BIO BOOST

{0} OCT 28 1996 K961426 510(k) SUMMARY 1. APPLICANT Bio Compression Systems, Inc. 120 Commercial Ave. Moonachie, NJ 07074 1-800-888-0908 (201) 939-4503 (Facsimile) Contact person: Daniel A. Kracov Patton Boggs, L.L.P. 2550 M Street, N.W. Washington, D.C. 20037 (202) 457-5623 (202) 457-6315 (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 {1} 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 2 {2} # 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. | 171052/v4 {3} - 2 - | 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. | 171052/v4