(75 days)
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.
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.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets these criteria:
Device Acceptance Criteria and Performance Study
The HEPATIQ device is a nuclear medicine software application used to display and process liver-spleen images for quantifying Perfused Hepatic Mass (PHM). The study aimed to demonstrate substantial equivalence to its predicate device, PEGASYS Ultra, particularly regarding its automation feature for PHM calculation.
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for HEPATIQ was its ability to calculate PHM values that are highly correlated with the manual PHM calculations from the predicate device, PEGASYS.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Minimum R² (coefficient of determination) of 90% | Achieved an R² of 97% between manual PHM calculations using PEGASYS and automatic PHM calculations using HEPATIQ. This exceeded the 90% validation criterion. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "a set of test images" was used. The exact sample size for the test set is not explicitly provided. The data provenance is also not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a "ground truth" in the traditional sense (e.g., multiple radiologists independently reviewing images). Instead, the validation was a direct comparison between HEPATIQ's automated calculations and the predicate device's manual calculations. The predicate device's manual calculations were presumed to be the "ground truth" or reference for comparison.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned because the validation was a direct comparison between two calculation methods (HEPATIQ vs. PEGASYS), not a human-adjudicated review of medical imagery.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed. The validation focused on the correlation of the automated calculation feature of HEPATIQ with the manual calculation of the predicate device. Therefore, no effect size of human readers improving with AI vs. without AI assistance is applicable or reported.
6. Standalone Performance Study
Yes, a standalone (algorithm only) performance study was performed. The study directly compared the automatic PHM calculations of HEPATIQ with the manual PHM calculations of the predicate device (PEGASYS) for a given set of images. This demonstrates the performance of the algorithm without human intervention, specifically for the automated calculation feature.
7. Type of Ground Truth Used
The "ground truth" used for this validation was the manual PHM calculations performed by the predicate device, PEGASYS. This served as the reference against which HEPATIQ's automated calculations were compared.
8. Sample Size for the Training Set
The document does not provide information about a separate training set or its sample size. The focus of the provided text is on the validation study comparing HEPATIQ's performance to its predicate device. This suggests that the development and training (if any involving machine learning) happened prior to this validation, and details are not included in this summary.
9. How Ground Truth for the Training Set Was Established
As no training set is described, the method for establishing its ground truth is also not mentioned.
{0}------------------------------------------------
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."
{3}------------------------------------------------
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 LLC1150 Main Street, Suite EIrvine, California 92614USA. |
| Primary Contact: | Dipu Ghosh, MSEE, MBA.Chief Executive OfficerPhone: (949) 250-1065 ext. 124Fax: (949) 250-1075E-mail: dghosh@hepatiq.com |
| Secondary Contact: | John Hoefs, MD.Chief Operating OfficerPhone: (714) 883-2208Fax: (949) 250-1075E-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 |
{4}------------------------------------------------
| HEPATIQTMHepatic Quantitation | 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 applicationused to display and process liver-spleen images.The results obtained may be used as a tool, by anuclear physician, in quantifying liver-spleen images.The data processed may be derived from anynuclear medicine liver-spleen procedure.The HEPATIQ software should only be used byqualified 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 allowsthe user to display and process nuclear medicine liver-spleen images.HEPATIQ software runs on any nuclear medicineworkstation running Windows XP SP3 or later.HEPATIQ software provides the user a means forquantification 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 applicationused to display and process liver-spleen images.The results obtained may be used as a tool, by anuclear physician, in quantifying liver-spleen images.The data processed may be derived from any nuclearmedicine liver-spleen procedure. |
|---|---|
| The HEPATIQ software should only be used byqualified 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 purposecommercialcomputer (Sun) | General purposecommercialcomputer (Intel) | Both products run on generalpurpose commercial computers.Neither product is relying on aspecialized computer. |
| Technology | PEGASYS(Predicate) | HEPATIQ | Comparison |
| OperatingSystem | General purposecommercialoperatingsystem (UNIX) | General purposecommercialoperatingsystem(Windows) | Both products use a generalpurpose commercial operatingsystem. Neither product is relyingon a specialized operating system.Both UNIX and Windows providestandard operating systemfunctions for the display andprocessing of images. |
| Launch | PEGASYSImageManipulationapplicationlaunched byclicking on anicon. | HEPATIQapplicationlaunched byclicking on anicon. | Both products use a graphical userinterface icon to launch theapplication. |
| PACSInterface | DICOM | DICOM | Both products use DICOMprotocols to interface to thehospital PACS for downloadingimages and uploading reports. |
| Configuration | PEGASYSscreens to setnetwork andoperationalparameters. | HEPATIQscreens to setnetwork andoperationalparameters. | Both products use a graphical userinterface dialog screen to setconfiguration parameters. |
| Manualimageprocessing | General purposesoftware toolsfor manualimageprocessing. | General purposesoftware toolsfor manualimageprocessing. | Both products provide similarmanual software tools for:·Image Display·Frame Selection·Spleen Length·Summarized Transaxial Image·ROI Identification•ROI Calculations |
| User | Qualified nuclearmedicineprofessionals | Qualified nuclearmedicineprofessionals | Both products require users to bequalified nuclear medicineprofessionals. |
| Technology PEGASYS(Predicate) | HEPATIQ | Comparison | |
| Automatedimageprocessing | No automation(manualcalculation ofPHM only) | Automatedcalculation ofPHM | The only difference in the imageprocessing by PEGASYS and HEPATIQis the automation feature. Both produceresults that are highly correlated witheach other. Automation of the imageprocessing is a feature of HEPATIQ thatsaves the user a tremendous amount oftime.For validation of the automation feature,the PHM calculation was performedmanually using PEGASYS andautomatically using HEPATIQ for a setof test images. The PHM value obtainedfrom the two devices were comparedand found to be highly correlated thusvalidating the automation feature. |
{6}------------------------------------------------
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
{7}------------------------------------------------
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.
{8}------------------------------------------------
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.
{9}------------------------------------------------
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 devicelegally marketed? | Yes - PEGASYS is a legally marketed device |
| 2 | Do the devices havethe same intendeduse? | Yes - HEPATIQ has the same intended use asPEGASYS. |
| 3 | Do the devices havethe same technologicalcharacteristics? | No - There is one difference:- PEGASYSprocesses liver-spleen images manually whileHEPATIQ processes them automatically (withmanual overrides available to the user). |
| 4 | Do the differenttechnologicalcharacteristics of thedevices raise differentquestions of safetyand effectiveness? | No - The automation feature of HEPATIQdoes not raise different questions of safetyand effectiveness. Validation testing provedthat the PEGASYS manual processing andHEPATIQ automated processing are highlycorrelated. |
| 5a | Are the methodsacceptable? | Yes - Direct comparison of the processing ofthe same images on both PEGASYS andHEPATIQ was performed and standardstatistical analysis used for comparison. |
| 5b | Do the datademonstratesubstantialequivalence? | Yes - Manual processing with PEGASYS andautomatic processing with HEPATIQ werecorrelated with an R2 of 97%, exceeding thevalidation requirement of a minimum of 90%. |
{10}------------------------------------------------
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.
§ 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).