(106 days)
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound dasta and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes.
The HERA W9/HERA W10 also give 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 HERA W9/HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
As compared with predicate device(HERA W10, K182595), the subject device has added new three transducers(EV2-10A, EA2-11AV and EA2-11AR) and nine biopsy kits (BP-KIT-079, BP-KIT-080, BP-KIT-081, BP-KIT-082, BP-KIT-085, BP-KIT-086, BP-KIT-089 and BP-KIT-089 and BP-KIT-090) and the product name of HERA W9. There are no change and new software features from the predicate device. The HERA ultrasound system is supported by software and the software is not modified for the subject system.
The provided FDA 510(k) summary for the HERA W9/HERA W10 Diagnostic Ultrasound System does not contain information about acceptance criteria or a study proving that the device meets such criteria.
This is because the submission is for a 510(k) pathway, specifically claiming substantial equivalence to a predicate device (HERA W10, K182595). In such cases, the primary goal is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel technology.
The document explicitly states:
"The subject of this premarket submission, HERA W9/ HERA W10, did not require clinical studies to support substantial equivalence."
Instead, the submission focuses on demonstrating:
- Technological equivalence: "The HERA W9/ HERA W10 employ the same fundamental scientific technology as its predicate device."
- Feature similarity: A detailed table comparing features, clinical applications, scanhead types, modes of operation, etc., between the new device and the predicate. The differences noted are primarily hardware variations (DVD, caster size, monitor size, active probe ports) and the addition of new transducers and biopsy kits. Critically, it states, "There are no change and new software features from the predicate device. The HERA ultrasound system is supported by software and the software is not modified for the subject system."
- Compliance with safety standards: The document lists several IEC, ISO, and NEMA standards that the device conforms to for acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety.
Therefore, since no clinical study was required or performed to prove specific performance metrics against acceptance criteria for the new device itself, I cannot provide the requested information. The device's "performance" is implicitly deemed equivalent to the predicate device through the demonstration of similar technology, intended use, and safety characteristics.
§ 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.