(199 days)
Not Found
No
The description focuses on mechanical functions (pump, compression, water circulation) and does not mention any AI/ML terms or capabilities.
Yes
The stated intended use of the device is to "provide a temporary increase in the circulation of fluids from the treated limb, reducing minor pain and swelling" and to "enhance healing secondary to the reduction of swelling in the limb," which are therapeutic effects.
No
Explanation: The device description states its purpose is to provide cold and compression therapies to reduce pain and swelling and enhance healing. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly outlines physical components like a pump, sleeves, and a system for circulating cold water, indicating it is a hardware device with potentially integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The COLDFLO™ device applies cold and compression therapy externally to the arms and legs. It does not analyze any biological samples from the patient.
- Intended Use: The intended use describes providing temporary relief from pain and swelling and potentially enhancing healing through external physical therapy. This is not a diagnostic purpose.
The device description clearly outlines a physical therapy device that combines cold water circulation and pneumatic compression, not a diagnostic test.
N/A
Intended Use / Indications for Use
The COLDFLO(TM) 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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Cold Flo(R) 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(R) provides massage therapy through a pump providing compression to the affected limb. This pressure, depending on the Cold Flo(R) model, is either sequential or intermittent. At the same time, the Cold Flo(R) 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(R) sleeve is made of nylon and poly-ether-urethane.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arms and legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Jobst Cryo/Temp(TM), K921540
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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.
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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 | 107ºF to 34ºF |
| 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 |