(262 days)
Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment of the cardiac and pulmonary systems and the abdomen by acquiring, processing, displaying, measuring, and storing ultrasound images.
With respect to its ultrasound imaging capabilities, Kosmos is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation:
Clinical Applications and Modes of Operation for Kosmos on Android
-
Clinical applications:
- Torso-One: Cardiac, Thoracic/Lung, Abdominal, and Obstetrics/Gynecology.
- Lexsa: Lung, Vascular/Peripheral Vascular, Musculoskeletal, Nerve and image Guidance for Needle/Catheter Placement (includes needle/catheter placement, fluid drainage, and nerve block)
-
Modes of operation: B-mode, M-mode, Color Doppler, Color Power Doppler, combined modes of B+M and B+CD, PW Doppler, CW Doppler, TDI, and Harmonic Imaging.
Kosmos is intended to be used in clinical care and medical education settings on adult and pediatric patient populations.
The device is non-invasive, reusable, and intended to be used on one patient at a time.
Not Found
The provided FDA 510(k) clearance letter for the EchoNous Kosmos device does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.
The letter is a standard clearance document, indicating that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines:
- The device name (Kosmos)
- The manufacturer (EchoNous, Inc.)
- The date of clearance (April 25, 2025)
- The regulation number and name (21 CFR 892.1550, Ultrasonic Pulsed Doppler Imaging System)
- The regulatory class (Class II)
- Product codes (IYN, IYO, ITX)
- General controls provisions of the Act that apply
- Information on changes requiring new premarket notification
- Quality System (QS) regulations
- UDI Rule requirements
- MDR reporting
- Contact information for FDA divisions
- Indications for Use: This section describes the intended uses, clinical applications (Cardiac, Thoracic/Lung, Abdominal, Obstetrics/Gynecology, Vascular/Peripheral Vascular, Musculoskeletal, Nerve and image Guidance for Needle/Catheter Placement), and modes of operation (B-mode, M-mode, Color Doppler, Color Power Doppler, combined modes, PW Doppler, CW Doppler, TDI, Harmonic Imaging) for the Kosmos device.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them based solely on the provided text.
To answer your request, I would need additional documentation, such as the full 510(k) submission, device design documents, or clinical study reports, which would contain detailed performance data, acceptance criteria, and study methodology.
§ 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.