(45 days)
The ImaCor Zura Handheld ZHH-010 is a software-based handheld ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging using the ImaCor ClariTEE probe. (Cardiac, TEE)
The system is intended for use in critical care environments where healthcare is provided by trained healthcare professionals.
It is not for pediatric use (Less than 18 years of age) It is not for use in EMS settings.
The ImaCor Zura Handheld ZHH-010 is a portable, cardiac, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial offthe-shelf (COTS) Android™ device. The scanner is Bluetooth and Wi-Fi- based, communicating with a traditional tablet/smartphone via direct Wi-Fi to allow users to export ultrasound images and display in different modes of operation. The ImaCor Zura Handheld ZHH-010 houses a battery and internal power supplies, multichannel beamformer, pre-scan converter and Wi-Fi components. The battery is removable and comes with a separate charger.
The system is a transportable (handheld) ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals. The ImaCor Zura Handheld ZHH-010 is not to be used in a fixed- or rotary-winged air ambulance.
Piezoelectric material in the system's transducer (ClariTEE probe) transmits high frequency, non-ionizing sound waves to the designated cardiac region of the body and converts the subsequent echoes detected into electronic signals to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external Android viewing device on which the image can be displayed. Communication between the scanner and the compatible viewing device is performed via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing.
The ImaCor Zura Handheld ZHH-010 product components include:
- Software: SOUP Imaging App for Android
- Transducers/Scanners: ImaCor ClariTEE probe (TEE probe);
- Accessories: ImaCor Battery (Li-ion); ImaCor Battery Charger; ImaCor Fan; Medical Power Supply (off-the-shelf power adaptor from GlobTek, Inc.; Model Number WR9QA3200USBNMEDR6B; approved in the US).
The provided document is a 510(k) premarket notification for the ImaCor Zura Handheld ZHH-010, an ultrasound imaging system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Clarius Ultrasound Scanner Model C3HD) and a reference device (ImaCor Zura TEE System with ClariTEE probe).
Crucially, the document states: "The ImaCor Zura Handheld ZHH-010 did not require clinical testing to establish substantial equivalence to the predicate devices indicated." This means that there was no clinical study conducted to prove the device met specific performance acceptance criteria for diagnostic accuracy, as is common for AI/ML-driven devices. Instead, the focus was on demonstrating that the new device, primarily an OEM modification with a tethered probe, performs similarly in terms of safety and technical specifications to existing cleared devices.
Therefore, many of the requested points regarding acceptance criteria and performance studies for an AI/ML device (e.g., effect size of human readers with AI assistance, standalone algorithm performance, ground truth establishment) cannot be answered from this document because such a study was not required or performed for this specific 510(k) clearance.
However, based on the information provided, we can infer the acceptance criteria for this type of submission were related to technical and safety standards compliance and demonstration of substantial equivalence to predicate devices.
Here's an attempt to address the points based on what is available in the document, and explicitly stating what is not available:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards Compliance)
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission didn't involve a clinical performance study with accuracy metrics, the "acceptance criteria" were primarily about meeting established safety and performance standards for ultrasound devices and demonstrating functional equivalence to predicate devices.
| Acceptance Criteria Category | Specific Criterion (Inferred from Document) | Reported Device Performance (Inferred/Stated) |
|---|---|---|
| Safety and Essential Performance | Compliance with IEC 60601-1 (General requirements for basic safety and essential performance) and related collateral standards (e.g., usability, EMC). | "Nonclinical performance tests show compliance to the following standards: IEC 60601-1 (2005/(R)2012, A1:2012, C1:2009(R)2012, A2:2010(R)2012), CAN/CSA-C22.2 No. 60601-1-6:11 (2011), CAN/CSA-C22.2 No. 60601-1:14 (2014), IEC 60601-1-2 (2014), IEC 60601-1-6 (2013), IEC 60601-2-37 AMDI (2015)." "The development and testing conducted on the device ascertain that it is safe for use by qualified physicians." |
| Software Life Cycle Processes | Compliance with ANSI/AAMI/IEC 62304 (Medical device software - Software life cycle processes). | "Nonclinical performance tests show compliance to... ANSI/AAMI/IEC 62304 (2006)." |
| Functional Equivalence (Core) | The "beamformer" (core imaging engine) is mechanically and electrically identical to the predicate device (Clarius Ultrasound Scanner C3HD). | "The beamformer in the ImaCor Zura Handheld ZHH-010 is mechanically and electrically identical to the predicate device." |
| Functional Equivalence (Probe) | Device functions with the specified probe (ClariTEE) which was previously cleared (K100989) and is used with a reference device. | The device uses the ImaCor ClariTEE probe, which was cleared under K100989. The device is a "portable, cardiac, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) Android™ device." |
| Intended Use & Indications for Use | Matches the predicate device's intended use and indications for use, with minor specificities for this device (e.g. no pediatrics, no EMS). | "The subject device does not introduce any new technology or indications for use; therefore, the system is similar to the predicate device." "All indications for use introduced by the ImaCor Zura Handheld ZHH-010 are similar to the predicate device." Indicates for diagnostic ultrasound imaging using the ImaCor ClariTEE probe (Cardiac, TEE) in critical care environments by trained healthcare professionals. Not for pediatric use ( |
§ 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.