Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)
Device Facts
| Record ID | K172750 |
|---|---|
| Device Name | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) |
| Applicant | Guangzhou Sonostar Technologies Co., Ltd. |
| Product Code | IYO · Radiology |
| Decision Date | Feb 28, 2018 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C) (frequency: 3.5Hz, module: convex) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetries (OB). gynecology (GY) and general (abdominal) imaging. The Wireless Probe Type Ultrasound Scanner (Model: UProbe-L) (frequency: 7.5Hz, module: linear) is intended for diagnostic ultrasound echo imaging, and analysis of the human body for general clinical applications including small organ and peripheral vessel imaging. The Wireless Probe Type Ultrasound Scanner (Model: BProbe) is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
Device Story
Wireless, hand-held, battery-operated ultrasound transducer; transmits pulsed-echo ultrasound waves into body; reflected echoes converted to electrical signals; wireless transmission to iOS mobile device (iPad/iPhone). Software app on mobile device processes signals; displays B-mode or BM-mode images. Used by healthcare professionals in hospitals, clinics, and medical offices. BProbe model specifically calculates bladder volume. Benefits include portability and non-invasive diagnostic imaging.
Clinical Evidence
No clinical data. Bench testing only. Safety and effectiveness verified via biocompatibility (ISO 10993-5/10), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance safety (IEC 60601-2-37).
Technological Characteristics
Piezoelectric transducer; wireless connectivity; iOS-based mobile display; battery-operated. Models: UProbe-C (3.5MHz convex), UProbe-L (7.5MHz linear), BProbe (3.5MHz mechanical sector). Standards: ISO 10993-5/10 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasound performance), FCC Part 15 (RF).
Indications for Use
Indicated for diagnostic ultrasound imaging, measurement, and analysis. UProbe-C: OB, GY, abdominal imaging. UProbe-L: small organ, peripheral vessel imaging. BProbe: non-invasive bladder volume calculation in non-pregnant patients. Contraindicated for fetal use, pregnant patients, patients allergic to coupling agents, or patients with abdominal wounds/skin disease.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- SONON Ultrasound Imaging System (Model: SONON 300C) (K151339)
- Penrith Elettra Ultrasound System (K100598)
- Palm Bladder Scanner - PBSV4.1 (K130229)
Submission Summary (Full Text)
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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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
February 28, 2018
Guangzhou Sonostar Technologies Co., Ltd. % Ms. Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302, NO.21 Building, Kaiyu Garden, Xishan South Road Wenzhou. Zhejiang 325000 CHINA
# Re: K172750
Trade/Device Name: Wireless Probe Type Ultrasound Scanner (Model: UProbe-L; BProbe) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: February 7, 2018 Received: February 7, 2018
Dear Ms. Nan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mechant D. O'Hara For
Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K172750
Device Name Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; U-Probe-L; BProbe)
Indications for Use (Describe)
The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C) (frequency: 3.5Hz, module: convex) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetries (OB). gynecology (GY) and general (abdominal) imaging.
The Wireless Probe Type Ultrasound Scanner (Model: UProbe-L) (frequency: 7.5Hz, module: linear) is intended for diagnostic ultrasound echo imaging, and analysis of the human body for general clinical applications including small organ and peripheral vessel imaging.
The Wireless Probe Type Ultrasound Scanner (Model: BProbe) is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
2 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 contains the logo for SonoStar. The logo features a green star with a green outline on the left side of the image. To the right of the star is the text "SonoStar" in green font.
| System: | Wireless Probe Type Ultrasound Scanner (Model: UProbe-C) | | | | | | | |
|----------------------------|------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-----------------|
| Transducer: | 3.5MHz, Convex | | | | | | | |
| Intended use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(PDI) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | | | | | N - Note 1 | |
| | Abdominal | N | | | | | N - Note 1 | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-Operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ<br>(breast, thyroid) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| Fetal<br>Imaging<br>&Other | Other (Gynecology) | N | | | | | N - Note 1 | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-epoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
### Diagnostic Ultrasound Indications For Use Format
N=new indication; P=previously cleared by FDA; E=added under this appendix
* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Note 1: B and M Combined
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Image /page/4/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a green outline on the left side of the image. To the right of the star is the text "SonoStar" in a green, sans-serif font.
| System: | Wireless Probe Type Ultrasound Scanner (Model: UProbe-L) | | | | | | | |
|--------------------------------------------------------------------------------------------------|----------------------------------------------------------|---|---|-----|-----|------------------|-----------------------|-----------------|
| Transducer: | 7.5MHz, Linear | | | | | | | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(PDI) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-Operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ<br>(breast, thyroid) | N | | | | | | N - Note 1 |
| Fetal<br>Imaging<br>&Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-epoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | N | | | | | | N - Note 1 |
| | Other (Specify) | | | | | | | |
### Diagnostic Ultrasound Indications For Use Format
N=new indication; P=previously cleared by FDA; E=added under this appendix
* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Note 1: B and M Combined_
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Image /page/5/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a green outline on the left side of the image. To the right of the star is the text "SonoStar" in green font.
| System: | Diagnostic Ultrasound Indications For Use Format<br>Wireless Probe Type Ultrasound Scanner (Model: BProbe) | | | | | | | |
|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-----------------|
| Transducer: | 3.5MHz | | | | | | | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(PDI) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | N | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-Operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ<br>(breast, thyroid) | | | | | | | |
| Fetal<br>Imaging<br>&Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Gynecology) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-epoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | | | | | | | |
| | Other (Bladder) | N | | | | | | |
#### Diagnostic Ultrasound Indications For Use Format
N=new indication; P=previously cleared by FDA; E=added under this appendix
* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
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Image /page/6/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a green outline on the left side of the image. To the right of the star is the text "SonoStar" in a green, sans-serif font. The text is slightly bolded and the letters are evenly spaced.
## 007 510(k) Summary
(As required by 21 CFR 807.92(a))
## 7.1 Submitter Information
- · Company: Guangzhou Sonostar Technologies Co., Ltd.
- · Address: 504#, C Building, #27 Yayingshi Road, Science Town,
Guangzhou, Guangdong, 510665, P.R.China
- ・ Phone: 086-20-32382095
- ・Fax: 086-20-62614030
- · Contact: Weizhong Cai, General Manager
- · Date: June 01, 2017
## 7.2 Device Information
· Trade/Device Name: Wireless Probe Type Ultrasound Scanner (Model:
UProbe-C; UProbe-L; BProbe)
- · Common Name: Diagnostic Ultrasound System and Transducer
- · Classification: 1) Device: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Description: Ultrasonic pulsed echo imaging
system
Review Panel: Radiology
Product Code: IYO
Regulation Number: 21 CFR 892.1560
Device Class: 2
- 2) Device: Transducer, Ultrasonic, Diagnostic
Regulation Description: Diagnostic ultrasonic transducer
Review Panel: Radiology
Product Code: ITX
Regulation Number: 21 CFR 892.1570
Device Class: 2
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Image /page/7/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a green outline. To the right of the star is the word "SonoStar" in green, with the first letter capitalized. The logo is simple and clean, and the green color gives it a fresh and modern look.
## 7.3 Predicate Device Information
## Predicate Device 1:
SONON Ultrasound Imaging System (Model: SONON 300C)
submitted by HEALCERION Co., Ltd.
510K Number: K151339
# Predicate Device 2:
Penrith Elettra Ultrasound System submitted by Penrith Corporation 510K Number: K100598
# Predicate Device 3:
Palm Bladder Scanner - PBSV4.1 submitted by Mianyang Meike Electronic Equipment Co., Ltd. 510K Number: K130229
# 7.4 Device Description
The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) is a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS operating system.
The mobile device for use with the Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) are those that utilizes the iOS operating system, i.e. all series of iPad or iPhone from Apple Inc.
The Wireless Probe Type Ultrasound Scanner is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS mobile device, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound
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Image /page/8/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star on the left side, with the word "SonoStar" in green, bold letters to the right of the star. The star has a thin green outline and is filled with a lighter shade of green.
Scanner transducer that communicates wirelessly with iOS mobile devices, and (iv) the instructions for use manual, USB Cable for Charging, wrist wrap.
The Wireless Probe Type Ultrasound Scanner utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
The device components are not supplied sterile and do not require sterilization prior to use.
# 7.5 Indications for Use
The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C) (frequency: 3.5Hz, module: convex) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging.
The Wireless Probe Type Ultrasound Scanner (Model: UProbe-L) (frequency: 7.5Hz, module: linear) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including small organ and peripheral vessel imaging.
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Image /page/9/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star outline on the left side of the image. To the right of the star is the word "SonoStar" in green, sans-serif font.
The Wireless Probe Type Ultrasound Scanner (Model: BProbe) is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
# 7.6 Comparison of Technological Characteristics with the Predicate Device
7.6.1 Comparison Table of Technological Characteristic with the Predicate Device for Model: UProbe-C
| Comparison Items | Subject Device:<br>Wireless Probe Type<br>Ultrasound Scanner<br>(Model: UProbe-C) | Predicate Device 1:<br>SONON Ultrasound<br>Imaging System<br>(Model: SONON<br>300C)<br>(K151339) |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification & Intended Use | | |
| Classification | IYO & ITX<br>Class 2 | IYO & ITX<br>Class 2 |
| Intended Use | Intended for diagnostic<br>ultrasound echo<br>imaging, measurement,<br>and analysis of the<br>human body for general<br>clinical applications<br>including obstetrics<br>(OB), gynecology (GY) | Intended for diagnostic<br>ultrasound echo<br>imaging, measurement,<br>and analysis of the<br>human body for general<br>clinical applications<br>including obstetrics<br>(OB), gynecology (GY) |
| | and general<br>(abdominal) imaging. | and general<br>(abdominal) imaging. |
| Technological Characteristics | | |
| Environment of Use | Hospital, clinic, and<br>medical office settings | Hospital, clinic, and<br>medical office settings |
| Acoustic Output Levels | Below Track 3 FDA<br>limits in accordance<br>with Sept. 2008<br>ultrasound systems<br>guidance document | Below Track 3 FDA<br>limits in accordance<br>with Sept. 2008<br>ultrasound systems<br>guidance document |
| Imaging Capacities | • pulsed-echo<br>ultrasound<br>• Mode B (2D) scan<br>• Mode BM scan | • pulsed-echo<br>ultrasound<br>• Mode B (2D) scan |
| Patient Population | For use in all patients | For use in all patients |
| Anatomic Structures /<br>Clinical applications | General clinical<br>applications, including<br>fetal\obstetrics,<br>gynecology, abdominal | General clinical<br>applications, including<br>fetal\obstetrics,<br>gynecology, abdominal |
| Users | Healthcare<br>professionals | Healthcare<br>professionals |
| Principle / Method of<br>Operation | Piezoelectric material<br>in the transducer is<br>used as an ultrasound<br>source to transmit<br>sound waves into the<br>body. Sound waves are<br>reflected back to the | Piezoelectric material<br>in the transducer is<br>used as an ultrasound<br>source to transmit<br>sound waves into the<br>body. Sound waves are<br>reflected back to the |
| | transducer and | transducer and |
| | converted to electrical | converted to electrical |
| | signals that are | signals that are |
| | processed and | processed and |
| | displayed as images of | displayed as images of |
| | anatomic structures. | anatomic structures. |
| Image Display Unit | Mobile device (4 to 13 | Mobile device (4 to 10 |
| | inches approximately) | inches approximately) |
| Probe Characteristics | Convex, 3.5 MHz | Convex, 3.5 MHz |
| | frequency; | frequency |
| Probe Connection to | Wireless | Wireless |
| Display | | |
| Off-the-shelf operating | iOS | iOS / Android |
| system | | |
| Software | Run as an app on | Run as an app on |
| | off-the-shelf mobile | off-the-shelf mobile |
| | device | device |
| System Components | • Commercial | • Commercial |
| | off-the-shelf iOS | off-the-shelf iOS or |
| | mobile device, | Android mobile device, |
| | • Wireless Probe Type | • SONON Ultrasound |
| | Ultrasound Scanner | Imaging System |
| | software that runs as an | software that runs as an |
| | app on the mobile | app on the mobile |
| | device, | device, |
| | • Wireless Probe Type | • SONON Ultrasound |
| | Ultrasound Scanner | Imaging System |
| | battery-operated, | battery-operated, |
| | hand-held ultrasound<br>diagnostic transducer<br>that communicates<br>wirelessly with iOS<br>mobile devices | hand-held ultrasound<br>diagnostic transducer<br>that communicates<br>wirelessly with iOS or<br>Android mobile devices |
| Safety & Effectiveness | | |
| Patient-Contacting<br>Materials | Evaluated according to<br>FDA recognized<br>standards - ISO<br>10993-5 and ISO<br>10993-10 | All materials with<br>patient contact are<br>biocompatible and can<br>be disinfected |
| Electrical Safety | Evaluated according to<br>IEC 60601-1 | Evaluated according to<br>IEC 60601-1 |
| EMC | Evaluated according to<br>IEC 60601-1-2 | Evaluated according to<br>IEC 60601-1-2 |
| Performance Safety | Evaluated according to<br>IEC 60601-2-37 | Evaluated according to<br>IEC 60601-2-37 |
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Image /page/10/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a green outline on the left side of the image. To the right of the star is the word "SonoStar" in green, with the "S" in "SonoStar" being larger than the other letters.
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Image /page/11/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with the word "SonoStar" written in green, bold font. The star is positioned to the left of the text.
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Image /page/12/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star on the left side of the image. To the right of the star is the text "SonoStar" in a green, sans-serif font.
## Brief Summary
First, the subject device (Model: UProbe-C) enjoys identical classification and intended use with the predicate device 1, which forms the foundation of their substantial equivalence.
Secondly, the subject device (Model: UProbe-C) boasts almost the same technological characteristics with the predicate device 1. And their slight differences in imaging capacities, image display unit and off-the-shelf operating system will not affect the core usage of the two devices, thus will not affecting the substantial equivalence comparison between the two devices. Such fact further supports that the two devices are substantial equivalent.
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Image /page/13/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a yellow outline on the left side of the image. To the right of the star is the word "SonoStar" in green, with the "S" in "Sono" being slightly larger than the rest of the letters.
Last but not least, the safety and effectiveness of the subject device (Model: UProbe-C) have been evaluated according to the same FDA recognized standards as the predicate device 1, which ensures that the subject device will be safe and effective for usage as the predicate device, that the two devices are substantial equivalent.
As a result, it is reasonable to conclude that subject device (Model:
UProbe-C) is substantial equivalent with predicate device 1.
# 7.6.2 Comparison Table of Technological Characteristic with the Predicate Device for Model: UProbe-L
| Comparison<br>Items | Subject Device:<br>Wireless Probe<br>Type<br>Ultrasound<br>Scanner<br>(Model:<br>UProbe-L) | Predicate<br>Device 1:<br>SONON<br>Ultrasound<br>Imaging System<br>(Model:<br>SONON 300C)<br>(K151339) | Predicate<br>Device 2:<br>Penrith Elettra<br>Ultrasound<br>System<br>(K100598) |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification & Intended Use | | | |
| Classification | IYO & ITX<br>Class 2 | IYO & ITX<br>Class 2 | IYN & IYO &<br>ITX - Class 2 |
| Intended Use | Intended for<br>diagnostic<br>ultrasound echo<br>imaging,<br>measurement,<br>and analysis of<br>the human body | Intended for<br>diagnostic<br>ultrasound echo<br>imaging,<br>measurement,<br>and analysis of<br>the human body | Intended for<br>diagnostic<br>imaging or fluid<br>flow analysis of<br>the human body<br>including: fetal,<br>abdominal, |
| | | | |
| | for general<br>clinical<br>applications<br>including small<br>organ and<br>peripheral vessel<br>imaging. | for general<br>clinical<br>applications<br>including<br>obstetrics (OB),<br>gynecology<br>(GY) and general<br>(abdominal)<br>imaging. | intraoperative,<br>intraoperative<br>neurological,<br>pediatric, small<br>organ, neonatal,<br>cephalic, cardiac,<br>peripheral vessel,<br>musculoskeletal<br>(conventional),<br>musculoskeletal<br>(superficial). |
| Technological Characteristics | | | |
| Environment of<br>Use | Hospital, clinic,<br>and medical<br>office settings | Hospital, clinic,<br>and medical<br>office settings | Hospital, clinic,<br>and medical<br>office settings |
| Acoustic Output<br>Levels | Below Track 3<br>FDA limits in<br>accordance with<br>Sept. 2008<br>ultrasound<br>systems<br>guidance<br>document | Below Track 3<br>FDA limits in<br>accordance with<br>Sept. 2008<br>ultrasound<br>systems<br>guidance<br>document | Below Track 3<br>FDA limits in<br>accordance with<br>Sept. 2008<br>ultrasound<br>systems<br>guidance<br>document |
| Imaging<br>Capacities | • pulsed-echo<br>ultrasound<br>• Mode B (2D)<br>scan<br>• Mode BM scan | • pulsed-echo<br>ultrasound<br>• Mode B (2D)<br>scan | • pulsed-echo<br>and Doppler<br>ultrasound<br>• Mode B (2D),<br>Color, Amplitude |
| | | | Doppler |
| Patient<br>Population | For use in all<br>patients | For use in all<br>patients | For use in all<br>patients |
| Anatomic<br>Structures /<br>Clinical<br>applications | General clinical<br>applications,<br>including small<br>organ and<br>peripheral vessel | General clinical<br>applications,<br>including<br>fetal\obstetrics,<br>gynecology,<br>abdominal | General clinical<br>applications,<br>including fetal,<br>abdominal,<br>intraoperative,<br>pediatric, small<br>organ, cephalic,<br>cardiac,<br>peripheral vessel,<br>and<br>musculoskeletal |
| Users | Healthcare<br>professionals | Healthcare<br>professionals | Healthcare<br>professionals |
| Principle /<br>Method of<br>Operation | Piezoelectric<br>material in the<br>transducer is<br>used as an<br>ultrasound<br>source to<br>transmit sound<br>waves into the<br>body. Sound<br>waves are<br>reflected back to | Piezoelectric<br>material in the<br>transducer is<br>used as an<br>ultrasound<br>source to<br>transmit sound<br>waves into the<br>body. Sound<br>waves are<br>reflected back to | Piezoelectric<br>material in the<br>transducer is<br>used as an<br>ultrasound<br>source to<br>transmit sound<br>waves into the<br>body. Sound<br>waves are<br>reflected back to |
| | the transducer<br>and converted to<br>electrical signals<br>that are<br>processed and<br>displayed as<br>images of<br>anatomic<br>structures. | the transducer<br>and converted to<br>electrical signals<br>that are<br>processed and<br>displayed as<br>images of<br>anatomic<br>structures. | the transducer<br>and converted to<br>electrical signals<br>that are<br>processed and<br>displayed as<br>images of<br>anatomic<br>structures. |
| Image Display<br>Unit | Mobile device (4<br>to 13 inches<br>approximately) | Mobile device (4<br>to 10 inches<br>approximately) | Video display<br>(unknown size) |
| Probe<br>Characteristics | Linear, 7.5MHz<br>frequency | Convex, 3.5MHz<br>frequency | L8-3 linear,<br>L12-5 linear, and<br>C5-2 curvilinear |
| Probe<br>Connection to<br>Display | Wireless | Wireless | Wireless or<br>wired |
| Off-the-shelf<br>operating system | iOS | iOS / Android | Unknown |
| Software | Run as an app on<br>off-the-shelf<br>mobile device | Run as an app on<br>off-the-shelf<br>mobile device | Unknown |
| System<br>Components | • Commercial<br>off-the-shelf iOS<br>mobile device,<br>• Wireless Probe<br>Type Ultrasound | • Commercial<br>off-the-shelf iOS<br>or Android<br>mobile device,<br>• SONON | • System console<br>housing<br>electronic<br>circuitry<br>• Video display |
| | Scanner software | Ultrasound | • Power supply |
| | that runs as an | Imaging System | • User controls |
| | app on the | software that | • Transducers |
| | mobile device, | runs as an app on | (L8-3 linear, |
| | • Wireless Probe | the mobile | L12-5 linear, |
| | Type Ultrasound | device, | C5-2 curvilinear) |
|…
