(380 days)
The OM-A device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. It is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.
Enhanced External Counterpulsation Device Plus OM-A is a computer-controlled system that applies external pressure via cuffs to the patient's lower extremities in synchronization with the patient's cardiac cycle. When the heart is in its relaxed state (diastole), pressure is applied sequentially; distal to proximal, from the lower legs (calves) to the lower thighs and then the upper thighs and buttocks, to propel blood back to the heart. The consequence is an increase in arterial blood pressure during diastole (diastolic augmentation) resulting in increased coronary perfusion pressure and coronary blood flow. Compression of the extremities also results in an increase in venous return to the heart. Just before the heart ejects blood (systole), air is released rapidly from all the cuffs simultaneously to release the externally applied pressure, allowing the compressed vessels to recover to their normal shape, thereby reducing vascular impedance. As a result, arterial pressure during systole is reduced (systolic unloading), as is cardiac workload. The patient's calves, lower thighs and buttocks are wrapped with cuffs containing air bladders. The patient's ECG is monitored via conventional, high-quality electrodes and detection of the R-wave is used to signal the System when to command sequential inflation of the cuffs. The start and duration of inflation, as well as the start of deflation, are adjustable by the Operator, within limits determined by the System. An algorithm is used to prevent the start of inflation during ejection of blood from the heart and to end inflation and begin deflation prior to the occurrence of the next heartbeat. The pressure applied by the cuffs is also adjustable by the Operator from 150mmHg to 300mmHg (for a patient with a heart rate of 60 bpm). The device also utilizes the following cleared components: ECG/EKG and SpO2: K123711
The provided document is a 510(k) summary for the "Enhanced External Counter Pulsation Device Plus Omay-A." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a new device meets specific performance acceptance criteria for an AI or imaging diagnostic tool.
Therefore, many of the requested categories for describing an AI/imaging device study (e.g., acceptance criteria for diagnostic performance, sample size for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable to this document.
This document describes a medical device called an "Enhanced External Counter Pulsation Device," which is a therapy device, not a diagnostic AI or imaging device. The performance data provided are related to safety and efficacy standards (biocompatibility, electrical safety, EMC), and comparative functional features, not diagnostic performance metrics.
Specifically addressing your points based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not define specific "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because it is a therapeutic device, not a diagnostic tool utilizing AI or advanced image analysis. The "acceptance" here is for market clearance based on substantial equivalence to an existing predicate device, primarily by meeting safety and performance standards (IEC 60601-1, IEC 60601-1-2) and demonstrating similar functional characteristics.
- Reported Device Performance:
- Biocompatibility: Passed Cytotoxicity, Sensitization, and Irritation tests according to ISO 10993-5 and ISO 10993-10.
- Non-clinical (Safety & EMC): Passed tests according to IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012 (General requirements for basic safety and essential performance) and IEC 60601-1-2:2014 (Electromagnetic compatibility).
- Functional Comparison to Predicate (K130439 P-ECP/TI):
- Triggering Mechanism: Same (R-Wave trigger)
- Microprocessor: Same (Windows Based)
- Emergency System Power-down: Same (Red)
- Pressure Setting: Subject device range (5mmHg to 350mmHg, Error: ± 10mmHg) is within predicate device range (1kPa~50kPa, Error: ± 2kPa)
- Treatment Time: Subject device range (1min
45min) is within predicate device range (1min60min) - Cuff System: Same (Three parts: calf, thigh, buttocks)
- Major Components: Same (Base Unit, Air-Tubes, ECG/SPO2, three Cuffs)
- Operating Environment: Same (10°C ~30°C; Relative humidity:
§ 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.