(32 days)
When used with GI-3045-T Knee/Thigh or GI-3045-K Knee garments:
- Intended for prophylaxis of deep vein thrombosis
When used with GI-3045-F Foot garments:
- Intended for prophylaxis of deep vein thrombosis
- Enhancement of venous and arterial circulation
- Prevention of venous stasis ulcers
- Assist in healing of cutaneous ulcers
- Reduction of acute or chronic edema
- Reduction of lower limb pain due to surgery or trauma
- Reduction of compartmental pressures
The device is intended for hospital and home use.
The device is available in two models (-KT and -F) and is intended for use to help prevent deep vein thrombosis (DVT) by increasing venous blood flow (prophylaxis). One DVT prophylaxis model is intended for use on the calves or calves and thighs, while the second model is intended for use on the feet. Connector variations prevent interchangeability of garments between the models.
The device for consists of a pump, inflatable garments, and interconnection tubing. The pump is manual (e.g., inflate/deflate cycle times remain constant, and pressure is pre-set at the factory), and contains a compressor capable of a maximum pressure of 150mmHg. A calibrated dial gauge displays pressure in the range of 0-125mmHg. Should the attending physician require a higher or lower pressure from the preset value, an over-ride adjustment control is available. An integrated wire bail is provided to conveniently attach the device to the patient bedrails.
For DVT prophylaxis, the device is attached via interconnect tubing to sleeves or garments containing discrete, interconnected, and segmented inflatable chambers applied externally and bilaterally over the lower extremities. The pump provides intermittent, rapid impulse pressurization to the chambers. The garment design achieves sequentially inflation of interconnected chambers distal to proximal, and a "bleeding" mechanism ensures that distal chambers are inflated to a greater pressure than the proximal ones. The last chamber bleeds off pressure to the ambient atmosphere. An external manual adjustment available for pressure override, and an alarm is provided for low/no pressure. When the bilateral DVT prophylaxis garments are inflated, they compress the veins in the calf, expelling blood from the leg, overcoming blood stasis and promoting circulation.
Garments are available in three anatomical configurations, are supplied non-sterile, and are intended for single patient use.
The device is intended for hospital and home use.
The provided text describes the 510(k) summary for the Bio Compression Systems Inc. Model Multi-Flo IC-1545-KT/-F Intermittent Circulator. The information focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for a novel device. Therefore, a direct table of acceptance criteria and reported device performance, as well as several other requested details pertinent to a new device validation study, cannot be fully extracted from this document.
However, I can provide information based on what is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantifiable manner for a new device. Instead, it refers to a comparison to predicate devices. The "performance data" section indicates:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar risetimes (time required to reach pressure) to predicate devices | Demonstrated similar risetimes to predicate devices |
| Similar cycle times (total inflated and deflated times within a cycle) to predicate devices | Demonstrated similar cycle times to predicate devices |
| Similar inflation pressures to predicate devices | Demonstrated similar inflation pressures to predicate devices |
| Product meets its specifications (general statement) | Performance testing was performed and assures that the product meets its specifications |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Bench testing." There is no information provided regarding:
- The specific sample size (e.g., number of units tested, number of cycles performed).
- The country of origin for the data.
- Whether the data was retrospective or prospective (bench testing is typically prospective, but details are not given).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This device is a mechanical pump for DVT prophylaxis. Its performance is assessed through physical parameters (pressure, time) via bench testing, not by expert interpretation of clinical data or images. Ground truth in this context relates to the accurate measurement of these physical parameters, not expert consensus on medical findings.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As stated above, this is bench testing of physical parameters. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical evaluations where multiple experts interpret ambiguous cases (e.g., medical imaging).
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
Not applicable. This device is not an AI-powered system or diagnostic tool that involves human readers interpreting cases. It is a mechanical medical device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This device does not have an "algorithm" in the sense of AI. It performs a mechanical function. Its standalone performance was assessed via bench testing, focusing on its physical output (inflation cycles, pressure) as compared to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is based on instrumentation measurements of physical parameters (risetimes, cycle times, inflation pressures) as compared to the specifications of the predicate devices. It is not based on expert consensus, pathology, or clinical outcomes data for this specific performance testing.
8. The sample size for the training set
Not applicable. The document describes a traditional 510(k) submission for a mechanical device, not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is mentioned or implied for this device's submission.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).