LogoFDA 510(k) Search
K Number
K152758
Device Name
Venue 50
Manufacturer
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
Date Cleared
2015-11-18

(55 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Venue 50 is intended for ultrasound masurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiae (adult & pediatic); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal); Thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures. 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 Venue 50 device is a compact and portable ultrasound system consisting of a hand-carried console (tablet sized) with the ability to dock it with a Docking station or mobile Docking cart. The portable design easily fits into tight spaces. High-resolution imaging, transducer options and wide range of applications help physicians care for a broad spectrum of patients. The singlesurface screen can be disinfected and cleaned with medical grade disinfectants. Flexible data management and connectivity options, with optional DICOM, help speed image storage and archiving for physicians at the Point of Care and patient bedside.
More Information

K133431, K142443

Not Found

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or functionalities that would typically involve AI/ML, such as automated image analysis, diagnosis support, or predictive modeling.

No.
The "Intended Use / Indications for Use" states that the device is for "ultrasound measurement and analysis" and "imaging guidance of interventional procedures," not for treatment or therapy.

Yes
The Venue 50 is an ultrasound system intended for "ultrasound measurement and analysis of the human body for multiple clinical applications," which directly implies its use in diagnosing medical conditions.

No

The device description explicitly states it is a "compact and portable ultrasound system consisting of a hand-carried console (tablet sized) with the ability to dock it with a Docking station or mobile Docking cart," indicating it includes significant hardware components beyond just software.

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

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body.
  • Device Function: The Venue 50 is an ultrasound system. Ultrasound uses sound waves to create images of internal body structures. This is a form of in vivo (within the living body) imaging.
  • Intended Use: The intended use clearly describes imaging and measurement of the human body for various clinical applications. It does not mention any analysis of samples taken from the body.
  • Device Description: The description focuses on the physical characteristics of the ultrasound system and its use for imaging at the point of care.

Therefore, the Venue 50, as described, is an in vivo diagnostic imaging device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Venue 50 is intended for ultrasound measurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatic); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal); Thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

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, IYO, ITX

Device Description

The Venue 50 device is a compact and portable ultrasound system consisting of a hand-carried console (tablet sized) with the ability to dock it with a Docking station or mobile Docking cart. The portable design easily fits into tight spaces. High-resolution imaging, transducer options and wide range of applications help physicians care for a broad spectrum of patients. The singlesurface screen can be disinfected and cleaned with medical grade disinfectants. Flexible data management and connectivity options, with optional DICOM, help speed image storage and archiving for physicians at the Point of Care and patient bedside.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Physicians at the Point of Care and patient bedside.

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 50, 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.

K133431, K142443

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

§ 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

November 18, 2015

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

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

Re: K152758 Trade/Device Name: Venue 50 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 23, 2015 Received: September 24, 2015

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

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oolo

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

Indications for Use

510(k) Number (if known)

K152758

Venue 50

Indications for Use (Describe)

The Venue 50 is intended for ultrasound masurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiae (adult & pediatic); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal); Thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

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.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Diagnostic Ultrasound Indications for Use Form GE Venue 50 Ultrasound System

Clinical ApplicationMode of Operation
Anatomy/Region of InterestBMDoppler ModesCombined
Modes*Harmonic
ImagingCoded
PulseOther
PW CW Color Color M Power
OphthalmicPPP P P PPPP
Fetal/OBPPP P P PPPP
Abdominal[1]PPP P P PPPP
PediatricPPP P P PPPP
Small Organ (specify)[2]PPP P P PPPP
Neonatal CephalicPPP P P PPPP
Adult CephalicPPP P P PPPP
Cardiac[3]PPP P P PPPP
Peripheral VascularPPP P P PPPP
Musculo-skeletal ConventionalPPP P P PPPP
Musculo-skeletal SuperficialPPP P P PPPPN[7]
Thoracic/Pleural (specify)[4]PPP P P PPPP
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
TransvaginalPPP P P PPPP
Intraoperative (specify)[5]PPP P P PPPP
Intraoperative Neurological
Intravascular/Intraluminal
Interventional Guidance
Tissue Biopsy/Fluid DrainagePPP P P PPPPN[7]
Vascular Access (IV, PICC)PPP P P PPPPN[7]
Nonvascular (specify)[6]PPP P P PPPPN[7]

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133431

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

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

[5] Intraoperative includes abdominal, thoracic and peripheral;

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block;

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

  • | Combined modes are color/power Doppler with B-mode

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Diagnostic Ultrasound Indications for Use Form GE Venue 50 with 12L-SC Transducer

Clinical ApplicationMode of Operation
Anatomy/Region of InterestBMPWCWColorColor MPowerCombined
Modes*Harmonic ImagingCoded PulseOther
OphthalmicPPPPPPP
Fetal/OB
Abdominal[1]PPPPPPP
PediatricPPPPPPP
Small Organ (specify)[2]PPPPPPP
Neonatal CephalicPPPPPPP
Adult Cephalic
Cardiac [3]
Peripheral VascularPPPPPPP
Musculo-skeletal ConventionalPPPPPPP
Musculo-skeletal SuperficialPPPPPPP
Thoracic/Pleural (specify) [4]PPPPPPP
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify) [5]PPPPPPP
Intraoperative Neurological
Intravascular/Intraluminal
Interventional Guidance
Tissue Biopsy/Fluid DrainagePPPPPPP
Vascular Access (IV, PICC)PPPPPPP
Nonvascular (specify) [6]PPPPPPP

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133431

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

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

[5] Intraoperative includes abdominal, thoracic and peripheral;

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block;

[7] Needle guidance with PinpointTM GT needle technology;

[*] Combined modes are color/power Doppler with B-mode

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Diagnostic Ultrasound Indications for Use Form GE Venue 50 with 3S-SC Transducer

Clinical ApplicationMode of Operation
Anatomy/Region of InterestBMPWCWColorColor
MPowerCombined
Modes*Harmonic
ImagingCoded
PulseOther
OphthalmicPPPPPPPPP
Fetal/OBPPPPPPPPP
Abdominal[1]PPPPPPPPP
PediatricPPPPPPPPP
Small Organ (specify)[2]
Neonatal CephalicPPPPPPPPP
Adult CephalicPPPPPPPPP
Cardiac[3]PPPPPPPPP
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP
Musculo-skeletal Superficial
Thoracic/Pleural (specify)[4]PPPPPPPPP
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)[5]PPPPPPPPP
Intraoperative Neurological
Intravascular/Intraluminal
Interventional Guidance
Tissue Biopsy/Fluid DrainagePPPPPPPPP
Vascular Access (IV, PICC)
Nonvascular (specify)[6]

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133431

Notes: [1] Abdominal includes GYN and Urological;

  • [2] Small Organ includes breast, testes, thyroid;
    [3] Cardiac is Adult and Pediatric;

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

[5] Intraoperative includes abdominal, thoracic and peripheral;

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block;

[7] Needle guidance with PinpointTM GT needle technology;

[*] Combined modes are color/power Doppler with B-mode

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

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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" intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and the entire logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form GE Venue 50 with 4C-SC Transducer

Clinical ApplicationMode of Operation
Anatomy/Region of InterestBMDoppler ModesCombined
Modes*Harmonic
ImagingCoded
Pulse`Other
Ophthalmic
Fetal/OBPPPPPP
Abdominal [1]PPPPPP
PediatricPPPPPP
Small Organ (specify) [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPP
Musculo-skeletal Superficial
Thoracic/Pleural (specify) [4]PPPPPP
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify) [5]PPPPPP
Intraoperative Neurological
Intravascular/Intraluminal
Interventional Guidance
Tissue Biopsy/Fluid DrainagePPPPPP
Vascular Access (IV, PICC)
Nonvascular (specify) [6]PPPPPP

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133431

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

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

[5] Intraoperative includes abdominal, thoracic and peripheral;

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block;

[7] Needle guidance with PinpointTM GT needle technology;

[*] Combined modes are color/power Doppler with B-mode

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Diagnostic Ultrasound Indications for Use Form GE Venue 50 with L8-18i-SC Transducer

| Clinical Application | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color
M | PDI | Combined
Modes* | Harmonic
Imaging | Coded
Pulse° | Other |
|--------------------------------|---|---|---------------|---------------|------------------|------------|-----|--------------------|---------------------|-----------------|-------|
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | | | | | | | | | | | |
| Abdominal [1] | P | P | | | P | | P | P | P | | |
| Pediatric | P | P | | | P | | P | P | P | | |
| Small Organ (specify)[2] | P | P | | | P | | P | P | P | | |
| Neonatal Cephalic | P | P | | | P | | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | | | P | | P | P | P | | |
| Musculo-skeletal Conventional | P | P | | | P | | P | P | P | | |
| Musculo-skeletal Superficial | P | P | | | P | | P | P | P | | |
| Thoracic/Pleural (specify) [4] | P | P | | | P | | P | P | P | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify)[5] | P | P | | | P | | P | P | P | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular/Intraluminal | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | P | P | | | P | | P | P | P | | |
| Vascular Access (IV, PICC) | P | P | | | P | | P | P | P | | |
| Nonvascular (specify) [6] | P | P | | | P | | P | P | P | | |

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133431

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

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

[5] Intraoperative includes abdominal, thoracic and peripheral;

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block;

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

[*] Combined modes are color/power Doppler with B-mode

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Diagnostic Ultrasound Indications for Use Form GE Venue 50 with E8CS-SC Transducer

Clinical ApplicationMode of Operation
Doppler Modes
Anatomy/Region of InterestBMPWCWColorColor
MPowerCombined
Modes*Harmonic
ImagingCoded
Pulse'Other
Ophthalmic
Fetal/OBPPPPPP
Abdominal[1]PPPPPP
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify) [4]
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
TransvaginalPPPPPP
Intraoperative (specify) [5]
Intraoperative Neurological
Intravascular/Intraluminal
Interventional Guidance
Tissue Biopsy/Fluid DrainagePPPPPP
Vascular Access (IV, PICC)
Nonyascular (specify)[6]

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133431

Notes: [1] Abdominal includes GYN and Urological;

  • [2] Small Organ includes breast, testes, thyroid;
    [3] Cardiac is Adult and Pediatric;

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

[5] Intraoperative includes abdominal, thoracic and peripheral;

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block;

[7] Needle guidance with PinpointTM GT needle technology;

[*] Combined modes are color/power Doppler with B-mode

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Diagnostic Ultrasound Indications for Use Form

GE Venue 50 with 10C-SC Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical ApplicationMode of Operation
Anatomy/Region of InterestBMPWCWDoppler ModesCombined
Modes*Harmonic
ImagingCoded
PulseOther
OphthalmicPPPPPPP
Fetal/OB
Abdominal[1]PPPPPPP
PediatricPPPPPPP
Small Organ (specify)[2]PPPPPPP
Neonatal CephalicPPPPPPP
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal SuperficialPPPPPPP
Thoracic/Pleural (specify) [4]PPPPPPP
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify) [5]PPPPPPP
Intraoperative Neurological
Intravascular/Intraluminal
Interventional Guidance
Tissue Biopsy/Fluid Drainage
Vascular Access (IV, PICC)
Nonvascular (specify) [6]

N = new indication; P= previously cleared by FDA K133431

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

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

[5] Intraoperative includes abdominal, thoracic and peripheral;

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block;

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

[*] Combined modes are color/power Doppler with B-mode

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Diagnostic Ultrasound Indications for Use Form

GE Venue 50 with L12n-SC Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical ApplicationMode of Operation
Anatomy/Region of InterestBMPWCWColorColor
MPowerCombined
Modes *Harmonic
ImagingCoded
PulseOther
OphthalmicNNNNNN
Fetal/OB
Abdominal[1]NNNNNN
PediatricNNNNNN
Small Organ (specify)[2]NNNNNN
Neonatal CephalicNNNNNN
Adult Cephalic
Cardiac[3]
Peripheral VascularNNNNNN
Musculo-skeletal ConventionalNNNNNN
Musculo-skeletal SuperficialNNNNNNN[7]
Thoracic/Pleural (specify)[4]NNNNNN
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)[5]NNNNNN
Intraoperative Neurological
Intravascular/Intraluminal
Interventional Guidance
Tissue Biopsy/Fluid DrainageNNNNNNN[7]
Vascular Access (IV, PICC)NNNNNNN[7]
Nonvascular (specify)[6]NNNNNNN[7]

N = new indication; P= previously cleared by FDA K133431

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

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

[5] Intraoperative includes abdominal, thoracic and peripheral;

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block;

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

[*] Combined modes are color/power Doppler with B-mode

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Image /page/11/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 blue circle. There are decorative flourishes resembling water droplets or stylized leaves surrounding the circle, adding a touch of elegance to the design. The logo is simple, recognizable, and has been used by GE for many years.

510(k) Summary

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

September 23,2015 Date: GE Medical Systems Ultrasound and Primary Care Diagnostics, Submitter: 9900 Innovation Drive Wauwatosa, WI 53226

Primary Contact Person:Tracey Ortiz
Regulatory Affairs Director
GE Healthcare
T:(262) 676-6120
F:(414) 918-8275

Yalan Wu Secondary Contact Person: Regulatory Affairs GE Medical Systems (China) Co, Ltd. T: +86 510 8527 8652 F: +86 510 8522 7347

  • Venue 50 Device: Trade Name:
    Common/Usual Name: Ultrasound system

  • Classification Names: Class II
    Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYN Product Code: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

  • Venue 50 K133431 Predicate Device(s): Site~Rite® 6 Ultrasound System - K142443
    The Venue 50 device is a compact and portable ultrasound Device Description: system consisting of a hand-carried console (tablet sized) with the ability to dock it with a Docking station or mobile Docking cart. The portable design easily fits into tight spaces. High-resolution imaging, transducer options and wide range of applications help physicians care for a broad spectrum of patients. The singlesurface screen can be disinfected and cleaned with medical grade disinfectants. Flexible data management and connectivity options, with optional DICOM, help speed image storage and archiving for physicians at the Point of Care and patient bedside.

The Venue 50 is intended for ultrasound imaging, measurement Intended Use: and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal

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Image /page/12/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 or flourishes around the letters, giving it a classic and recognizable appearance.

510(k) Premarket Notification Submission

Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular: Musculoskeletal Conventional & Sunerficial: Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

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.

The Venue 50 employs the same fundamental scientific Technology: technology as its predicate devices.

Comparison to Predicates Determination of

Substantial Equivalence: The Venue 50 is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technologicial characteristics and safety and effectiveness.

  • The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
  • The proposed Venue 50 and predicate Venue 50 system ● have the same clinical intended use
  • . The proposed Venue 50 and predicate Venue 50 system have the same imaging modes.
  • The transducers of proposed Venue 50 and predicate . Venue 50 system are the same except for:
    • o Adding L12n-SC, it is a linear transducer similar to the 12L-SC that was cleared on the predicate Venue 50 system (K133431). The L12n-SC includes programmable buttons and works with the Pinpoint™ GT Technology.
  • Utilization of the Pinpoint GT Technology from C.R. Bard, which allows the user to track the needle location during interventional guidance. This technology is equivalent to that cleared by C.R. Bard, Inc. in K142443.
  • Addition of data privacy features includes internal storage ● encryption, which allows the user to encrypt patient data, and a passcode requirement to unlock the screen.
  • The proposed Venue 50 and predicate Venue 50 system are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.

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Image /page/13/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 circle is surrounded by decorative, swirling elements, also in blue, giving the logo a classic and recognizable appearance.

510(k) Premarket Notification Submission

  • The proposed Venue 50 and predicate Venue 50system have acoustic power levels which are below the applicable FDA limits.
  • The proposed Venue 50 and predicate Venue 50 system ● have the same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
  • The proposed Venue 50 and predicate Venue 50 system have been designed in compliance with approved electrical and physical safety standards.

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The Venue 50 and its applications comply with voluntary standards:

  • o AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety
  • IEC60601-1-2, Medical Electrical Equipment Part 1-● 2:General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility Requirements and Tests
  • IEC60601-2-37, Medical Electrical Equipment - Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
  • NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
  • ISO10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing
  • NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
  • ISO14971, Application of risk management to medical devices
  • NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

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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 border. The color of the logo is a light blue.

The following quality assurance measures were 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)
  • o Safety testing (Verification)
  • o Simulated use Testing (Validation)

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Venue 50, did not require clinical studies to support substantial equivalence.

  • Conclusion: GE Healthcare considers the Venue 50 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).