(89 days)
Increase blood flow from lower extremities in recumbent patients to help prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).
The System 2600 is a three component system consisting of a control unit, inflatable multi-segment leg sleeves, and conduit tubing (4 port) with detachable connections. The control unit is an electro/mechanical device designed to apply a specific degree of pressure to the leg in a precise cycle beginning at the ankle (or lower calf) and continuing sequentially to the thigh. The unit utilizes a software based electronic control system, electro/mechanical compressor, and solenoid operated air inflation control valves. All electrical and mechanical components are contained in a molded plastic housing.
Pressure is generated in the control unit and is transferred to the patient by air inflation of the multisegment leg sleeves. The segments are inflated sequentially to various pressure settings to create a decreasing gradient, distal to proximal, on the lower extremity.
The inflatable multi-segment leg sleeves are designed to be wrapped comfortably around the patient's leg. They consist of multiple air chambers which can be inflated independently. There are four sizes of sleeves offered for use with the system. Two sizes have all four air chambers positioned between the ankle and knee. The other two sizes position two chambers between the ankle and knee and two chambers above the knee on the thigh.
The Jobst System 2600 monitors the sleeve pressure repeatedly during sleeve segment inflation via a pressure transducer. Solenoid activated valves, controlled by the electronic control system, regulate the air pressure in the segment's pressure is controlled by specific solenoid valves and is isolated from the other segments. Segment inflation and cycle timing are based on each segment achieving a preset (non-adjustable) pressure within a maximum allowable time limit. The pressures in each segment are repeatedly monitored and corrected throughout the cycle to ensure the preset pressures are maintained within each segment. After the four segments in the sleeve are inflated in a sequential pressure gradient manner, the solenoid valves open and the air is exhausted. The creation of the gradient sequential condition is dependent on the sequential opening of the solenoid valves and the pressure, monitored by the pressure transducer, in each segment of the sleeve. The pressure setting is fixed and is not user selected.
The provided document describes the K980456 submission for the Jobst Athrombic Pump System 2600. The acceptance criteria and the study proving the device meets them are based on demonstrating substantial equivalence to a predicate device, the Jobst Athrombic Pump System 2500, through bench testing.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Target Parameter for System 2600) | Reported Device Performance (System 2600) | Predicate Device Performance (System 2500) |
|---|---|---|
| Target pressure: Segment 1 | 50 mmHg (controlled within tolerance) | 50 mmHg (controlled within tolerance) |
| Target pressure: Segment 2 | 45 mmHg (controlled within tolerance) | 45 mmHg (controlled within tolerance) |
| Target pressure: Segment 3 | 40 mmHg (controlled within tolerance) | 40 mmHg (controlled within tolerance) |
| Target pressure: Segment 4 | 30 mmHg (controlled within tolerance) | 30 mmHg (controlled within tolerance) |
| Rise times (time to reach target pressures) | Under three seconds | Under three seconds |
| Inflation times (total time sleeve inflated in a cycle) | Less than 30 seconds | Less than 30 seconds |
| Total cycle time | Approximately 60 seconds | Approximately 60 seconds |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical sample size of "devices" or "runs." The study was a bench test comparing two systems (System 2600 and System 2500).
- Data Provenance: Retrospective, as it refers to performance data obtained during bench testing of the two systems for comparison. The country of origin is not specified, but the submission is to the U.S. FDA by a company (Beiersdorf - Jobst, Inc.) whose address is in Charlotte, NC, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth was established through direct measurement of physical parameters (pressures and times) during bench testing, not through expert interpretation of data.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. The "ground truth" was objective physical measurements, not subjective evaluations requiring adjudication.
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:
- MRMC Study: No. This device is a mechanical pump system for DVT prevention, not an AI-assisted diagnostic tool requiring human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in a sense. The bench testing evaluated the performance of the device (both System 2600 and System 2500) on its own, measuring its output (pressures and timing) against predefined parameters. There is no "human-in-the-loop" component in the operational function of this particular device being evaluated for its core mechanical properties.
7. The type of ground truth used:
- Type of Ground Truth: Objective physical measurements and fixed engineering parameters. The "ground truth" for the comparison was that both systems should produce the same inflation cycle parameters (target pressures, rise times, inflation times, total cycle time) as they use the same controlling parameters and sleeves.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is a mechanical system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a device would be its engineering design and calibration, likely based on iterative development and testing, rather than a distinct "training set" of data.
9. How the ground truth for the training set was established:
- How Ground Truth Established for Training Set: Not applicable for an AI training set. For a mechanical device like this, the "ground truth" for its design and calibration would have been established through engineering specifications, biomechanical requirements for DVT prevention (e.g., specific pressure gradients required for effective blood flow), and iterative testing during the development process to ensure the device performs according to these specifications.
§ 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).