ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT

K040013 · Possis Medical, Inc. · QEZ · May 18, 2004 · Cardiovascular

Device Facts

• Record ID: K040013
• Device Name: ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT
• Applicant: Possis Medical, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: May 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioJet Xpeedior 120 Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infrainguinal peripheral arteries ≥3.0 mm in diameter. The AngioJet Power Pulse Spray Ancillary Kit is intended for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system using the Xpeedior 120 Catheter and the AngioJet System.

Device Story

AngioJet Xpeedior 120 Catheter is a single-use component of the AngioJet Rheolytic Thrombectomy System; utilizes high-velocity saline jets for percutaneous thrombus break-up and removal. Catheter features a tapered flexible polymeric tip and large outflow lumen for debris removal and guide wire passage; small second lumen supplies pressurized saline to the tip. Ancillary Kit includes a Y-set with vented bag spikes, PVC tubing, clamps, and a one-way stopcock to enable pulsed infusion of physician-specified fluids. Used in peripheral vascular interventions; operated by physicians in clinical settings. System requires connection to an AngioJet Pump Set and Drive Unit. Output is the mechanical removal of thrombus or localized delivery of therapeutic fluids. Benefits include effective thrombus clearance and targeted drug delivery in peripheral arteries.

Clinical Evidence

Bench testing only. Representative samples underwent mechanical testing, biocompatibility, sterility, comparative testing, and animal testing to demonstrate functional and performance characteristics.

Technological Characteristics

6 FR catheter with tapered flexible polymeric tip; dual-lumen design (outflow lumen and pressurized saline supply lumen). Ancillary kit consists of PVC tubing, vented bag spikes, clamps, and a one-way stopcock. Operates as part of the AngioJet Rheolytic Thrombectomy System (requires external pump and drive unit).

Indications for Use

Indicated for patients requiring thrombus removal from infrainguinal peripheral arteries ≥3.0 mm in diameter and for the controlled infusion of physician-specified fluids (including thrombolytics) into the peripheral vascular system.

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 LF140 Catheter (K972610)
• AngioJet Xpeedior 60 Catheter (K993564)
• AngioDynamics Power Pulsed Spray Infusion System (K905447)
• AngioDynamics Power Pulsed Spray Infusion System (K951509)
• B.Braun Universal Spike Adaptor Y-Set (K780551)

Submission Summary (Full Text)

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October 8, 2021

Possis Medical, Inc. Mark Stenoien Manager, Clinical & Regulatory Affairs 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003

Re: K040013

Trade/Device Name: AngioJet Xpeedior 120 Catheter And AngioJet Power Pulse Spray Ancillary Kit Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

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 May 18, 2004. 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 O'connell -S Date: 2021.10.08

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 8 2004

Possis Medical, Inc. c/o Mr. Mark Stenoien Manager, Clinical and Regulatory Affairs 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003

Re: K040013

KU40013
Trade Name: AngioJet Xpeedior 120 Catheter and AngioJet Power Pulse Spray Ancillary Kit Regulation Numbers: 21 CFR 870.5150, 870.1210 Regulation Nambers: Embolectomy Catheter, Continuous Flush Catheter Regulatory Class: II (two) Product Codes: DXE, KRA Dated: March 31, 2004 Received: April 01, 2004

Dear Mr. Stenoien:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Security (10(x) premainted is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave decemined the article predicate devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the energions of the Federal Food. Drug. commerce prior to May 28, 1970, the enactinent with the provisions of the Federal Food, Drug, devices that have been reculted in accordance was as a proval application (PMA).
and Cosmetic Act (Act) that do not require approval assessed sprovisions of the Act. The and Cosmetic Act (Act) that do not require approvate controls provisions of the Act. The
You may, therefore, market the device, subject to the enqual registration, listing You may, therefore, market the device, subject, subject on une legistration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mender requirement misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it c If your device is classified (see above) mits end of regulations affecting your device can
may be subject to such additional controls. Existing major regulations allection, may be subject to such additional controlis. Existing in 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Peacharter concerning your device in the Federal Register.

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Page 2 - Mr. Mark Stenoien

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ issualice of a substitive requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decemmation that your and your recent agencies. You must or any Federal statules and regulations administered of not limited to: registration and listing (21 comply with all the Act s requirements, morades wantacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manata 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 200); 11 CFR 1000 105 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-10 product radiation control provisions (Dections 55 r device as described in your Section 510(k) This letter will anow you to begin harketing yobstantial equivalence of your device to a legally premarket nothication. The PDA midning of subscribed on thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please If you desire specific acvice for Jour at [phone]. Also, please note the regulation entitled, Contact the Office of Compulation at (301) >>Traction" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its to the succine broad Manufacturers, micemational and Goness http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duana R. Holmes

Co- 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): K040013

### Device Name: AngioJet Xpeedior 120 Catheter, and AngioJet Power Pulse Spray Ancillary Kit

Indications For Use:

- The AngioJet Xpeedior 120 Catheter is intended for use with the AngioJet System 1. The Angloset Apeculor T20 Catherironmus from infrainguinal peripheral arteries >3.0 mm in diameter.
- 2. The AngioJet Power Pulse Spray Ancillary Kit is intended for the control and The Airer Fower False bpr specified fluids, including thrombolytic agents, into the peripheral vascular system using the Xpeedior 120 Catheter and the AngioJet System.

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

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)

Dmna R. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko40013

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#### SUMMARY AND CERTIFICATION SECTION 2.

| 510(k) Summary<br>A. | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Possis Medical, Inc. | |
| | 9055 Evergreen Boulevard NW | |
| | Minneapolis, MN 55433-8003 USA | |
| Contact Person: | Mr. Mark Stenoien, Manager, Clinical & Regulatory Affairs | |
| | 9055 Evergreen Boulevard NW | |
| | Minneapolis, MN 55433-8003 USA | |
| | Phone: [phone] Fax: [phone] | |
| | Email: [e-mail] | |
| Date Prepared: | 31-Dec-2003 | |
| Trade Name: | The AngioJet Xpeedior 120 Catheter and the | |
| | AngioJet Power Pulse Spray Ancillary Kit | |
| Classification Name | AngioJet Xpeedior 120 Catheter is a class II device per 21 CFR | |
| and Number: | 870.5150 for peripheral use and the Power Pulse Spray Ancillary Kit | |
| | is a class II devices as defined by 21 CFR 870.1210. | |
| Product Code: | AngioJet Xpeedior 120 Catheter product code is DXE. | |
| | AngioJet Power Pulse Spray Ancillary Kit product code is 74 KRA. | |
| Predicate Device(s): | The AngioJet 120 Catheter is substantially equivalent to the devices | |
| | listed below: | |
| | • The AngioJet LF140 Catheter (K972610) | |
| | • The AngioJet Xpeedior 60 Catheter (K993564). | |
| | | |
| | The AngioJet Power Pulse Spray Ancillary Kit is substantially | |
| | equivalent to: | |
| | • AngioDynamics Power Pulsed Spray Infusion System (K905447 | |
| | and K951509) | |
| | • B.Braun Universal Spike Adaptor Y-Set (K780551). | |
| Device Description: | The AngioJet Xpeedior 120 Catheter is a single-use component of | |
| | the AngioJet Rheolytic Thrombectomy System. The AngioJet<br>System uses high velocity saline jets for percutaneous break-up and | |
| | removal of thrombus. The 6 FR Catheter has a tapered flexible | |
| | polymeric tip, and a large outflow lumen for guide wire passage and | |
| | removal of thrombus debris. A small second lumen contained within | |
| | the large outflow lumen supplies pressurized saline to the Catheter | |
| | tip. The Catheter is designed to track over a 0.305" guide wire and | |
| | through a guide catheter or sheath having an inner diameter of 0.086" | |
| | or larger, with sufficient clearance to allow manual contrast injection, | |
| | if desired. The Catheter connects to the AngioJet Pump Set and the | |
| | multiple-use AngioJet Drive Unit (each packaged separately), which | |
| | are necessary for operation of the AngioJet System. | |
| | The AngioJet Power Pulse Spray Ancillary Kit enables the AngioJet | |
| | Xpeedior 120 Catheter to deliver a pulsed infusion of a physician- | |
| | specified fluid to a local treatment area during a peripheral | |
| | | intervention. The Ancillary Kit also enables the Catheter to convert<br>easily back to conventional AngioJet thrombectomy procedure. |
| | | The AngioJet Power Pulse Spray Ancillary Kit includes a Y-set that<br>is comprised of two vented bag spikes bonded to PVC tubing with a<br>clamp attached on each tube and a short, larger diameter section of<br>PVC tubing bonded to a Y-junction. The Y-set is used to access the<br>standard intravenous saline solution bag, used with AngioJet<br>thrombectomy, and a second intravenous bag containing physician<br>specified fluid. The tube clamps are used to control the flow of each<br>fluid. |
| | | A separate one-way stopcock is included in the kit. This stopcock is<br>placed between the Xpecdior 120 Catheters' outflow port, located on<br>the underside of Catheter manifold, and the outflow tubing. |
| | | The Power Pulse Spray Ancillary Kit is an accessory that is to be<br>used only with the AngioJet Rheolytic Thrombectomy System and<br>Xpeedior 120 Catheter and will be packaged independent from the<br>AngioJet System components (i.e. the Drive Unit, Pump Set, and<br>Catheter.) |
| Intended Use: | | The AngioJet Xpeedior 120 Catheter is intended for use with the<br>AngioJet System in breaking apart and removing thrombus from<br>infrainguinal peripheral arteries ≥3.0 mm in diameter. |
| | | The AngioJet Power Pulse Spray Ancillary Kit is intended for the<br>control and selective infusion of physician specified fluids, including<br>thrombolytic agents, into the peripheral vascular system using the<br>Xpeedior 120 Catheter and the AngioJet System. |
| Functional and<br>Safety Testing: | | Representative samples of the device underwent bench testing,<br>including but not limited to mechanical testing, biocompatibility,<br>sterility, comparative testing, and animal testing to safety and<br>effectiveness and to demonstrate appropriate functional and<br>performance characteristics. |
| Conclusion: | | Possis Medical, Inc. considers the Xpeedior 120 Catheter and the<br>Power Pulse Spray Ancillary Kit to be substantially equivalent to the<br>predicate devices listed above. This conclusion is based upon the<br>devices' similarities in functional design, materials, indications for<br>use and principles of operation. |

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