(94 days)
S-TCT Health, Inc.'s US-ECP Model IV is a non-invasive external counterpulsating device intended for use in the treatment of patients with stable angina pectoris, acute myocardial infarction and cardiogenic shock.
The US-ECP is a painless, non-invasive medical device for performing external, sequential counterpulsation. Treatment is administered as the patient lies on the padded top of the device. The patient's calves, thighs, and buttocks are wrapped with specially designed adjustable pneumatic pressure cuffs, similar to blood pressure cuffs. Hoses connect the cuffs to an air pressure/vacuum pump enclosed in the device's base. The patient is also connected to an electrocardiogram to monitor the patient's heart rate. Once everything is properly in place, the device inflates and deflates the cuffs. The design of the cuffs permits significant pressure to be applied to the arteries and veins at relatively low air pressures. Timing for inflation and deflation is controlled electronically by running the patient's electrocardiogram signals through a microprocessor that monitors the entire treatment process. Each wave of pressure is electronically timed to the patient's heartbeat, so that the increased blood flow is delivered to the heart at the exact moment it is relaxing. When the patient's heart pumps again, pressure in the cuffs is released instantaneously. In short, the device pumps when the patient's heart is resting and releases pressure when the patient's heart is pumping. The intent of the treatment is to encourage cardiac circulation.
This submission for the S-TCT Health Inc. US-ECP external counterpulsation device, K030587, states that the device is substantially equivalent to a predicate device and does not include specific acceptance criteria or a detailed study proving the device meets performance criteria. Instead, it relies on the similarity to the predicate device.
However, based on the provided text, here's what can be inferred and stated regarding the device's characteristics and the basis for its clearance:
-
A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission focuses on substantial equivalence, implying that the performance of the US-ECP is expected to be similar to its predicate device, the Vasomedical Model EECP®-MC2 (K940264). The document explicitly states: "Technological and functional characteristics of the US-ECP are essentially the same as those of the predicate devices. Differences are speed of microprocessor (US-ECP is a faster, more current model) and cosmetic (e.g., table color)." This suggests that performance metrics for this device would mirror those established for the cleared predicate, but these specific metrics and direct performance data for the US-ECP are not presented in this 510(k) summary.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable / Not provided. The submission does not describe a new clinical study to test the US-ECP device and therefore does not mention a test set, sample size, or data provenance. The clearance is based on substantial equivalence to a previously cleared device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable / Not provided. As no new clinical study for the US-ECP is described, there's no mention of ground truth establishment by experts for a test set.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Not provided. No test set or related adjudication method is mentioned in this summary.
-
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
Not applicable. The US-ECP is an external counterpulsation device; it is not an AI-assisted diagnostic device, and therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant to this device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The US-ECP is a physical medical device that applies pneumatic pressure, not a standalone algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable / Not provided. No new ground truth data was established for this submission, as it relies on substantial equivalence. The predicate device's clearance would have relied on clinical data to establish its safety and effectiveness for its intended uses, which are related to patient outcomes (treatment of stable angina pectoris, acute myocardial infarction, and cardiogenic shock).
-
The sample size for the training set
Not applicable / Not provided. No training set for an algorithm is mentioned as this is a physical medical device submission based on substantial equivalence.
-
How the ground truth for the training set was established
Not applicable / Not provided. No training set or ground truth establishment for it is mentioned.
§ 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.