(63 days)
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Unknown
The summary describes automated image processing for segmentation and quantification, which can be achieved with or without AI/ML. There is no explicit mention of AI, ML, or related terms, nor is there information about training or test sets typically associated with AI/ML development.
No
The "Intended Use / Indications for Use" section explicitly states that the software is "NOT intended to diagnose, treat, cure or prevent any disease." It is a tool for automatic labeling, visualization, and volumetric quantification of brain structures from MRI images.
No
The device explicitly states that it is "NOT intended to diagnose, treat, cure or prevent any disease." While it provides information that can be reviewed by a healthcare professional for diagnosis, the device itself does not perform the diagnostic function.
Unknown
The provided text does not contain a "Device Description" section, which is crucial for determining if the device is software-only. While the intended use describes software functionality, the absence of a device description prevents confirmation that no hardware components are included.
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.
- CliniscanSM MRI's Intended Use: The intended use clearly states that CliniscanSM MRI processes MRI images of the brain. This is an in vivo (within the living body) imaging modality, not an in vitro test performed on samples outside the body.
- Lack of Mention of Samples: The description does not mention the processing of any biological samples.
Therefore, CliniscanSM MRI falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- CliniscanSM MRI is intended for automatic labeling, visualization and volumetric quantification of segmented brain structures from a set of MRI images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmental brain structures identified on MR images.
- This software is intended for use on adult patients only (18+ years).
- CliniscanSM MRI is NOT intended to diagnose, treat, cure or prevent any disease. All results must be reviewed by a qualified healthcare professional prior to any diagnosis.
Product codes
LLZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
MRI images
Anatomical Site
brain
Indicated Patient Age Range
adult patients only (18+ years)
Intended User / Care Setting
qualified healthcare professional
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 17, 2016
Picofemto LLC % Ms. Jessica Phillips QA Engineer 228 East 45th Street, 2nd Floor NEW YORK NY 10017
Re: K153593
Trade/Device Name: CliniscanSM MRI Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 28, 2016 Received: January 29, 2016
Dear Ms. Phillips:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153593
Device Name CliniscanSM MRI
Indications for Use (Describe)
-
CliniscanSM MRI is intended for automatic labeling, visualization and volumetric quantification of segmented brain structures from a set of MRI images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmental brain structures identified on MR images.
-
This software is intended for use on adult patients only (18+ years).
-
CliniscanSM MRI is NOT intended to diagnose, treat, cure or prevent any disease. All results must be reviewed by a qualified healthcare professional prior to any diagnosis.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
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