(35 days)
The intended use of the EPIQ series, Affiniti 50 and Affiniti 70 system is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:
Fetal/Obstetric, Abdominal, Intraoperative (Vascular), Intraoperative (Cardiac), Pediatric, Small Organ (Breast, Thyroid, Testicle), Cephalic (Neonatal), Cephalic (Adult), Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial) Gynecological, Other: Urology, Cardiac Adult, Cardiac Pediatric, Transesophageal (Cardiac), Cardiac other (Fetal), Peripheral Vessel, Cerebral Vascular.
When Philips EPIQ system is integrated with Philips EchoNavigator. the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.
The proposed EPIO and Affiniti Diagnostic Ultrasound Systems are general purpose. software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers).
The removable transducers are connected to the system using a standard technology, multipin connectors.
The acceptance criteria for the Philips EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems, and Affiniti 30, 50, and 70 Diagnostic Ultrasound Systems, are detailed via compliance with several international and FDA-recognized consensus standards for medical electrical equipment and diagnostic ultrasound. The reported performance is that the devices meet these standards and are substantially equivalent to their predicate devices.
Here's an breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety and Essential Performance Standards | IEC 60601-1: General requirements for basic safety and essential performance (2005, Amendment 1, 2012) | The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems comply with this standard. |
| IEC 60601-1-2: Electromagnetic Compatibility (2007) | The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems comply with this standard. | |
| IEC 60601-1-6: Usability (2010) | The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems comply with this standard. | |
| IEC 60601-2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (2007) | The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems comply with this standard. | |
| IEC 62359: Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields (2010) | The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems comply with this standard. | |
| Acoustic Output Limits | Ispta.3 ≤ 720 mW/cm2 | The system acoustic output limits are met. |
| MI |
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.