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When used with GID-3045-T Calf/Thigh or GID-3045-K Calf 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
• Reduction of acute or chronic edema
• Reduction of lower limb pain due to surgery or trauma
• Reduction of compartment pressures

The IC-1545-DL Multi-Flo DVT Combo (applicant device) provides intermittent pressure to the calf and thigh or foot through the use of inflatable garments. The applicant device is a digitally-controlled version of the predicate device, with identical specifications. There is no change in fundamental technology and no change in intended use from the predicate device, K610857. The digital modification provides identical call/thigh (KT) and foot (F) timing and pressure options as the predicate and it has the same intended use as the predicate, including prophylaxis of deep vein thrombosis (DVT) and enhancing venous and arterial circulation. Tubing connector design variations prevent interchangeability of garments between the models. The user interface consists of a soft keypad where the predicate has a rocker on/off switch and a pressure adjustment knob. The analogue pressure gauge and regulator have been removed, making the applicant unit 27% smaller and 47% lighter than the predicate, and both are designed to hang on bedrails for easy access to bed-ridden patients. The device consists of a pump, inflatable garments, and interconnection tubing. The pump compressor is capable of no more than 150 mmHg maximum pressure and has pre-set inflate/deflate cycle times. Default pressure and timing is pre-set at the factory to 50 mmHg, with a cycle of 15 seconds on and 45 seconds off (KT option). This is consistent with the majority of indications prescribed. All controls and measurement functions are contained in the PCB assembly. When turned on, the timer sends a signal to start the pump sends air to the output ports, filling the garments with air. A digital pressure sensor maintains the pressure by turning the compression pump on and off. After 45 seconds, the timer stops the pump and opens a valve to deflate the garnents and 15 seconds later the cycle repeats. In order to achieve its intended use, the device is attached via interconnecting tubing to sleeves (garments) applied externally and bilaterally over the lower extremities. The garments contain discrete, interconnected and segmented inflatable chambers. The pump provides intermittent, rapid impulse pressurization to the chambers. The pressure can be adjusted up or down in increments of I mmHg with up and down soft key arrows, and an alarm is provided for low/no pressure. When the garnents are inflated, they compress the veins in the calf, expelling blood from the leg, overcoming blood stasis and promoting circulation. The device runs continuously until turned off. An LED display shows the pressure setting during the inflation cycle and "0" during the deflation cycle. Pressure setting can be changed by the user, while timing cycles can be changed with special instructions provided to the distributor. An alarm will alert the user if inflation pressures do not exceed 30 mmHg. All garments are supplied non-sterile and for single patient use. DVT prophylaxis garments are available in a total of three anatomical configurations as indicated to the calves or the calves and the thighs (KT) and the feet (F).

This document describes the IC-1545-DL Multi-Flo DVT Combo Intermittent Pneumatic Compression Device, a device intended for prophylaxis of deep vein thrombosis and enhancement of venous and arterial circulation, among other uses. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Model Multi-Flo IC-1545-KT/F Intermittent Circulator).

Acceptance Criteria and Device Performance

The device's performance is accepted based on functional testing and comparison to the predicate device. The key acceptance criteria revolve around maintaining similar performance specifications and inflation cycle profiles to the predicate device, despite changes in the user interface (digital vs. analog).

The overall acceptance criteria appear to be that the applicant device (IC-1545-DL Multi-Flo DVT Combo) demonstrates equivalent inflation cycle profiles (rise times, inflation pressures, deflation times, and cycle times) compared to the predicate device (Model Multi-Flo IC-1545-KT/F). The device also underwent aesthetic and electrical leakage testing.

Study Information

The provided document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials for safety and effectiveness.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of a clinical performance study with a distinct "test set" as typically understood. The closest equivalent is the functional testing performed on every device before release. The document states, "Before being released every device is tested and must meet all performance specifications." This suggests a 100% inspection/testing of manufactured units.
   • Data Provenance: The functional testing is conducted internally by the manufacturer (Bio Compression Systems, Inc.). No external clinical data or country of origin for a "test set" is provided as this is not a clinical study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The "ground truth" for the functional testing is the device's technical specifications and the performance of the predicate device. This is established by engineering and manufacturing standards, not medical experts.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods are typically used in clinical studies for interpretation of results by multiple experts. The functional testing described is objective and quantitative, based on predefined technical specifications.

4. 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:

   • No MRMC comparative effectiveness study was done, as this is a physical medical device (intermittent pneumatic compression device), not an imaging or AI-assisted diagnostic tool involving human reader interpretation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable, as this is not an algorithm or AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for demonstrating substantial equivalence and meeting performance specifications relies on:
     • Engineering Specifications: Defined parameters for pressure, timing, etc.
     • Predicate Device Performance: The established operating characteristics and clinical efficacy of the predicate device (K610857). The applicant device is designed to operate within these "clinically-established parameters."

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set.

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