The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

Device Description

The Venue 40 device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ablify to dock it with a stand or mobile cart. The primary means of control is a small number of dedicated push buttons and graphical user interface implemented by a touch sensitive screen over the color LCD display. It utilizes interchangeable electronic-array transducers with digital acquisition, processing and display capability operating. Powered by an integrated battery or from a separate power supply/charger in the docking station or docking car, the Venue 40 is used primarily where portability, size and convenience are essential.

AI/ML Overview

The GE Venue 40 Ultrasound device is a diagnostic ultrasound system. As a 510(k) submission, the device does not require clinical studies. The submission makes a claim of substantial equivalence to a predicate device, the GE LOGIQ e Diagnostic Ultrasound (K091374) and the GE Venue 40 Diagnostic Ultrasound (K091164).

1. Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and clinical tests were "None required," there are no specific performance acceptance criteria or reported device performance metrics like sensitivity, specificity, or accuracy derived from a clinical study.

The acceptance criteria for the device are based on non-clinical testing and comparison to the predicate device. The device is considered to meet acceptance criteria if it is found to comply with applicable medical device safety standards and is substantially equivalent to the predicate device in terms of safety and effectiveness.

Acceptance Criteria Category	Reported Device Performance
Non-clinical Tests	Conforms to applicable medical device safety standards for:
Acoustic Output	Met
Biocompatibility	Met
Cleaning and Disinfection Effectiveness	Met
Electromagnetic Compatibility	Met
Thermal, Electrical, and Mechanical Safety	Met
Clinical Tests	None required, as per FDA guidelines.
Substantial Equivalence	Demonstrated to be substantially equivalent to predicate devices (GE LOGIQ e Diagnostic Ultrasound K091374, GE Venue 40 Diagnostic Ultrasound K091164) with comparable type, overall performance, characteristics, key safety and effectiveness features, physical design, general construction, materials, and intended uses/operating modes.

2. Sample Size Used for the Test Set and Data Provenance

No clinical test set was used, as clinical tests were not required for this 510(k) submission. Therefore, there is no sample size or data provenance to report in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical test set requiring ground truth establishment by experts was used.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission states "Clinical Tests: None required."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable, as this device is a diagnostic ultrasound system, not an AI algorithm, and no clinical performance study was conducted.

7. Type of Ground Truth Used

Not applicable, as no clinical study requiring ground truth was performed. The device's "ground truth" for regulatory purposes relies on its demonstrated compliance with safety standards and substantial equivalence to legally marketed predicate devices, rather than a specific clinical ground truth dataset.

8. Sample Size for the Training Set

Not applicable, as this is a medical device (ultrasound system) clearance, not an AI/ML algorithm requiring a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, for the same reason as above.

Summary

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AUG 1 2 2010

K102 113

Attachment B

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

GE Healthcare

Section a):	GE Medical Systems (China) Co., LtdNo. 19 Changjiang Road, National Hi-Tech Development ZoneWuxi, Jiangsu Province, CHINA 214028
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1. Submitter:	GE Medical Systems (China) Co., Ltd.No. 19 Changjiang Road, National Hi-Tech Development Zone, Wuxi, Jiangsu Province,CHINA 214028
Contact Person:	Yalan Wu,Manager, Safety and RegulatoryTelephone: 86-510-85278652; Fax: 86-510-85227347
Date Prepared:	July 8, 2010
2. Device Name:	GE Venue 40 UltrasoundUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYOUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYNDiagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX
3. Marketed Device:	GE LOGIQ e Diagnostic Ultrasound K091374, GE Venue 40 Diagnostic Ultrasound K091164(90-IYO/IYN/ITX) A device currently in commercial distribution.

Device Description: The Venue 40 device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ablify to dock it with a stand or mobile cart. The primary means of control is a small number of dedicated push buttons and graphical user interface implemented by a touch sensitive screen over the color LCD display. It utilizes interchangeable electronic-array transducers with digital acquisition, processing and display capability operating. Powered by an integrated battery or from a separate power supply/charger in the docking station or docking car, the Venue 40 is used primarily where portability, size and convenience are essential.
Indications for Use: The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Intraoperative (abdominal; thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.
Comparison with Predicate Device: The GE Venue 40 is of a comparable type and substantially equivalent to the current GE LOGIQ e with overall performance in a small and compact package. It has the same overall characteristics, key safety and effectiveness features, physical design, general construction, and materials, and has the less intended uses and operating modes as the predicate device.

Section b):

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.

1. Clinical Tests: None required.

Conclusion: Intended uses and other key features are consistent with traditional clinical practice. FDA quidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE Venue 40 Ultrasound imaging device is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

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

Ge Medical Systems, Ultrasound and Primary Care Diagnostics, LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313

AUG 1 2 2010

Re: K102113

Trade/Device Name: GE Venue 40 Diagnostic Ultrasound Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 27, 2010 Received: July 28, 2010

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the GE Venue 40 Diagnostic Ultrasound, as described in your premarket notification:

Transducer Model Number

12L-SC
3S-SC
4C-SC
L8-18i-SC

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

If you have any questions regarding the content of this letter, please contact Andrew Kang at (301) 796-6544.

Sincerely yours.

Michael D. Thomas for

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

Enclosure(s)

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Indications for Use Form

510(k) Number (if known): _ K / D 2 / / 3

AUG 1 2 2010

Device Name: _GE Venue 40 Diagnostic Ultrasound

Indications For Use:

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics

Mhhl D. Thm
Division Sign Off

vision Sign=Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102113

Page 1 of 1

GE Healthcare

E-2

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GE Venue 40 Ultrasound

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

Clinical Application		Mode of Operation
				Doppler Modes					Combined Harmonic Coded Elasto-
Anatomy/Region of Interest	B	M	PW	CW	Color	ColorM	l Power	Modes	Imaging	Pulse' graphy	Other
Ophthalmic
Fetal/OB	P	N			P		P	P	P
Abdominal(1)	P	N			P		P	P	P
Pediatric	P	N			P		P	P	P
Small Organ (specify)[2]	P	N			P		P	P	P
Neonatal Cephalic	P	ਨ			P		P	P	P
Adult Cephalic	P	N			P		P	P	P
Cardiac (3)	P	N			P		P	P	P
Peripheral Vascular	P	N			P		P	P	P
Musculo-skeletal Conventional	P	N			P		P	P	P
Musculo-skeletal Superficial	P	N			P		P	P	P
Thoracic/Pleural (specify) 141	P	N			P		P	P	P
Other (specify)
Exam Type, Means of Access
Transcranial	P	N			P		P	P	P
Transorbital
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify) (5)	P	N			P		P	P	P
Intraoperative Neurological
Intravascular/Intraluminal
Intracardiac
Laparoscopic
Interventional Guidance
Tissue Biopsy/Fluid Drainage	P	N			p		P	P	P
Vascular Access (IV, PICC)	P	N			P		P	P	P
Nonvascular (specify) bl	P	N			P		P	P	P
Brachytherapy

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes GYN and Urological;

[2] Smali 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;

(*) Combined modes are color/power Doppler with B-mode

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Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

hADOh
Division Sign Of

Prescription Use (21 CFR 801 Subpart D)

Division Sian-Of Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KW2113

GE Healthcare

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GE Venue 40 with 12L-SC Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows: Mode of Operation Clinical Application Doppler Modes Combined Harmonic Coded Elastoв M Pulse' graphy Color Modes Imaging Anatomy/Region of Interest Other PW CW Color Power M Ophthalmic Fetal/OB Abdominal(1) P N P P P P Pediatric P P N p P P Small Organ (specify)[2] P P N P P P Neonatal Cephalic P N P P P P Adult Cephalic Cardiac 31 Peripheral Vascular P P N P P P Musculo-skeletal Conventional P N P P b P Musculo-skeletal Superficial P P N P P P Thoracic/Pleural (specify) (4) P N P P P P Other (specify) Exam Type, Means of Access Transcranial Transorbital Transesophageal Transrectal Transvaginal Intraoperative (specify) [5] P N P P P P Intraoperative Neurological Intravascular/Intraluminal Intracardiac Laparoscopic Interventional Guidance Tissue Biopsy/Fluid Drainage P P N P P P Vascular Access (IV, PICC) P N P P P P Nonvascular (specify) (6) P P N P P P

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Division Sign-Off

Prescription Use (21 CFR 801 Subpart D)

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102113

GE Healthcare

Brachytherapy

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GE Venue 40 with 3S-SC Transducer

Clinical Application		Mode of Operation
Anatomy/Region of Interest	B	M	Doppler Modes	CombinedModes	HarmonicImaging	CodedPulse	Elastography
Ophthalmic
Fetal/OB	P	N	P	P	P	P
Abdominal[1]	P	N	P	P	P	P
Pediatric	P	N	P	P	P	P
Small Organ (specify)[2]
Neonatal Cephalic	P	N	P	P	P	P
Adult Cephalic	P	N	P	P	P	P
Cardiac[3]	P	N	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional	P	N	P	P	P	P
Musculo-skeletal Superficial
Thoracic/Pleural (specify)[4]	P	N	P	P	P	P
Other (specify)
Exam Type, Means of Access
Transcranial	P	N	P	P	P	P
Transorbital
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)[5]	P	N	P	P	P	P
Intraoperative Neurological
Intravascular/Intraluminal
Intracardiac
Laparoscopic
Interventional Guidance
Tissue Biopsy/Fluid Drainage	P	N	P	P	P	P
Vascular Access (IV, PICC)
Nonvascular (specify)[6]
Brachytherapy

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

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

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Division Sign-Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102113

GE Healthcare

Page 9

Prescription Use (21 CFR 801 Subpart D)

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GE Venue 40 with 4C-SC Transducer

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

Clinical Application		Mode of Operation
Anatomy/Region of Interest	B	M	PW	CW	Color	ColorM	Power	CombinedModes	HarmonicImaging	CodedPulse	Elasto-graphy	Other
Ophthalmic
Fetal/OB
Abdominal[1]	E	N			E		E	E	E
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	E	N			E		E	E	E
Musculo-skeletal Superficial
Thoracic/Pleural (specify)[4]	E	N			E		E	E	E
Other (specify)
Exam Type, Means of Access
Transcranial
Transorbital
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)[5]	E	N			E		E	E	E
Intraoperative Neurological
Intravascular/Intraluminal
Intracardiac
Laparoscopic
Interventional Guidance
Tissue Biopsy/Fluid Drainage	E	N			E		E	E	E
Vascular Access (IV, PICC)
Nonvascular (specify) [6]
Brachytherapy

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Muhal DOH
Division Sign-Off

Prescription Use (21 CFR 801 Subpart D)

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102113

GE Healthcare

Page 10

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GE Venue 40 with L8-18i-SC Transducer

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

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

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

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

currence of CDRH, Office of In Vitro Diagnostics (OIVD)

Prescription Use (21 CFR 801 Subpart D)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102113

GE Healthcare

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.