(88 days)
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No
The summary describes basic digital record storage and viewing features, with no mention of AI or ML algorithms for analysis, interpretation, or decision support.
No
The device is for storing and transmitting medical records, and for viewing images with zoom features, which are administrative and viewing functions, not direct treatment or diagnosis.
No
The device is described as storing, transmitting, and allowing digital zoom of patient records, including x-ray images. While it facilitates the examination of diagnostic images, its primary functions are record management and viewing, not the direct generation of diagnostic information or analysis of patient data to determine a medical condition. The ability to "enlarge an x-ray film/images... for closer examination" is a viewing utility, not a diagnostic one in itself.
Unknown
The provided text describes software functionalities (storing records, transmitting data, digital zoom) but does not explicitly state that the device is only software and does not include any associated hardware. Without a "Device Description" section or further information, it's impossible to definitively confirm it's software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The described device, "Maestro," is primarily a system for storing and transmitting patient medical and dental records. It also includes features for viewing and zooming on digital images (like x-rays) and documents.
- No mention of testing biological samples: The description does not indicate that the device performs any tests on biological samples from patients. Its function is related to managing and viewing existing patient data.
Therefore, based on the intended use and device description, Maestro falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended to be used by all medical and dental personnel to store all patient medical or dental records on CD. Digital Audio Tapes or any future digital archivable media. The Maestro product is capable of transmitting patient records or claims to third party administrators or insurance companies for processing of patient insurance claims. Maestro allows a user to use digital zoom-in features to enlarge an x-ray film/images, or any type of document for closer examination.
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
x-ray film/images
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
all medical and dental personnel
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)
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three curved lines that resemble a bird in flight or a symbolic representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MO 20850
Roger C. Claar, Ph.D. Vice President and Regulatory Affairs International Imaging Electronics 881 Remington Blvd. Bolingebrook, IL 604404932
JUN 1 3
Re: K970964 Maestro Digital Image and Patient Record Storage System Dated: March 14, 1997 Received: March 17, 1997 ... Regulatory class: II 21 CFR 892.1680/Procode: 90 LLZ
Dear Dr. Claar:
参
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined 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 scoordance 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 (Prematce 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 Good Manufacturing Practice for Modical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will vertly 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 51 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 of substantial equivalence of your device to a legally marketed predication 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 vite diagnostic devices), please contact the Office of Compliance al (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please of 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 with 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/cdrtv/dsmamain.html".
Sincerely yours,
William
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
MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM
INTENDED USE
This device is intended to be used by all medical and dental personnel to store all patient medical or dental records on CD. Digital Audio Tapes or any future digital archivable media. The Maestro product is capable of transmitting patient records or claims to third party administrators or insurance companies for processing of patient insurance claims. Maestro allows a user to use digital zoom-in features to enlarge an x-ray film/images, or any type of
document for closer examination.
David A. Seymore
(Division Sign-Off)
7
Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)