(198 days)
The Pure Flow External Counter-Pulsation device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased blood flow. It is intended for use under the oversight of a healthcare professional.
The Pure Flow External Counter-Pulsa-tion device is a mechanical device used to increase aortic pressure during early native heart diastole to augment myocardial perfusion, and to decrease aortic pressure during early native heart systole to reduce ventricular workload and vascular afterload.
The PureFlow consists of a main unit, and applied parts (computer monitor, keyboard, flexible tubes which connect to fabric cuffs, inside each cuff is an inflatable plastic balloon), EKG wires, and SpO2 sensors.
PureFlow works on the basis of external counter pulsation. The pressure is created by inflating a series of cuffs (similar to blood-pressure cuffs) that squeeze the extremities (calf's, thighs, buttocks) forcing blood back up to the heart on each heart cycle. This process ultimately restores (by force) sufficient blood flow to parts of the heart that is lacking oxygen. The treatment process generally spans for a period of 1 hour each day for a period of 35 total treatments. ECP Treatment is proven to develop existing pathways of oxygenated blood back to the heart muscle. In other words, External Counterpulsation Therapy restores pathways for adequate & necessary blood flow back to heart through vessels that already exist.
The device also utilizes the following cleared components: Cable/Lead wire (ECG/EKG, SpO2, and Invasive Blood Pressure): K120010 LNCS/M-LNCS Oximetry Sensor: K101896
This document, a 510(k) Summary for the Pure Flow External Counter-Pulsation Device (K173483), describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device, not a study designed to prove the device meets acceptance criteria for a new clinical application or algorithm performance. Therefore, many of the requested categories are not applicable.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pressure Control Timing Measurement Test | Timer accuracy within +/- 5% of the set value (per JIS T0601-2-204) | Three models tested, each met the pass criteria. |
| Pressure Accuracy Test | Pressure within +/- 20% from the set pressure value (per JIS T 0601-2-204) | Three models tested, each met the pass criteria. |
| Electrical safety and electromagnetic compatibility (EMC) | Compliance with IEC 60601-1 and 60601-1-2 | Found to comply with IEC 60601-1 and 60601-1-2. |
| Shelf-Life Testing | Not explicitly stated as a pass/fail criterion, but a calculated shelf-life. | Shelf-life calculated to be three years. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): For the Pressure Control Timing Measurement Test and Pressure Accuracy Test, "Three models were tested."
- Data Provenance: Not specified, but the tests are non-clinical, likely internal laboratory testing. Country of origin not mentioned. The tests are prospective in the sense that they were designed to evaluate the physical device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This document describes non-clinical performance testing of a physical device, not an AI/algorithm-based diagnostic or prognostic tool that would require expert-established ground truth. The "ground truth" for these tests refers to the expected physical performance of the device as measured by calibrated equipment against established engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
5. 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. This relates to an external counter-pulsation device, not an AI diagnostic/imaging system. No human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware medical device with some software control, not a standalone algorithm. Software verification and validation were done, but this refers to the robust operation of the device's control software, not a standalone algorithmic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Non-clinical-specific ground truth: For the Pressure Control Timing Measurement Test and Pressure Accuracy Test, the "ground truth" was established by reference standards (JIS T0601-2-204), which define acceptable ranges for device performance. These are engineering standards, not medical ground truths like pathology or expert consensus.
8. The sample size for the training set
- Not applicable. This document describes the testing of a physical device, and therefore does not involve a "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
- Not applicable. See point 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.