(53 days)
Not Found
No
The description focuses on data transportation and storage using standard DICOM protocols and proxy applications, with no mention of AI/ML terms or functionalities like image analysis, pattern recognition, or learning algorithms.
No.
The device is described as software for the transportation, storage, and retrieval of digital patient files, acting as a proxy for DICOM storage service classes. It does not exert any direct therapeutic action on a patient.
No
Explanation: The device is described as software for the transportation, storage, and retrieval of digital patient files, specifically acting as a proxy for DICOM storage services. Its function is to move and store medical images, not to analyze them or provide diagnostic information. This is further supported by the predicate devices which are Picture Archiving Systems.
Yes
The device description explicitly states that the functionality is provided by "two applications that execute on the NAD platform," acting as proxies for DICOM storage. This indicates the device is primarily software designed for managing digital patient files (DICOM data) and does not describe any hardware components developed or included as part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "transportation, storage, and retrieval of digital patient files." This describes a data management function, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on the technical aspects of moving and storing DICOM files. It describes proxy applications and network connections, which are related to data handling, not in vitro analysis.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition based on in vitro testing.
The device's function is purely related to the infrastructure for managing medical images (DICOM files), which are often generated by diagnostic devices, but the device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
The NetCo MDTS software is intended to be used in the transportation, storage, and retrieval of digital patient files.
Product codes
90 LMD
Device Description
The DICOM storage service class functionality is provided by two applications that execute on the NAD platform. The applications act as proxies for DICOM storage Service Class Provider (SCP) devices and storage Service Class User (SCU) devices on either end of a transportation network connection. The storage SCP proxy is configure-able to emulate another SCP device that is the destination of DICOM data. The file is moved across the transportation network to one or more destination NADs. On the destination NAD is a proxy SCU application that is configured to emulate the original SCU that sent the data. The original DICOM message file is kept intact as it is processed through the originating NAD and transmitted via the pathway.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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K980241
ATTACHMENT 5: 510(K) SUMMARY
1. Submitter Information
MAR 17 1998
NetCo Communications Corp. NetCo Medical Data Management Division 6100 West 110th Street Minneapolis, MN 55438
Tom Quintavalle, Manager of Quality Contact: Systems and Regulatory Affairs 612-886-5403 tel Phone: 612-886-5474 fax
Summary Preparation Date: January 22, 1998
2. Device Names
| Proprietary Name: | NetCo Medical Data Transportation Service software |
|---|---|
| Common/Usual Name: | medical image communications and storage device component |
| Classification Name: | No formal classifications have been issued for medical image management devices or their components |
| Classification: | Class I--proposed (See Federal Register Monday, December 2, 1996 Vol. 61 No. 232 p 63769 (Proposed rule) Docket No. 96-30650) |
3. Predicate devices
4. Device Description
The DICOM storage service class functionality is provided by two applications that execute on the NAD platform. The applications act as proxies for DICOM storage Service Class Provider (SCP) devices and storage Service Class User (SCU) devices on either end of a transportation network connection. The storage SCP proxy is configure-able to emulate another SCP device that is the destination of DICOM data. The file is moved across the transportation network to one or more destination NADs. On the destination NAD is a proxy SCU application that is configured to emulate the original SCU that sent the data. The original DICOM message file is kept intact as it is processed through the originating NAD and transmitted via the pathway.
5. Intended use
The NetCo MDTS software is intended to be used in the transportation, storage, and retrieval of digital patient files.
6. Comparison of technological characteristics
The NetCo MDTS software and the predicate product software all employ proprietary software and DICOM file standards to interface with a health care subscriber's network to transmit, store and retrieve medical image data.
1
Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the top of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 17 1998
Tom Quintavalle Manager of Quality Systems and Regulatory Affairs NetCo.Communications Corp. NetCo Medical Data Management Division 6100 West 110th Street Minneapolis, MN 55438
Re:
K980241 NetCo Medical Data Transporation Service Software Dated: January 22, 1998 Received: January 23, 1998 Regulatory class: Unclassified Procode: 90 LMD
Dear Mr. Quintavalle:
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 Device Amendments, or to devices that have been reclassified in accordance with the receral 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 II (Special Controls) or 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 requirements, as set forth in the Quality System Regulation (OS) 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 the Electronic Product 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 marketed 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 questions on the promotion 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,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page_ /_ of_ /
510(k) Number (if known): ূ८९४० 24 /
Device Name: NETO MECICAL DATH TRANSPORTATI
Indications For Use:
The NetCo MDTS software is intended to be used in the transportation, storage, and
retrieval of digital patient files.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Divis
active, Abdominal, ENT,
and
Devices
510(k) Number K980241
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)