(918 days)
Currem Indication for use includes patients with: Stable Angina Pectoris
The NICORE™ model ESP-1™ is a proprietary, non-invasive medical device for performing external, sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs which compress vascular beds in the calves, lower thighs, and upper thighs/buttocks to achieve the desired therapy.
The provided text is related to a 510(k) submission for a medical device called the NICORE™ ESP-1™ External Counterpulsation Device. It describes the device, its intended use, and the FDA's clearance of the device as substantially equivalent to a predicate device.
However, the provided document does not contain the detailed study information, acceptance criteria, or performance data that would allow me to populate the requested table and answer questions 2 through 9.
The document mainly covers:
- Premarket Notification (510(k)) Summary details (submitter, contact, trade name, common name, classification name).
- Identification of the legally marketed predicate device (Vasomedical Model EECP-MC2).
- Description of the NICORE™ ESP-1™ device.
- Intended Use (Stable Angina Pectoris).
- The FDA's decision letter confirming substantial equivalence.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) because this information is not present in the provided text.
To answer your request, I would need a section of the 510(k) submission (or a separate study report) that specifically details:
- The clinical or performance testing conducted.
- The acceptance criteria defined for that testing.
- The results of the testing against those criteria.
- Information about the study design, data collection, and ground truth establishment.
§ 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.