(90 days)
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No
The summary only mentions "real-time digital image enhancement" and "image processing" without any reference to AI, ML, or related concepts like deep learning or neural networks.
No
The device is described as performing "real-time digital image enhancement of screen/film mammograms," which is an image processing function and not a direct therapeutic action.
No
The device enhances images, but it does not provide a diagnosis or aid in diagnosis directly.
Yes
The device is described as an "Image Processing System" that performs "digital image enhancement." This strongly suggests the device's primary function is software-based manipulation of existing digital images, without mention of any hardware components being 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 "real-time digital image enhancement of screen/film mammograms." This describes a process applied to medical images, not a test performed on biological samples (like blood, urine, or tissue) to diagnose or monitor a disease.
- Device Description: The description is an "Image Processing System." This further supports the idea that it works with images, not biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or prognosis based on biological sample analysis.
Therefore, the MACOM™ Image Processing System, as described, falls under the category of medical image processing software or a medical device that processes images, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MACOM ™ performs real-time digital image enhancement of screen/film mammograms.
Product codes
90 LLZ
Device Description
MACOM™ Image Processing System
Mentions image processing
MACOM™ Image Processing System
MACOM ™ performs real-time digital image enhancement
Mentions AI, DNN, or ML
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Input Imaging Modality
screen/film mammograms
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)
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Reference Device(s)
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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).
0
Image /page/0/Picture/0 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 symbol that resembles a caduceus, a traditional symbol of medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 20 1997
Sophisview Technologies. Ltd. c/o Ahava Stein Regulatory Affairs Consulting POB 454 Ginot Shomron 44853 Israel
Re: K973148
MACOM™ Image Processing System Dated: July 30, 1997 Received: August 22, 1997 Regulatory class: Unclassified Procode: 90 LLZ
Dear Ms. Stein:
な
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 ise 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, 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 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 conceming 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 marked 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 809.00 for in yitre. . 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
1
Indications for Use Statement
Page 1 of 1
| 510(k) Number (if known): | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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| --------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
MACOM™ Image Processing System Device Name:
MACOM ™ performs real-time digital image enhancement Indications for use: of screen/film mammograms.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) -
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. de yong
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 4973148 510(k) Number
OR
Prescription Use V (Per 21 C.F.R. 801.109) Over-The-Counter Use (Optional Format 1-2-96)