(43 days)
Not Found
None
No
The summary describes image processing software but makes no mention of AI, ML, or related concepts, nor does it provide details about training or test sets typically associated with such technologies.
No.
Explanation: The device processes and displays images to quantify liver-spleen images for a physician and does not directly treat or diagnose a disease.
Yes
The intended use section states that "The results obtained may be used as a tool, by a nuclear physician, in quantifying liver-spleen images" and that the software is used to display and process these images. This indicates that the device is used to analyze biological images to aid in diagnosis, which is characteristic of a diagnostic device. While it is described as a "tool", processing and quantifying medical images for a physician to use in making medical decisions falls under the umbrella of diagnostic devices.
Yes
The device is described solely as a "software application" used to display and process images. There is no mention of any accompanying hardware components or physical device.
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.
- HEPATIQ's function: HEPATIQ is a software application that processes and displays images obtained from a nuclear medicine procedure. It works with data derived from the imaging process, not directly with biological samples from the patient.
Therefore, HEPATIQ falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
HEPATIQ is a nuclear medicine software application used to display and process liver-spleen images.
The results obtained may be used as a tool, by a nuclear physician, in quantifying liver-spleen images.
The data processed may be derived from any nuclear medicine liver-spleen procedure.
The HEPATIQ software should only be used by qualified nuclear medicine professionals.
Product codes
LLZ
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
nuclear medicine
Anatomical Site
liver-spleen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
nuclear physician, qualified nuclear medicine professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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).
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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 features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2016
HEPATIQ LLC % Mr. Dipu Ghosh CEO 1150 Main Street, Suite E IRVINE CA 92614
Re: K161188
Trade/Device Name: HEPATIO 1.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 23, 2016 Received: May 25, 2016
Dear Mr. Ghosh:
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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161188
Device Name
HEPATIQ 1.1
Indications for Use (Describe)
HEPATIQ is a nuclear medicine software application used to display and process liver-spleen images.
The results obtained may be used as a tool, by a nuclear physician, in quantifying liver-spleen images.
The data processed may be derived from any nuclear medicine liver-spleen procedure.
The HEPATIQ software should only be used by qualified nuclear medicine professionals.
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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