(55 days)
The EKO 7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-esophageal (non-Cardiac, Cardiac), Muscular-Skeletal (conventional, superficial), Cardiac Adult, Cardiac Pediatric and Peripheral-vessel.
The EKO 7 is a dedicated cardiac purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, color Doppler imaging, power Doppler imaging, Harmonic imaging, PW spectral Doppler mode, CW spectral Doppler mode or as a combination of these modes. The EKO 7 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The EKO 7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided text is a 510(k) Premarket Notification for the EKO 7 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, the requested information about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, and MRMC comparative effectiveness studies is not available in the provided text for the EKO 7 Diagnostic Ultrasound System itself.
The document primarily outlines:
- Device Description: The EKO 7 is a mobile, software-controlled diagnostic ultrasound system for cardiac purposes and other applications. It acquires and displays ultrasound data in various modes (B-mode, M-mode, Doppler, Harmonic imaging, etc.).
- Intended Uses: Diagnostic ultrasound imaging and fluid analysis of the human body for various clinical applications include Fetal, Abdominal, Pediatric, Small Organs, Adult Cephalic, Trans-esophageal, Muscular-Skeletal, Cardiac Adult, Cardiac Pediatric, and Peripheral-vessel.
- Technological Characteristics: The device is stated to be substantially equivalent to previously cleared ACCUVIX V20 and V10 systems.
- Safety Standards: The EKO 7 has been designed to meet several product safety standards (e.g., UL 60601-1, IEC60601-2-37, NEMA UD-2).
- Transducers: A list of transducers compatible with the EKO 7 system is provided, along with their respective cleared indications for use, indicating whether they are new ("N") or previously cleared ("P") for specific modes of operation and clinical applications.
Note on "P" and "N" in Transducer Tables:
The tables for each transducer (e.g., C1-4EC, L3-8, P2-4BA) indicate "N" for new indications and "P" for previously cleared indications. This "P" refers to whether that specific transducer model had its indications cleared under a previous 510(k) submission for a different device, or if the indication was previously cleared for the EKO 7 in an earlier submission (which is unlikely in a new 510(k) for the system itself). It does not imply a performance study comparing the EKO 7's performance against pre-defined acceptance criteria.
In summary: This 510(k) submission establishes substantial equivalence based on technological characteristics and intended uses aligning with predicate devices, and adherence to recognized safety standards. It does not contain the detailed performance study information requested.
§ 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.