(57 days)
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No
The document describes standard image display and manipulation software without mentioning AI, ML, or related concepts.
No.
The device is described as a diagnostic review station used to display and manipulate patient images and demographic information for diagnostic, review, and referral purposes, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states that DDS is used "for diagnostic, review and referral purposes" and forms a "diagnostic review station".
Yes
The device description explicitly states that DDS is a "software package which may be marketed as a software only solution". While it can be combined with hardware, the option to market and presumably use it as software only indicates it qualifies as a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description of this device focuses on displaying and manipulating patient images and demographic information. It does not mention analyzing biological samples like blood, urine, tissue, etc.
- The intended use is for diagnostic review, referral, and image manipulation. This aligns with medical imaging software used by healthcare professionals to interpret images, not with tests performed on biological specimens.
- The predicate device is medical imaging software. The predicate device listed, "Radworks Medical Imagining Software with Quality Control Module," is clearly in the realm of medical imaging, not in vitro diagnostics.
Therefore, based on the provided text, this device functions as medical imaging software and does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.
Product codes
90 LLZ
Device Description
DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.
Mentions image processing
Both systems allow digital processing, measurement and annotation of images.
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
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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
Software testing follows standard procedures: test plans are developed, testing is carried out through a variety of automated and manual testing, and test results are recorded and reported. The DDS software has been extensively tested by programmers, quality assurance specialists, and potential customers.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Radworks Medical Imagining Software with Quality Control Module
Reference Device(s)
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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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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
510K Summary of Safety and Effectiveness for DDS
DEC 1 5 1990
COMPANY INFORMATION:
Impax Technology Inc., 455 Phillip Street, Waterloo, Ontario Canada N2L 3X2
Phone: (519) 746-2900 Fax: (519) 746-3745
CONTACT:
Paula Pfeifle, Regulatory Affairs
DATE OF SUBMISSION:
October 18, 1999
DEVICE:
DEVICE NAME: DDS
TRADE/PROPRIETARY NAME: DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (amongst other names)
COMMON NAME: Diagnostic Review Station CLASSIFICATION NAME: System, Image Processing
DEVICE DESCRIPTION AND INTENDED USE:
DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.
SUBSTANTIAL EQUIVALENCE DEVICE:
Radworks Medical Imagining Software with Quality Control Module
SUBSTANTIAL EQUIVALENCE TECHNOLOGICAL COMPARISON:
Both DDS and Radworks are sold as software packages which can be used on standard PC hardware with Windows NT, and the DDS can also be used on standard Unix hardware with Solaris.
1
Both systems can query, retrieve, and transmit medical images over phone lines or networks. Both systems provide high quality display capability. Both systems allow digital processing, measurement and annotation of images.
SUBSTANTIAL EQUIVALENCE NON-CLINICAL PERFORMANCE AND TEST DATA:
Software testing follows standard procedures: test plans are developed, testing is carried out through a variety of automated and manual testing, and test results are recorded and reported. The DDS software has been extensively tested by programmers, quality assurance specialists, and potential customers.
SUBSTANTIAL EQUIVALENCE CONCLUSIONS:
Impax Technology Inc. concludes that the intended use for the DDS is that same as that of the predicate device, and that the technological characteristics demonstrate that they are equivalent to the predicate device. Thus, this premarket notification has demonstrated Substantial Equivalence.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with the profiles overlapping to create a sense of unity. The profiles are rendered in black, and the text is also in black.
Food and Drug Administration 1 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 1999
Paula Pfeifle Regulatory Affairs Impax Technology, Inc. 455 Phillip Street Waterloo, Ontario Canada N2L 3X2
Re:
K993532 DDS Software (Diagnostic Image Review Station) Dated: October 18, 1999 Received: October 19, 1999 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Ms. Pfeifle:
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 legally marketed predicate 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 provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, 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 Requlations, 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 (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 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 requlations.
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 labeling requlation (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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D Acting 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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Statement of Indications of Use
510(k) Number: K993532
Device Name: Impax Technology Inc., DDS
Indications for Use:
DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Segerson
ision of Reproductive, Abdominal, ENT and Radiological D 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over the Counter Use