(77 days)
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No
The description focuses on standard PACS archival and retrieval functions (storage, pre-fetching, auto-routing) and does not mention any AI/ML specific terms or functionalities like image analysis, diagnosis support, or predictive capabilities. The device description details a software architecture for data management, not intelligent processing.
No
The device is a software for archiving and retrieving medical images, not for treating any condition.
No
The device is a software for archival storage and retrieval of medical images within a PACS, which is an administrative function, not a diagnostic one.
Yes
The device description explicitly states "The ID.Store device is a software package composed of several application modules". While it mentions supported hardware and recommended hardware, these are described as standard general purpose equipment and storage media, not components included as part of the device itself. The device's function is described purely in terms of software operations (archival storage and retrieval control).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the archival storage and retrieval of digital medical images within a PACS. It focuses on managing and accessing image data, not on analyzing biological samples or providing diagnostic information based on in vitro testing.
- Device Description: The description details software modules for managing image storage and retrieval, not for performing laboratory tests or analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing chemical or biological reactions, or providing diagnostic results based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely related to the management of medical images.
N/A
Intended Use / Indications for Use
ID.Store is a software device intended to direct the lossless archival storage and retrieval, including the use of pre-fetching and auto-routing capabilities, of digital medical images within a Picture Archiving and Communications System (PACS).
ID.Store may be used for the permanent storage and subsequent retrieval of any medical imaging data presented in DICOM or other supported format, within a Picture Archiving and Communications System (PACS).
Product codes
90 LMB
Device Description
The ID.Store device is a software package composed of several application modules which work in tandem using a distributed storage architecture to control the archival storage and retrieval of digitized medical images. The ID.gate (gateway), ID.store (archiving), and ID.dbs (image database manager) modules communicate with each other using the dedicated administrative communication protocol ImageTalk. Permanent archival storage media supported include CD-R, WORM, MOD/WORM, DVD, etc. Recommended hardware are standard general purpose equipment, e.g. Sun Sparc or UltraSparc CPU's, and RAID devices for temporary data storage.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
digital medical images, medical imaging data presented in DICOM or other supported format
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
Kodak Medical Image and Information Library (MIIL).
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(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.
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Image /page/0/Picture/0 description: The image shows a logo with the letters "ISC" stacked vertically. Below the letters, the words "VISUAL DATA" are written in a smaller font. A partial circle is drawn around the right side of the logo. The logo is black and white.
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| 510(k) Summary of Safety and Effectiveness | K973413 | |
|---|---|---|
| Submitter: | ISG Technologies, Inc. | |
| Address: | 6509 Airport Road | |
| Mississauga, Ontario | ||
| Canada L4V 1S7 | NOV 25 1997 | |
| Contact: | Carol Nakagawa, Clinical Scientist | |
| Telephone: | (905) 672-2100 | |
| Date: | September 8, 1997 | |
| Trade Name: | ID.Store | |
| Common Name: | Picture Archiving and Communication System (PACS) component | |
| software. | ||
| Classification Name: | PACS: Image Storage Device. | |
| Predicate Device: | Kodak Medical Image and Information Library (MIIL). | |
| Device Description: | The ID.Store device is a software package composed of several | |
| application modules which work in tandem using a distributed | ||
| storage architecture to control the archival storage and retrieval of | ||
| digitized medical images. The ID.gate (gateway), ID.store | ||
| (archiving), and ID.dbs (image database manager) modules | ||
| communicate with each other using the dedicated administrative | ||
| communication protocol ImageTalk. Permanent archival storage | ||
| media supported include CD-R, WORM, MOD/WORM, DVD, | ||
| etc. Recommended hardware are standard general purpose | ||
| equipment, e.g. Sun Sparc or UltraSparc CPU's, and RAID devices | ||
| for temporary data storage. | ||
| Intended Use: | ID.Store is a software device intended to direct the lossless | |
| archival storage and retrieval, including the use of pre-fetching and | ||
| auto-routing capabilities, of digital medical images within a Picture | ||
| Archiving and Communications System (PACS). | ||
| Comparison to | ||
| Predicate: | The intended use and technological characteristics of the ID.Store | |
| device are substantially equivalent, in the opinion of ISG | ||
| Technologies, to those of the predicate device and do not pose any | ||
| additional issues of safety and effectiveness |
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 25 1997
Carol Nakagawa Clinical Scientist ISG Technologies, Inc. 6509 Airport Road Mississauga, Ontario Canada L4V 1S7
Re:
K973413 ID. Store (PACS Component Software) Dated: September 8, 1997 Received: September 9, 1997 Regulatory class: Unclassified Procode: 90 LMB
Dear Ms. Nakagawa:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally market predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K973413 510(k) Number (if known):
Device Name:
ID.Store
Indications For Use:
ID.Store may be used for the permanent storage and subsequent retrieval of any medical imaging data presented in DICOM or other supported format, within a Picture Archiving and Communications System (PACS).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Segner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices K973413 510(k) Number _
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)