No
The provided text does not mention the use of AI, ML, or related terms like deep learning or neural networks in the device's functionality or processing. The description focuses on standard ultrasound imaging modes and processing.
No
The device is described as a "general-purpose diagnostic ultrasound imaging system" used for "visualization and measurement of anatomical structures and fluid," as well as for "clinical diagnosis purposes." It is not described as providing treatment.
Yes
The "Device Description" section explicitly states, "Vscan Air™ is a battery-operated general-purpose diagnostic ultrasound imaging system..."
No
The device description explicitly states that Vscan Air consists of both an app (software) and a probe (hardware) which uses wireless technology for communication. This indicates it is not a software-only device.
Based on the provided text, the Vscan Air is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Vscan Air's Function: The Vscan Air is an ultrasound imaging system. It uses sound waves to create images of internal anatomical structures and fluid. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's for "visualization and measurement of anatomical structures and fluid including blood flow." This is consistent with imaging, not in vitro testing.
- Device Description: The description reinforces that it's a "diagnostic ultrasound imaging system."
- Lack of Mention of Biological Samples: There is no mention of the device being used with or analyzing biological samples.
Therefore, the Vscan Air falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Vscan Air is a battery-operated software-based general-purpose ultrasound imaging system for use by qualified and trained healthcare professionals or practitioners that are legally authorized by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. The device is enabling visualization and measurement of anatomical structures and fluid including blood flow.
Vscan Air's pocket-sized portability and simplified user interface enables integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and other environments as 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 follow-up, and triage.
Vscan Air supports Black/ white (B-mode), Color flow (Color doppler), Combined (B + Color Doppler) and Harmonic imaging modes with both the curved and linear array transducers.
With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatric, 40 kg and above), vascular/peripheral vascular, musculoskeletal (conventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).
With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoraciclung, ophthalmic, pediatrics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy).
Product codes
ITX, IYN, IYO
Device Description
Vscan Air is a battery-operated general-purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. It enables ultrasound imaging guidance, visualization and measurement of anatomical structures and fluid. Vscan Air consists of an app which can be installed on Android™ or iOS devices, and a probe which uses wireless technology for communication. Its pocket-sized portability and simplified user interface enable integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and in other environments. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage assessments for adult, pediatric and neonatal patients. Vscan Air can also be useful for interventional guidance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac, vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, ophthalmic, neonatal cephalic.
Indicated Patient Age Range
Adult, pediatric, and neonatal patients. For cardiac applications: adult and pediatric, 40 kg and above.
Intended User / Care Setting
Qualified and trained healthcare professionals or practitioners that are legally authorized by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.
Care settings: professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and other environments as 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 subject of this premarket submission, Vscan Air, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Vscan Extend (K180995)
Reference Device(s)
Clarius Ultrasound Scanner (K192107), Venue Go (K183362), Versana Active (K200998)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226
Re: K202035
Trade/Device Name: Vscan Air Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: ITX, IYN, IYO Dated: October 16, 2020 Received: October 19, 2020
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. 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/cfpmp/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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
November 20, 2020
1
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 medical devices and radiation-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) K202035
Device Name
Vscan Air
Indications for Use (Describe)
Vscan Air is a battery-operated software-based general-purpose ultrasound imaging system for use by qualified and trained healthcare professionals or practitioners that are legally authorized by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. The device is enabling visualization and measurement of anatomical structures and fluid including blood flow.
Vscan Air's pocket-sized portability and simplified user interface enables integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and other environments as 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 follow-up, and triage.
Vscan Air supports Black/ white (B-mode), Color flow (Color doppler), Combined (B + Color Doppler) and Harmonic imaging modes with both the curved and linear array transducers.
With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatric, 40 kg and above), vascular/peripheral vascular, musculoskeletal (conventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).
With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoraciclung, ophthalmic, pediatrics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy).
| 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) |
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Image /page/3/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 blue circle. The circle is surrounded by a decorative pattern of curved lines, also in blue, which gives the logo a classic and recognizable appearance.
K202035 GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: Date: July 22, 2020
| 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
9900 Innovation Drive
Wauwatosa, WI 53226
U.S.A |
| Secondary Contact
Person: | Liwen Wei
Regulatory Affairs Leader
GE Healthcare
T:(086)180-5194-9162
No.19, Changjiang Road Wuxi National Hi-Tech Dev.Zone 214028
Jiangsu China |
| Trade Name:
Common/Usual Name:
Classification Names:
Product Code: | Vscan Air
Diagnostic Ultrasound Imaging System
Class II
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX;
Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-
IYN;
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO |
| Predicate Device:
Product Code: | Vscan Extend (K180995)
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX;
Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-
IYN;
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO |
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Image /page/4/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 blue circle. The circle has a decorative, swirling pattern around its edge, also in blue. The logo is simple, recognizable, and associated with the multinational conglomerate corporation.
510(k) Premarket Notification Submission
Reference Devices: Clarius Ultrasound Scanner (K192107)
Product Code: Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX; Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN;
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Venue Go (K183362)
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX; Ultrasonic Pulsed Doppler Imaging System. 21CFR, 892.1550 90-IYN:
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Versana Active (K200998) Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX; Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
- Vscan Air™ is a battery-operated general-purpose diagnostic Device Description: ultrasound imaging system for use by qualified and trained healthcare professionals. It enables ultrasound imaging guidance, visualization and measurement of anatomical structures and fluid.
Vscan Air consists of an app which can be installed on Android™ or iOS devices, and a probe which uses wireless technology for communication.
Its pocket-sized portability and simplified user interface enable integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and in other environments. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage assessments for adult, pediatric and neonatal patients. Vscan Air can also be useful for interventional guidance.
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font, enclosed within a circular border. The logo is colored in blue.
510(k) Premarket Notification Submission
Intended Use: Vscan Air is a battery-operated software-based general-purpose ultrasound imaging system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. The device is enabling visualization and measurement of anatomical structures and fluid including blood flow.
Vscan Air's pocket-sized portability and simplified user interface enables integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and other environments as 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 follow-up, and triage.
Vscan Air supports Black/ white (B-mode), Color flow (Color doppler), Combined (B + Color Doppler) and Harmonic imaging modes with both the curved and linear array transducers.
With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatric, 40 kg and above), vascular/peripheral vascular. musculoskeletal (conventional), interventional guidance (includes free hand needle/ catheter placement, fluid drainage, nerve block and biopsy).
With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, ophthalmic, pediatrics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy).
- Technology: The Vscan Air employs the same fundamental scientific technology as its predicate and reference devices.
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510(k) Premarket Notification Submission
Determination of Comparison to Predicate Devices
Substantial Equivalence: The Vscan Air system is substantially equivalent to the predicate and reference devices with regards to intended use, capabilities, technological characteristics, safety and effectiveness.
The systems are intended for diagnostic ultrasound imaging and fluid flow analysis
The proposed Vscan Air and the predicate Vscan Extend(K180995) have the similar clinical intended use and clinical applications however the following are being added to Vscan Air:
- Ophthalmic, musculoskeletal (superficial) and neonatal cephalic that are found in cleared Venue Go (K183362).
- Vascular is added to peripheral vascular for clarity to . include all the vessels that was also cleared in Versana Active (K200998).
- Interventional guidance (biopsy and nerve block) ● already cleared in Venue Go (K183362).
- Imaging guidance for foreign bodies ●
The proposed Vscan Air and the predicate Vscan Extend have the same imaging modes.
The proposed Vscan Air probe 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 Air and the predicate Vscan Extend have linear array transducer for shallow scanning and a similar transducer for deep scanning. Vscan Air uses a curved array for the deep scanning, like is cleared in Versana Active (K200998) and a linear array for shallow scanning like is cleared in Venue Go (K183362).
The proposed Vscan Air has acoustic power levels that are below FDA applicable limits.
The proposed Vscan Air has additional presets based on the indications for use. The proposed Vscan Air supports same
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GE Healthcare 510(k) Premarket Notification Submission
distance measurement as predicate Vscan Extend and adds ellipse measurement like in reference device Versana Active (K200998).
The proposed Vscan Air has a software app which can be installed on user's mobile device that provides some of the processing and uses the screen of the mobile device as the display like is done for cleared Clarius Ultrasound System (K192107).
The proposed Vscan Air does not have a physically wired probe but uses Wi-Fi technology (Wi-Fi direct) to communicate between the probe and the mobile device with the installed Vscan Air app similar to cleared Clarius Ultrasound System (K192107).
The proposed Vscan Air and predicate Vscan Extend have been designed in compliance with approved electrical and physical safety standards.
The proposed Vscan Air and predicate Vscan Extend have difference in charging method, Vscan Air probe battery shall be charged via a wireless charging pad where the Vscan required the charging cable to be plugged into it.
Summary of Non-Clinical Tests:
The Vscan Air device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection as well as thermal, electrical, electromagnetic, mechanical safety and wireless, and has been found to conform to applicable medical device safety standards. The Vscan Air and its applications comply with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment -. Part 1: General Requirements for Safety and Essential Performance, 2005/A2:2012
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: ● General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2014
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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a blue circle. The letters are stylized with curved lines and a vintage aesthetic. The logo is simple and recognizable, representing the company's brand identity.
510(k) Premarket Notification Submission
- IEC 60601-2-37, Medical Electrical Equipment Part 2o 37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015
- ISO 10993-1, Biological Evaluation of Medical Devices-● Part 1: Evaluation and Testing- Third Edition, 2009
- ISO 14971, Application of risk management to medical devices, 2012
- IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017
- IEC 60601-1-11, Medical Electrical Equipment Part 1-● 11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment, 2015
- o IEC 60601-1-12, Medical Electrical Equipment - Part 1-12: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Intended For Use In The Emergency Medical Services Environment, 2014
The following quality assurance measures are applied to the development of the system:
- Risk Analysis 0
- Requirements Reviews ●
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification & Validation) ●
- o Safety testing (Verification)
Probe materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, Vscan Air, did not require clinical studies to support substantial equivalence.
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GE Healthcare 510(k) Premarket Notification Submission
Conclusion: GE Healthcare considers the Vscan Air to be as safe, as effective, and performance is substantially equivalent to the predicate devices.