BIO BOOST

K961426 · Bio Compression Systems, Inc. · IRP · Oct 28, 1996 · Physical Medicine

Device Facts

• Record ID: K961426
• Device Name: BIO BOOST
• Applicant: Bio Compression Systems, Inc.
• Product Code: IRP · Physical Medicine
• Decision Date: Oct 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Like other Powered Inflatable Tube Massagers, the Bio Boost™ provides intermittent compression therapy for control, management and treatment of lower limb conditions such as lymphedema of the lower limb, edema from sports injuries, and venous insufficiency.

Device Story

Bio Boost™ provides intermittent compression therapy for lower limb conditions. Device consists of a foot-worn pad and leg sleeve. Initial inflation achieved via manual squeeze bulb; subsequent compression powered by patient's walking action, which exerts pressure on foot pad to deliver air-based 'boost' to limb. Used by patients during ambulation. Output is mechanical intermittent compression, improving circulation. Benefits include management of edema and venous insufficiency without requiring electrical power, eliminating electrical shock risks associated with powered pumps.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and performance characteristics compared to predicate device.

Technological Characteristics

Materials: Thermoplastic poly-ether-urethane and nylon with velcro fasteners. Energy source: Mechanical (patient ambulation). Form factor: Single-chamber inflatable sleeve/pad. Pressure range: 0-40 mmHg initial fill, 80 mmHg maximum. Connectivity: None. Software: None.

Indications for Use

Indicated for lymphedema of lower limbs, edema following trauma/sports injuries, post-immobilization edema, prophylaxis of deep vein thrombosis, and venous insufficiencies. Contraindicated in acute pulmonary edema, acute thrombophlebitis, acute congestive cardiac failure, and acute infections.

Regulatory Classification

Identification

A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.

Predicate Devices

• Talley Intermittent Multicom™ Compression System With Calf Applicator (K915638)

Submission Summary (Full Text)

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OCT 28 1996
K961426
510(k) SUMMARY

1. APPLICANT

Bio Compression Systems, Inc.
120 Commercial Ave.
Moonachie, NJ 07074
1-800-888-0908
[phone] (Facsimile)

Contact person:

Daniel A. Kracov
Patton Boggs, L.L.P.
2550 M Street, N.W.
Washington, D.C. 20037
[phone]
[phone] (Facsimile)

Summary Prepared: April 8, 1996

2. DEVICE NAME

PROPRIETARY/TRADE NAME: Bio Boost™

COMMON/USUAL NAME: Intermittent Compression System; Extremity Pump; Pneumatic Therapy Device

CLASSIFICATION NAME: Powered Inflatable Tube Massager.

3. PREDICATE DEVICE

The Bio Boost™ is substantially equivalent to the Talley Intermittent Multicom™ Compression System With Calf Applicator (510(k) number K915638).

4. DESCRIPTION OF THE BIO BOOST™

The Bio Boost™ provides intermittent compression therapy for control, management and treatment of a range of lower limb conditions. The stimulation provided by the compression action improves circulation to the area treated. The Bio Boost™ is initially inflated by manually squeezing an inflation bulb. Use of different inflation bulbs provides a different baseline pressure. Thereafter, the compression action is powered by the walking action of the wearer, which exerts pressure on a pad underneath the foot. With each step, the air in the pad provides

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an inflation "boost," thus delivering intermittent compression therapy to the patient's lower limb. The Bio Boost™ is made of thermoplastic poly-ether-urethane and nylon, with velcro fasteners.

5. INTENDED USE

Like other Powered Inflatable Tube Massagers, the Bio Boost™ provides intermittent compression therapy for control, management and treatment of lower limb conditions such as lymphedema of the lower limb, edema from sports injuries, and venous insufficiency. Devices providing intermittent compression therapy have been marketed for many years for these indications.

6. TECHNOLOGICAL DIFFERENCES FROM PREDICATE DEVICE

The only significant difference between the Bio Boost™ and other Powered Inflatable Tube Massagers such as the Talley Intermittent Multicom™ Compression System With Calf Applicator, is that the Bio Boost™ does not require an electric power source. As described above, the initial inflation of the Bio Boost™ is done manually, with an inflation bulb. Subsequent compression action comes from the walking action of the wearer. This modification has no significant effect on the device's performance relative to the predicate device. While the Bio Boost™ offers pressures comparable to many electrically-powered massagers, it does not utilize an electrical power source. This eliminates concerns related to potential electrical shock due to leakage or excess current. A table comparing the design, material, physical characteristics, and intended uses of the devices is attached as Exhibit A.

177156
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# SPECIFICATIONS

| BIOBOOST | TALLEY INTERMITTENT UNIT WITH CALF APPLICATOR |
| --- | --- |
| INDICATIONS
Lymphedema of the lower limbs
Edema following trauma and sports injuries
Post immobilization edema
Prophylaxis of deep vein thrombosis
Venous insufficiencies | INDICATIONS
Lymphedema of the lower limbs
Edema following trauma and sports injuries
Post immobilization edema
Prophylaxis of deep vein thrombosis
Venous insufficiencies |
| CONTRAINDICATIONS
Acute pulmonary edema
Acute thrombophlebitis
Acute congestive cardiac failure
Acute infections | CONTRAINDICATIONS
Acute pulmonary edema
Acute thrombophlebitis
Acute congestive cardiac failure
Acute infections |
| MODE OF COMPRESSION
Intermittent. | MODE OF COMPRESSION
Intermittent. |
| POWER SOURCE
Pressure from patient ambulation. | POWER SOURCE
For Multicom Power Unit
Electricity Supply: 220/250V50Hz (other voltages available)
Electricity Consumption: 8 watts
For Pressure Therapy Units (Cat. Ref. PT101)
Electricity Supply: 200/250V50Hz
Electricity Consumption: 52 watts |
| THERAPY TIME
Continuous when walking. Unit can be worn all day. | THERAPY TIME
30, 60, 120 minutes. or continuous. |
| MAXIMUM AND MINIMUM PRESSURE
0-40 mm/Hg initial fill, and sustained during therapy (depending upon pressure bulb used).
80 mm/Hg maximum total pressure. | MAXIMUM AND MINIMUM PRESSURE
0-150 mmHg. |
| NUMBER OF CHAMBERS
Single Chamber. | NUMBER OF CHAMBERS
1 to 10 chambers. |

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| BIOBOOST | TALLEY INTERMITTENT UNIT WITH CALF APPLICATOR |
| --- | --- |
| COMPRESSION CYCLE TIME
Varies with rate at which patient walks. | COMPRESSION CYCLE TIME
30, 70,110 seconds. |
| COMPRESSION APPLICATOR GARMENTS SLEEVE MATERIAL
Thermoplastic poly-ether-urethane-coated nylon with velcro fastener on leg applicators. | COMPRESSION APPLICATOR GARMENTS SLEEVE MATERIAL
Polyurethane coated nylon with zip fastener on leg applicators. |
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