(87 days)
The Mobile External Counter Pulsation System AngioNew-IV is a non-invasive external counter pulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction or cardiogenic shock.
The Mobile External Counter Pulsation System AngioNew-IV is a mobile noninvasive external counter pulsation device for the treatment of patients suffering from congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock. The Living Data Technologies AngioNew-IV system consists of a central control unit and three pairs of inflatable/deflatable cuffs that are wrapped respectively around a patient's calves, thighs and buttocks. External pressure is applied via the cuffs to the lower extremities of the patient in synchronization with the heartbeat. When the heart is in the relaxed state during diatolic period, pressure is applied sequentially from calves to thighs and then to buttocks to force blood back to the hear, increase coronary perfusion pressure (diatolic and augmentation) and, at the same time, increases coronary blood flow and enchances the development of coronary collateral circulation. Just before the heart starts eiecting blood during systolic period, air is quickly withdrawn from all cuffs simultaneously to remove all the external applied pressure, leaving behind empty vasculature in the lower extremities to receive the output of the heart, thereby reducing systolic pressure (systolic unloading) and the workload of the heart.
Here's an analysis of the provided text regarding the acceptance criteria and study for the AngioNew-IV device:
1. Table of Acceptance Criteria & Reported Device Performance
The provided 510(k) summary focuses on non-clinical testing to demonstrate substantial equivalence, rather than a clinical study with detailed performance metrics against specific acceptance criteria. The "acceptance criteria" are more implicitly defined by the successful completion of these non-clinical tests and the device operating within expected parameters.
| Acceptance Criteria Category/Function | Reported Device Performance |
|---|---|
| Critical Functions: | |
| ECG Signal Processing | Testing was conducted and demonstrated no differences in technological characteristics compared to predicate. |
| QRS Detection and Inflation/Deflation Timing | Testing was conducted and demonstrated no differences in technological characteristics compared to predicate. |
| Effective Heart Rate Range | Testing was conducted and demonstrated no differences in technological characteristics compared to predicate. |
| Inflation/Deflation Duration Time | Testing was conducted and demonstrated no differences in technological characteristics compared to predicate. |
| Time Intervals between the Three Sequential Inflation Signals | Testing was conducted and demonstrated no differences in technological characteristics compared to predicate. |
| Non-Critical Functions: | |
| CRT Display Freezing | Testing was conducted and demonstrated no differences in technological characteristics compared to predicate. |
| CRT Display Sweep Speed | Testing was conducted and demonstrated no differences in technological characteristics compared to predicate. |
| Treatment Timer | Testing was conducted and demonstrated no differences in technological characteristics compared to predicate. |
| Number Display on CRT | Testing was conducted and demonstrated no differences in technological characteristics compared to predicate. |
| Electrical Safety | In accordance with IEC 60601-1 |
| EMC Testing | In accordance with IEC 60601-1-2, EN 55011, EN 6100-4-2, EN 61000-4-3, EN 61000-4-4, and EN 61000-4-5 |
Study That Proves the Device Meets Acceptance Criteria:
The study described is primarily a non-clinical bench testing study, not a clinical trial. The purpose was to demonstrate substantial equivalence to predicate devices (Vasogenics EECP-MC2, Vasomedical EECP®MC-2, Beit Hapa'amon AECP-A) by showing that differences in certain components (inflation/deflation timing control, valves, cuff dimensions, and use of artery plethysmography) do not result in changes to safety, effectiveness, intended use, precautions, or contraindications.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of patients or a dataset for clinical evaluation. The testing performed was bench testing of the device's functional components.
- Data Provenance: Not applicable as it was non-clinical bench testing. There is no information about country of origin or whether it was retrospective/prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided as the study was non-clinical bench testing. Ground truth, in the sense of expert consensus on patient data, was not established for this type of test. The "ground truth" for these tests would be the established engineering specifications and performance of the predicate devices.
4. Adjudication Method for the Test Set
- An adjudication method is not applicable as the study was non-clinical bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission focuses on engineering and performance testing for substantial equivalence to predicate devices, not on a clinical comparison of human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not an AI device in the context of image analysis or diagnostic algorithms. Therefore, the concept of "standalone performance" of an algorithm is not directly applicable. The device's critical functions (ECG signal processing, QRS detection, timing of inflation/deflation) can be seen as the "algorithm only" aspects, and their performance was tested on the bench.
7. The Type of Ground Truth Used
- The "ground truth" for this non-clinical testing was based on:
- Engineering specifications and operational parameters of the predicate devices.
- Established standards for electrical safety (IEC 60601-1) and EMC (IEC 60601-1-2, EN 55011, etc.).
- The expected output and timing of the device's critical functions as designed to mimic the predicate devices.
8. The Sample Size for the Training Set
- This is not applicable. The AngioNew-IV device is not described as utilizing machine learning or AI that requires a "training set" in the conventional sense. Its functionality is based on pre-programmed logic for physiological monitoring and control.
9. How the Ground Truth for the Training Set was Established
- This is not applicable for the same reasons as #8.
§ 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.