(67 days)
The device is 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-rectal, Trans-cranial, Trans-cranial, Trans-esophageal (non-cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/Pediatric/Fetal; Intra-Cardiac; Pelvio; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.
The z.one Ultra is a general purpose diagnostic ultrasound system which consists of a combination of portable scanner(s) less than 10 inches wide and 3 inches high, embedded in the cart, or that can be held by the user in one hand. They include buttons for controlling the system and may have a screen that display ultrasound mages and user interface or be without the screen (monitor) and user interface. The portable scanner can be held by the user in one hand accommodates a removable transducer module. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and both transmit and receive ultrasound energy.
The docking station (aka carts) provides holders for the portable scanner, and transducer modules, as well as battery chargers and other accessories. The modification for this submission includes new indication for use and off the shelf transducers.
Here's an analysis of the provided information, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary and associated forms do not detail specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or quantitative performance metrics for the ZONARE z.one Ultra Ultrasound System.
Instead, the submission primarily focuses on functional equivalence and compliance with recognized standards for safety and effectiveness. The "acceptance criteria" for this type of submission are implicitly tied to demonstrating that the device is "substantially equivalent" to predicate devices and adheres to relevant safety and performance standards.
The "reported device performance" is essentially that the device (including its transducers and new indications for use) performs comparably to the predicate devices and meets established safety benchmarks.
Here's how we can represent the "acceptance criteria" and "reported device performance" based on the document:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (K022858, K082326, K031066, K073709, K062247, K053069) in terms of: | "With respect to features and applications, the ZONARE z.one Ultra with the new ophthalmic indication for use and the off the shelf intra-cardiac echo catheter (View-Flex) is comparable and substantially equivalent to the currently marketed ZONARE z.one and the predicate devices listed in predicate devices section in terms of portability, features and functionality, they have the same important safety and effectiveness features, as well as design, materials, and construction." |
| - Portability | Comparable |
| - Features | Comparable |
| - Functionality | Comparable |
| - Safety and Effectiveness Features (Acoustic Output, Biocompatibility, Electrical/Mechanical Safety, etc.) | "The device has been evaluated according to the applicable medical device quality systems, safety standards for acoustic output, biocompatibility, verification, cleaning, and disinfection effectiveness as well as for thermal, electrical, and mechanical safety, those applicable to ZONARE's ultrasound product are: ISO 14971, IEC/UL 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, IEC 62304, ISO 10993, AIUM Medical Ultrasound Safety (2002)." |
| "The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance." | |
| - Design, Materials, and Construction | Comparable |
| Compliance with Applicable Medical Device Safety Standards | "The device conforms to applicable medical device safety standards..." (See list of ISO/IEC standards above) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical Tests: Not Required."
This indicates that no dedicated clinical test set (i.e., a set of patient data specifically collected for performance evaluation against a ground truth) was used in this 510(k) submission. The basis for safety and effectiveness is the substantial equivalence to previously cleared devices and compliance with non-clinical standards.
Therefore, information regarding data provenance (country of origin, retrospective/prospective) and sample size for a test set is not applicable to this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical tests or dedicated test sets were used, there were no experts required for establishing ground truth from such a set.
4. Adjudication Method for the Test Set
Not applicable, as no dedicated clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This is a 510(k) submission for an ultrasound system, not an AI-powered diagnostic device. The application does not mention any AI components or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical imaging system, not an algorithm being submitted for standalone performance evaluation.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not describe the use of specific ground truth types (like pathology or outcomes data) in a clinical study context for this submission, as no clinical studies were deemed necessary. The ground truth for demonstrating safety and effectiveness relied on the established performance of the predicate devices and the compliance with engineering and safety standards.
8. The Sample Size for the Training Set
Not applicable. Given that "Clinical Tests" were "Not Required" and there's no mention of an algorithm or AI being developed, there would be no training set in the context of device performance evaluation. The device development process would have involved engineering testing and verification, but not "training data" in the sense of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (for an algorithm/AI) was mentioned or used in this submission.
§ 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.