(14 days)
The ZS3 and z.one PRO Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric: small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-recinal, Trans-cranial, Trans-sophageal (non-cardiac and cardiac); Musculosketal (conventional & superficial); 3D/4D; Cardiac - Adultí Pediativ Fetal; Echo, Intra-Cardiac; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.
The ZS3 and z.onewo Ultrasound Systems (hereafter referred to as "ZS3 Ultrasound Platform" or "ZS3" for simplicity) are full-featured, general purpose, software controlled, diagnostic ultrasound systems used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The platform utilizes ZONARE's patented zone technology which allows the system to collect more data at one time, thereby optimizing image quality.
This document describes the ZONARE Medical Systems, Inc. ZS3 and z.onepro Ultrasound Systems, which were submitted for 510(k) premarket notification (K151175). The submission primarily concerns adding new patient contacting materials to the E9-4 transducer and expanding the indications for use for one transducer (C9-3sp), stating that the core system and other transducers remain unchanged from a previous clearance (K150249).
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
For this submission, the acceptance criteria are based on compliance with various safety and performance standards for ultrasound systems and the equivalence to a previously cleared predicate device. The reported device performance is presented as "PASS" for all tested categories.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Verification | In accordance with device performance specifications (details not provided) | PASS |
| Electrical Safety | In accordance with IEC 60601-1 | PASS |
| EMC Testing | In accordance with IEC 60601-1-2 | PASS |
| Thermal & Acoustic Output | In accordance with IEC 60601-2-37, and specific limits for Derated IspTA (720mW/cm² max), Mechanical Index (≤ 1.9 max or Derated IsPPA ≤ 190 W/cm² max), and Ophthalmic use (TI ≤ 1, ISPTA.3 |
§ 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.