K Number
K200852
Device Name
EchoPAC Software Only, EchoPAC Plug-In
Date Cleared
2020-09-18

(171 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images. Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D). Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN), Urology (including prostate), Pediatric; Small organs (breast, testes, thyroid), Neonatal and Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Transesophageal (TEE), Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal (TR), Transvaginal (TV), Intraoperative (vascular), Intra-cardiac, and Intra-luminal.
Device Description
EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the Vivid family of ultrasound scanners by GE Healthcare. The EchoPAC Software Only / EchoPAC Plug-in software is an integral component of each Vivid system, providing the post-acquisition image management and reporting functions of the scanner. EchoPAC Software Only will be offered as SW-only to be installed directly on customer PC hardware, and EchoPAC Plug-in will be offered as an accessory to image management workstations. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations.
More Information

Yes
The document explicitly mentions "Al (Artificial Intelligence) based Cardiac Auto 2D feature" and "Al based Spectrum Recognition feature".

No.
The device is intended for diagnostic review and analysis of ultrasound images, patient record management, and reporting, not for treatment.

Yes
The "Intended Use / Indications for Use" section explicitly states that "EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images".

Yes

The device description explicitly states "EchoPAC Software Only will be offered as SW-only to be installed directly on customer PC hardware". While it interacts with hardware (ultrasound scanners and PCs), the device itself is the software component.

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

Here's why:

  • IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
  • This device analyzes medical images: The EchoPAC Software Only / EchoPAC Plug-in is clearly described as a device for the "diagnostic review and analysis of ultrasound images." It processes and analyzes images acquired directly from ultrasound scanners, not biological samples.

While the device is used for diagnostic purposes and involves analysis, the nature of the input data (medical images) places it outside the definition of an In Vitro Diagnostic.

No
The document does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.

Intended Use / Indications for Use

EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.

Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D).

Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN), Urology (including prostate), Pediatric; Small organs (breast, testes, thyroid), Neonatal and Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Transesophageal (TEE), Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal (TR), Transvaginal (TV), Intraoperative (vascular), Intra-cardiac, and Intra-luminal.

Product codes

LLZ

Device Description

EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the Vivid family of ultrasound scanners by GE Healthcare. The EchoPAC Software Only / EchoPAC Plug-in software is an integral component of each Vivid system, providing the post-acquisition image management and reporting functions of the scanner. EchoPAC Software Only will be offered as SW-only to be installed directly on customer PC hardware, and EchoPAC Plug-in will be offered as an accessory to image management workstations. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/Obstetrics; Abdominal (including renal and GYN), Urology (including prostate), Pediatric; Small organs (breast, testes, thyroid), Neonatal and Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Transesophageal (TEE), Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal (TR), Transvaginal (TV), Intraoperative (vascular), Intra-cardiac, and Intra-luminal.

Indicated Patient Age Range

Neonatal and Adult Cephalic, Cardiac (adult and pediatric)

Intended User / Care Setting

licensed physician

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)

The subject of this premarket submission, EchoPAC Software Only / EchoPAC Plug-in, did not require clinical studies to support substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K170847

Reference Device(s)

K182450, K181685, K200743

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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GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226

Re: K200852

Trade/Device Name: EchoPAC Software Only, EchoPAC Plug-In Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 21, 2020 Received: August 25, 2020

Dear Tracey Ortiz:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

September 18, 2020

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K200852

Device Name

EchoPAC Software Only, EchoPAC Plug-in

Indications for Use (Describe)

EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.

Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D).

Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN), Urology (including prostate), Pediatric; Small organs (breast, testes, thyroid), Neonatal and Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Transesophageal (TEE), Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal (TR), Transvaginal (TV), Intraoperative (vascular), Intra-cardiac, and Intra-luminal.

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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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are white and are set against a blue circular background. The blue background has a textured appearance, resembling a swirling pattern.

K200852 GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:March 27, 2020
Submitter:GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
9900 Innovation Drive
Wauwatosa, WI 53226
Primary Contact Person:Tracey Ortiz
Regulatory Affairs Director
GE Healthcare T:(262)676-
6120
Secondary Contact Person:Charlotte K. Munthe Jørgensen
Senior Regulatory Affairs Leader
GE Vingmed Ultrasound AS
Device Trade Name:EchoPAC Software Only / EchoPAC Plug-in
Common/Usual Name:Workstation Software for ultrasound image review, analysis and
reporting
Classification Names:Class II
Product Code:Picture archiving and communications system, 21 CFR 892.2050
LLZ
Primary Predicate
Device(s):EchoPAC Software Only / EchoPAC Plug-in (K170847)
Reference Predicate
Device(s):Vivid S70N (K182450)
Vivid E95 (K181685)
Vivid E95 (K200743)

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The logo is enclosed within a circular border, and the color of the logo and border is a light blue.

GE Healthcare 510(k) Premarket Notification Submission

EchoPAC Software Only / EchoPAC Plug-in provides image Device Description: processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the Vivid family of ultrasound scanners by GE Healthcare. The EchoPAC Software Only / EchoPAC Plug-in software is an integral component of each Vivid system, providing the post-acquisition image management and reporting functions of the scanner. EchoPAC Software Only will be offered as SW-only to be installed directly on customer PC hardware, and EchoPAC Plug-in will be offered as an accessory to image management workstations. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations. EchoPAC Software Only / EchoPAC Plug-in is intended for Intended Use/ Indication for Use: diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images. Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D). Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN), Urology (including prostate), Pediatric; Small organs (breast, testes, thyroid), Neonatal and Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Transesophageal (TEE), Musculo-skeletal Conventional, Musculoskeletal Superficial, Transrectal (TR), Transvaginal (TV), Intraoperative (vascular), Intra-cardiac, and Intra-luminal. Technology: EchoPAC Software Only / EchoPAC Plug-in employs the same fundamental scientific technology as its predicate device. Determination of Comparison to Predicates Substantial Equivalence: EchoPAC Software Only / EchoPAC Plug-in is substantially equivalent to the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

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GE Healthcare 510(k) Premarket Notification Submission

The following is an overview of the difference between the proposed EchoPAC Software Only / EchoPAC Plug-in and its predicates.

Features/Functionality additions:

  • . Al Auto Measure – 2D: same feature as cleared on Vivid E95 (K200743). It is Al (Artificial Intelligence) based Cardiac Auto 2D feature that enables semi-automated measurements on a PLAX image.
  • Al Auto Measure – Spectrum Recognition: same feature as cleared on Vivid E95 (K200743). It is Al based Spectrum Recognition feature that enables automated recognition of common Doppler spectra and automatically starts the Auto Doppler measurement or opens the appropriate manual measurement folder.
  • . AFI 3.0: same feature as cleared on Vivid E95 (K200743), based on AFI 2.0 (cleared in Vivid E95, K181685), adds the ability to analyze the left ventricle on both GEHC raw data images and DICOM images from 3rd party ultrasound scanners.
  • Auto EF 3.0: same feature as cleared on Vivid E95 ● (K200743), based on Auto EF 2.0 (cleared in Vivid E95, K181685), adds the ability to assess LV function on raw data images acquired with GEHC scanners as well as on DICOM images from other vendors systems.
  • . AFI RV: same feature as cleared on Vivid E95 (K200743), based on AFI 2.0 (cleared in Vivid E95, K181685) but modified for the right ventricle (RV). It is a parametric tool giving quantitative data for right ventricular longitudinal global strain, free wall strain and segmental strain derived from the apical 4-chamber RV focused view.
  • AFI LA: same feature as cleared on Vivid E95 (K200743), ● based on AFI 2.0 (cleared in Vivid E95, K181685) but modified for the left atrium. It provides quantitative data for left atrial (LA) global strain. The tool also supports measurements of LA volumes and emptying fraction (EF).
  • Launchpad: same feature as cleared on Vivid E95 ● (K200743), allows the display and launch/starting of thirdparty software apps. The offered apps are verified to be compatible with EchoPAC Software Only / EchoPAC Plugin.

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Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle is surrounded by swirling, wave-like shapes, also in blue, giving the logo a dynamic and recognizable appearance. The logo is simple, yet distinctive, and has been used by GE for many years.

GE Healthcare

510(k) Premarket Notification Submission

  • FlexiLight and HD Color: same features as cleared on ● Vivid E95 (K200743), are visualization tools enhancing depth and color perception respectively of 3D objects on a 2D monitor
  • 4D Auto TVQ: same feature as cleared on Vivid E95 ● (K200743), based on 4D Auto MVQ (cleared in EchoPAC Software Only/EchoPAC Plug-in, K170847), but modified for quantification of tricuspid annulus and valve in 4D echocardiographic data.
  • DICOM PDF Read: same feature as cleared on Vivid E95 (K200743). The system supports read-only access to DICOM PDF reports created on a DICOM server
  • The new feature "Open 4D" loads 3D or 4D ultrasound ● images from 300 party vendors and allows user to do measurements and analysis.
  • . Z-score enhancement: same enhancements as cleared on Vivid E95 (K200743). More Z-score sets of values added based on published literature - are being added to those previously cleared in predicate EchoPAC Software Only / EchoPAC Plug-in.
  • 4D marker enhancement: same feature as cleared on Vivid ● E95 (K200743). Feature cleared in predicate Vivid E95 (K181685), is modified to allow user to modify individual markers.
  • Adding clinical applications Obstetrics, Intra-luminal and ● Indications for use: Intra-Cardiac which were cleared with Vivid S70N (K182450).
    • Clarified Real time 3D as 4D and listed 3D.

The EchoPAC Software Only / EchoPAC Plug-in and its applications Summary of Non-Clinical Tests: comply with voluntary standards: 1. ISO 14971:2007 - Medical devices - Application of risk management to medical devices 2. NEMA PS 3.1 -3.20 Digital Imaging and Communications in Medicine (DICOM) Set, (Radiology), 2016 3. IEC 62304:2006 A1 2015 - Medical device software -Software life cycle process 4. IEC 62366-1: 2015 – Medical Device-Part 1: Application of Usability.

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GE Healthcare 510(k) Premarket Notification Submission

The following quality assurance measures are applied to the development of the system:

  • Risk Analysis
  • Requirements Reviews ●
  • Design Reviews
  • Testing on unit level (Module verification) ●
  • Integration testing (System verification) ●
  • Performance testing (Verification)
  • Safety testing (Verification ●

The subject of this premarket submission, EchoPAC Software Conclusion: Only / EchoPAC Plug-in, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the proposed EchoPAC Software Only / EchoPAC Plug-in to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

Summary of Clinical Tests: