GE ECHOPAC

K120221 · GE Healthcare · LLZ · Mar 30, 2012 · Radiology

Device Facts

• Record ID: K120221
• Device Name: GE ECHOPAC
• Applicant: GE Healthcare
• Product Code: LLZ · Radiology
• Decision Date: Mar 30, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Device Story

GE EchoPAC is a software-only workstation for post-acquisition ultrasound image management; analysis; reporting. Inputs: ultrasound images acquired via GE Vivid family scanners. Operation: software installed on customer PC hardware or as accessory to 3rd party workstations; enables image processing; annotation; measurement; report generation; storage; retrieval. Connectivity: DICOM compliant; transfers data via LAN between scanners; file servers; workstations. Usage: clinical environment; operated by healthcare professionals. Output: processed images; clinical reports. Benefit: facilitates diagnostic review; clinical decision-making through centralized image management.

Clinical Evidence

No clinical studies required to support substantial equivalence. Bench testing only.

Technological Characteristics

Software-only workstation; DICOM compliant; operates on customer PC hardware or 3rd party workstations. Connectivity via LAN. No specific materials or energy sources defined as it is a software application.

Indications for Use

Indicated for diagnostic review and analysis of ultrasound images in patients requiring fetal, abdominal, urological, pediatric, small organ, neonatal, cephalic, cardiac, peripheral vascular, transesophageal, musculoskeletal, transrectal, transvaginal, or intraoperative imaging. No specific contraindications listed.

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).

Predicate Devices

• GE EchoPAC (K101324)

Submission Summary (Full Text)

{0}------------------------------------------------

MAR 3 0 2012

GE Healthcare Special 510(k) Premarket Notification GE EchoPAC Review station January 20, 2012

# 510(k) Summary

In accordance with 21 CFR 807.92 the follow ing summary of information is provided:

January 20, 2012

Date: Submitter:

Primary Contact Person:

GE Healthcare 9900 Innovation Drive Wauwatosa, WI, USA 53226 Bryan Behn Requlatory Affairs Manager GE Healthcare Phone: [phone] Fax: [phone]

Secondary Contact Person:

Charlotte Kaas Munthe Jørgensen Requlatory Affairs Specialist GE Healthcare, GE Vingmed Ultrasound AS Phone: [phone] Fax: [phone] GE EchoPAC

Device: Trade Name: Common/Usual Name:

Workstation Software for ultrasound i mage review, analysis and reporting

Classification Names:

21 CFR 892.2050 LLZ

Predicate Device(s):

Product Code:

K101324 - GE EchoPAC

Device Description:

GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family ultrasound scanners, primarily for cardiology ultrasound of applications but also for general imaging. The EchoPAC software is an integral component of each Vivid system, providing the postacquisition image management and reporting functions of the scanner. EchoPAC will be offered as SW-only to be installed directly on customer PC hardware, or as an accessory to selected 3rd party image management workstations. EchoPAC is DICOM compliant. transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations. The modified or added software features for GE EchoPAC are substantially equivalent to the predicate device and functionality cleared on GE EchoPAC K101324.

Intended Use: The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B. M. Color M modes, Color, Power, Pulsed &

Image /page/0/Picture/18 description: The image contains the letters 'SU' with a line underneath. The letters are in a simple, sans-serif font and appear to be part of a larger text or label. The line beneath the letters suggests emphasis or that they are part of a title or heading.

{1}------------------------------------------------

K120221
Page 2 of 2

Image /page/1/Picture/1 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'GE' intertwined within a circular border. The design is stylized and recognizable as the brand symbol for the company.

GE Healthcare

Special 510(k) Premarket Notification GE EchoPAC Review station January 20, 2012

CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

### Technology:

Determination of Substantial Equivalence:

The EchoPAC employs the same fundamental scientific technology as its predicate device.

Summary of Non-Clinical Tests:

The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. It is further verified for system compatibility with the devices with which it communicates, including conformance to DICOM standard.

#### Summary of Clinical Tests:

The subject of this premarket submission, EchoPAC, did not require clinical studies to support substantial equivalence.

#### Conclusion:

GE Healthcare considers the EchoPAC to be as safe, as effective, and performance is substantially equivalent to the predicate device.

18

{2}------------------------------------------------

Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive, RP-2138 WAUWATOSA WI 53226

Re: K120221

Trade/Device Name: GE EchoPAC Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 21, 2012 Received: March 22, 2012

Dear Mr. Behn:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

MAR 3 0 2012

{3}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The letters are stylized and appear to be in a sans-serif font. The logo is black and white, with the letters and border being black against a white background. The image quality is somewhat grainy, suggesting it may be a scan or a low-resolution image.

GE Healthcare Special 510(k) Premarket Notification GE EchoPAC Review station January 20, 2012

510(k) Number: K120221

Device Name: GE EchoPAC

### Indications for Use:

workstation is indicated for diagnostic review and analysis of The GE EchoPAC ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Clinical applications include: Fetal; Abdominal; Urology (including Realtime 3D. prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative skeletal (abdominal, thoracic, & vascular).

Prescription Use: YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: NO (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

### Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Klaaza

510K