(88 days)
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."
§ 870.5225 External counter-pulsating device.
(a)
Identification. An external counter-pulsating device is a noninvasive, prescription device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle.(b)
Classification. (1) Class II (special controls) when the device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. The special controls for this device are:(i) Nonclinical performance evaluation of the device must demonstrate a reasonable assurance of safety and effectiveness for applied pressure, synchronization of therapy with the appropriate phase of the cardiac cycle, and functionality of alarms during a device malfunction or an abnormal patient condition;
(ii) Reliabilities of the mechanical and electrical systems must be established through bench testing under simulated use conditions and matched by appropriate maintenance schedules;
(iii) Software design and verification and validation must be appropriately documented;
(iv) The skin-contacting components of the device must be demonstrated to be biocompatible;
(v) Appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device; and
(vi) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) for the following intended uses: Unstable angina pectoris; acute myocardial infarction; cardiogenic shock; congestive heart failure; postoperative treatment of patients who have undergone coronary artery bypass surgery; peripheral arterial disease associated with ischemic ulcers rest pain or claudication, threatened gangrene, insufficient blood supply at an amputation site, persisting ischemia after embolectomy or bypass surgery, and/or pre- and post-arterial reconstruction to improve runoff; diabetes complicated by peripheral arterial disease or other conditions possibly related to arterial insufficiency including nocturnal leg cramps and/or necrobiosis diabeticorum; venous diseases, including prophylaxis of deep vein thrombophlebitis, edema (e.g., chronic lymphedema) and/or induration (e.g., stasis dermatitis) associated with chronic venous stasis, venous stasis ulcers, and/or thrombophlebitis; athletic injuries, including Charley horses, pulled muscles and/or edematous muscles; necrotizing cellulitis.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before March 31, 2014, for any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other external counter-pulsating device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.