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The CPCA2000™ Counterpulsation System is a non-invasive external counterpulsation device intended for use in the treatment of patients with stable or unstable angina pectoris, congestive heart failure, acute myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure or myocardial infarction and may enhance coronary function.

The CPCA2000 Counter Pulsation System consists of a portable console containing computer, electrocardiogram. plethysmogram, pump and reservoir, integral strip chart recorder, and leg cuffs and hoses. The microprocessor is used to operate and monitor the system via proprietary software, with the operator using touch screen interface to control its operation. The screen displays information pertinent to operating the system, as well as treatment parameters and patient waveforms during use. An external floppy disk drive is used to record data onto transferable media, and a printer is used to produce a hard copy of site, patient and physiologic data. The system accommodates the use of any bed or treatment table.

The provided document is a 510(k) summary for the CPCA2000 Counterpulsation System. It focuses on demonstrating substantial equivalence to a predicate device and outlines non-clinical tests conducted.

It does not contain the kind of information typically found in a clinical study report that would establish acceptance criteria and prove a device meets them with specific performance metrics. This type of information is usually found in clinical trial results, which are not detailed in this regulatory submission.

Therefore, I cannot provide the requested information from the given document. The document primarily describes:

• Device Name: CPCA2000™ Counterpulsation System
• Intended Use: Treatment of patients with stable or unstable angina pectoris, congestive heart failure, acute myocardial infarction, and cardiogenic shock.
• Predicate Device: Enhanced External Counterpulsation Device - Model EECP-MC2 (K940264).
• Non-Clinical Tests:
  • IEC60601-1-2; 2001 Medical Electrical Equipment Safety (Electromagnetic Compatibility)
  • UL 2601-1 Medical Electrical Equipment Safety
  • Software Verification & Validation (per CDRH guidance)
  • Device Risk & Hazard Analysis (per 21CFR820.30(g), Design Validation)

The document asserts that the "principle technological and functional characteristics of the current device are same as the predicate devices" and that treating congestive heart failure patients "does not significantly change the safety and effectiveness of the device" or "require any changes in software, device design or treatment regimen." This suggests that the substantial equivalence argument relies heavily on the predicate device's established safety and effectiveness.

To answer your specific questions, a clinical study report would be required, which is not available in these provided materials.

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