(199 days)
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.
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.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the Bio Compression Cold Flo®, which aims to establish substantial equivalence to predicate devices for regulatory clearance. It describes the device's intended use, technological characteristics, and compares it to other similar devices.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts for ground truth, or adjudication methods for any test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- A standalone algorithm performance study.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- The sample size for a training set or how its ground truth was established, as this is a medical device, not an AI/ML algorithm requiring such training.
The document primarily focuses on demonstrating that the Cold Flo® is substantially equivalent to existing legally marketed devices, which is the typical pathway for 510(k) clearance.
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510(k) SUMMARY
1. APPLICANT
Bio Compression Systems, Inc. 120 Commercial Ave. Moonachie, NJ 07074 1-800-888-0908 (201) 939-4503 (Facsimile)
OCT 28 1996
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: 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
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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.
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COLD FLO® COMPARISON: COLD CIRCULATING DEVICES AND POWERED INFLATABLE TUBE MASSAGERS
| PARAMETER | BIOCOMPRESSIONCOLD FLO® | JOBSTCRYO/TEMP | BIOCOMPRESSIONSEQUENTIALCIRCULATOR | TEMPACURECOOLING/HEATINGTHERAPY DEVICE(K921540) |
|---|---|---|---|---|
| Intended Use | Cold andcompressiontherapy totemporarilyincrease circulation,reduce edema, andalleviate pain in thetreated limb. Mayenhance healingsecondary toreduction of edema. | Cold andpressuretherapy forfracture,contusions,sprains, musclespasms andedema | Pressure therapy forprimary and secondarylymphedema, venousand lymphaticinsufficiency, andpost-traumatic edema | To provide hot and coldtherapy |
| Energy Source | 120V 60Hz | Starting Amps: 110 V,1.42 Amps, 156.20WattsMaximum RunningAmps: 110V, 0.78Amps, 85.80 Watts | 90-270V 40-60Hz | |
| Materials | Nylon andpoly-ether-urethane(sleeve) | Nylon reinforcedpolyurethane. | Polyvinylchloride(sleeve) | |
| Anatomical Sites | Arms and legs | Arms and legs | Arms and legs | Arms, legs, or otherdiscrete body locations |
| WaterCapacity/FlowRate | 1250 ml fluidcapacity; flow rateof 16-20 oz. perminute | Flow rate of 16oz. per minute | N/A | 6 oz. reservoir capacity;flow rate of 10-15gallons per hour |
| High/lowTemperature | Room temperatureto 40° | 70° F to 40° F | N/A | 107ºF to 34ºF |
| High/LowPressures | 30-125 mm/Hg | 10-120 mm/Hg | 30-180 mm Hg | N/A |
| Filling/DeflationTimes | Inflation time: 60seconds.Deflation time:12-15 seconds. | Inflation time:90 seconds.Deflation time:30 seconds. | Inflation time: 24-60secondsDeflation time: 6-72seconds | N/A |
§ 890.5720 Water circulating hot or cold pack.
(a)
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.(b)
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.