(164 days)
No
The summary does not mention AI, ML, or any related terms in the device description or performance studies. The focus is on standard ultrasound technology and image processing controls.
No.
The device is intended for "diagnostic ultrasound imaging" to aid in diagnosis, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The VistaScan™ USB Ultrasound Imaging System is intended for diagnostic ultrasound imaging."
No
The device description explicitly states that the system comprises handheld probes containing hardware components such as an ultrasound generator/receiver, analog to digital converter, microcontroller, and control logic, in addition to software.
Based on the provided information, the VistaScan™ USB Ultrasound Imaging System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- VistaScan™ Function: The VistaScan™ is an ultrasound imaging system. It uses sound waves to create images of structures within the body. It does not analyze specimens taken from the body.
The intended use and device description clearly indicate that the VistaScan™ is used for in vivo (within the living body) diagnostic imaging, not in vitro (in glass/outside the body) diagnostic testing.
N/A
Intended Use / Indications for Use
The VistaScan™ USB Ultrasound Imaging System is intended for diagnostic ultrasound imaging in B mode for the following applications: Fetal/obstetric Gynecology Abdominal Pediatric Small organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Pelvic floor Neuro-muscular Peripheral vessel Indications for use vary by probe type. The VistaScan™ USB Ultrasound Imaging System is indicated for Rx (prescription) use and intended for use by appropriately trained healthcare professionals such as physicians and ultrasound technologists. The VistaScan™ USB Ultrasound Imaging System is intended for use in healthcare facilities such as hospitals, clinics and facilities where ultrasound testing is performed.
Product codes
IYO, ITX
Device Description
The VistaScan™ USB Ultrasound Imaging System is a self-contained portable single-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and software-based controls offering B operating mode, parameter controls, and recording functions. The selection of transducers offered with the system permit a wide range of clinical applications including Fetal/Obstetric, Abdominal, Pediatric, Small Organ, Muscular-skeletal, Urology, Gynecology, Pelvic Floor, Neuromuscular, and Peripheral Vessel. The initial operational settings for each transducer are preprogrammed in the system. User-customized parameter settings for each transducer may be set by the operator within a specific range which is controlled by the transducer hardwareffirmware and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the Cine function. The VistaScan™ USB Ultrasound Imaging System is a B-Mode scanner and supports a wide variety of applications. It is an ultrasound scanner providing high resolution and high penetration performance. Probes are supported in frequencies from 2.5 MHz to 10.0 MHz. The product family uses non-array, curved, and flat linear array transducers and includes two General Purpose (GP) probes and a Small Parts (SP) probe. The probes can be connected to a USB 2.0 port (micro USB and USB-C). System Components: - Android™ based device operating VistaScan™ application . - Transducer GP-3.5 ● - Transducer GP-C01 ● - . Transducer SP-L01
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained healthcare professionals such as physicians and ultrasound technologists. The VistaScan™ USB Ultrasound Imaging System is intended for use in healthcare facilities such as hospitals, clinics and facilities where ultrasound testing is performed.
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 VistaScan™ USB Ultrasound Imaging System was generally evaluated against relevant requirements in Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Guidance for Industry and Food and Drug Administration Staff, June 27, 2019.
- Acoustic Output ●
- Clinical measurement accuracy and system sensitivity
- Thermal, mechanical, and electrical safety ●
- Patient -contacting materials ●
- Cleaning, disinfection, sterilization, and pyrogenicity
- Software ●
Verification testing was conducted against predetermined acceptance criteria and recognized standards to show that the subject device performs functions equivalent to the predicate device. VistaScan™ successfully passed verification testing. The results support substantial equivalence to the predicate device and demonstrate that is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows 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.
January 23, 2020
Emagine Solutions Technology, LLC % Ms. Michelle Lott Senior RA & QA Consultant Lean RAQA, LLC 12602 North Summerwind Drive MARANA AZ 85658
Re: K192170
Trade/Device Name: VistaScan™ USB Ultrasound Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: December 18, 2019 Received: December 23, 2019
Dear Ms. Lott:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192170
Device Name
VistaScan™ USB Ultrasound Imaging System
Indications for Use (Describe) The VistaScan™ USB Ultrasound Imaging System is intended for diagnostic ultrasound imaging in B mode for the following applications: Fetal/obstetric Gynecology Abdominal Pediatric Small organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Pelvic floor Neuro-muscular Peripheral vessel
Indications for use vary by probe type. The VistaScan™ USB Ultrasound Imaging System is indicated for Rx (prescription) use and intended for use by appropriately trained healthcare professionals such as physicians and ultrasound technologists. The VistaScan™ USB Ultrasound Imaging System is intended for use in healthcare facilities such as hospitals, clinics and facilities where ultrasound testing is performed.
| 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
K192170
510(k) Summary
GENERAL INFORMATION
This 510(k) Summary is submitted in accordance with 21 CFR 807, Section 807.92.
Submitted by:
| Owner's Name:
Address:
Contact:
Title:
Tel:
Fax:
Email: | Emagine Solutions Technology, LLC
9040 S. Rita Road, Suite 1270 Tucson, AZ 85747
Courtney Williams
CEO
+1 (520) 485-9905
None
courtney.williams@emaginesolutionstech.com |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | |
| Name:
Title:
Tel:
Email: | Michelle Lott
Senior RA & QA Consultant at Lean RAQA, LLC
+1 (520) 275 9838
michelle@leanraqa.com |
| Date Prepared: | January 15, 2020 |
| Trade Name: | VistaScan™ USB Ultrasound Imaging System |
| Common Name: | Diagnostic Ultrasound System and Accessories |
| Classification Name:
Classification: | Ultrasonic pulsed echo imaging system, Diagnostic Ultrasound
Transducer
Class II |
| Product Code: | IYO, ITX |
| Regulation Number: | 892.1560, 892.1570 |
| Predicate Device(s): | Interson USB Ultrasound System, Interson Corporation.
(K163443) (Primary Predicate device) |
| | Interson USB Ultrasound Probe System, Interson Corporation.
(K070907) |
| Reference Device: | Philips Lumify
(K152899) |
4
DEVICE DESCRIPTION:
The VistaScan™ USB Ultrasound Imaging System is a self-contained portable single-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and software-based controls offering B operating mode, parameter controls, and recording functions. The selection of transducers offered with the system permit a wide range of clinical applications including Fetal/Obstetric, Abdominal, Pediatric, Small Organ, Muscular-skeletal, Urology, Gynecology, Pelvic Floor, Neuromuscular, and Peripheral Vessel.
The initial operational settings for each transducer are preprogrammed in the system. User-customized parameter settings for each transducer may be set by the operator within a specific range which is controlled by the transducer hardwareffirmware and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the Cine function.
The VistaScan™ USB Ultrasound Imaging System is a B-Mode scanner and supports a wide variety of applications. It is an ultrasound scanner providing high resolution and high penetration performance. Probes are supported in frequencies from 2.5 MHz to 10.0 MHz. The product family uses non-array, curved, and flat linear array transducers and includes two General Purpose (GP) probes and a Small Parts (SP) probe. The probes can be connected to a USB 2.0 port (micro USB and USB-C).
System Components:
- Android™ based device operating VistaScan™ application .
- Transducer GP-3.5 ●
- Transducer GP-C01 ●
- . Transducer SP-L01
Supported Hardware
The VistaScan™ USB Ultrasound Imaging System has been verified and validated on the Samsung Galaxy S4 Tablet using the Android software Operating System (OS). Device safety and performance cannot be assured when using other computing hardware which utilizes the Android OS. Computing hardware other than the Samsung Galaxy S4 Tablet using the Android software Operating System (OS) is not supported and should not be used with the VistaScan USB Ultrasound Imaging System.
Automated Safety/Performance Checks
The VistaScan™ USB Ultrasound Imaging System includes several automated safety/performance checks to verify that the USB ultrasound probe is functioning properly prior to use. These automated performance checks include:
- System Initialize
- . Hardware Initialize
- Hardware Check ●
- Probe ID Code Read ●
- . Setup Control
5
INTENDED USE / INDICATIONS FOR USE:
The VistaScan™ USB Ultrasound Imaging device is intended for diagnostic ultrasound imaging in B mode for the following applications:
- . Fetal/obstetric
- Gynecology ●
- Abdominal ●
- Pediatric ●
- Small Organ ●
- Musculo-skeletal (conventional) ●
- Musculo-skeletal (superficial)
- Urology
- Pelvic Floor ●
- Neuro-muscular
- . Peripheral Vessel
Indications for use vary by probe type. The VistaScan™ USB Ultrasound Imaging System is indicated for Rx (prescription) use and intended for use by appropriately trained healthcare professionals such as physicians and ultrasound technologists. The VistaScan™ USB Ultrasound Imaging System is intended for use in healthcare facilities such as hospitals, clinics and facilities where ultrasound testing is performed.
PRODUCT MODELS:
| Model | Track | Common Applications |
|---|---|---|
| Transducer Model GP 3.5 MHz | 1 | Fetal, Abdominal, Small Organ |
| Transducer Model GP-C01 | 3 | Fetal/Obstetric, Abdominal, Pelvic Floor, Urology, Musculoskeletal, Small Organs, Neuromuscular |
| Transducer Model SP-L01 | 3 | Pediatric, Small Organs, Peripheral Vessel, Pelvic Floor |
Table 1: Common Applications of Transducer Models
LABELING AND TECHNOLOGICAL CHARACTERISTICS COMPARISON:
Both the proposed VistaScan™ USB Ultrasound Imaging System and the predicate devices are provided nonsterile. They use similar packaging systems except for adapted product documentation (instructions for use in package labeling). The proposed VistaScan™ device has an identical intended use for B mode imaging, and similar technology characteristics to the currently marketed Interson USB Ultrasound Probe System (K070907, K163443). Technological differences are limited to the software operating system. The VistaScan™ device uses a commercially available electronic mobile device with an Android-based operating system, while the predicate Interson USB Ultrasound Probe System (K070907, K163443) device uses a proprietary Windows-based imaging system. All other technological features are substantially equivalent to the Interson USB Ultrasound Probe System (K070907, K163443). The reference device was selected as a point of comparison for the software operating system. Both the
6
VistaScan™ device and the reference device, Philips Lumify (K152899), use an Android based operating system.
| Device
Features | Subject Device:
VistaScan ™ USB
Ultrasound
Imaging System | Primary Predicate:
Interson Ultrasound
System: K163443 | Secondary Predicate:
Interson Ultrasound
System K070907 | Reference Device:
Philips Lumify K152899 |
|-------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound
imaging in B mode. | Diagnostic ultrasound
imaging in B, color
Doppler and Combined
(B + Color)
modes. | Diagnostic ultrasound
imaging in B mode (all
transducers), A mode
(ophthalmic) | Diagnostic ultrasound
imaging in B, color
Doppler, and Combined
(B + Color)
modes. |
| Indications for
Use | Indicated for diagnostic
ultrasound imaging in
specified applications | Indicated for diagnostic
ultrasound imaging and
fluid flow analysis in
specified applications | Indicated for diagnostic
ultrasound imaging in
specified applications | Indicated for diagnostic
ultrasound imaging and
fluid flow analysis in
specified applications |
| Array
Geometry | Non-Array
Curved and linear | Curved and linear | Non-Array | Curved and linear |
| Mechanics | Mechanical
Solid State | Solid State | Mechanical | Solid State |
| Software
platform | Commercial off-the-shelf
operating system
(Android) | Commercial off-the-shelf
operating system
(Windows) | Commercial off-the-shelf
operating system
(Windows) | Commercial off-the-
shelf operating system
(Android) |
| Software
control | Standalone | Standalone | Standalone | Standalone |
| Measurement
function | 2D measurement | 2D measurement and
area measurement | 2D measurement tool | 2D measurement tool |
| Wireless
networking | Not supported | Not supported | Not supported | Supported |
| Connector | USB | USB | USB | USB |
Table 2: Predicate Comparison Table
NON-CLINICAL PERFORMANCE TESTING
The VistaScan™ USB Ultrasound Imaging System was generally evaluated against relevant requirements in Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Guidance for Industry and Food and Drug Administration Staff, June 27, 2019.
- Acoustic Output ●
- Clinical measurement accuracy and system sensitivity
- Thermal, mechanical, and electrical safety ●
- Patient -contacting materials ●
- Cleaning, disinfection, sterilization, and pyrogenicity
- Software ●
7
Verification testing was conducted against predetermined acceptance criteria and recognized standards1 to show that the subject device performs functions equivalent to the predicate device. VistaScan™ successfully passed verification testing. The results support substantial equivalence to the predicate device and demonstrate that is safe and effective for its intended use.
Electrical Safety / Electromagnetic Compatibility
Evaluation per standard IEC 60601 1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) and IEC/EN 60601-1-2:2014 was performed for use of the transducer with a specific computer model (HP Netbook). Use of alternate USB 2.0 compatible computer hardware requires verification by the end user. Further information is provided in the Instructions for Use.
Standards Conformity
The VistaScan™ USB Ultrasound Imaging System references the following FDA recognized standards:
| Standard Number/FDA Recognition# | Standard Name |
|---|---|
| IEC 60601 1: 2005 + CORR. 1 (2006) + | Medical electrical equipment-Part 1: General |
| CORR. 2 (2007), | requirements for basic safety and essential performance |
| FDA Recognition#: 19-4 | |
| IEC/EN 60601-1-2:2014 4th Ed. | Medical electrical equipment -Part 1-2: General |
| FDA Recognition#: 19-8 | requirements for basic safety and essential performance . |
| Collateral Standard: Electromagnetic disturbances - | |
| Requirements and tests | |
| IEC 60601-2-37:2007 | Medical electrical equipment -Part 2-37: Particular |
| FDA Recognition#: 12-293 | requirements for the basic safety and essential |
| performance of ultrasonic medical diagnostic and | |
| monitoring equipment |
ANIMAL AND CLINICAL TESTING
VistaScan™ USB Ultrasound Imaging System introduces no new indication for use, modes, features, or technologies relative to the predicate devices that require animal or clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.
CONCLUSION OF COMPARISON
The VistaScan™ USB Ultrasound Imaging System device and its predicate device are technologically The devices are identical in their use of probes, and similar in design, materials, and similar. technological characteristics. The packaging and labeling has been designed to provide sufficient information to the user to ensure the safe and effective use of the proposed device. Furthermore, the proposed device is comparable to the reference device which was cleared for the same intended use for B mode operation, the same indication for use, and utilizes the same operating platform. The proposed device does not raise substantial new questions of safety or effectiveness. Therefore, the proposed device (VistaScan™ USB Ultrasound Imaging System) is determined to be substantially equivalent to the predicate device.
1 Electrical Safety and EMC standards are applied by 'right of reference'.