WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL

K961292 · Wright Linear Pump, Inc. · JOW · Nov 6, 1996 · Cardiovascular

Device Facts

• Record ID: K961292
• Device Name: WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL
• 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

WLP Solo VI is an electromechanical pneumatic sequential compression pump; used in hospitals, clinics, or homes to treat fluid accumulation in extremities. Device consists of a compressor, precision timer, regulator, and pressure gage; connects to a limb sleeve. Operates by sequentially inflating sleeve cells to apply pressure; at cycle end, disengages cells in proximal-to-distal succession (C then B then A) to prevent reverse pressure gradients. Factory-preset to maximum pressure <101 mm Hg. Healthcare providers or patients use the device per physician prescription to manage edema and associated complications. Output is mechanical compression of the limb; aids fluid return, reducing pain and swelling.

Clinical Evidence

No clinical data. Bench testing only: prototype cell pressures measured using precision regulators; confirmed pressures reach prescribed settings 10+ seconds before next cell activation; proximal cell pressure is sustained.

Technological Characteristics

Electromechanical pneumatic system; dimensions 8"W x 6.75"H x 5.5"D; weight <15 lbs. Features compressor, precision timer, regulator, and pressure gage. Sequential inflation/deflation mechanism with proximal-to-distal cell disengagement. Factory-preset maximum pressure <101 mm Hg.

Indications for Use

Indicated for patients with acute or chronic fluid accumulation disorders in extremities, including those experiencing pain, swelling, or ulceration, to improve return circulation and reduce 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

• Wright Linear Pump gradient (K830577B)
• Huntleigh Flowpress AC300 (K871271)
• Huntleigh Flowtron AC 200/2 (K874688)
• Chattanooga Presssion sequential (K921608)

Submission Summary (Full Text)

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K961292

NOV - 6 1996

## 4. 510(k) Summary

### 4.1. submitter

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

412 695-0800
FAX [phone]

4.1.2. contact Edward J. Wright
4.1.3. prepared 04/06/96

### 4.2. product identification

4.2.1. trade name...WLP Solo VI
4.2.2. common name ...sequential compression pump
4.2.3. classification name Compressible Limb Sleeve (Class II)
21 CFR 870.5800
4.2.4. product number...74JOW

### 4.3. equivalence

4.3.1. The proposed device is similar in design, function, and composition to existing compression pump devices such as document K830577B (Wright Linear Pump gradient), document K871271 (Huntleigh ✓ Flowpress AC300) pump, document K874688 (Huntleigh Flowtron AC 200/2), and document K921608 (Chattanooga Presssion sequential).

4.3.1.1. As a sequential pressure system, the proposed device is simpler than existing gradient pressure systems (Wright Linear Pump K830577B) for treating "simple lymphedema" or mild patient cases.

### 4.4. description

4.4.1. This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to sequentially inflate a sleeve appliance that fits over the patient's extremity.
4.4.2. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 15 lbs.

### 4.5. intended use

4.5.1. The proposed device is to be used to improve the return circulation

03 April 1996
©1996 Wright Linear Pump, Inc.
510k Submission -- Sequential Compression Therapy Device
contains CONFIDENTIAL material

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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.

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

4.5.3. Complies with physician-prescribed treatment pressures.

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

4.6. technological characteristics

4.6.1. This device is a new state-of-the-art sequential compression pump and appliance system which produces better results than single-pressure systems currently in use.

4.6.1.1. At end of the pressure phase of the treatment cycle, this device disengages cells in quick succession, from proximal to distal, to ensure a reverse gradient is never applied despite any slight irregularities inherent in mechanical pneumatic systems. Cell C is disengaged just before cell B and, in turn, B just before A.

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

4.7. safety and effectiveness performance data

4.7.1. non-clinical test data

4.7.1.1. Cell pressures of prototype device were measured using separate precision regulators for each appliance cell.

4.7.1.2. Pressures in each cell reach the prescribed setting 10 or more seconds before the next cell is activated.

4.7.1.3. Maximum pressure in the proximal cell (cell C) is reached before the end of the cycle and, thus, sustained.

4.7.2. clinical test data

4.7.2.1. not applicable

03 April 1996

61996 Wright Linear Pump, Inc.

510k Submission -- Sequential Compression Therapy Device

contains CONFIDENTIAL material