Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasound system with image processing capabilities but makes no mention of AI or ML.

Therapeutic

No.
The Venue 40 is described as an ultrasound system intended for imaging, measurement, and analysis, and its indicated uses are diagnostic in nature (e.g., Fetal/OB, Abdominal, Cardiac), not therapeutic.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states that the device is "intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications." This aligns with the purpose of a diagnostic device. Furthermore, the "Predicate Device(s)" section explicitly lists "GE LOGIQ e Diagnostic Ultrasound" and "GE Venue 40 Diagnostic Ultrasound," directly indicating its diagnostic classification.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "compact and extremely portable ultrasound system consisting of a hand-carried console" and utilizes "interchangeable electronic-array transducers," indicating it includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device is for "ultrasound imaging, measurement and analysis of the human body for multiple clinical applications." This describes a device used for in vivo (within the living body) imaging and diagnosis, not for testing samples in vitro (outside the living body).
Device Description: The description details a portable ultrasound system with transducers that interact directly with the patient's body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or using reagents, which are hallmarks of IVD devices.

Therefore, the Venue 40 is a diagnostic imaging device, specifically an ultrasound system, and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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; 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.

Product codes

IYN, IYO, ITX

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.

Mentions image processing

digital acquisition, processing and display capability operating

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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; Transcranial; Tissue Biopsy/Fluid Drainage; Vascular Access (IV, PICC); Nonvascular (image guidance for freehand needle/catheter placement, including nerve block)

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Not Found

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)

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.
Clinical Tests: None required.

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

Not Found

Predicate Device(s)

K091374, K091164

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

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., Ltd
No. 19 Changjiang Road, National Hi-Tech Development Zone
Wuxi, Jiangsu Province, CHINA 214028 |

-------------	------------------------------------------------------------------------------------------------------------------------------------------

| 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 Regulatory
Telephone: 86-510-85278652; Fax: 86-510-85227347 |
| Date Prepared: | July 8, 2010 |
| 2. Device Name: | GE Venue 40 Ultrasound
Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN
Diagnostic 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.

1

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

2

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)

3

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:

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.

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

4

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	Color
M	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

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

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

5

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

6

GE Venue 40 with 3S-SC Transducer

Clinical Application		Mode of Operation
Anatomy/Region of Interest	B	M	Doppler Modes	Combined
Modes	Harmonic
Imaging	Coded
Pulse	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

(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

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)

7

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	Color
M	Power	Combined
Modes	Harmonic
Imaging	Coded
Pulse	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

8

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