(82 days)
Artis zee / zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Procedures that can be performed with the Artis zee / zeego family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Artis zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.
The Artis zee / zeego Modular Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. These models now will be equipped with a new user interface. In addition a new multi-anis. stand will be offered.
The Artis zee / zeego Modular Angiography System is basically equal to the AXIOM Artis Modular Angiography System family with all its components.
This document is a 510(k) premarket notification for the Siemens Artis zee / zeego Modular Angiography System. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for proving new performance against acceptance criteria in the same way a de novo or PMA submission would.
Therefore, the document does not contain the detailed acceptance criteria and study results you would expect in a clinical performance study. Instead, it focuses on demonstrating that the new device is substantially equivalent to previously cleared devices.
Here's an breakdown of the information that can be extracted from the provided text, and what cannot be found:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided here. This document focuses on substantial equivalence, not on establishing new performance claims against specific acceptance criteria for a novel device. The "performance" being evaluated is essentially "equivalent to the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be determined from this document. No test set, clinical data, or study details are provided. This is a technical equivalence submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be determined from this document. No ground truth establishment is described as there is no performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be determined from this document. No test set or adjudication method is described.
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
- No, an MRMC study was not done, and is not applicable. The device is an angiography system, not an AI-powered diagnostic tool, and this submission type does not involve human reader studies for new performance claims.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical performance study requiring ground truth is described in this submission.
8. The sample size for the training set
- Not applicable. This device is hardware and software for an angiography system, not a machine learning model developed with a training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set mentioned for this type of device and submission.
Summary of what the document does provide:
- Device Name: Artis zee / zeego Modular Angiography System
- Intended Use: Dedicated angiography systems for single and biplane diagnostic imaging and interventional procedures, including pediatric and obese patients. Procedures include cardiac angiography, neuro-angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography, and whole-body radiographic/fluoroscopic procedures. It can also support position-triggered imaging for spatial data synthesis.
- Predicate Devices (for Substantial Equivalence):
- Device Classification: Class II, Product Code IZI, under 21 CFR §892.1600 (Angiographic x-ray system).
- Technological Characteristics: Described as "basically equal" to the AXIOM Artis Modular Angiography System family, with updated user interface and a new multi-axis stand. Many components are existing Siemens parts or minor modifications.
- Safety and Effectiveness Concerns Addressed: Instructions for use, visual and audible safety features, continuous monitoring with error messages, and adherence to industry practice to minimize electrical, mechanical, and radiation hazards.
In essence, this 510(k) submission argues for substantial equivalence by showing that the Artis zee / zeego system has a similar intended use and fundamental technological characteristics to already legally marketed devices, rather than presenting novel performance data against specific acceptance criteria.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.