device Name: ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120
• Applicant: Possis Medical, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Nov 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioJet Xpeedior 120 Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infra-inquinal peripheral arteries 3.0 mm in diameter and upper extremity and infrainguinal lower extremity peripheral veins > 3.0 mm in diameter.

Device Story

The XPEEDIOR Rheolytic Thrombectomy Catheter is a percutaneous device used with the AngioJet System to treat thrombus. It utilizes high-velocity saline jets contained within the catheter to create a localized suction effect (rheolytic principle), which breaks up and removes thrombus from peripheral arteries and veins. The device is operated by a physician in a clinical setting. By mechanically fragmenting and aspirating the thrombus, the catheter restores blood flow in the affected peripheral vessels, providing a minimally invasive treatment option for patients with thrombotic occlusions.

Clinical Evidence

The submission relies on existing preclinical and clinical experience to support the expanded indications for use. No new clinical study data was provided in the summary.

Technological Characteristics

Rheolytic thrombectomy catheter; utilizes high-velocity saline jets for suction and thrombus fragmentation. Designed for use with the AngioJet System. Class II device, 21 CFR 870.5150.

Indications for Use

Indicated for breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥ 3.0 mm diameter and upper/lower extremity peripheral veins ≥ 3.0 mm diameter.

Regulatory Classification

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.

Predicate Devices

• AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter (K993564)
• AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter (K040013)
• AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter (K052256)

Submission Summary (Full Text)

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September 21, 2021

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

Re: K061951

Trade/Device Name: 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 November 22, 2006. 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. [phone]. Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2021.09.21
07:30:27 -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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#### 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 caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a semi-circle around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 2 2 2006

Possis Medical, Inc. c/o Frank B. Freedman. Ph.D. Senior Regulatory Affairs Associate 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003

Re: K061951

AngioJet XPEEDIOR 120 Rheolytic Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II (Two) Product Code: DXE Dated: November 16, 2006 Received: November 17, 2006

Dear Mr. 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 - Frank B. Freedman, Ph.D.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

:

Sincerely yours,

B Hemmermon for

2

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): K061951

Device Name: AngioJet Xpeedior 120 Rheolytic Thrombectomy Catheter

Indications For Use:

The AngioJet Xpeedior 120 Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infra-inquinal peripheral arteries 3.0 mm in diameter and upper extremity and infrainguinal lower extremity peripheral veins > 3.0 mm in diameter.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Bimmima

(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number

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K061951

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## Attachment 2 Revised 510(k) Summary

| Submitter: | Frank B. Freedman, Ph.D.<br>Possis Medical, Inc.<br>9055 Evergreen Boulevard, N.W.<br>Rapids, MN 55433<br>Phone: [phone]<br>Fax: [phone] | | NOV 22 2000 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-------------|
| Contact Person: | Primary Contact<br>Frank B. Freedman<br>Possis Medical, Inc. | Secondary Contact<br>Mark D. Stenoien<br>Possis Medical, Inc. | |
| Device Common Name: | Thrombectomy Catheter | | |
| Device Trade Name: | XPEEDIOR Rheolytic Thrombectomy Catheter | | |
| Device Classification Name: | Embolectomy Catheter | | |
| Predicate Devices: | AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter<br>(K993564, K040013 and K052256) and other thrombectomy<br>catheters | | |

## Device Description

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

### Indications for Use

The AngioJet Xpeedior 120 Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal pserifier al arteries TM 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 (K993364, K040013 and K052556).

## Supporting Information

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