JOBST ATHROMBIC PUMP SYSTEM 2100

K963929 · Jobst A Beiersdorf Co. · JOW · Jan 27, 1997 · Cardiovascular

Device Facts

• Record ID: K963929
• Device Name: JOBST ATHROMBIC PUMP SYSTEM 2100
• Applicant: Jobst A Beiersdorf Co.
• Product Code: JOW · Cardiovascular
• Decision Date: Jan 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow return from the lower extremities. This is accomplished by intermittent compression of the muscles in the calf and thigh.

Device Story

Jobst Athrombic Pump System 2100; pneumatic compression device; provides intermittent compression to calf and thigh muscles via thigh-length sleeves; increases deep venous blood flow return; prevents deep vein thrombosis and pulmonary embolism in recumbent patients; clinical setting; operated by healthcare personnel; console-based system; upgrade from System 2000; utilizes mechanical compression cycles.

Clinical Evidence

No clinical data provided; substantial equivalence based on established effectiveness of predicate systems (Jobst System 2000 and Flowtron DVT/thigh sleeve) and similarity in design and intended use.

Technological Characteristics

Pneumatic compression system; console-driven; thigh-length sleeves; intermittent compression mechanism; 21 CFR 870.5800 classification.

Indications for Use

Indicated for recumbent patients requiring prophylaxis against deep vein thrombosis and pulmonary embolism via intermittent compression of calf and thigh muscles.

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Predicate Devices

• Flowtron DVT/thigh sleeve system (Huntleigh Healthcare)
• Jobst Athrombic Pump System 2000

Submission Summary (Full Text)

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JAN 27 1997
K963929

# 510(k) Summary of Safety and Effectiveness

This submission covers the upgrade of the Jobst Athrombic Pump System 2000 to the System 2100. It also covers the use of thigh length sleeves with the System 2100. This device is classified as a compressible limb sleeve under 21 CFR 870.5800.

The System 2100 with the thigh length sleeve is substantially equivalent to the Flowtron DVT/thigh sleeve system marketed by Huntleigh Healthcare in the mode of operation and the indications for use. Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow return from the lower extremities. This is accomplished by intermittent compression of the muscles in the calf and thigh.

Furthermore, the Jobst Athrombic Pump console for the System 2100 is almost identical to the pump console for the System 2000 previously cleared, except for a few minor modifications that are clearly identified in this submission.

The Jobst Athrombic Pump System 2000 with calf sleeve and the Flowtron DVT/thigh sleeve systems have both proven effective for several years. The System 2100 combines the benefits of the two systems and provides a device that is safe and effective.

Date: August 16, 1996

Prepared by: Angelo R. Pereira
Beiersdorf-Jobst, Inc.
5825 Carnegie Boulevard
Charlotte, NC 28209
Phone: [phone]