Vscan Extend is a general-purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, and triage.

With the phased array transducer on the specific clinical applications and exam types include: Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Imaging Guidance for Needle/Catheter Placement (e.g. paracentesis, pericardiocentesis, amniocentesis); Peripheral Vascular Imaging (e.g. arteries and veins); Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); Adult Cephalic; and Pediatrics.

With the addition of the linear array transducer on the single dual headed probe solution, the specific clinical applications and exam types are expanded to include: Peripheral vascular imaging (e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels (e.g. central lines, upper extremity); Small Organs (e.g. thyroid); and Musculoskeletal (Long Bone; Hip, shoulder, elbow and Knee Joints); Evaluation of Presence of Fluid; Thoracic/Lung (e.g., pleural motion/ sliding, line artifacts); and Pediatrics.

Device Description

Vscan Extend is a pocket-sized, battery powered general purpose, track 3, diagnostic ultrasound system. The system consists of a handheld unit with a 5 inch touch screen display and a permanently attached probe. The probe is available in one of two configurations: a sector probe with phased array transducer or both phased and linear array transducers in the single probe (dual probe). It has digital acquisition, processing and display capabilities. The device specific battery can be charged either in the system or independently. The system also may include an AC/DC adapter with cable, case, Micro SD card, USB cable, or other accessories. The system is capable of transferring images wirelessly to a DICOM server or Windows share. Data can also be exported to the user's computer by using the USB export option and a standard USB/micro USB cable. Capabilities also include access to GE Marketplace, which shall allow the user to download software applications to the device.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for the GE Vscan Extend Ultrasound System. It details the device's indications for use, comparison to predicate devices, and a summary of non-clinical tests. However, it explicitly states:

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

Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria because the document indicates that clinical studies were not required or performed for this submission to demonstrate substantial equivalence.

Specifically, the following information is not available in the provided text:

A table of acceptance criteria and the reported device performance: This would typically come from clinical study results, which are explicitly stated as not being required.
Sample size used for the test set and the data provenance: No clinical test set details are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set is described.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
Sample size for the training set: No information on machine learning model training is provided, as the submission focuses on the ultrasound system itself, not necessarily an AI component requiring a training set in the context of clinical performance evaluation.
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and non-clinical safety and performance testing.

Summary

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GE Medical Systems Ultrasound and Primary Care Diagnostics c/o Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA, WI 53226

June 25th, 2018

Re: K180995

Trade/Device Name: Vscan Extend Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 13, 2018 Received: April 16, 2018

Dear Tracey Ortiz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Rogers

for Robert A. 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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Indications for Use

510(k) Number (if known) K180995

Device Name Vscan Extend

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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GE Healthcare

510(k) Premarket Notification Submission

GE Vscan Extend Ultrasound System

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes[*]	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics	P				P			P	P		7
Abdominal [1]	P				P			P	P		7
Pediatric	P				P			P	P		7
Small Organ [2]	P				P			P			7
Neonatal Cephalic
Adult Cephalic	P				P			P	P
Pediatric Cardiac	P				P			P	P		7
Adult Cardiac	P				P			P	P		7
Peripheral Vascular[3]	P				P			P	P		7
Musculo-skeletal Conventional[4]	P				P			P			7
Musculo-skeletal Superficial
Thoracic/Pleural [5]	P				P			P	P		7
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidance
Vascular Access [6]	P				P			P			7
Nonvascular	P				P			P	P		7

N = new indication; P = previously cleared by FDA (K161588)

Notes:

[1] Abdominal includes Gynecology, Renal and Urology;

[2] Small Organ includes, thyroid;

[3] Peripheral Vascular includes arteries and veins, lower extremity, carotid;

[4] Musculo-skeletal Conventional includes long bone, hip, shoulder, elbow and knee joint visualization;

[5] Thoracic/Pleural is pleural motion/sliding, line artifacts as well as fluid detection;

[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;

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

*] Combined mode is B/Color

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Diagnostic Ultrasound Indications for Use Form

Vscan Extend with deep scanning-phased array transducer (G3S)

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes[*]	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics	P				P			P	P		7
Abdominal [1]	P				P			P	P		7
Pediatric	P				P			P	P		7
Small Organ [2]
Neonatal Cephalic
Adult Cephalic	P				P			P	P
Pediatric Cardiac	P				P			P	P		7
Adult Cardiac	P				P			P	P		7
Peripheral Vascular[3]	P				P			P	P		7
Musculo-skeletal Conventional[4]
Musculo-skeletal Superficial
Thoracic/Pleural [5]	P				P			P	P		7
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidance
Vascular Access [6]
Nonvascular	P				P			P	P		7

N = new indication; P = previously cleared by FDA (K161588)

Notes:

[1] Abdominal includes Gynecology, Renal and Urology;

[2] Small Organ includes, thyroid;

[3] Peripheral Vascular includes arteries and veins, lower extremity, carotid;

[4] Musculo-skeletal Conventional includes long bone, hip, shoulder, elbow and knee joint visualization;

[5] Thoracic/Pleural is pleural motion/sliding, line artifacts as well as fluid detection;

[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;

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

*] Combined mode is B/Color.

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Diagnostic Ultrasound Indications for Use Form

Vscan Extend with deep scanning-phased array transducer (G8L)

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes[*]	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal [1]
Pediatric	P				P			P			7
Small Organ [2]	P				P			P			7
Neonatal Cephalic
Adult Cephalic
Pediatric Cardiac
Adult Cardiac
Peripheral Vascular[3]	P				P			P			7
Musculo-skeletal Conventional [4]	P				P			P			7
Musculo-skeletal Superficial
Thoracic/Pleural [5]	P				P			P			7
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidance
Vascular Access [6]	P				P			P			7
Nonvascular

N = new indication; P = previously cleared by FDA (K161588)

Notes:

[1] Abdominal includes Gynecology, Renal and Urology;

[2] Small Organ includes, thyroid;

[3] Peripheral Vascular includes arteries and veins, lower extremity, carotid;

[4] Musculo-skeletal Conventional includes long bone, hip, shoulder, elbow and knee joint visualization;

[5] Thoracic/Pleural is pleural motion/sliding, line artifacts as well as fluid detection;

[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;

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

*] Combined mode is B/Color.

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510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	April 13, 2018
Submitter:	GE Medical Systems Ultrasound and Primary Care Diagnostics9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Tracey OrtizRegulatory Affairs DirectorGE HealthcareT:(262)470-1003
Secondary Contact Person:	Sreedhar JVRegulatory Affairs LeaderGE Healthcare
Device Trade Name:	Vscan Extend
Common/Usual Name:	Diagnostic Ultrasound System
Classification Names:	Class IIUltrasonic 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
Primary Predicate Device:	Vscan Extend - K161588
Secondary Predicate Device(s):	LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 – K161224LVivo EF System from DiACardio Ltd. – K130779
Device Description:	Vscan Extend is a pocket-sized, battery powered general purpose,track 3, diagnostic ultrasound system. The system consists of ahandheld unit with a 5 inch touch screen display and a permanentlyattached probe. The probe is available in one of two configurations: asector probe with phased array transducer or both phased and lineararray transducers in the single probe (dual probe). It has digitalacquisition, processing and display capabilities. The device specificbattery can be charged either in the system or independently. Thesystem also may include an AC/DC adapter with cable, case, MicroSD card, USB cable, or other accessories.The system is capable of transferring images wirelessly to a DICOMserver or Windows share. Data can also be exported to the user's

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

computer by using the USB export option and a standard USB/micro USB cable. Capabilities also include access to GE Marketplace, which shall allow the user to download software applications to the device.

Intended Use: Vscan Extend is a general purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, and triage.
With the phased array transducer on the sector probe, the specific clinical applications and exam types include: Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Imaging Guidance for Needle/Catheter Placement (e.g. paracentesis, pericardiocentesis, thoracentesis, amniocentesis); Peripheral Vascular Imaging (e.g. arteries and veins); Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); Adult Cephalic; and Pediatrics.

With the addition of the linear array transducer on the single dual headed probe solution, the specific clinical applications and exam types are expanded to include: Peripheral vascular imaging (e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels (e.g. central lines, upper extremity); Small Organs (e.g. thyroid); and Musculoskeletal (Long Bone; Hip, shoulder, elbow and Knee Joints); Evaluation of Presence of Fluid; Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); and Pediatrics.

Technology: The Vscan Extend employs the same fundamental scientific technology as its predicate devices.

Determination of Substantial Equivalence: Comparison to Predicate Devices

The Vscan Extend 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.

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GE Healthcare

510(k) Premarket Notification Submission

The proposed Vscan Extend and the predicate Vscan Extend ● have the same clinical intended use and clinical applications.
The proposed Vscan Extend and the predicate Vscan Extend have the same imaging modes.
The proposed Vscan Extend and the predicate Vscan Extend ● are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
The proposed Vscan Extend and the predicate Vscan Extend ● have the same phased array transducer for deep scanning & linear array transducer for shallow scanning.
The proposed Vscan Extend and predicate Vscan Extend have similar acoustic power levels. All values are below FDA applicable limits.
o The proposed Vscan Extend and predicate Vscan Extend have the same capability in terms of performing measurements, capturing digital images and reviewing the images.
The proposed Vscan Extend has WiFi connectivity & DICOM ● similar to the predicate Vscan Extend device.
The proposed Vscan Extend and predicate Vscan Extend device have same data privacy features including internal storage encryption which allows the user to encrypt patient data.
The proposed Vscan Extend adds SW options Scan Coach FATE, Scan Coach FCU, Scan Coach RHD, LVivo EF & AV Plane to the predicate product Vscan Extend. Scan Coach is similar to the Scan Coach on LOGIQ V3/V5/V5 Expert (K161224) but expanded to provide pathology focused protocols and images. LVivo EF is similar to a component of LVivo EF System from DiA Cardio Ltd (K130779).
The proposed Vscan Extend and predicate Vscan Extend have . been designed in compliance with approved electrical and physical safety standards.

Summary of Non-Clinical Tests:

The Vscan Extend 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 Vscan Extend and its applications comply with voluntary standards:

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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle is surrounded by a decorative pattern of curved lines, also in blue. The logo is simple and recognizable, representing the multinational conglomerate corporation.

GE Healthcare

510(k) Premarket Notification Submission

1. AAMI/ANSI ES60601-1, Medical Electrical Equipment Part 1 : General Requirements for Safety and Essential Performance, 2005
1. IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2007
IEC 60601-2-37, Medical Electrical Equipment Part 2-37: 3. Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
1. ISO 10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition, 2009
1. NEMA UD 2. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, 2004.
1. ISO 14971, Application of risk management to medical devices: Second edition, 2007
1. NEMA PS 3.1 3.20 (2011), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

The following quality assurance measures were applied to the development of the system:

Risk Analvsis
Requirements Reviews ●
Design Reviews
Testing on unit level (Module verification) ●
Integration testing (System verification)
Performance testing (Verification) ●
Safety testing (Verification) ●
Verification of Privacy & Security Design ●

Transducer material and other patient contact materials are biocompatible.

Summary of Clinical Tests:

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

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

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.