Not Found
No
The document does not mention AI, ML, or any related terms in the device description, intended use, or performance studies. While it mentions "digital acquisition, processing and display capabilities" and the ability to download "software applications," these are not specific indicators of AI/ML.
No
The device is described as a "general-purpose diagnostic ultrasound imaging system" used for visualizing and measuring anatomical structures and fluid, and for clinical diagnosis purposes, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "Vscan Extend is a general-purpose diagnostic ultrasound imaging system" and that the information can be used "for clinical diagnosis purposes." The "Device Description" also refers to it as a "diagnostic ultrasound system."
No
The device description explicitly states it is a "pocket-sized, battery powered general purpose, track 3, diagnostic ultrasound system" consisting of a "handheld unit with a 5 inch touch screen display and a permanently attached probe." This clearly indicates the presence of hardware components beyond just software.
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 Vscan Extend is a "general-purpose diagnostic ultrasound imaging system" used for "visualization and measurement of anatomical structures and fluid." It is used to provide information that can be used for "basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes." This describes an imaging device used to visualize internal structures, not a device that performs tests on biological samples (like blood, urine, or tissue) to diagnose conditions.
- Device Description: The device description details an ultrasound system with a probe, screen, and processing capabilities. This aligns with the description of an imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device analyzing biological samples, using reagents, or performing any kind of in vitro test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The Vscan Extend is an imaging device that provides visual information about the body itself.
N/A
Intended Use / Indications for 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 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.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application / Anatomy/Region of Interest: Fetal / Obstetrics, Abdominal, Pediatric, Small Organ, Adult Cephalic, Pediatric Cardiac, Adult Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Thoracic/Pleural, Vascular Access, Nonvascular.
Exam Type, Means of Access: Interventional Guidance, Vascular Access, Nonvascular.
Product codes
IYN, IYO, ITX
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal; Peripheral Vascular; Thoracic/Lung; Adult Cephalic; Pediatrics; Lower extremity; Carotid; Arterial or Venous Vessels (e.g. central lines, upper extremity); Small Organs (e.g. thyroid); Musculoskeletal (Long Bone; Hip, shoulder, elbow and Knee Joints); Pleural motion/sliding, line artifacts.
Indicated Patient Age Range
Adult, Pediatric, Fetal.
Intended User / Care Setting
Qualified and trained healthcare professionals. Integrated into examination and training sessions indoors and in other environments described in the user manual.
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 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 subject of this premarket submission, Vscan Extend, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Vscan Extend - K161588, LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 – K161224, LVivo EF System from DiACardio Ltd. – K130779
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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);
1
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
2
Indications for Use
510(k) Number (if known) K180995
Device Name Vscan Extend
Indications for Use (Describe)
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.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The letters are also blue. The circle is surrounded by a decorative border of swirling lines.
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 Application | |||||||||||
| Anatomy/Region of Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes[*] | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P | P | P | P | 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
4
Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The frame has a decorative pattern resembling swirling lines or leaves. The logo is colored in a light blue hue.
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 Application | |||||||||||
| Anatomy/Region of Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes[*] | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P | P | P | P | 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.
5
Image /page/5/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 circular frame. The logo is colored in a light blue hue, and the background is white.
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 Application | |||||||||||
| Anatomy/Region of Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes[*] | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal [1] | |||||||||||
| 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.
6
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The frame has decorative, swirling elements around the perimeter. The logo is presented in a blue color.
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 Diagnostics |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Tracey Ortiz |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262)470-1003 | |
| Secondary Contact Person: | Sreedhar JV |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Device Trade Name: | Vscan Extend |
| Common/Usual Name: | Diagnostic 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 | |
| Primary Predicate Device: | Vscan Extend - K161588 |
| Secondary Predicate Device(s): | LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 – K161224 |
| LVivo 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 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 |
7
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.
8
Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, which is consistent with GE's branding.
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:
9
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
-
- AAMI/ANSI ES60601-1, Medical Electrical Equipment Part 1 : General Requirements for Safety and Essential Performance, 2005
-
- 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
-
- ISO 10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition, 2009
-
- NEMA UD 2. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, 2004.
-
- ISO 14971, Application of risk management to medical devices: Second edition, 2007
-
- 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).