(28 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetabl/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 clinical environments where the EPIQ Diagnostic Ultrasound System can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.
The EPIQ Diagnostic Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The device consists 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). In addition to the physical knobs and buttons of the main control panel, the user interface consists of a touch screen with soft key controls, and a QWERTY keyboard. The removable transducers are connected to the system using a standard technology, multi-pin connectors. The EPIQ system uses standard transducer technology, and supports phased, linear, curved linear array, TEE, motorized 3D curved linear arrays as well as non-imaging (pencil) probes. Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industrystandard formats (Ex: JPEG, AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow. The EPIQ system gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used by competent healthcare professionals to make a diagnosis. The EPIQ system enables image guided navigation and image fusion via the optional PercuNav feature.
The Philips EPIQ Diagnostic Ultrasound System, K132304, is a general-purpose, software-controlled diagnostic ultrasound system. It is designed to acquire ultrasound data and display it in various modes for diagnostic purposes across a wide range of clinical applications. Its acceptance for marketing was primarily based on substantial equivalence to predicate devices, rather than new clinical trials demonstrating de novo safety and effectiveness.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the EPIQ Diagnostic Ultrasound System are not presented as a direct performance table with numerical targets. Instead, acceptance is based on demonstrating substantial equivalence to previously cleared devices (Philips iU22 Diagnostic Ultrasound System, K130499, K121498, K093563, K042540, K030455) and compliance with relevant safety standards.
The reported device performance, in terms of meeting acceptance criteria for substantial equivalence, is articulated as follows:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Intended Use | Identical to predicate devices (diagnostic ultrasonic imaging and fluid flow analysis). |
| Indications for Use | Unchanged from predicate devices, covering a broad range of clinical applications: Abdominal, Cardiac (Adult, Fetal, Pediatric, Trans-esophageal), Cerebral Vascular, Cephalic (Adult, Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular, Cardiac), Musculoskeletal (Conventional, Superficial), Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transrectal, Transvaginal. |
| Technological Characteristics | Employs the "same fundamental scientific technology" as predicate (Track 3 system). Features like hard and soft keys are present on both, though their implementation may differ (e.g., more soft keys on EPIQ). Transducers use standard technology, with a new compact multi-pin connector being the primary hardware change. |
| Gray-scale and Doppler Capabilities | Identical to predicate devices. |
| Signal Processing | Essentially the same as predicate devices. |
| Acoustic Output Limits | Complies with IEC 60601-2-37 Ed 2.0 and IEC 62359, Ed 2.0. Meets FDA ultrasound specific guidance (September 9, 2008). |
| Specific Acoustic Output Values | Ispta.3 ≤ 720 MW/cm²; 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.