(28 days)
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Unknown
The summary mentions "processing (enhancement)" of images, which could potentially involve AI/ML, but there is no explicit mention of AI, ML, or related terms like DNN, nor is there information about training or test sets typically associated with AI/ML development.
No
The device is indicated for image acquisition, storage, processing, printing, and display, which are diagnostic functions, not therapeutic.
No
The device is described as being for the acquisition, storage, processing, printing, and display of images. This is an image management system which does not perform a diagnostic function itself, but rather facilitates the use of images that may be used for diagnosis. There is no mention of analysis or interpretation of images to make a diagnosis.
No
The description explicitly states the device is for the "acquisition, storage, processing (enhancement), printing and display" of images from fluoroscopic and digital x-ray modalities. Acquisition, printing, and display typically involve hardware components beyond just software. While the summary is incomplete, the stated functions strongly suggest a system that includes hardware.
Based on the provided information, the SmartSpot 2000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the acquisition, storage, processing, printing, and display of fluoroscopic and digital x-ray spot images. This involves imaging the human body directly, which is characteristic of medical imaging devices, not IVDs.
- IVD Definition: IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. The SmartSpot 2000 does not perform this function.
- Input Modality: The input modalities are fluoroscopic and digital x-ray, which are imaging techniques applied to the patient, not to in vitro samples.
Therefore, the SmartSpot 2000 falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SmartSpot 2000 is indicated for the acquisition, storage, processing (enhancement), printing and display of fluoroscopic and digital x-ray spot images.
Product codes
90 LLZ
Device Description
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Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
fluoroscopic and digital x-ray
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 (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)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 1999
Yeshavahu Raz CMT Medical Technologies, LTD MATAM High Technology Center Haifa, 31905 ISRAEL
Re:
K991578 SmartSpot 2000 Image Processing System Dated: May 2, 1999 Received: May 6, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Raz:
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, 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 dass 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 (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 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/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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Image /page/1/Picture/0 description: The image shows a handwritten text string. The string appears to be a combination of letters and numbers. The text reads "K991578/A".
Image /page/1/Picture/1 description: The image shows the logo for CMT Medical Technologies LTD. The logo features the letters CMT in a stylized font, with the letters overlapping each other. Below the letters, the words "MEDICAL TECHNOLOGIES LTD" are printed in a smaller, sans-serif font. The logo is simple and modern, and the use of black and white gives it a clean and professional look.
SmartSP07 2000
510(k) Number K991578
INDICATIONS FOR USE
The SmartSpot 2000 is indicated for the acquisition, storage, processing (enhancement), printing and display of fluoroscopic and digital x-ray spot images.
David Ch. Sezamm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)