(199 days)
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.
INDICATIONS
Lymphedema of the lower limbs
Edema following trauma and sports injuries
Post immobilization edema
Prophylaxis of deep vein thrombosis
Venous insufficiencies
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.
This 510(k) summary describes a medical device, the Bio Boost™, which is an intermittent compression system. Since it is a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, not necessarily to prove specific performance metrics through an independent study with acceptance criteria.
Therefore, the requested information elements related to clinical studies, acceptance criteria, sample sizes, expert ground truth, adjudication, and reader studies are not applicable in the context of this specific regulatory document. The document focuses on comparing the new device's specifications and intended use against a known predicate device.
Here's an explanation of why each requested section is not found in the provided text:
- 1. A table of acceptance criteria and the reported device performance: This document does not establish new acceptance criteria as it's not a de novo submission or a detailed performance study report. It compares the Bio Boost's specifications to the predicate device.
- 2. Sample sized used for the test set and the data provenance: No clinical test set data is presented. The submission relies on the established safety and effectiveness of the predicate device and the minor technological differences of the new device.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant for this type of submission, as no new performance data requiring expert interpretation is provided.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set requiring adjudication is described.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a mechanical compression system, not an AI-powered diagnostic device, so MRMC studies and AI performance metrics are not relevant.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a physical device, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no new performance data requiring ground truth is presented.
- 8. The sample size for the training set: Not applicable, as there is no AI/algorithm component to train.
- 9. How the ground truth for the training set was established: Not applicable, as there is no AI/algorithm component to train.
The document primarily provides a comparison of specifications to demonstrate substantial equivalence.
Here is the table comparing the Bio Boost™ and its predicate device, as provided in the submission (serving as the "performance" comparison in this context):
| Feature/Specification | BIOBOOST | TALLEY INTERMITTENT UNIT WITH CALF APPLICATOR (Predicate Device) |
|---|---|---|
| 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 | 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 | Intermittent. | Intermittent. |
| 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 | Continuous when walking. Unit can be worn all day. | 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. | 0-150 mmHg. |
| NUMBER OF CHAMBERS | Single Chamber | 1 to 10 chambers |
| COMPRESSION CYCLE TIME | Varies with rate at which patient walks. | 30, 70, 110 seconds. |
| 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. |
Summary of Device Equivalence (as presented in the document):
The Bio Boost™ is deemed "substantially equivalent" to the predicate device because:
- Intended Use: Both devices share the same intended use: intermittent compression therapy for control, management, and treatment of lower limb conditions such as lymphedema, edema from sports injuries, and venous insufficiency.
- Technological Characteristics: The only significant technological difference is the power source. The Bio Boost™ uses patient ambulation (walking action) for compression after manual initial inflation, eliminating the need for an electric power source like the predicate device. The submission states this modification "has no significant effect on the device's performance relative to the predicate device."
- Performance (comparative): While pressures, cycle times, and number of chambers differ, the core therapeutic action (intermittent compression) is maintained, and the Bio Boost™ offers comparable pressures to many electrically-powered massagers. The elimination of an electrical power source addresses concerns related to potential electrical shock.
In essence, this 510(k) submission leverages the established safety and effectiveness of the predicate device, arguing that the Bio Boost's modifications do not raise new questions of safety or effectiveness.
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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 UNITWITH CALF APPLICATOR |
|---|---|
| INDICATIONS | INDICATIONS |
| Lymphedema of the lower limbsEdema following trauma and sports injuriesPost immobilization edemaProphylaxis of deep vein thrombosisVenous insufficiencies | Lymphedema of the lower limbsEdema following trauma and sports injuriesPost immobilization edemaProphylaxis of deep vein thrombosisVenous insufficiencies |
| CONTRAINDICATIONS | CONTRAINDICATIONS |
| Acute pulmonary edemaAcute thrombophlebitisAcute congestive cardiac failureAcute infections | Acute pulmonary edemaAcute thrombophlebitisAcute congestive cardiac failureAcute infections |
| MODE OF COMPRESSION | MODE OF COMPRESSION |
| Intermittent. | Intermittent. |
| POWER SOURCE | POWER SOURCE |
| Pressure from patient ambulation. | For Multicom Power UnitElectricity Supply: 220/250V50Hz (othervoltages available)Electricity Consumption: 8 watts |
| For Pressure Therapy Units (Cat. Ref. PT101)Electricity Supply: 200/250V50HzElectricity Consumption: 52 watts | |
| THERAPY TIME | THERAPY TIME |
| Continuous when walking. Unit can be wornall 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 withvelcro fastener on leg applicators. | Polyurethane coated nylon with zip fastener onleg applicators. |
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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).