CliniscanSM MRI

K153593 · Picofemto, LLC · LLZ · Feb 17, 2016 · Radiology

Device Facts

• Record ID: K153593
• Device Name: CliniscanSM MRI
• Applicant: Picofemto, LLC
• Product Code: LLZ · Radiology
• Decision Date: Feb 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

CliniscanSM MRI is a software-based medical device that processes MRI image sets to automatically identify, label, and quantify the volume of segmented brain structures. It replaces manual segmentation processes. The device is intended for use by qualified healthcare professionals in clinical settings. The software outputs visualizations and volumetric data, which are reviewed by clinicians to support clinical decision-making. It does not provide diagnostic conclusions; it serves as an automated tool for anatomical quantification.

Clinical Evidence

No clinical data provided. The submission relies on the device's intended use as an automated tool for image processing and quantification.

Technological Characteristics

Software-based device for image processing and volumetric quantification. Operates on MRI image sets. Intended for adult patient data. No specific hardware or material specifications provided.

Indications for Use

Indicated for automatic labeling, visualization, and volumetric quantification of segmented brain structures from MRI images in adult patients (18+ years). Not intended for diagnosis, treatment, cure, or prevention of disease. Results require review by a qualified healthcare professional.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## Indications for Use

510(k) Number (if known) K153593

Device Name CliniscanSM MRI

## Indications for Use (Describe)

1. 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.

2. This software is intended for use on adult patients only (18+ years).

3. 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)

| <span style="font-size: 10pt;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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