(88 days)
The SonoSite NanoMaxx Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Trans-rectal; Trans-vaginal Peripheral Vessel; Intraoperative (abdominal organs, vascular); Musculoskeletal Conventional & Superficial, Cardiac Adult and Pediatric.
The SonoSite NanoMaxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, Doppler, M-Mode, Color Power Doppler or in a combination of these modes. The hand-carried system weighs less than 6 pounds and has a touch screen interface with minimal controls to facilitate disinfection and cleaning. The system provides measurement capabilities for anatomical structures and fetal biometry to provide information used for clinical diagnostic purposes. The system also includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images, which is used in conjunction with traditional risk assessment models to assess individual cardiovascular disease risk. The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities, including wireless networking, to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images. Security support is also provided to facilitate HIPAA compliance. The system supports the eFilm Lite™ application, which allows studies stored on a memory device in DICOMDIR format to be viewed. This viewing software can be launched on a PC when the license option is enabled. The system includes a variety of accessories including a stand, dock featuring a video in/out port, a printer port, printer, VESA mounting arm and needle guide kits. The system includes three USB host supports for peripherals and an Ethernet port for data transfer of patient data. The system also features SiteLink™ allowing an additional method for the export of patient data. Storage devices include memory sticks. The V-Universal™ stand provides a mobile work platform for the NanoMaxx, as well as a storage area for transducers and other supplies. It also provides connections for system accessories and peripherals. The PowerPark docking stand consists of two components, the dock (plugs into a power outlet and sits on the floor) and the stand module (attaches to underside of stand). An AC adapter on the stand module allows for manual connection to AC power. The PowerPack battery uses lithium-ion technology and mounts on the V Universal™ stand. LED lights on the PowerPack indicate the amount of available battery power, as well as charge status. SonoSite Workflow Solutions (SWS) is a software program for organizing exams from the NanoMaxx. SWS operates on a host server and users require a login to access the program. Patient exam information can be transferred from the ultrasound to SWS by exporting data from the ultrasound to a USB storage device, then importing it from the USB storage device. The use of a USB keyboard, barcode reader and medical grade printer is supported by the system, which allows manual entry of patient demographics, scanning entry of patient demographics and the capability to print images and/or reports. The system/transducer is capable of exceeding a TI or an MI of 1.0 in certain operating modes or mode combinations. The system monitor displays the current output level in terms of the bioeffects indices ("Mechanical Index [M]" and "Thermal Index [TI]") in accordance with the AIUM/NEMA Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
The provided text is a 510(k) Summary of Safety and Effectiveness for the SonoSite NanoMaxx™ Series Ultrasound System. This document outlines the device's description, intended use, and substantial equivalence to predicate devices, but it does not contain a study that proves the device meets acceptance criteria in the way a clinical performance study for an AI/CAD/software device would.
The document primarily focuses on:
- Device Description: What the device is and its capabilities (e.g., 2D, Doppler, M-Mode imaging, measurement capabilities).
- Intended Use: The specific clinical applications for which the ultrasound system is designed (e.g., Fetal/OB, Abdominal, Cardiac).
- Technological Characteristics: Technical specifications like frequency range and acoustic output limits, and compliance with various standards (e.g., IEC 60601-1, NEMA UD 2-2004).
- Substantial Equivalence: The claim that the NanoMaxx system is substantially equivalent to previously cleared SonoSite ultrasound systems (K092058, K071134, K082098). This is the basis for its clearance, rather than a new clinical study demonstrating specific performance metrics against acceptance criteria for a diagnostic aid.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because the provided text does not contain such a study or performance metrics for acceptance criteria related to a diagnostic algorithm or AI.
The tables detailing the "Indications for Use Form" (Tables 1.3-1 through 1.3-8) simply list clinical applications and the modes of operation available for the main system and each transducer. The "P" indicates "previously cleared by FDA," and "N" indicates a "new indication" for this specific device as compared to its predicate (which means the new indication is covered by the substantial equivalence argument, not necessarily by a new clinical performance study for this specific 510k submission).
Here's a breakdown of why the requested information cannot be extracted from this document:
- Table of acceptance criteria and reported device performance: Not present. The document lists technical specifications (e.g., acoustic output) and intended uses, but not performance metrics (e.g., sensitivity, specificity, accuracy) against specific acceptance criteria for a diagnostic outcome.
- Sample size used for the test set and data provenance: Not applicable as no diagnostic performance study is presented.
- Number of experts used to establish ground truth and qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This document is for a diagnostic ultrasound system, not an AI/CAD/software device designed to assist human readers.
- Standalone performance (algorithm only): Not applicable. This device is an ultrasound system operated by a human user.
- Type of ground truth used: Not applicable for a performance study. Clinical diagnostic use implies clinicians interpret the images.
- Sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How ground truth for the training set was established: Not applicable.
§ 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.