WLP SINGLE-SEGMENT VERSION WLP SOLO VII

K961891 · Wright Linear Pump, Inc. · JOW · Nov 6, 1996 · Cardiovascular

Device Facts

• Record ID: K961891
• Device Name: WLP SINGLE-SEGMENT VERSION WLP SOLO VII
• Applicant: Wright Linear Pump, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Nov 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation. Compression pumps of various kinds are in wide use in hospitals, clinics, patient homes, and elsewhere for treating acute and chronic fluid accumulation disorders. Complies with physician-prescribed treatment pressures.

Device Story

Electromechanical pneumatic device; consists of compressor, precision timer, regulator, and gauge. Operates by inflating a sleeve appliance fitted over patient's extremity to apply physician-prescribed pressure. Used in hospitals, clinics, and home settings. Provides single-pressure compression therapy to improve fluid circulation; reduces pain, swelling, and risk of complications like ulceration or infection. Simple design intended for mild cases of lymphedema compared to sequential systems.

Clinical Evidence

No clinical data. Bench testing performed comparing on-board gauge readings to a calibrated Hg manometer to verify cell pressure accuracy and cycle timing.

Technological Characteristics

Electromechanical pneumatic compression pump. Dimensions: 8"W x 6.75"H x 5.5"D; weight < 13 lbs. Factory-preset maximum pressure < 101 mm Hg. System includes pump and sleeve appliance.

Indications for Use

Indicated for patients with acute or chronic fluid accumulation disorders in one or more extremities requiring improved return circulation to reduce pain, swelling, ulceration, and associated risks of infection or amputation.

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

• Huntleigh Flowtron AC200/2 (K874688)
• Jobst Extremity Pump System 7000 (K882683)
• Talley MicroSystem/Talley (K914775)

Submission Summary (Full Text)

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NOV - 6 1996
K961891

# 5. 510(k) Summary

## 5.1. submitter

5.1.1. Wright Linear Pump, Inc.
303 Robinson Road
Imperial, PA 15126

412 695-0800
FAX [phone]

5.1.2. contact Edward J. Wright
5.1.3. prepared 5-May-96

## 5.2. product identification

5.2.1. trade name...WLP Solo VII
5.2.2. common name ...single-pressure compression pump
5.2.3. classification name Compressible Limb Sleeve (Class II)
21 CFR 870.5800
5.2.4. product number...74JOW

## 5.3. equivalence

5.3.1. The proposed device is similar in design, function, and composition to existing compression pump devices such as document K874688 Huntleigh Flowtron AC200/2, document K882683 Jobst Extremity Pump System 7000, and document K914775 Talley MicroSystem/Talley.

5.3.1.1. As a single pressure system, the proposed device is simpler than existing sequential pressure or gradient sequential pressure systems for treating "simple lymphedema" or mild patient cases.

## 5.4. description

5.4.1. This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to inflate a sleeve appliance that fits over the patient's extremity.
5.4.2. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 13 lbs.

## 5.5. intended use

5.5.1. The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of

05 May 1996
©1996 Wright Linear Pump, Inc.
510(k) -- "Solo VII" Single-pressure Compression Therapy Device
contains CONFIDENTIAL material

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dermatological impact, infection, and amputation.

5.5.2. Compression pumps of various kinds are in wide use in hospitals, clinics, patient homes, and elsewhere for treating acute and chronic fluid accumulation disorders.

5.5.3. Complies with physician-prescribed treatment pressures.

5.5.3.1. section 513, 801(b), 52 Stat. 1055, 90 Stat. 540-546 (21 U.J.C. 360C 371(A))

5.6. technological characteristics

5.6.1. This device is a new compression pump and appliance system which produces results similar to other single-pressure systems currently in use.

5.6.2. The proposed device is factory-preset for a maximum pressure less than 101 mm Hg.

5.7. summary of comparison

5.7.1. The proposed device is similar in terms of medical efficacy and operational function to the cited devices. The proposed device employs similar controls and features similar pressure ranges, degrees of accuracy, cycle times, and so on to those of the cited devices.

5.8. safety and effectiveness performance data

5.8.1. non-clinical test data

5.8.1.1. Cell pressure of prototype device was measured comparing on-board gauge reading to calibrated Hg manometer.

5.8.1.2. Pressure in appliance reaches the prescribed setting 10 or more seconds before the end of the cycle.

5.8.2. clinical test data

5.8.2.1. not applicable

06 May 1996
510(k) -- "Solo VII" Single-pressure Compression Therapy Device
01996 Wright Linear Pump, Inc.
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contains CONFIDENTIAL material