(77 days)
EPIQ:
The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal, Lung.
The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image quidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Affiniti:
The intended use of Affiniti Series 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), Cardiac Pediatric, 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, Lung.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Smart Doppler View ID software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems.
The purpose of the Smart Doppler View ID feature is to enhance the user's workflow through providing automation of the navigation of the touch screen groups on the Ultrasound System associated with Dopler Measurements. Without the Smart Doppler View ID feature, users must manually navigate to the desired Doppler Calculation Package Group on the Ultrasound System's various screens to perform a measurement. The Smart Doppler View ID feature automates this navigation and selects the associated calculation package group for the user based on the provided Doppler Spectrum acquired by the user using an artificial intelligence-based algorithm.
Smart Doppler View ID maps to six Doppler Calculations Package groups on the Ultrasound System screen:
- Aortic Valve
- Mitral Valve
- Tricuspid Valve
- Pulmonic Valve
- Venous Flow
- TDI Vel (Tissue Doppler Imaging Velocity) & Ratio
No hardware changes to the EPIQ or Affiniti systems are required when using the Smart Doppler View ID feature, and existing, commercialized Philips transducers are used for the Smart Doppler View ID feature.
The feature is supported by all EPIQ and Affiniti models running software version 11.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ 7, EPIQ 5, Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The Smart Doppler View ID feature is associated with the cardiac adult indication.
Here's a breakdown of the acceptance criteria and study details for the Smart Doppler View ID feature, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Algorithm Accuracy | 97.5% (95% CI 96.3%, 98.3%), p-value |
§ 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.