(199 days)
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No
The device description details a purely mechanical system powered by manual inflation and the wearer's walking action. There is no mention of AI, ML, or any computational processing.
Yes
The device is described as providing "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," which directly indicates a therapeutic purpose.
No
The device description and indications for use clearly state that the Bio Boost provides therapy (treatment/management of conditions) by delivering intermittent compression, rather than diagnosing conditions.
No
The device description explicitly states it is made of physical materials (thermoplastic poly-ether-urethane and nylon) and uses mechanical action (manual inflation bulb, foot pad pressure from walking) to provide therapy, indicating it is a hardware device.
Based on the provided text, the Bio Boost™ 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.
- Bio Boost™ Function: The description clearly states that the Bio Boost™ provides intermittent compression therapy to the lower limbs. This is a physical therapy method applied externally to the body.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely mechanical compression.
Therefore, the Bio Boost™ falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Lymphedema of the lower limbs
Edema following trauma and sports injuries
Post immobilization edema
Prophylaxis of deep vein thrombosis
Venous insufficiencies
Product codes
Not Found
Device Description
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 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
lower limb/lower limbs
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 890.5650 Powered inflatable tube massager.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
1. APPLICANT
OCT 28 1996
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
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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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SPECIEICATIONS
| BIOBOOST | TALLEY INTERMITTENT UNIT
WITH CALF APPLICATOR |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS | INDICATIONS |
| Lymphedema of the lower limbs
Edema following trauma and sports injuries
Post immobilization edema
Prophylaxis of deep vein thrombosis
Venous insufficiencies | Lymphedema of the lower limbs
Edema following trauma and sports injuries
Post immobilization edema
Prophylaxis of deep vein thrombosis
Venous insufficiencies |
| CONTRAINDICATIONS | CONTRAINDICATIONS |
| Acute pulmonary edema
Acute thrombophlebitis
Acute congestive cardiac failure
Acute infections | Acute pulmonary edema
Acute thrombophlebitis
Acute congestive cardiac failure
Acute infections |
| MODE OF COMPRESSION | MODE OF COMPRESSION |
| Intermittent. | Intermittent. |
| POWER SOURCE | POWER SOURCE |
| Pressure from patient ambulation. | 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 | THERAPY TIME |
| Continuous when walking. Unit can be worn
all day. | 30, 60, 120 minutes. or continuous. |
| MAXIMUM AND MINIMUM PRESSURE | 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. | 0-150 mmHg. |
| NUMBER OF CHAMBERS | NUMBER OF CHAMBERS |
| Single Chamber | 1 to 10 chambers |
| BIOBOOST | TALLEY INTERMITTENT UNIT WITH CALF APPLICATOR |
| COMPRESSION CYCLE TIME | COMPRESSION CYCLE TIME |
| Varies with rate at which patient walks. | 30, 70,110 seconds. |
| COMPRESSION APPLICATOR GARMENTS SLEEVE MATERIAL | COMPRESSION APPLICATOR GARMENTS SLEEVE MATERIAL |
| Thermoplastic poly-ether-urethane-coated nylon with
velcro fastener on leg applicators. | Polyurethane coated nylon with zip fastener on
leg applicators. |
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