(81 days)
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No
The document describes a standard PACS archiving system with no mention of AI/ML capabilities. The focus is on storage, retrieval, and basic viewing for identification purposes.
No.
The device acts as a long-term storage and archive system for medical images and explicitly states that its display utility is "not intended to be used for diagnosis". There is no mention of treating or diagnosing a disease or condition; it is solely for data management.
No
The document explicitly states that the device "is not intended to be used for diagnosis." Its primary function is long-term storage and retrieval of medical images.
No
While the device description mentions it may be marketed as a software-only solution, it also explicitly states it can be marketed "in conjunction with standard PC hardware" and includes components like "high capacity storage media" and the ability to use "standard magnetic tapes" and "CD-R media," which are hardware components. The description also mentions using "standard 'off-the-shelf' PC hardware." Therefore, it is not exclusively a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use of Vault is for the long-term storage and archiving of medical images. It acts as a repository for images received via the DICOM protocol and allows for their retrieval.
- No Diagnostic Function: The description explicitly states that the simple display utility for viewing images is "not intended to be used for diagnosis." This is a key differentiator from IVD devices, which are designed to provide information for diagnostic purposes.
- No Analysis of Biological Samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue). Vault deals with medical images, not biological samples.
- Focus on Storage and Retrieval: The device description emphasizes its function as a DICOM Storage Service Class Provider (SCP) and its optimization for secure storage and rapid retrieval of images.
In summary, Vault is a medical device focused on the infrastructure for managing medical images, specifically storage and retrieval, and does not perform any diagnostic analysis or interact with biological samples.
N/A
Intended Use / Indications for Use
Image Vault is intended to act as a long term storage device (archive) for medical images.
Vault is a networked device that acts as a DICOM Storage Service Class Provider (SCP):
- Images can be sent to it via the DICOM protocol, from modalities or other devices that are sources of medical images.
- Images can subsequently be queried and retrieved via the DICOM protocol, to imaging workstations and other processing devices.
- Internally, Vault is optimized to provide secure storage for a very large number of images, and to provide rapid retrieval on demand. To that end, Vault includes high capacity storage media, and has implemented hierarchical storage management software to manage cache storage effectively.
Product codes (comma separated list FDA assigned to the subject device)
90 LMD
Device Description
Image Vault is a software package which may be marketed as a software only solution, as well as in conjunction with standard PC hardware. Image Vault is a PC-based, DICOMcompliant PACS device that is able to send & receive, display, store, and archive DICOM non-compressed and JPEG-compressed images. Images can be archived using standard magnetic tapes. It also has the ability to read/write a collection of images to/from CD-R media in a method defined by DICOM.
Images can be viewed using a simple display utility, for the purposes of properly identifying patients and their corresponding studies, and is not intended to be used for diagnosis.
Image Vault uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Image Vault.
Mentions image processing
No
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
The Vault will be located in a hospital department. The expected users are as follows:
- Service personnel for installation, configuration and support.
- System administrator within the department, who in many cases will be chief technologist or other designated clinical staff.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive testing of the software package has been performed by programmers, by non-programmers, and by potential customers. Software is only used for control purposes and has no bearing on image quality. There is no image processing used with this software.
Images that are compressed are properly identified in the images information as being compressed as specified by the DICOM standard. Information is maintained concerning the compression throughout the entire life of the image.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.