K Number

Device Name

Venue

Manufacturer

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

Date Cleared

2017-06-21

(104 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

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/OB, Small Organ (including breast, testes, thyroid), Peripheral vascular, neonatal and adult cephalic, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transvaginal, and imaging guidance of interventional procedures (e.g. Nerve block, vascular access). When Pinpoint GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

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, with a focus in critical care and emergency rooms settings. 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 19" 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 Venue has a battery that allows scanning continuously for hours without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is optionally 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 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 and Pinpoint GT option is also available.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K152758, K151028, K142323, K163596

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a general-purpose diagnostic ultrasound system and does not mention any AI or ML capabilities.

Therapeutic

No.
The device is described as a "general purpose diagnostic ultrasound system" and is intended for "ultrasound imaging, measurement and analysis" for diagnosis, not for treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The Venue is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals." The "Device Description" also refers to it as a "diagnostic ultrasound device."

SaMD (Software as a Medical Device)

The device description explicitly mentions hardware components such as a 19" high resolution color LCD monitor, transducers, a battery, and optional barcode reader and biopsy kits. It is a physical ultrasound system with integrated software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, outside of the body 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 internal structures of the human body in vivo (within the living body).
Intended Use: The Intended Use clearly states it's for "ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications." This describes an in vivo imaging process, not the analysis of in vitro specimens.
Device Description: The description reinforces that it's a "general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid."

While the system can analyze "fluid," this is in the context of imaging fluid within the body (e.g., ascites, pleural effusions), not analyzing fluid samples collected from the body.

Therefore, the Venue system falls under the category of medical imaging devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transvaginal, and imaging guidance of interventional procedures (e.g. Nerve block, vascular access).

When Pinpoint GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

Product codes (comma separated list FDA assigned to the subject device)

IYN, ITX, IYO

Device Description

Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions.

The Venue has a battery that allows scanning continuously for hours without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is optionally 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 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 and Pinpoint GT option is also available.

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/OB, Small Organ (including breast, testes, thyroid), Peripheral vascular, neonatal and adult cephalic, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transvaginal, Transrectal.

Indicated Patient Age Range

neonatal and adult cephalic, Pediatric, Adults.

Intended User / Care Setting

Qualified healthcare professionals for use in 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Venue 50 (K152758), LOGIQe (K151028), Vivid S60/S70 (K142323), LOGIQ P9 and LOGIQ P7 (K163596)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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

June 22, 2017

GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC MS. TRACEY ORTIZ REGULATORY AFFAIRS DIRECTOR 9900 W. INNOVATION DRIVE WAUWATOSA, WI 53226

Re: K170714

Trade/Device Name: Venue Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, IYO Dated: May 25, 2017 Received: May 26, 2017

Dear Ms. Ortiz:

This letter corrects our substantially equivalent letter of June 21, 2017.

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 (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.

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,

Michael D. O'Hara For

Robert Ochs Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K170714

Device Name Venue

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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

Image /page/4/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, swirling elements around the letters. The logo is colored in a light blue hue, and the background is white.

GE Healthcare 510(k) Premarket Notification Submission

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes[*1]	Harmonic
Imaging	Coded
Pulse•	Other
Ophthalmic	N	N	N	N	N	N	N	N	N	N	N
Fetal / Obstetrics	N	N	N	N	N	N	N	N	N	N	N
Abdominal [1]	N	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N	N
Small Organ [2]	N	N	N	N	N	N	N	N	N	N	N
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N	N
Adult Cephalic	N	N	N	N	N	N	N	N	N	N	N
Cardiac [3]	N	N	N	N	N	N	N	N	N	N	8
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N	N
Thoracic/Pleural [4]	N	N	N	N	N	N	N	N	N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal	N	N	N	N	N	N	N	N	N	N	N
Transvaginal	N	N	N	N	N	N	N	N	N	N	N
Intraoperative
Interventional Guidance
Vascular Access (IV, PICC)	N	N	N	N	N	N	N	N	N	N	6,7,9
Nonvascular [5]	N	N	N	N	N	N	N	N	N	N	6,7,9

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 K151028; P1 = previously cleared by FDA K163596;

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

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

[3] Cardiac is Adult and Pediatric;

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

[5] Nonvascular includes nerve block or biopsy;

[6] Needle guidance with Pinpoint™ GT needle technology;

[7] Biopsy bracket available;

[8] Combined modes also include: B/CWD, B/Color/CWD;

[9] 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.

Image /page/5/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, swirling elements around the perimeter. The logo is presented in a blue color.

GE Healthcare 510(k) Premarket Notification Submission

	Mode of Operation
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		P
Fetal / Obstetrics	P	P	P		P	P	P	P	P
Abdominal [1]	P	P	P		P	P	P	P	P
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic	P	P	P		P	P	P	P	P
Cardiac [3]	P	P	P	P	P	P	P	P	P	8
Peripheral Vascular	N	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural [4]	P	P	P		P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Vascular Access (IV, PICC)	P	P	P		P	P	P	P	P	9
Nonvascular [5]

GE Venue with 3Sc-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 K151028; P1 = previously cleared by FDA K163596;

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

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Including detection of fluid and pleural motion/sliding;
[5] Nonvascular includes nerve block or biopsy;
[6] Needle guidance with Pinpoint™ GT needle technology;

[7] Biopsy bracket available;

[8] Combined modes also include: B/CWD, B/Color/CWD;
[9] 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.

Image /page/6/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 border. The color of the logo is a light blue.

510(k) Premarket Notification Submission

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 Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes[*]	Harmonic
Imaging	Coded
Pulse♦	Other
Ophthalmic
Fetal / Obstetrics
Abdominal [1]	P	P	P	P	P	P1	P	P	P	P
Pediatric	P	P	P	P	P	P1	P	P	P	P
Small Organ [2]	P	P	P	P	P	P1	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P	P	P	P	P1	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	N	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	N	P	P	P	P
Thoracic/Pleural [4]	P	P	P	P	P	N	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Vascular Access (IV, PICC)	P	P	P	P	P	N	P	P	P	P	9
Nonvascular [5]	P	P	P	P	P	N	P	P	P	P	9

N = new indication; P = previously cleared by FDA K151028; P1 = previously cleared by FDA K163596;

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

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Including detection of fluid and pleural motion/sliding;
[5] Nonvascular includes nerve block or biopsy;
[6] Needle quidance with Pinpoint™ GT needle technology:

[7] Biopsy bracket available;

[8] Combined modes also include: B/CWD, B/Color/CWD;
[9] 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.

Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a shade of blue.

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 Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes[*]	Harmonic
Imaging	Coded
Pulse *	Other
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P1	P	P	P	P
Abdominal [1]	P	P	P	P	P1	P	P	P	P
Pediatric	P	P	P	P	P1	P	P	P	P
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P1	P1	P1	P1	P1	P1	P1	P1	P1
Musculo-skeletal Conventional	P	P	P	P	N	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	N	P	P	P	P
Thoracic/Pleural [4]	N	N	N	N	N	N	N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Vascular Access (IV, PICC)	N	N	N	N	N	N	N	N	N	9
Nonvascular [5]	P	P	P	P	N	P	P	P	P	9

N = new indication; P = previously cleared by FDA K151028; P1 = previously cleared by FDA K163596;

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

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Including detection of fluid and pleural motion/sliding;
[5] Nonvascular includes nerve block or biopsy;
[6] Needle quidance with Pinpoint™ GT needle technology:

[7] Biopsy bracket available;

[8] Combined modes also include: B/CWD, B/Color/CWD;
[9] 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.

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 is surrounded by decorative flourishes, giving it a classic and recognizable appearance.

GE Healthcare 510(k) Premarket Notification Submission

	Mode of Operation
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
Fetal / Obstetrics
Abdominal [1]	P	P	P	P	P1	P	P	P	P1
Pediatric	P	P	P	P	P1	P	P	P	P1
Small Organ [2]
Neonatal Cephalic	P	P	P	P	P1	P	P	P	P1
Adult Cephalic	P	P	P	P	N	P	P	P	N
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P	P	N	P	P	P	N
Musculo-skeletal Superficial	P	P	P	P	N	P	P	P	N
Thoracic/Pleural [4]	P	P	P	P	N	P	P	P	N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Vascular Access (IV, PICC)
Nonvascular [5]

GE Venue with 8C-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 K151028; P1 = previously cleared by FDA K163596;

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Including detection of fluid and pleural motion/sliding;
[5] Nonvascular includes nerve block or biopsy;
[6] Needle guidance with Pinpoint™ GT needle technology;
[7] Biopsy bracket available;
[8] Combined modes also include: B/CWD, B/Color/CWD;
[9] Image guidance supports freehand needle/catheter placement;
*1 Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;
- ] Coded pulse is for digitally encoded harmonics.

Image /page/9/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 is surrounded by decorative flourishes, giving it a classic and recognizable appearance.

GE Healthcare 510(k) Premarket Notification Submission

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes[1]	Harmonic
Imaging	Coded
Pulse•	Other
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P1	P	P	P	P1
Abdominal [1]	P	P	P	P	P1	P	P	P	P1
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural [4]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P	P	P1	P	P	P	P1
Transvaginal	P	P	P	P	P1	P	P	P	P1
Intraoperative
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 K151028; P1 = previously cleared by FDA K163596;

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Including detection of fluid and pleural motion/sliding;
[5] Nonvascular includes nerve block or biopsy;
[6] Needle guidance with Pinpoint™ GT needle technology;
[7] Biopsy bracket available;
[8] Combined modes also include: B/CWD, B/Color/CWD;
[9] 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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GE Healthcare 510(k) Premarket Notification Submission

	Mode of Operation
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	P	P		P	P	P	P
Fetal / Obstetrics
Abdominal [1]	P	P	P	P	P	P1	P	P	P	P
Pediatric	P	P	P	P	P	P1	P	P	P	P
Small Organ [2]	P	P	P	P	P	P1	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P	P	P	P	P1	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P1	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P1	P	P	P	P
Thoracic/Pleural [4]	P	P	P	P	P	N	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Vascular Access (IV, PICC)	P	P	P	P	P	N	P	P	P	P	7,9
Nonvascular [5]	P	P	P	P	P	N	P	P	P	P	7,9

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 K151028; P1 = previously cleared by FDA K163596;

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Including detection of fluid and pleural motion/sliding;
[5] Nonvascular includes nerve block or biopsy;
[6] Needle guidance with Pinpoint™ GT needle technology;
[7] Biopsy bracket available;
[8] Combined modes also include: B/CWD, B/Color/CWD;
[9] 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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GE Healthcare 510(k) Premarket Notification Submission

	Mode of Operation
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	P1			P1		P1	P1	P1	N
Fetal / Obstetrics
Abdominal [1]	P1	P1	N	P1	N	P1	P1	P1	N
Pediatric	P1	P1	N	P1	N	P1	P1	P1	N
Small Organ [2]	P1	P1	N	P1	N	P1	P1	P1	N
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P1	P1	N	P1	N	P1	P1	P1	N
Musculo-skeletal Conventional	P1	P1	N	P1	N	P1	P1	P1	N
Musculo-skeletal Superficial	P1	P1	N	P1	N	P1	P1	P1	N
Thoracic/Pleural [4]	N	N	N	N	N	N	N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Vascular Access (IV, PICC)	N	N	N	N	N	N	N	N	N	6, 9
Nonvascular [5]	N	N	N	N	N	N	N	N	N	6, 9

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 K151028; P1 = previously cleared by FDA K163596;

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Including detection of fluid and pleural motion/sliding;
[5] Nonvascular includes nerve block or biopsy;
[6] Needle guidance with Pinpoint™ GT needle technology;
[7] Biopsy bracket available;
[8] Combined modes also include: B/CWD, B/Color/CWD;
[9] 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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510(k) Premarket Notification Submission

510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:
Submitter:	March 8, 2017
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)676-6120
F:(414)918-8275
Secondary Contact Person:	Karin Shimoni
Regulatory Affairs Leader
GE Medical Systems Israel LTD.
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 50 (K152758)
LOGIQe (K151028)
Vivid S60/S70 (K142323)
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, with a
focus in critical care and emergency rooms settings.
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 19" 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.

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Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions.

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/OB, Small Organ (including breast, testes, thyroid), Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, and imaging guidance of interventional procedures (e.g. Nerve block, vascular access). When PinpointTM GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
- Technology: The Venue employs the same fundamental scientific technology as its predicate devices.

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510(k) Premarket Notification Submission

Determination of Comparison to Predicate Devices The Venue system is substantially equivalent to the predicate Substantial Equivalence: 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 50 (K152758) have similar clinical indications for use. Proposed Venue has Transrectal indication which has been cleared on predicate LOGIQe (K151028).
The Venue and predicate LOGIQ e (K151028) have similar imaging modes. Venue has additional Combined Modes (B/Color M, B/CWD, B/Color/CWD).
The Venue and predicate LOGIQ e (K151028) systems transducers are similar however there are new applications added to the 3Sc-RS and C1-5-RS probes. The Venue includes the L12n-RS transducer which was cleared on LOGIQ P9 and LOGIQ P7 (K163596). Two new applications are being added to this probe.
New automated features are being added to assist the user workflow.
The embedded operating system used is Windows 10, which is latest version introduced by Microsoft.
The Venue and predicates Venue 50 (K152758) and LOGIQ e (K151028) 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.
o The Venue and predicate Venue 50 (K152758) have been designed in compliance with approved electrical and physical safety standards.

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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:

o 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
NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 2004
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), 2011

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) 0
Performance testing (Verification) o
. Safety testing (Verification)

Transducer material and other patient contact materials are biocompatible.

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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).