BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS

K961425 · Bio Compression Systems, Inc. · ILO · Oct 28, 1996 · Physical Medicine

Device Facts

• Record ID: K961425
• Device Name: BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS
• Applicant: Bio Compression Systems, Inc.
• Product Code: ILO · Physical Medicine
• Decision Date: Oct 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The COLDFLO™ models combine cold and compression therapies. This combination is intended to provide a temporary increase in the circulation of fluids from the treated limb, reducing minor pain and swelling. The device may also enhance healing secondary to the reduction of swelling in the limb.

Device Story

Cold Flo® combines cold therapy and compression massage for limb treatment. Device consists of a pump and limb sleeve; sleeve contains chambers for air inflation and an inner layer for cold water circulation. Single-chamber models provide intermittent pressure; multi-chamber models provide sequential (distal to proximal) compression. Operated by healthcare providers or patients in clinical or home settings. Pump circulates cold water through sleeve while simultaneously inflating/deflating chambers to apply pressure. Output is physical compression and cooling of the limb. Clinical benefit includes temporary increase in fluid circulation, reduction of minor pain and swelling, and secondary enhancement of healing. Materials include nylon and poly-ether-urethane.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional comparison to predicate devices.

Technological Characteristics

Energy source: 120V 60Hz. Materials: Nylon and poly-ether-urethane sleeve. Function: Powered inflatable tube massager with cold water circulation. Pressure range: 30-125 mm/Hg. Fluid capacity: 1250 ml. Flow rate: 16-20 oz/min. Temperature range: Room temperature to 40°F. Inflation time: 60 seconds; Deflation time: 12-15 seconds.

Indications for Use

Indicated for patients requiring cold and compression therapy to increase fluid circulation, reduce minor pain, and decrease swelling in the limbs.

Regulatory Classification

Identification

A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

Predicate Devices

• Jobst Cryo/Temp™
• Tempacure (K921540)
• Sequential Circulator

Submission Summary (Full Text)

{0}

510(k) SUMMARY
K961425

# 1. APPLICANT

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

OCT 28 1996

Contact person:

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

Summary Prepared: October 24, 1996

# 2. DEVICE NAME

PROPRIETARY/TRADE NAME: Bio Compression Cold Flo®

COMMON/USUAL NAME: Cold Therapy Massager, Single Chamber Intermittent and Multi-Chamber Sequential Models

CLASSIFICATION NAME: Cold Water Circulating Pack/Powered Inflatable Tube Massager

# 3. PREDICATE DEVICE

The Bio Compression Cold Flo® is substantially equivalent in design, materials and use to the Jobst Cryo/Temp™. According to Jobst, the Cryo/Temp™ device was legally marketed by that company prior to May 28, 1976. Like the Bio Compression Cold Flo®, the Jobst Cryo/Temp™ provides a simultaneous application of cold therapy along with controlled pressure.

Two other devices also serve as predicates for the Cold Flo®. The Cold Flo® is substantially equivalent to the Tempacure, which provides cold or hot therapy, (510(k) number K921540), and the Sequential Circulator, which provides

{1}

sequential compression therapy (sold by Bio Compression prior to May 28, 1976). The Cold Flo® combines the functions of each of these predicate devices, and it is substantially equivalent in design, materials and use to them.

## 4. DESCRIPTION OF THE COLD FLO®

The Cold Flo® is a device that combines the function of two devices traditionally used for providing cold therapy and massage therapy. Like a Powered Inflatable Tube Massager, the Cold Flo® provides massage therapy through a pump providing compression to the affected limb. This pressure, depending on the Cold Flo® model, is either sequential or intermittent. At the same time, the Cold Flo® delivers cold therapy by circulating cold water through the limb sleeve, like a Cold Water Circulating Pack. The single version contains one chamber that inflates or deflates to provide intermittent pressure. The sequential version contains 3 chambers that inflate and deflate sequentially (from distal to proximal), and an inner sleeve through which the cold water flows. The Cold Flo® sleeve is made of nylon and poly-ether-urethane.

## 4. INTENDED USE

The COLDFLO™ models combine cold and compression therapies. This combination is intended to provide a temporary increase in the circulation of fluids from the treated limb, reducing minor pain and swelling. The device may also enhance healing secondary to the reduction of swelling in the limb.

## 5. TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE

The Cold Flo® is substantially equivalent in design, materials and use to the Jobst Cryo/Temp™ as well as to the Tempacure and the Sequential Circulator Model 2000. A table comparing the design, material, physical characteristics, and intended uses of the devices is attached as Exhibit A.

177187

{2}

# COLD FLO® COMPARISON: COLD CIRCULATING DEVICES AND POWERED INFLATABLE TUBE MASSAGERS

| PARAMETER | BIO COMPRESSION COLD FLO® | JOBST CRYO/TEMP | BIOCOMPRESSION SEQUENTIAL CIRCULATOR | TEMPACURE COOLING/HEATING THERAPY DEVICE (K921540) |
| --- | --- | --- | --- | --- |
| Intended Use | Cold and compression therapy to temporarily increase circulation, reduce edema, and alleviate pain in the treated limb. May enhance healing secondary to reduction of edema. | Cold and pressure therapy for fracture, contusions, sprains, muscle spasms and edema | Pressure therapy for primary and secondary lymphedema, venous and lymphatic insufficiency, and post-traumatic edema | To provide hot and cold therapy |
| Energy Source | 120V 60Hz | | Starting Amps: 110 V, 1.42 Amps, 156.20 Watts
Maximum Running Amps: 110V, 0.78 Amps, 85.80 Watts | 90-270V 40-60Hz |
| Materials | Nylon and poly-ether-urethane (sleeve) | | Nylon reinforced polyurethane. | Polyvinylchloride (sleeve) |
| Anatomical Sites | Arms and legs | Arms and legs | Arms and legs | Arms, legs, or other discrete body locations |
| Water Capacity/Flow Rate | 1250 ml fluid capacity; flow rate of 16-20 oz. per minute | Flow rate of 16 oz. per minute | N/A | 6 oz. reservoir capacity; flow rate of 10-15 gallons per hour |
| High/low Temperature | Room temperature to 40° | 70° F to 40° F | N/A | 107°F to 34°F |
| High/Low Pressures | 30-125 mm/Hg | 10-120 mm/Hg | 30-180 mm Hg | N/A |
| Filling/Deflation Times | Inflation time: 60 seconds.
Deflation time: 12-15 seconds. | Inflation time: 90 seconds.
Deflation time: 30 seconds. | Inflation time: 24-60 seconds
Deflation time: 6-72 seconds | N/A |