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The CardioMedics, Inc., CardiAssist™ CounterPulsation System is intended to provide external counterpulsation (ECP) by increasing perfusion during diastole for the treatment of angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock and may enhance coronary function.

The CardioMedics CardiAssist™ ECP System is a non-invasive circulatory assist device which provides increased circulation via external counterpulsation (ECP) for the treatment of ischemic heart disease including congestive heart failure, angina pectoris, myocardial infarction and cardiogenic shock. External counterpulsation therapy improves cardiac function by enhancing the perfusion of the coronary vasculature, the development of coronary collateral circulation, and by reducing the workload of the heart. The CardiAssist ECP System consists of the portable console containing the computer and pumps with a touch screen for user interface, an integral strip chart recorder, and leg cuffs and hoses. Additional components provided with the System include a finger plethysmograph and 3-lead ECG cable and leads.

This CardiAssist™ ECP System sequentially compresses the legs from the calves, thighs and buttocks, 40 milliseconds apart, by inflating three sets of flexible fabric cuffs during diastole. This results in movement of blood from the legs to the heart and entire upper body. Pressure, up to 310 mmHg, is applied with the timing and duration of each pulse, synchronized with the patient's ECG. When properly triggered, the pressure pulses applied to the vascular bed of the legs and buttocks transmit retrograde pressure through the entire vascular system. At the aorta, the aortic valve prevents retrograde flow into the left ventricle. Thus, a peak pulse of diastolic pressure occurs at or above systolic levels which increases the driving pressure in the coronary vasculature.

The provided text is a 510(k) summary for the CardioMedics, Inc. CardiAssist Counterpulsation System Mark 3000. It focuses on demonstrating substantial equivalence to a predicate device for an expanded indication (treatment of non-chronic angina pectoris patients).

The submission does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

• No acceptance criteria table or reported device performance is provided.
• No information about sample sizes (test or training set), data provenance, number or qualifications of experts, or adjudication methods is present.
• No mention of MRMC comparative effectiveness studies or standalone algorithm performance is made.
• The type of ground truth used is not specified.
• No details on how ground truth for a training set (if one existed, which is not stated) was established are given.

Instead, the submission primarily focuses on:

• Device Description: Explaining how the CardiAssist ECP System works (sequential compression of legs during diastole to enhance perfusion).
• Intended Use/Indications for Use: Listing the conditions the device is intended to treat (angina pectoris, congestive heart failure, myocardial infarction, cardiogenic shock).
• Comparison to Predicate Device: Stating that the new device is substantially equivalent in function and intended use to a previously cleared CardiAssist ECP System (K022107) and the Vasomedical EECP Therapy System Model TS3 (K020857). The key difference is an expanded indication to include non-chronic angina pectoris patients, with the claim that this does not change the safety or effectiveness.
• Regulatory Information: Including contact details, classification, and the FDA's clearance letter.

This type of 510(k) submission, especially for an expanded indication where technological and functional characteristics are identical to a predicate, often relies on demonstrating that the new indication does not introduce new questions of safety or effectiveness, rather than providing completely new performance study data if the core technology remains unchanged. The claim here is that the treatment of "all angina pectoris patients" (including non-chronic ones) "does not significantly change the safety or effectiveness of the device."

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