ALBA HEALTH PAS WRAP SYSTEM

K961405 · Alba-Waldensian, Inc. · JOW · Dec 26, 1996 · Cardiovascular

Device Facts

• Record ID: K961405
• Device Name: ALBA HEALTH PAS WRAP SYSTEM
• Applicant: Alba-Waldensian, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Dec 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PAS Wrap System is composed of two leg wrap members constructed of an inflatable bladder enclosed in a fabric cover with an outside surface that will accept a Velcro fastener hook strip. Extending from one side of this enclosed bladder is an elastic fabric cut to conform to the shape of the calf area of the leg. This fabric is wrapped around the back of the calf and is attached to the other side of the bladder with a Velcro fastener. The Velcro fastener allows for a tight fit on various size legs. The inflation pump is attached to the bladders and is energized. The bladder on each leg is alternately inflated and deflated to yield approximately 65mm Hg pressure on the calf area of the leg. This pressure causes pooled blood to be expelled from the calf and to proceed toward the heart. This helps to prevent embolisms from forming in the calf area.

Device Story

PAS Wrap System consists of two leg wraps featuring inflatable bladders within fabric covers; elastic fabric extensions with Velcro fasteners ensure calf fit. System connects to albahealth Pulsatile Anti-Embolism System pump; pump alternates inflation/deflation of bladders to apply ~65mm Hg pressure to calf. Mechanism expels pooled blood toward heart to prevent embolism formation. Used in clinical settings; operated by healthcare personnel. Output is mechanical compression; clinical benefit is reduction of embolism risk.

Clinical Evidence

No clinical data provided; summary references articles regarding device benefits and MDR/adverse experience reports.

Technological Characteristics

Inflatable bladder system; fabric cover with Velcro fasteners; elastic calf-conforming fabric. Energy source: external pneumatic pump. Pressure output: ~65mm Hg. Operation: alternating pneumatic inflation/deflation.

Indications for Use

Indicated for the prevention of embolisms in the calf area by expelling pooled blood toward the heart.

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

• Jobst Athrombic Pump System 2000 (not specified)
• PAS-Pulsatile Anti-Embolism System (not specified)

Submission Summary (Full Text)

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K961405

D

DEC 26 1995

albahealth™

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

ALBA-WALDENSIAN, INC.
201 St. Germain Avenue, S.W.
Valdese, NC 28690

Telephone: [phone]
Fax: [phone]

Contact Person: Victor H. Garrou

Date Prepared: March 22, 1996

The following is a summary of Safety and Effectiveness for the albahealth PAS Wrap System.

The PAS Wrap System is composed of two leg wrap members constructed of an inflatable bladder enclosed in a fabric cover with an outside surface that will accept a Velcro fastener hook strip. Extending from one side of this enclosed bladder is an elastic fabric cut to conform to the shape of the calf area of the leg. This fabric is wrapped around the back of the calf and is attached to the other side of the bladder with a Velcro fastener. The Velcro fastener allows for a tight fit on various size legs. The inflation pump is attached to the bladders and is energized. The bladder on each leg is alternately inflated and deflated to yield approximately 65mm Hg pressure on the calf area of the leg. This pressure causes pooled blood to be expelled from the calf and to proceed toward the heart. This helps to prevent embolisms from forming in the calf area.

The albahealth PAS Wrap System is applied to the leg in the same manner as the Jobst Athrombic Pump System 2000. It uses the albahealth Pulsatile Anti-Embolism System pump to supply the pressure to the calf of the leg at the same values as the PAS-Pulsatile Anti-Embolism System. The indications for use and the contraindication are listed separately in this application.

Following is a summary of articles showing the benefits of this device and also MDR's and adverse experience reports.

HEALTH PRODUCTS
Division of Alba Waldensian, Inc.
201 St Germain Avenue
Valdese, NC 28690
704-879-6500
Fax [phone]