(51 days)
The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/ Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.
The proposed EPIQ 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, multi-pin connectors.
The Philips EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50, and Affiniti 70 Diagnostic Ultrasound Systems are general purpose, software-controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and display it in various modes of operation. They consist of a system console and transducers.
The device's performance was evaluated through non-clinical testing to demonstrate substantial equivalence to a predicate device (Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System, K172607). No clinical studies were required.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Safety and Performance Standards) | Reported Device Performance (Compliance) |
|---|---|
| Acoustic output display requirements of IEC 60601-2-37 Ed 2.0 and IEC 62359. | System and transducers are compliant. |
| FDA ultrasound guidance document: "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 9, 2008). | System complies with the guidance document. |
| Ispta.3 ≤ 720 MW/cm2 | Met (acoustic output limits are within this range). |
| 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.