(77 days)
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).
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.
The provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets them. The document is primarily a 510(k) summary for the "ID.Store" device, focusing on its intended use, description, comparison to a predicate device, and regulatory approval.
Specifically, the text is a 510(k) summary for the "ID.Store" (PACS Component Software) and letters from the FDA regarding its clearance. It describes the device's function as software for archival storage and retrieval of digital medical images within a PACS, and states its substantial equivalence to a predicate device (Kodak Medical Image and Information Library (MIIL)).
Therefore, I cannot provide the requested information, which typically involves performance metrics, study design, and ground truth establishment. This type of information is usually found in detailed performance studies or validation reports, which are not part of this 510(k) summary.
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| 510(k) Summary of Safety and Effectiveness | K973413 | |
|---|---|---|
| Submitter: | ISG Technologies, Inc. | |
| Address: | 6509 Airport RoadMississauga, OntarioCanada 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) componentsoftware. | |
| 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 severalapplication modules which work in tandem using a distributedstorage architecture to control the archival storage and retrieval ofdigitized medical images. The ID.gate (gateway), ID.store(archiving), and ID.dbs (image database manager) modulescommunicate with each other using the dedicated administrativecommunication protocol ImageTalk. Permanent archival storagemedia supported include CD-R, WORM, MOD/WORM, DVD,etc. Recommended hardware are standard general purposeequipment, e.g. Sun Sparc or UltraSparc CPU's, and RAID devicesfor temporary data storage. | |
| Intended Use: | ID.Store is a software device intended to direct the losslessarchival storage and retrieval, including the use of pre-fetching andauto-routing capabilities, of digital medical images within a PictureArchiving and Communications System (PACS). | |
| Comparison toPredicate: | The intended use and technological characteristics of the ID.Storedevice are substantially equivalent, in the opinion of ISGTechnologies, to those of the predicate device and do not pose anyadditional issues of safety and effectiveness |
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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
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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)
§ 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.