ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS

K091593 · Possis Medical, Inc. · QEZ · Jun 22, 2009 · Cardiovascular

Device Facts

• Record ID: K091593
• Device Name: ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS
• Applicant: Possis Medical, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Jun 22, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are intended for use with the Angiojet Ultra Console to break apart and remove thrombus from: upper and lower extremity peripheral arteries ≥ 3.0mm in diameter, upper extremity peripheral veins ≥ 3.0mm in diameter, ileofemoral and lower extremity veins ≥ 3.0mm in diameter, A-V access conduits ≥ 3.0mm in diameter and for use with the Angiojet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Device Story

AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single-use, disposable units comprising a thrombectomy catheter and pump. Used in conjunction with the AngioJet Ultra Console. Principle of operation involves mechanical thrombus fragmentation and removal (rheolytic thrombectomy) and selective fluid/thrombolytic infusion via Power Pulse Kit. Operated by physicians in clinical/interventional settings. Output is the physical removal of thrombus and delivery of therapeutic agents. Benefits include restoration of blood flow in peripheral vasculature.

Clinical Evidence

Bench testing only. Representative samples underwent mechanical bench testing to verify functional and performance characteristics.

Technological Characteristics

Sterile, single-use, disposable thrombectomy catheter and pump unit. Operates via rheolytic thrombectomy principle. Designed for use with AngioJet Ultra Console. Materials and design consistent with predicate devices.

Indications for Use

Indicated for patients requiring thrombus removal from peripheral arteries, peripheral veins, and A-V access conduits ≥ 3.0mm in diameter, and for controlled infusion of physician-specified fluids/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 Ultra Xpeedior Thrombectomy Set (K071342, K090253)
• AngioJet Ultra DVX Thrombectomy Set (K072269, K090253)

Submission Summary (Full Text)

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K091593

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| Submitter: | MEDRAD Interventional / Possis<br>9055 Evergreen Boulevard NW<br>Minneapolis, MN 55433-8003 USA |
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| Contact Person: | Doug Atkins<br>Sr. Regulatory Affairs Associate<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | JUN 22 2009 |
| Date Prepared: | May 29, 2009 |
| Trade Name: | AngioJet® Ultra DVX® Thrombectomy Set<br>AngioJet® Ultra Xpeedior® Thrombectomy Set |
| Classification: | 870.5150 and 870.1210 |
| Product Code: | DXE and KRA |
| Predicate Device(s): | The subject devices are equivalent to the following devices:<br><ul><li>K071342 and K090253 AngioJet Ultra Xpeedior Thrombectomy Set</li><li>K072269 and K090253 AngioJet Ultra DVX Thrombectomy Set</li></ul> |
| Device Description: | AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console. |
| Intended Use: | The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are intended for use with the Angiojet Ultra Console to break apart and remove thrombus from:<br><ul><li>upper and lower extremity peripheral arteries ≥ 3.0mm in diameter,</li><li>upper extremity peripheral veins ≥ 3.0mm in diameter,</li><li>ileofemoral and lower extremity veins ≥ 3.0mm in diameter,</li><li>A-V access conduits ≥ 3.0mm in diameter and</li><li>for use with the Angiojet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.</li></ul> |
| Functional and Safety Testing: | Representative samples of the device underwent mechanical bench testing to demonstrate safety and effectiveness and appropriate functional and performance characteristics. |
| Conclusion: | MEDRAD Interventional / Possis considers the AngioJet Ultra DVX and Xpeedior Thrombectomy Sets 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. |