THE AMPLATZ THROMBECTOMY DEVICE

K954205 · Microvena Corp. · MCW · Aug 13, 1996 · Cardiovascular

Device Facts

• Record ID: K954205
• Device Name: THE AMPLATZ THROMBECTOMY DEVICE
• Applicant: Microvena Corp.
• Product Code: MCW · Cardiovascular
• Decision Date: Aug 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Amplatz Thrombectomy Device is intended for mechanical dissolution of acute and subacute thrombus in dialysis fistulae. This device is not intended to be used for the removal of atheroma and is contraindicated in coronary, cerebral, and pulmonary vessels.

Device Story

Polyurethane catheter; distal rotor housing with recessed impeller attached to drive shaft; powered by disposable high-speed air-driven motor. Infusion line allows delivery of saline, contrast, or thrombolytic agents. Used by clinicians for mechanical thrombus dissolution in dialysis fistulae. Device functions by mechanical maceration of thrombus; output is cleared fistula. Benefits include minimally invasive alternative to surgical embolectomy.

Clinical Evidence

Clinical studies demonstrated device is as safe and effective as surgery for removal of acute and subacute thrombus in dialysis fistulae. Testing included design validation, animal studies, and clinical trials.

Technological Characteristics

Polyurethane catheter; distal rotor housing; recessed impeller; drive shaft; high-speed air-driven motor; infusion line with luer connector. Mechanical thrombus dissolution principle.

Indications for Use

Indicated for mechanical dissolution of acute and subacute thrombus in dialysis fistulae. Contraindicated for use in coronary, cerebral, and pulmonary vessels; not for removal of atheroma.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Fogarty Arterial Embolectomy Catheters (pre-amendment)

Submission Summary (Full Text)

{0}

K 954205

AUG 13 1996

# 510(k) SUMMARY

Contact/Submitter: Jodi Locher, Manager, Regulatory Affairs
Date Prepared: August 29, 1995
Trade Name: Amplatz Thrombectomy Device
Common Name: Thrombectomy Catheter
Classification Name: Percutaneous Catheter (per 21 CFR 870.1250)

Predicate Devices: Fogarty Arterial Embolectomy Catheters (pre-amendment)

Device Description: The Amplatz Thrombectomy Device is a polyurethane catheter that contains a distal rotor housing in which a small diameter, recessed impeller is attached to a drive shaft. The shaft is connected to a disposable, high-speed, air-driven motor. An infusion line with luer connector, attached to the proximal casing, allows infusion of saline, contrast medium, or thrombolytic medications.

Intended Use: The Amplatz Thrombectomy Device is intended for mechanical dissolution of acute and subacute thrombus in dialysis fistulae. This device is not intended to be used for the removal of atheroma and is contraindicated in coronary, cerebral, and pulmonary vessels.

Comparative Analysis: It has been demonstrated (through clinical studies) that the ATD is as safe and effective as surgery for the removal of acute and subacute thrombus within dialysis fistulae.

Functional/Safety Testing: The Amplatz Thrombectomy Device has successfully undergone design validation, animal, and clinical testing.

Conclusion: The Amplatz Thrombectomy Device is substantially equivalent to the predicate device based on the results of laboratory, animal and clinical testing.

1861 Buerkle Road ▲ White Bear Lake, Minnesota 55110-5246
612-777-6700 ▲ Fax [phone]