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K Number
K180599
Device Name
Venue
Manufacturer
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Date Cleared
2018-05-02

(56 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Venue is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Venue can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients. The Venue is intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/Organ (including breast, testes, thyroid). Peripheral vascular, neonatal and adult cephalic, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transvaginal, Transesophageal, and imaging guidance of interventional procedures (e.g. Nerve block, vascular access).
Device Description
The proposed Venue system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. Venue can be used in offices, clinical areas and hospitals. The Venue is a mobile system with a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user. The Venue has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The single surface screen can be cleaned with disinfectants. Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions. The proposed Venue has the capability for displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG is not intended for monitoring or diagnosis. The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is available to be used as an input device. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices. The user documentation is available via electronic media. The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some biopsy kits are available for needle-guidance procedures. The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments.
More Information

K170714, K151028, K161706, K163596

Not Found

No
The document describes "automated tools designed to simplify and shorten the workflow time," but does not explicitly mention AI or ML, nor does it provide details about training or test sets which are typical for AI/ML-based devices.

No.
The "Intended Use" section explicitly states that the Venue is a "general purpose diagnostic ultrasound system" and that it is "intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications" for the "diagnosis of patients." There is no mention of treating or preventing diseases or conditions.

Yes

The "Intended Use / Indications for Use" section explicitly states, "The Venue is a general purpose diagnostic ultrasound system..." and "The Venue is intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications... for diagnosis of patients." The "Device Description" also refers to it as a "diagnostic ultrasound device."

No

The device description explicitly mentions hardware components such as a high resolution color LCD monitor, battery, wireless communication capabilities, barcode reader, and various transducers (linear, convex, phased array). It is a physical ultrasound system, not solely software.

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

Here's why:

  • Definition of IVD: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
  • Venue's Function: The Venue is a diagnostic ultrasound system. It uses sound waves to create images of the inside of the human body. It does not analyze specimens taken from the body.
  • Intended Use: The intended use clearly states it's for "ultrasound imaging, measurement and analysis of the human body and fluid". While it mentions "fluid", this is in the context of imaging fluid within the body (like in the abdomen or pleural space), not analyzing fluid samples taken from the body.

Therefore, the Venue falls under the category of in vivo diagnostic devices, as it performs diagnosis by examining the body directly.

N/A

Intended Use / Indications for Use

The Venue is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Venue can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients.

The Venue is intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/Organ (including breast, testes, thyroid). Peripheral vascular, neonatal and adult cephalic, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transvaginal, Transesophageal, and imaging guidance of interventional procedures (e.g. Nerve block, vascular access).

Product codes

IYN, IYO, ITX

Device Description

The proposed Venue system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. Venue can be used in offices, clinical areas and hospitals. The Venue is a mobile system with a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user. The Venue has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The single surface screen can be cleaned with disinfectants. Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions.

The proposed Venue has the capability for displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG is not intended for monitoring or diagnosis.

The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is available to be used as an input device. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices. The user documentation is available via electronic media.

The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some biopsy kits are available for needle-guidance procedures. The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/Organ (including breast, testes, thyroid). Peripheral vascular, neonatal and adult cephalic, musculoskeletal (conventional and superficial), cardiac (adults and pediatric)

Indicated Patient Age Range

neonatal and adult cephalic, pediatric, adults and pediatric

Intended User / Care Setting

qualified healthcare professionals. The clinical environments where the Venue can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings

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, Venue, did not require clinical studies to support substantial equivalence.

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

Not Found

Predicate Device(s)

K170714, K151028, K161706, K163596

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K180599

Trade/Device Name: Venue Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 7, 2018 Received: March 8, 2018

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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

May 2, 2018

1

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'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

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K180599

Device Name

Venue

Indications for Use (Describe)

The Venue is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Venue can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients.

The Venue is intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/Organ (including breast, testes, thyroid). Peripheral vascular, neonatal and adult cephalic, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transvaginal, Transesophageal, and imaging guidance of interventional procedures (e.g. Nerve block, vascular access).

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

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"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 shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are white and are set against a blue circular background. The blue background is surrounded by a white border with three stylized swirls.

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Venue. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.

The following Indication for Use forms are appended:

System: Venue Transducer: 3Sc-RS Transducer: 9L-RS Transducer: C1-5-RS Transducer: 8C-RS Transducer: E8C-RS Transducer: 12L-RS Transducer: L12n-RS Transducer: 6Tc-RS

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GE Healthcare 510(k) Premarket Notification Submission

| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse♦ | Other |
|----------------------------------------------------|----|----|---------------|---------------|------------------|--------------------|------------------|----------------------|---------------------|-----------------|-------|
| Ophthalmic | P | | | | P | | P | | | | |
| Fetal / Obstetrics | P | P | P | | P | P | P | P | P | P | |
| Abdominal [1] | P | P | P | | P | P | P | P | P | P | |
| Pediatric | P | P | P | | P | P | P | P | P | P | |
| Small Organ [2] | P | P | P | | P | P | P | P | P | P | |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | | P | P | P | P | P | P | |
| Pediatric Cardiac | P | P | P | P | P | P | P2 | P | P | P2 | 6 |
| Adult Cardiac | P | P | P | P | P | P | P2 | P | P | P2 | 6 |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | |
| Thoracic/Pleural [3] | P | P | P | | P | P | P | P | P | P | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P2 | P2 | P2 | P2 | P2 | P2 | | N | P2 | P2 | 6 |
| Transrectal | P | P | P | | P | P | P | P | P | P | |
| Transvaginal | P | P | P | | P | P | P | P | P | P | |
| Interventional Guidance | | | | | | | | | | | |
| Vascular Access (IV, PICC) | P | P | P | | P | P | P | P | P | P | 5,7 |
| Nonvascular [5] | P | P | P | | P | P | P | P | P | P | 5,7 |

GE Venue Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD, B/Color/CWD;

[7] Image guidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[+] Coded pulse is for digitally encoded harmonics;

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has a decorative border with wave-like patterns around the edge.

GE Healthcare

510(k) Premarket Notification Submission

GE Venue with 3Sc-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes[*]Harmonic
ImagingCoded
Pulse•Other
OphthalmicPPP
Fetal / ObstetricsPPPPPPPP
Abdominal [1]PPPPPPPP
PediatricP1P1P1P1P1P1P1P1
Small Organ [2]
Neonatal Cephalic
Adult CephalicPPPPPPPP
Pediatric CardiacPPPPPPPPP6
Adult CardiacPPPPPPPPP6
Peripheral VascularPPPPPPPP
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural [3]PPPPPPPP
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)PPPPPPPP7
Nonvascular [5]

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,

B/Color/CWD:

[7] Image quidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[ +] Coded pulse is for digitally encoded harmonics;

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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance.

GE Venue with 9L-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes[*]Harmonic
ImagingCoded
PulseOther
OphthalmicNNN
Fetal / ObstetricsNNNNNNNNN
Abdominal [1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ [2]PPPPPPPPPP
Neonatal CephalicP2P2P2P2P2NP2NP2P2
Adult Cephalic
Pediatric CardiacNNNNNNNNNN
Adult CardiacNNNNNNNNNN
Peripheral VascularPPPPPPPPPP
Musculo-skeletal ConventionalPPPPPPPPPP
Musculo-skeletal SuperficialPPPPPPPPPP
Thoracic/Pleural [3]PPPPPPPPPP
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)PPPPPPPPPP5,7
Nonvascular [5]PPPPPPPPPP5,7

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,

B/Color/CWD:

[7] Image quidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[+] Coded pulse is for digitally encoded harmonics.

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance.

GE Healthcare

510(k) Premarket Notification Submission

GE Venue with C1-5-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes[*]Harmonic
ImagingCoded
Pulse♦Other
Ophthalmic
Fetal / ObstetricsPPPPPPPPPP
Abdominal [1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Pediatric CardiacNNNNNNNNNN
Adult CardiacNNNNNNNNNN
Peripheral VascularPPPPPPPPPP
Musculo-skeletal ConventionalPPPPPPPPPP
Musculo-skeletal SuperficialPPPPPPPPPP
Thoracic/Pleural [3]PPPPPPPPPP
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)PPPPPPPPPP7
Nonvascular [5]PPPPPPPPPP7

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,

B/Color/CWD:

[7] Image quidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[↓] Coded pulse is for digitally encoded harmonics.

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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance.

GE Healthcare

510(k) Premarket Notification Submission

GE Venue with 8C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes[*]Harmonic
ImagingCoded
Pulse *Other
Ophthalmic
Fetal / Obstetrics
Abdominal [1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ [2]
Neonatal CephalicPPPPPPPPPP
Adult CephalicPPPPPPPPPP
Pediatric CardiacP2P2P2P2P2P2P2NP2P2
Adult CardiacP2P2P2P2P2P2P2NP2P2
Peripheral VascularP2P2P2P2P2P2P2NP2P2
Musculo-skeletal ConventionalPPPPPPPPPP
Musculo-skeletal SuperficialPPPPPPPPPP
Thoracic/Pleural [3]PPPPPPPPPP
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)
Nonvascular [5]NNNNNNNNN

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,

B/Color/CWD:

[7] Image quidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[↓] Coded pulse is for digitally encoded harmonics.

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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has a decorative border with wave-like patterns around the edge.

Mode of Operation Clinical Application Color Color M PW CW Power Combined Harmonic Coded Other B M Doppler Doppler Doppler Doppler Doppler Modes[*] lmaqinq Anatomy/Region of Interest Pulse * Ophthalmic Fetal / Obstetrics P P P P P P P P P P P P P P P P P P Abdominal [1] Pediatric Small Organ [2] Neonatal Cephalic Adult Cephalic Pediatric Cardiac Adult Cardiac Peripheral Vascular Musculo-skeletal Conventional Musculo-skeletal Superficial Thoracic/Pleural [3] Exam Type, Means of Access Transesophageal b P P P P P Р b b Transrectal P P P P P P P P P Transvaginal Interventional Guidance Vascular Access (IV, PICC) Nonvascular [5]

GE Venue with E8C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD, B/Color/CWD:

[7] Image guidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[↓] Coded pulse is for digitally encoded harmonics.

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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background. The logo is simple and recognizable, representing the well-known multinational corporation.

GE Healthcare 510(k) Premarket Notification Submission

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes[*]Harmonic
ImagingCoded
Pulse♦Other
OphthalmicPPP
Fetal / Obstetrics
Abdominal [1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ [2]PPPPPPPPPP
Neonatal CephalicP2P2P2P2P2NP2P2P2P2
Adult Cephalic
Pediatric CardiacNNNNNNNNNN
Adult CardiacNNNNNNNNNN
Peripheral VascularPPPPPPPPPP
Musculo-skeletal ConventionalPPPPPPPPPP
Musculo-skeletal SuperficialPPPPPPPPPP
Thoracic/Pleural [3]PPPPPPPPPP
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)PPPPPPPPPP5,7
Nonvascular [5]PPPPPPPPPP5,7

GE Venue with 12L-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD, B/Color/CWD:

[7] Image guidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[+] Coded pulse is for digitally encoded harmonics.

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Image /page/11/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The circle has decorative, swirling elements around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the long-standing brand identity of General Electric.

GE Healthcare 510(k) Premarket Notification Submission

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes[*]Harmonic
ImagingCoded
Pulse•Other
OphthalmicPPP
Fetal / Obstetrics
Abdominal [1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ [2]PPPPPPPPPP
Neonatal CephalicP1P1NP1NP1P1P1N
Adult Cephalic
Pediatric CardiacNNNNNNNNNN
Adult CardiacNNNNNNNNNN
Peripheral VascularPPPPPPPPPP
Musculo-skeletal ConventionalPPPPPPPPPP
Musculo-skeletal SuperficialPPPPPPPPPP
Thoracic/Pleural [3]PPPPPPPPPP
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)PPPPPPPPP5,7
Nonvascular [5]PPPPPPPPP5,7

GE Venue with L12n-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD, B/Color/CWD:

[7] Image guidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[+] Coded pulse is for digitally encoded harmonics.

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Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background of the circle.

GE Healthcare 510(k) Premarket Notification Submission

| Clinical Application

Anatomy/Region of InterestMode of Operation
BMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes[*]Harmonic ImagingCoded Pulse •Other
Ophthalmic
Fetal / Obstetrics
Abdominal [1]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Pediatric Cardiac
Adult CardiacP2P2P2P2P2P2P2NP2P26
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural [3]
Exam Type, Means of Access
TransesophagealP2P2P2P2P2P2P2NP2P26
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)
Nonvascular [5]

GE Venue with 6Tc-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,

B/Color/CWD;

[7] Image guidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[ +] Coded pulse is for digitally encoded harmonics.

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Image /page/13/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a dynamic and recognizable appearance. The logo is simple, yet iconic, representing the long-standing brand identity of General Electric.

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:
Submitter:March 6, 2018
GE Medical Systems Ultrasound and Primary Care Diagnostics
9900 Innovation Drive
Wauwatosa, WI 53226
Primary Contact Person:Tracey Ortiz
Regulatory Affairs Director
GE Healthcare
T:(262)470-1003
F:(414)918-8275
Secondary Contact Person:Karin Shimoni
Regulatory Affairs Leader
GE Healthcare
Device Trade Name:
Common/Usual Name:
Classification Names:Venue
Diagnostic Ultrasound System
Class II
Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-
Product Code:IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,
90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,
90-ITX
Primary Predicate Device:
Secondary Predicate
Device(s):Venue (K170714)
LOGIQ e (K151028)
Vivid iq (K161706)
LOGIQ P9 and LOGIQ P7 (K163596)
Device Description:The proposed Venue system is a general-purpose, Track 3,
diagnostic ultrasound device, intended for ultrasound imaging,
measurement and analysis of the human body and fluid that
provides digital acquisition, processing and display capabilities.
Venue can be used in offices, clinical areas and hospitals.
The Venue is a mobile system with a small footprint that easily
fits into tight spaces and positioned to accommodate the
sometimes-awkward work settings of the point of care user.
The Venue has a high resolution color LCD monitor, with a
simple, multi-touch user interface that makes the system intuitive.
The single surface screen can be cleaned with disinfectants.
Articulated monitor arm enables flexible display positions in

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Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The frame has decorative swirls or flourishes around the letters. The logo is presented in a blue color.

order to be accessible and clearly visible in both user-standing and sitting positions.

The proposed Venue has the capability for displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG is not intended for monitoring or diagnosis.

The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is available to be used as an input device. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices. The user documentation is available via electronic media.

The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some biopsy kits are available for needle-guidance procedures. The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments.

  • The Venue is a general purpose diagnostic ultrasound system for Intended Use: use by qualified healthcare professionals. The clinical environments where the Venue can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients. The Venue is intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, and imaging guidance of interventional procedures (e.g. Nerve block, vascular access).
  • Technology: The Venue employs the same fundamental scientific technology as its predicate devices.

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Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters 'GE' in a stylized script inside. The letters are also blue, and the circle is surrounded by a series of curved lines that resemble water droplets or waves. The logo is simple and recognizable, and it is associated with a well-known and established company.

GE Healthcare 510(k) Premarket Notification Submission

| Determination of

Substantial Equivalence:Comparison to Predicate Devices
The Venue system is substantially equivalent to the predicate
devices with regards to intended use, imaging capabilities,
technological characteristics and safety and effectiveness.
The systems are all intended for ultrasound imaging,
measurement and analysis of the human body and fluid
for multiple clinical applications. The Venue and predicate Venue (K170714) have similar
clinical indications for use however the proposed Venue
has the Transesophageal indication which has been
cleared on predicate Vivid iq (K161706). Proposed Venue
has removed Pinpoint™ GT Technology SW. The Venue and predicate Venue (K170714) have identical
imaging modes. The Venue and predicate Venue (K170714) systems
transducers are similar, except for adding 6Tc-RS, cleared
in Vivid iq (K161706), and adding clinical applications to
the 9L-RS, C1-5-RS, 8C-RS, 12L-RS and L12n-RS
probes. Automated features cleared on predicate Venue
(K170714) have improvements, to assist the user
workflow. Addition of the ECG module for ECG trace/image
synchronization that was cleared with predicate LOGIQ e
(K151028). Adding eFAST Navigation Tool and Review Summary
feature that automates the workflow for the eFAST exam
that can be done manually. The Venue and predicate Venue (K170714) have similar
capability in terms of performing measurements,
capturing digital images, reviewing and reporting studies. The system is manufactured with materials which have
been evaluated and found to be safe for the intended use
of the device. The systems have acoustic power levels which are below
the applicable FDA limits. The Venue and predicate Venue (K170714) have been
designed in compliance with approved electrical and
physical safety standards.

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Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font, enclosed within a circular frame. The logo is colored in a light blue hue, and the background is white.

Summary of Non-Clinical Tests:

Venue has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to comply with applicable medical device safety standards. The Venue complies with voluntary standards:

  • . AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety, 2005/ A2:2012
  • . IEC60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2014
  • IEC60601-2-37, Medical Electrical Equipment Part 2-● 37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
  • ISO10993-1, Biological Evaluation of Medical Devices-. Part 1: Evaluation and Testing- Third Edition, 2009
  • NEMA UD 2, Acoustic Output Measurement Standard for . Diagnostic Ultrasound Equipment, 2004
  • ISO14971. Application of risk management to medical . devices, 2007
  • . NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2016

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)

Transducer material and other patient contact materials are biocompatible.

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Image /page/17/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are decorative swirls around the letters. The logo is simple and recognizable, and it is associated with a well-known company.

Summary of Clinical Tests:

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

Conclusion: GE Healthcare considers the Venue to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).