Vscan Air
Device Facts
| Record ID | K231301 |
|---|---|
| Device Name | Vscan Air |
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| Product Code | IYN · Radiology |
| Decision Date | Aug 15, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Pediatric |
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 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 mode, M-mode, M-mode, combined (B + Color Doppler) and Harmonic Imaging modes with curved, linear and sector array transducers. With the curved array transducer of the dual headed probesolution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatio, 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, pediatics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy). With the sector array transducer of the dual headed probe solution, the specific clinical applications and exam types include: cardiac (adult and pediatic, 40 kg and above), abdominal, fetal/obstetnes, gynecological, urology, thoracic/ lung, pediatics, adult cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).
Device Story
Vscan Air is a battery-operated, pocket-sized, wireless diagnostic ultrasound system. It consists of a dual-headed probe (curved/linear or sector array) and a mobile application installed on a user-provided Android or iOS device. The probe transmits ultrasound data via Wi-Fi Direct to the mobile app, which performs image processing and displays the output on the mobile device screen. Used by healthcare professionals in hospitals, clinics, home environments, and ambulances for basic/focused assessments, triage, and interventional guidance. The system supports B-mode, Color Doppler, Pulsed Wave Doppler, M-mode, and Harmonic Imaging. It provides visualization and measurement of anatomical structures and blood flow. The device aids clinicians in clinical diagnosis and routine follow-up by providing portable, real-time imaging.
Clinical Evidence
No clinical data required; substantial equivalence supported by bench testing, including acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety testing.
Technological Characteristics
Wireless, battery-operated ultrasound system using Wi-Fi Direct. Transducers: curved, linear, and sector arrays. Biocompatible materials. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, IEC 62359, IEC 60601-1-11, IEC 60601-1-12. Software-based processing via mobile app.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in adult, pediatric, and neonatal patients. Applications include abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (≥40kg), vascular/peripheral vascular, musculoskeletal, small organs, ophthalmic, and cephalic. Supports interventional guidance (needle/catheter placement, fluid drainage, nerve block, biopsy).
Regulatory Classification
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.
Predicate Devices
- Vscan Air (K202035)
Reference Devices
Submission Summary (Full Text)
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August 15, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
GE Medical Systems Ultrasound and Primary Care Diagnostics % Lee Bush Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K231301
Trade/Device Name: Vscan Air Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: August 1, 2023 Received: August 1, 2023
Dear Lee Bush:
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
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801); medical device 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 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,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2023 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Indications for Use | See PRA Statement below. |
| | |
| 510(k) Number (if known) | |
| K231301 | |
| 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<br>trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other<br>local municipality in which he or she practices. The users may or may not be working under supervision or authority of a<br>physician. Users may also include medical students working under the supervision or authority of a physician during their<br>education / training. The device is enabling visualization and measurement of anatomical structures and fluid including<br>blood flow.<br>Vscan Air's pocket-sized portability and simplified user interface enables integration into training sessions and<br>examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air<br>ambulance and other environments as described in the user manual. The information can be used for basic/focused<br>assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up,<br>and triage.<br>Vscan Air supports black/white (B-mode), color flow (Color Doppler mode, M-mode, M-mode, combined<br>(B + Color Doppler) and Harmonic Imaging modes with curved, linear and sector array transducers.<br>With the curved array transducer of the dual headed probesolution, the specific clinical applications and exam types<br>include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatio, 40 kg and above),<br>vascular/peripheral vascular, musculoskeletal (conventional guidance (includes free hand<br>needle/catheter placement, fluid drainage, nerve block and biopsy).<br>With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types<br>include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoraciclung,<br>ophthalmic, pediatics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid<br>drainage, nerve block, vascular access and biopsy).<br>With the sector array transducer of the dual headed probe solution, the specific clinical applications and exam types<br>include: cardiac (adult and pediatic, 40 kg and above), abdominal, fetal/obstetnes, gynecological, urology, thoracic/ | |
| lung, pediatics, adult cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, | |
| nerve block and biopsy). | |
| Type of Use (Select one or both, as applicable) | |
| [X] 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<br>time to review instructions, search existing data sources, gather and maintain the data needed and complete<br>and review the collection of information. Send comments regarding this burden estimate or any other aspect<br>of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov<br>"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of<br>information unless it displays a currently valid OMB number." | |
| Dago 1 of 1 | |
FORM FDA 3881 (6/20)
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## 510(k) Summary
K231301
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | May 4, 2023 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics<br>9900 Innovation Drive<br>Wauwatosa, WI 53226 |
| Primary Contact Person: | Lee Bush<br>Regulatory Affairs Director<br>GE Healthcare<br>T:(262)309-9429 |
| Secondary Contact Person: | Liwen Wei<br>Regulatory Affairs Leader<br>GE Healthcare |
| Trade Name: | Vscan Air |
| Common/Usual Name: | Diagnostic Ultrasound Imaging System |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN;<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Predicate Device: | Vscan Air (K202035) |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN;<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
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Image /page/4/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. There are also three water droplets or stylized swirls surrounding the circle, adding a dynamic element to the design. The logo is simple, recognizable, and represents the brand identity of General Electric.
| Reference Devices: | Vscan Extend (K180995) |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN;<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX<br><br>Venue Go (K220800)<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR, 892.1550 90-IYN;<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Device Description: | Vscan Air™ is a battery-operated general-purpose diagnostic ultrasound<br>imaging system for use by qualified and trained healthcare professionals.<br>It enables ultrasound imaging guidance, visualization and measurement<br>of anatomical structures and fluid.<br><br>Vscan Air consists of an app which can be installed on Android™ or iOS<br>devices, and 2 probes which use wireless technology for communication.<br><br>Its pocket-sized portability and simplified user interface enable<br>integration into training sessions and examinations in professional<br>healthcare facilities (ex. Hospital, clinic, medical office), home<br>environment, road/air ambulance and in other environments. The<br>information can be used for basic/focused assessments and adjunctively<br>with other medical data for clinical diagnosis purposes during routine,<br>periodic follow-up, and triage assessments for adult, pediatric and<br>neonatal patients. Vscan Air can also be useful for interventional<br>guidance. |
| | |
| Intended Use/ Indications<br>for Use: | Vscan Air is a battery-operated software-based general-purpose<br>ultrasound imaging system for use by qualified and trained healthcare<br>professionals or practitioners that are legally authorized or licensed by law<br>in the country, state or other local municipality in which he or she<br>practices. The users may or may not be working under supervision or<br>authority of a physician. Users may also include medical students working<br>under the supervision or authority of a physician during their education /<br>training. The device is enabling visualization and measurement of<br>anatomical structures and fluid including blood flow. |
| | Vscan Air's pocket-sized portability and simplified user interface enables<br>integration into training sessions and examinations in professional<br>healthcare facilities (ex. Hospital, clinic, medical office), home<br>environment, road/air ambulance and other environments as described<br>in the user manual. The information can be used for basic/focused<br>assessments and adjunctively with other medical data for clinical<br>diagnosis purposes during routine, periodic follow-up, and triage. |
| | Vscan Air supports Black/ white (B-mode), Color flow (Color doppler),<br>Pulsed wave Doppler mode, M-mode, combined (B + Color Doppler) and<br>Harmonic Imaging modes with curved, linear and sector array<br>transducers.<br>With the curved array transducer of the dual headed probe solution, the<br>specific clinical applications and exam types include: abdominal,<br>fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and<br>pediatric, 40 kg and above), vascular/peripheral vascular, musculoskeletal<br>(conventional), pediatrics, interventional guidance (includes free hand<br>needle/catheter placement, fluid drainage, nerve block and biopsy). |
| | With the linear array transducer of the dual headed probe solution, the<br>specific clinical applications and exam types include: vascular/peripheral<br>vascular, musculoskeletal (conventional and superficial), small organs,<br>thoracic/lung, ophthalmic, pediatrics, neonatal cephalic, interventional<br>guidance (includes free hand needle/catheter placement, fluid drainage,<br>nerve block, vascular access and biopsy). |
| | With the sector array transducer of the dual headed probe solution, the<br>specific clinical applications and exam types include: cardiac (adult and<br>pediatric, 40 kg and above), abdominal, fetal/obstetrics, gynecological,<br>urology, thoracic/ lung, pediatrics, adult cephalic, interventional guidance<br>(includes free hand needle/catheter placement, fluid drainage, nerve<br>block and biopsy). |
| Technology: | The Vscan Air employs the same fundamental scientific technology as its<br>predicate and reference devices. |
| Determination of<br>Substantial Equivalence: | Comparison to Predicate Devices<br>The Vscan Air system is substantially equivalent to the predicate and<br>reference devices with regards to intended use, capabilities, technological<br>characteristics, safety and effectiveness. |
| | Intended Use/Indications for Use |
| | The systems are intended for diagnostic ultrasound imaging and fluid flow<br>analysis<br>The proposed Vscan Air and the predicate Vscan Air (K202035) have the<br>similar clinical intended use and clinical applications however the<br>following applications are being added to the proposed Vscan Air:<br>• Adult Cephalic, which can be found in reference device Vscan<br>Extend (K180995). |
| | Modes and Transducers |
| | The proposed Vscan Air and the predicate Vscan Air (K202035) both<br>support Black/white (B-mode), Color flow (Color doppler), combined (B +<br>Color Doppler) and Harmonic Imaging modes. In addition, the proposed<br>Vscan Air also supports Pulsed wave Doppler mode and M-mode, which<br>are cleared in reference device Venue Go (K220800).…
