Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard image processing and quantification techniques, with no mention of AI, ML, or related concepts. The validation focuses on comparing automatic processing to manual processing, not on training or evaluating an AI/ML model.

Therapeutic

No
The device is a software application used to display and process medical images for diagnostic purposes, not to provide therapy or treatment.

Diagnostic

No

The "Intended Use" states that the results obtained "may be used as a tool, by a nuclear physician, in quantifying liver-spleen images." It processes existing medical images for quantification rather than directly providing a medical diagnosis or disease detection.

SaMD (Software as a Medical Device)

Yes

The device is described as "Microsoft Windows software" that runs on a "nuclear medicine workstation running Windows XP SP3 or later." The description focuses solely on the software's functionality for displaying and processing images, with no mention of accompanying hardware developed or provided by the manufacturer. The workstation itself is assumed to be existing hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body).
HEPATIQ processes in vivo images (images taken of the body) obtained from nuclear medicine procedures. It works with images of the liver and spleen, not with biological samples.
The intended use and device description clearly state it's a software application for displaying and processing nuclear medicine liver-spleen images.

Therefore, HEPATIQ falls under the category of medical imaging software, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

HEPATIQ is Microsoft Windows software that allows the user to display and process nuclear medicine liver-spleen images.

HEPATIQ software runs on any nuclear medicine workstation running Windows XP SP3 or later.

HEPATIQ software provides the user a means for quantification of nuclear medicine liver-spleen images.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

nuclear medicine liver-spleen images

Anatomical Site

liver-spleen

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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

Substantial equivalence was established by conducting a (non-clinical) validation test that collected performance data on HEPATIQ and the predicate device PEGASYS. The validation test consisted of directly comparing the manual processing of the liver-spleen images using the PEGASYS predicate device with the automatic processing of the same images using HEPATIQ.

A correlation analysis was performed between the manual PHM calculations using PEGASYS and the automatic PHM calculations using HEPATIQ. The analysis produced a coefficient of determination R2 of 97% which exceeded the validation criterion of a minimum R2 of 90%. Thus the validation test produced performance data that proved that HEPATIQ was substantially equivalent to PEGASYS.

Key Metrics

coefficient of determination R2 of 97%

Predicate Device(s)

K993946

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads or faces.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 17, 2014

HEPATIQ LLC % Mr. Dipu Ghosh CEO 1150 Main Street. Suite E IRVINE CA 92614

Re: K142891 Trade/Device Name: HEPATIO Regulation Number: 21CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 27, 2014 Received: Oct. 3. 2014

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.

Robert A Ochs

Robert A. Ochs, PhD Acting 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) K142891

Device Name HEPATIQ

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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image is a document header for HEPATIQ software. The title is "HEPATIQ SOFTWARE" and the subtitle is "510(k) Premarket Notification". The document number is H-029, the version is 0, and the page number is 14 of 82. The company is HEPATIQ LLC and the document is marked as confidential.

5 510(K) SUMMARY

In accordance with 21 CFR 807.92, the following summary of the information in the 510(k) submission is provided.

5.1 807.92(A)(1)

Summary Date:	9/27/2014
Submitter:	HEPATIQ LLC
1150 Main Street, Suite E
Irvine, California 92614
USA.
Primary Contact:	Dipu Ghosh, MSEE, MBA.
Chief Executive Officer
Phone: (949) 250-1065 ext. 124
Fax: (949) 250-1075
E-mail: dghosh@hepatiq.com
Secondary Contact:	John Hoefs, MD.
Chief Operating Officer
Phone: (714) 883-2208
Fax: (949) 250-1075
E-mail: jhoefs@hepatiq.com

5.2 807.92(A)(2)

Trade Name:	HEPATIQ
Common Name:	Radiology Image Processing Software
Device:	System, Image Processing, Radiological
Regulation Number:	21 CFR 892.2050
Regulation Description:	Picture Archiving & Communication System (PACS)
Review Panel:	Radiology
Device Class:	Class II
Product Code:	LLZ

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| HEPATIQTM

TITLE:	HEPATIQ SOFTWARE
SUBTITLE:	510(k) Premarket Notification
NUMBER:	H-029	VER:
CONFIDENTIAL	COMPANY:	HEPATIQ LLC

| Indication 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. |

---------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

5.3 807.92(A)(3) — Predicate Device

Predicate Device:	PEGASYS Ultra
Manufacturer:	ADAC Laboratories
510(k) Number:	K993946
Product Code:	LLZ
Regulation Number:	21 CFR 892.2050
Regulation Description:	Picture Archiving & Communication System (PACS)

5.4 807.92(A)(4) — Device Description

| Device Description: | HEPATIQ is Microsoft Windows software that allows
the user to display and process nuclear medicine liver-
spleen images.

HEPATIQ software runs on any nuclear medicine
workstation running Windows XP SP3 or later.

HEPATIQ software provides the user a means for
quantification of nuclear medicine liver-spleen images. |

---------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

5

HEPATIO" " "	HEPATIQ SOFTWARE
	subtitle: 510(k) Premarket Notification
Hepatic Quantitation NUMBER: H-029		VER: 0
CONFIDENTIAL	COMPANY: HEPATIQ LLC		PAGE: 16 of 82

5.5 807.92(A)(5) — Intended Use

| Intended 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. |

5.6 807.92(A)(6) — Technological Characteristics

HEPATIQ software has two major technologies:

Image Display: HEPATIQ interfaces with the hospital PACS to display nuclear medicine liver-spleen images using the standard Digital Imaging and Communications in Medicine (DICOM) protocols..

Image Quantification: Regions of interest (ROI) are identified automatically for the liver and spleen. An ROI is also automatically identified for the marrow between the liver and the spleen. The user is required to review and approve these ROI or re-draw them manually. ROI parameters are computed. Image quantification parameter Perfused Hepatic Mass (PHM) is calculated from the ROI parameters using standard formulas. A report is prepared showing serial PHM values and saved on PACS.

5.6.1 Technological Similarities

The following table summarizes the similarities in the technological characteristics of HEPATIQ and the predicate device PEGASYS.

| Technology | PEGASYS
(Predicate) | HEPATIQ | Comparison |
|-----------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer | General purpose
commercial
computer (Sun) | General purpose
commercial
computer (Intel) | Both products run on general
purpose commercial computers.
Neither product is relying on a
specialized computer. |
| Technology | PEGASYS
(Predicate) | HEPATIQ | Comparison |
| Operating
System | General purpose
commercial
operating
system (UNIX) | General purpose
commercial
operating
system
(Windows) | Both products use a general
purpose commercial operating
system. Neither product is relying
on a specialized operating system.
Both UNIX and Windows provide
standard operating system
functions for the display and
processing of images. |
| Launch | PEGASYS
Image
Manipulation
application
launched by
clicking on an
icon. | HEPATIQ
application
launched by
clicking on an
icon. | Both products use a graphical user
interface icon to launch the
application. |
| PACS
Interface | DICOM | DICOM | Both products use DICOM
protocols to interface to the
hospital PACS for downloading
images and uploading reports. |
| Configuration | PEGASYS
screens to set
network and
operational
parameters. | HEPATIQ
screens to set
network and
operational
parameters. | Both products use a graphical user
interface dialog screen to set
configuration parameters. |
| Manual
image
processing | General purpose
software tools
for manual
image
processing. | General purpose
software tools
for manual
image
processing. | Both products provide similar
manual software tools for:
·Image Display
·Frame Selection
·Spleen Length
·Summarized Transaxial Image
·ROI Identification
•ROI Calculations |
| User | Qualified nuclear
medicine
professionals | Qualified nuclear
medicine
professionals | Both products require users to be
qualified nuclear medicine
professionals. |
| Technology PEGASYS
(Predicate) | HEPATIQ | Comparison | |
| Automated
image
processing | No automation
(manual
calculation of
PHM only) | Automated
calculation of
PHM | The only difference in the image
processing by PEGASYS and HEPATIQ
is the automation feature. Both produce
results that are highly correlated with
each other. Automation of the image
processing is a feature of HEPATIQ that
saves the user a tremendous amount of
time.
For validation of the automation feature,
the PHM calculation was performed
manually using PEGASYS and
automatically using HEPATIQ for a set
of test images. The PHM value obtained
from the two devices were compared
and found to be highly correlated thus
validating the automation feature. |

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Image /page/6/Picture/0 description: The image contains the word "HEPATIQ" in large, bold, red letters, with the letters slightly overlapping each other. Below the word is a green swoosh and the words "Hepatic Quantitation" in a smaller, green font. At the bottom of the image, there is a gray rectangle with the word "CONFIDENTIAL" in bold, black letters.

HEPATIQ SOFTWARE TITLE: subtitle: 510(k) Premarket Notification H-029 NUMBER: VER: 0

COMPANY: HEPATIQ LLC

PAGE: 17 of 82

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Image /page/7/Picture/0 description: The image shows a document header with the HEPATIQ logo and the words "Hepatic Quantitation" below it. The title of the document is "HEPATIQ SOFTWARE" and the subtitle is "510(k) Premarket Notification". The document number is H-029, the version is 0, the company is HEPATIQ LLC, and the page number is 18 of 82.

5.6.2 Technological Differences

The following table summarizes the differences in the technological characteristics of HEPATIQ and the predicate device PEGASYS.

As the HEPATIQ and predicate device PEGASYS calculation of PHM are highly correlated, the automation feature of HEPATIQ does not raise any different questions of safety or efficacy.

5.7 807.92(B)(1) - Non-Clinical Performance Data

5.7.1 Design Controls

HEPATIQ was developed under the Quality System Regulation using Design Controls 21 CFR 820.30. This included establishing and maintaining procedures to ensure design requirements are met. All elements of the process have been documented, including design and development plan, design input, design output, design review, design verification, design validation, design transfer, design changes, and design history file.

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Image /page/8/Picture/0 description: The image is a document header for a company called HEPATIQ LLC. The title of the document is "HEPATIQ SOFTWARE" and the subtitle is "510(k) Premarket Notification". The document number is H-029, the version is 0, and the page number is 19 of 82.

5.7.2 Software Verification

HEPATIQ has successfully undergone extensive verification testing to ensure that all requirements for the software have been met.

A Software Verification Protocol was developed and executed. All verification tests passed and this was documented in a Software Verification Report. These results provide objective evidence that the outputs of the software design activity meet all of the specified requirements for that activity. For details on the verification testing performed, please see Section 12.9 - Verification Testing.

5.7.3 Software Validation

Substantial equivalence was established by conducting a (non-clinical) validation test that collected performance data on HEPATIQ and the predicate device PEGASYS. The validation test consisted of directly comparing the manual processing of the liver-spleen images using the PEGASYS predicate device with the automatic processing of the same images using HEPATIQ.

A correlation analysis was performed between the manual PHM calculations using PEGASYS and the automatic PHM calculations using HEPATIQ. The analysis produced a coefficient of determination R2 of 97% which exceeded the validation criterion of a minimum R2 of 90%. Thus the validation test produced performance data that proved that HEPATIQ was substantially equivalent to PEGASYS.

As the HEPATIQ and predicate device PEGASYS calculation of PHM are highly correlated, the automation feature of HEPATIQ does not raise anv different questions of safety or efficacy. For details on the validation testing performed, please see Section 12.10 - Validation Testing (Performance Data).

5.7.4 Site Testing

Site testing was performed at a beta test hospital to test the installation procedures. The site testing was successful.

For details on the site test protocol, please see Attachment 11: H-026 -Site Test Protocol.

For details on the site test results, please see Attachment 12: H-027 -Site Test Report.

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Image /page/9/Picture/0 description: The image shows a document header with the HEPATIQ logo and the words "Hepatic Quantitation" below it. The title of the document is "HEPATIQ SOFTWARE" and the subtitle is "510(k) Premarket Notification". The document number is H-029, the version is 0, the company is HEPATIQ LLC, and the page number is 20 of 82. The word "CONFIDENTIAL" is written in bold letters on the left side of the header.

807.92(B)(2) — Clinical Performance Data 5.8

Based on the criteria listed under Section F of the guidance document: "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications", no clinical testing of HEPATIQ was required or performed. For a detailed rationale, please see Section 20: Performance Testing - Clinical.

5.9 807.92(B)(3) - Conclusion

Substantial equivalence of HEPATIQ and PEGASYS has been positively established in accordance with the flowchart in Appendix A of the guidance document: "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications"

Decision	Question	Answer
1	Is the predicate device
legally marketed?	Yes - PEGASYS is a legally marketed device
2	Do the devices have
the same intended
use?	Yes - HEPATIQ has the same intended use as
PEGASYS.
3	Do the devices have
the same technological
characteristics?	No - There is one difference:- PEGASYS
processes liver-spleen images manually while
HEPATIQ processes them automatically (with
manual overrides available to the user).
4	Do the different
technological
characteristics of the
devices raise different
questions of safety
and effectiveness?	No - The automation feature of HEPATIQ
does not raise different questions of safety
and effectiveness. Validation testing proved
that the PEGASYS manual processing and
HEPATIQ automated processing are highly
correlated.
5a	Are the methods
acceptable?	Yes - Direct comparison of the processing of
the same images on both PEGASYS and
HEPATIQ was performed and standard
statistical analysis used for comparison.
5b	Do the data
demonstrate
substantial
equivalence?	Yes - Manual processing with PEGASYS and
automatic processing with HEPATIQ were
correlated with an R2 of 97%, exceeding the
validation requirement of a minimum of 90%.

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Image /page/10/Picture/0 description: The image shows a document with the title "HEPATIQ SOFTWARE" and subtitle "510(k) Premarket Notification". The document number is H-029 and the version is 0. The company is listed as HEPATIQ LLC and the page number is 21 of 82. The document is marked as confidential.

Furthermore, no applicable mandatory performance standards or special controls exist for HEPATIQ. The product design, development and manufacturing conform to Quality System Regulations. Results of testing and standards conformance demonstrate safety and effectiveness of HEPATIQ.

We conclude that HEPATIQ and PEGASYS are substantially equivalent.