EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)
Device Facts
| Record ID | K234153 |
|---|---|
| Device Name | EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) |
| Applicant | Edgelife Technologies, LLC |
| Product Code | IYN · Radiology |
| Decision Date | Sep 18, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications. The specific clinical applications and exam types for the linear transducer include vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system, non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body. The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, gynecology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric). The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures. The system is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.
Device Story
Handheld, wireless, portable ultrasound system; uses pulsed-echo technology via piezoelectric transducers; acquires/displays B-Mode, M-Mode, Color Doppler, and PW Doppler data. System comprises dual-headed scanner (E8200: convex/linear; E8220: convex/endocavitary), mobile app on iOS device, and wireless Qi charger. Operated by trained healthcare professionals in hospitals/clinics. Scanner transmits images to app via Wi-Fi. Healthcare providers view images on mobile device for diagnostic imaging, measurement, and fluid flow analysis. Facilitates clinical decision-making through real-time visualization and needle guidance. Benefits include portability and wireless operation for point-of-care diagnostics.
Clinical Evidence
Bench testing only. No clinical data. Performance verified via biocompatibility (ISO 10993), electrical/mechanical safety (ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 62359), battery safety (IEC 62133-2), wireless coexistence (ANSI C63.27), and cleaning/disinfection validation (AAMI TIR30/TIR12). Measurement accuracy verified via internal methods.
Technological Characteristics
Handheld wireless ultrasound; piezoelectric transducer elements; 128 elements per transducer. Frequencies: Convex (2-5 MHz), Linear (4-12 MHz), Endocavitary (4-9 MHz). Connectivity: Wi-Fi (IEEE 802.11n/5GHz) with WPA2 security. Power: Internal Li-ion battery, Qi wireless charging. Form factor: Dual-headed probe. Software-controlled via iOS app. Biocompatibility per ISO 10993-1. Acoustic output: Track 3.
Indications for Use
Indicated for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis in adult and pediatric populations. Clinical applications include vascular, musculoskeletal, small organs, thoracic/lung, abdominal, intraoperative, urology, gynecology, obstetrics, fetal, carotid, and cardiac exams, plus interventional needle guidance.
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
- Clarius Ultrasound Scanner (K192107)
Submission Summary (Full Text)
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September 18, 2024
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EdgeLife Technologies LLC % Quinn Place Chief Operating Officer 485 Brickell Avenue Suite 4802 Miami, Florida 33031
Re: K234153
Trade/Device Name: EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 13, 2023 Received: August 23, 2024
Dear Quinn Place:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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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,
# 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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### Indications for Use
510(k) Number (if known) K234153
### Device Name
EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)
### Indications for Use (Describe)
The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable softwarecontrolled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications.
The specific clinical applications and exam types for the linear transducer include vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system, non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body.
The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric).
The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures.
The system is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.
Type of Use (Select one or both, as applicable)
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE . TECHNOLOGIES", with the word "LIFE" in blue, a red dot in the middle, and the word "TECHNOLOGIES" in blue.
## K234153
### EdgeLife Handheld Wireless Ultrasound System - 510(k) Summary
The following 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.
| Subject Device Trade Name: | EdgeLife Handheld Wireless Ultrasound System |
|-------------------------------|----------------------------------------------|
| Subject Device Model Numbers: | E8200, E8220 |
| Common Name: | Diagnostic Ultrasound System and Accessories |
| Regulation Number | Regulation Name | Product Code |
|-------------------|---------------------------------------------|--------------|
| 21 CFR § 892.1550 | Ultrasonic Pulsed Doppler Imaging<br>System | IYN |
| 21 CFR § 892.1560 | Ultrasonic Pulsed Doppler Imaging<br>System | IYO |
| 21 CFR § 892.1570 | Diagnostic Ultrasonic Transducer | ITX |
### Regulation Number, Name and Product Codes 1.1
| FDA 510(k) Review Panel: | Radiology |
|-------------------------------|------------------------------------------------------------------------------------------|
| Classification: | Class II |
| Manufacturer: | Edge Life Technologies<br>485 Brickell Avenue, Suite 4802<br>Miami, Florida 33031 U.S.A. |
| Contact Name: | Quinn Place, Chief Operating Officer<br>qplace@edgelifetech.com |
| Date 510(k) Summary Prepared: | December 20, 2023 |
| Predicate Device: | Vscan Air K202035 |
| Reference Device: | Clarius Ultrasound Scanner K192107 |
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Image /page/5/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is written in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE • TECHNOLOGIES", with the word "LIFE" in black, a red dot in the middle, and the word "TECHNOLOGIES" in black. The logo is simple and modern.
### 1.2 Device Description
The EdgeLife Handheld Wireless Ultrasound System, including Scanners, follows Track 3.
The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes.
The EdgeLife Ultrasound Scanner receives instructions from and transmits images to the EdgeLife Ultrasound App running on a paired mobile device that utilizes the iOS operating system via wireless Wi-Fi communication.
The system is a transportable ultrasound system intended for use in environments where healthcare is provided.
The EdgeLife Handheld Wireless Ultrasound System consists of:
- EdgeLife Handheld Ultrasound Scanner:
- o Model E8200 with convex and linear transducers
- o Model E8220 with convex and endocavitary transducers
- EdgeLife Ultrasound App .
- Standard off-the-shelf Wireless Qi charger (not a medical device) ●
#### Indications for Use 1.2.1
The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications.
The specific clinical applications and exam types for the linear transducer include vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system,
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Image /page/6/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is written in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE • TECHNOLOGIES" in smaller, gray letters. The bullet point between the words "LIFE" and "TECHNOLOGIES" is red.
non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body.
The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, gynecology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric).
The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures.
The system is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.
### 1.2.2 Comparison of Subject Device and Predicate Device
Comparison of intended use and technological characteristics between EdgeLife Handheld Wireless Ultrasound Scanner and the predicate device, Vscan Air, is presented in the following table.
| | EdgeLife Handheld<br>Wireless Ultrasound<br>System | Vscan Air<br>(K202035) | Substantial Equivalence<br>Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Scanner Type | Dual-Headed | Dual-Headed | Same |
| Transducer | Convex and Linear<br>(E8200)<br>Convex and Endocavitary<br>(E8220) | Convex and<br>Linear | Similar |
| | | | The subject and predicate<br>have the same convex and<br>linear transducers. The<br>subject device also<br>includes an endocavitary<br>transducer on one of the<br>dual headed probes.<br>Endocavitary transducers<br>are commonly found in<br>current ultrasound systems<br>including the predicate<br>device. Performance test<br>results support that this |
| | EdgeLife Handheld<br>Wireless Ultrasound<br>System | Vscan Air<br>(K202035) | Substantial Equivalence<br>Comparison |
| | | | difference does not raise<br>new questions of safety<br>and effectiveness. |
| Classification | Class II | Class II | Same |
| Product Codes | IYN, IYO, ITX | ITX, IYN,<br>IYO | Same |
| Clinical Settings | Hospitals, clinics and other<br>professional healthcare<br>facility settings | Hospitals,<br>clinics and<br>medical office<br>settings, home,<br>emergency<br>environments | Similar. The only<br>difference is that the<br>subject device is not<br>intended for use in home<br>health or road/air<br>ambulance environments.<br>This difference does not<br>raise new questions of<br>safety and effectiveness. |
| Users | Trained Healthcare<br>professionals | Trained<br>Healthcare<br>professionals | Same |
| Patient<br>Population | adult and pediatric | adult and<br>pediatric | Same |
| Intended Use | Diagnostic ultrasound<br>imaging and fluid flow<br>analysis. | Diagnostic<br>ultrasound<br>imaging and<br>fluid flow<br>analysis | Same |
| Indications for<br>Use | The EdgeLife Handheld<br>Wireless Ultrasound<br>System is a<br>general-purpose, handheld,<br>wireless, portable<br>software-controlled<br>ultrasonic diagnostic<br>system that uses<br>pulsed-echo technology to<br>acquire and display<br>ultrasound data in B-Mode,<br>M-Mode, Color Doppler,<br>and Pulse-Wave Doppler<br>(PW) modes. The<br>EdgeLife Handheld<br>Wireless Ultrasound<br>System is intended for | Refer to<br>K202035<br>510(k)<br>Summary. | Similar. Both subject and<br>predicate devices are<br>intended for diagnostic<br>ultrasound echo imaging,<br>measurement and analysis<br>of the human body for the<br>same applications.<br>The subject device also<br>includes an endocavitary<br>transducer that allows for<br>clinical applications<br>including gynecology,<br>obstetrics, urology,<br>transvaginal, transrectal,<br>and interventional<br>procedures. These |
| EdgeLife Handheld<br>Wireless Ultrasound<br>System | Vscan Air<br>(K202035) | Substantial Equivalence<br>Comparison | |
| imaging, measurement,<br>and fluid flow analysis of<br>the human body for the<br>following clinical<br>applications.<br><br>The specific clinical<br>applications and exam<br>types for the linear<br>transducer include<br>vascular/peripheral<br>vascular, musculoskeletal<br>(conventional and<br>superficial), small organs,<br>thoracic/lung, abdominal,<br>intraoperative (excluding<br>neurological, central<br>nervous system,<br>non-central cardiovascular<br>system), urology,<br>gynecology, pediatric,<br>fetal, peripheral vessel,<br>carotid, interventional and<br>procedure guidance of<br>needles into the body.<br><br>The specific clinical<br>applications and exam<br>types for the convex<br>transducer include:<br>abdominal, pulmonary,<br>thoracic, intra-operative<br>(abdominal organs &<br>vascular), pediatric, small<br>organ, urology,<br>gynecology, obstetrics,<br>musculoskeletal<br>(conventional and<br>superficial), vascular,<br>carotid, and cardiac (adult<br>and pediatric). | | application types are<br>found in other legally<br>marketed ultrasound<br>systems including the<br>Reference Device and are<br>not novel. Performance<br>data support the<br>indications for use.<br>Therefore, these<br>differences do not raise<br>new questions of safety<br>and effectiveness. | |
| | EdgeLife Handheld<br>Wireless Ultrasound<br>System | Vscan Air<br>(K202035) | Substantial Equivalence<br>Comparison |
| | The specific clinical<br>applications and exam<br>types for the Endocavitary<br>transducer include<br>gynecology, obstetrics,<br>urology, transvaginal,<br>transrectal, and<br>interventional procedures.<br><br>The system is a portable<br>ultrasound system intended<br>for use in environments<br>where healthcare is<br>provided by trained<br>healthcare professionals. | | |
| Portability | Handheld portable | Handheld<br>portable | Same |
| System<br>Components | Dual-headed probes<br>Mobile app<br>Charger | Dual-headed<br>probe<br>Mobile app<br>Charger | Same. |
| Frequency | Convex:2-5 MHz with<br>center frequency of 3.2<br>MHz<br>Linear 4-12 MHz, with<br>center frequency of 7.5<br>MHz<br>Endocavitary: 4-9 MHz<br>with the center frequency<br>of 6.5 MHz | Convex: from<br>2 - 5 MHz with<br>center<br>frequency of<br>3.3 MHz<br>Linear: From 3<br>- 12 MHz with<br>center<br>frequency of<br>7.7 MHz | Similar. The differences<br>don't raise any issues<br>about safety and<br>effectiveness of the<br>device. |
| Elements | All transducers have 128<br>elements | GE: Linear<br>192, convex:<br>192 | Similar. The differences<br>don't raise any issues<br>about safety and<br>effectiveness of the<br>device. |
| Display | iOS device | iOS or Android<br>device | Similar. This difference<br>does not raise new<br>questions of safety or<br>effectiveness. |
| | EdgeLife Handheld<br>Wireless Ultrasound<br>System | Vscan Air<br>(K202035) | Substantial Equivalence<br>Comparison |
| Software | Mobile app downloads on<br>iOS viewing device | Mobile app<br>downloads on<br>iOS and<br>Android<br>viewing device | Similar. This difference<br>does not raise new<br>questions of safety or<br>effectiveness. |
| Image Format | JPG and DICOM, DICOM<br>transfer to PACS or<br>imaging archive systems | JPG and<br>DICOM,<br>DICOM<br>transfer to<br>PACS or<br>imaging<br>archive<br>systems | Same |
| Penetration depth | Convex up to 30 cm<br>Linear < 8 cm<br>Endocavity < 12 cm | Convex up to<br>24 cm and<br>linear up to 8<br>cm | Similar.<br>The linear end has the<br>same maximum<br>penetration depth.<br>Performance data support<br>that the penetration depths<br>of the Subject devices<br>don't raise any issues<br>about safety and<br>effectiveness of the<br>device. |
| Principle of<br>Operation | Piezoelectric transducer<br>elements. | Piezoelectric<br>transducer<br>elements | Same. |
| Power Source | Built in lithium-ion<br>Battery | Built in<br>lithium-ion<br>Battery | Same |
| Charging Plate | Anker and other off-the<br>shelf charging plates. | Anker | Similar. The performance<br>doesn't raise any issues<br>about safety and<br>effectiveness of the<br>device. |
| Battery And<br>Charging…
