Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound technology and image processing without mentioning AI, ML, or related concepts.

Therapeutic

No.
The device is intended for diagnostic ultrasound echo imaging, measurement, and analysis, not for therapeutic purposes.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body." Furthermore, the "Device Description" calls it a "hand-held diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer, which is a hardware component responsible for emitting and receiving ultrasound waves. While it includes software, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
Device Function: The Wireless Probe Type Ultrasound Scanner uses ultrasound waves to create images of structures within the human body. It does not analyze samples taken from the body.
Intended Use: The intended use clearly states "diagnostic ultrasound echo imaging, measurement, and analysis of the human body" and "project ultrasound energy through the lower abdomen... to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively." This describes in-vivo imaging, not in-vitro testing.

Therefore, this device falls under the category of medical imaging devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

IYO, ITX

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 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Human body (general clinical applications), obstetrics (OB), gynecology (GY), general (abdominal), small organ, peripheral vessel, lower abdomen (for bladder), breast, thyroid

Indicated Patient Age Range

For Model: UProbe-C and UProbe-L: For use in all patients
For Model: BProbe: nonpregnant patient, Adult and Children

Intended User / Care Setting

Healthcare professionals in Hospital, clinic, and medical office settings.

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)

Non-Clinical Tests were performed to ensure effectiveness and safety, including:

Biocompatibility according to AAMI / ANSI / ISO 10993-5:2009/(R)2014 and AAMI / ANSI / ISO 10993-10:2010/(R)2014.
Electrical Safety according to AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text).
Electromagnetic Compatibility according to AAMI / ANSI / IEC 60601-1-2:2007/(R)2012.
Performance Safety and Effectiveness according to IEC 60601-2-37 Edition 2.0 2007.
FCC Radio Frequency Testing according to FCC CFR Title 47 Part 15 Subpart C Section 15.247.

Clinical testing was not performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K151339, K100598, K130229

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

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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.

1

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

2

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
(Track 1 Only)	Specific
(Track 1&3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(PDI)
Ophthalmic	Ophthalmic
	Fetal	N				N - Note 1
	Abdominal	N				N - Note 1
	Intra-operative (Specify)
	Intra-Operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ
(breast, thyroid)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Fetal
Imaging
&Other	Other (Gynecology)	N				N - Note 1
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-epoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
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
(Track 1 Only)	Specific
(Track 1&3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(PDI)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-Operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ
(breast, thyroid)	N					N - Note 1
Fetal
Imaging
&Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-epoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
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
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
(Track 1 Only) | Specific
(Track 1&3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other*
(PDI) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | N | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-Operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ
(breast, thyroid) | | | | | | | |
| Fetal
Imaging
&Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Gynecology) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-epoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
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

1. 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.

9

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:
Wireless Probe Type
Ultrasound Scanner
(Model: UProbe-C) | Predicate Device 1:
SONON Ultrasound
Imaging System
(Model: SONON
300C)
(K151339) |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification & Intended Use | | |
| Classification | IYO & ITX
Class 2 | IYO & ITX
Class 2 |
| Intended Use | Intended for diagnostic
ultrasound echo
imaging, measurement,
and analysis of the
human body for general
clinical applications
including obstetrics
(OB), gynecology (GY) | 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. | and general
(abdominal) imaging. |
| Technological Characteristics | | |
| Environment of Use | Hospital, clinic, and
medical office settings | Hospital, clinic, and
medical office settings |
| Acoustic Output Levels | Below Track 3 FDA
limits in accordance
with Sept. 2008
ultrasound systems
guidance document | Below Track 3 FDA
limits in accordance
with Sept. 2008
ultrasound systems
guidance document |
| Imaging Capacities | • pulsed-echo
ultrasound
• Mode B (2D) scan
• Mode BM scan | • pulsed-echo
ultrasound
• Mode B (2D) scan |
| Patient Population | For use in all patients | For use in all patients |
| Anatomic Structures /
Clinical applications | General clinical
applications, including
fetal\obstetrics,
gynecology, abdominal | General clinical
applications, including
fetal\obstetrics,
gynecology, abdominal |
| Users | Healthcare
professionals | Healthcare
professionals |
| Principle / Method of
Operation | Piezoelectric material
in the transducer is
used as an ultrasound
source to transmit
sound waves into the
body. Sound waves are
reflected back to the | Piezoelectric material
in the transducer is
used as an ultrasound
source to transmit
sound waves into the
body. Sound waves are
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
diagnostic transducer
that communicates
wirelessly with iOS
mobile devices | hand-held ultrasound
diagnostic transducer
that communicates
wirelessly with iOS or
Android mobile devices |
| Safety & Effectiveness | | |
| Patient-Contacting
Materials | Evaluated according to
FDA recognized
standards - ISO
10993-5 and ISO
10993-10 | All materials with
patient contact are
biocompatible and can
be disinfected |
| Electrical Safety | Evaluated according to
IEC 60601-1 | Evaluated according to
IEC 60601-1 |
| EMC | Evaluated according to
IEC 60601-1-2 | Evaluated according to
IEC 60601-1-2 |
| Performance Safety | Evaluated according to
IEC 60601-2-37 | Evaluated according to
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.

11

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.

12

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
Items | Subject Device:
Wireless Probe
Type
Ultrasound
Scanner
(Model:
UProbe-L) | Predicate
Device 1:
SONON
Ultrasound
Imaging System
(Model:
SONON 300C)
(K151339) | Predicate
Device 2:
Penrith Elettra
Ultrasound
System
(K100598) |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification & Intended Use | | | |
| Classification | IYO & ITX
Class 2 | IYO & ITX
Class 2 | IYN & IYO &
ITX - Class 2 |
| Intended Use | Intended for
diagnostic
ultrasound echo
imaging,
measurement,
and analysis of
the human body | Intended for
diagnostic
ultrasound echo
imaging,
measurement,
and analysis of
the human body | Intended for
diagnostic
imaging or fluid
flow analysis of
the human body
including: fetal,
abdominal, |
| | | | |
| | for general
clinical
applications
including small
organ and
peripheral vessel
imaging. | for general
clinical
applications
including
obstetrics (OB),
gynecology
(GY) and general
(abdominal)
imaging. | intraoperative,
intraoperative
neurological,
pediatric, small
organ, neonatal,
cephalic, cardiac,
peripheral vessel,
musculoskeletal
(conventional),
musculoskeletal
(superficial). |
| Technological Characteristics | | | |
| Environment of
Use | Hospital, clinic,
and medical
office settings | Hospital, clinic,
and medical
office settings | Hospital, clinic,
and medical
office settings |
| Acoustic Output
Levels | Below Track 3
FDA limits in
accordance with
Sept. 2008
ultrasound
systems
guidance
document | Below Track 3
FDA limits in
accordance with
Sept. 2008
ultrasound
systems
guidance
document | Below Track 3
FDA limits in
accordance with
Sept. 2008
ultrasound
systems
guidance
document |
| Imaging
Capacities | • pulsed-echo
ultrasound
• Mode B (2D)
scan
• Mode BM scan | • pulsed-echo
ultrasound
• Mode B (2D)
scan | • pulsed-echo
and Doppler
ultrasound
• Mode B (2D),
Color, Amplitude |
| | | | Doppler |
| Patient
Population | For use in all
patients | For use in all
patients | For use in all
patients |
| Anatomic
Structures /
Clinical
applications | General clinical
applications,
including small
organ and
peripheral vessel | General clinical
applications,
including
fetal\obstetrics,
gynecology,
abdominal | General clinical
applications,
including fetal,
abdominal,
intraoperative,
pediatric, small
organ, cephalic,
cardiac,
peripheral vessel,
and
musculoskeletal |
| Users | Healthcare
professionals | Healthcare
professionals | Healthcare
professionals |
| Principle /
Method of
Operation | Piezoelectric
material in the
transducer is
used as an
ultrasound
source to
transmit sound
waves into the
body. Sound
waves are
reflected back to | Piezoelectric
material in the
transducer is
used as an
ultrasound
source to
transmit sound
waves into the
body. Sound
waves are
reflected back to | Piezoelectric
material in the
transducer is
used as an
ultrasound
source to
transmit sound
waves into the
body. Sound
waves are
reflected back to |
| | the transducer
and converted to
electrical signals
that are
processed and
displayed as
images of
anatomic
structures. | the transducer
and converted to
electrical signals
that are
processed and
displayed as
images of
anatomic
structures. | the transducer
and converted to
electrical signals
that are
processed and
displayed as
images of
anatomic
structures. |
| Image Display
Unit | Mobile device (4
to 13 inches
approximately) | Mobile device (4
to 10 inches
approximately) | Video display
(unknown size) |
| Probe
Characteristics | Linear, 7.5MHz
frequency | Convex, 3.5MHz
frequency | L8-3 linear,
L12-5 linear, and
C5-2 curvilinear |
| Probe
Connection to
Display | Wireless | Wireless | Wireless or
wired |
| Off-the-shelf
operating system | iOS | iOS / Android | Unknown |
| Software | Run as an app on
off-the-shelf
mobile device | Run as an app on
off-the-shelf
mobile device | Unknown |
| System
Components | • Commercial
off-the-shelf iOS
mobile device,
• Wireless Probe
Type Ultrasound | • Commercial
off-the-shelf iOS
or Android
mobile device,
• SONON | • System console
housing
electronic
circuitry
• 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) |
| | Scanner | • SONON | that |
| | battery-operated, | Ultrasound | communicate |
| | hand-held | Imaging System | wirelessly or via |
| | ultrasound | battery-operated, | wire with system |
| | diagnostic | hand-held | console |
| | transducer that | ultrasound | |
| | communicates | diagnostic | |
| | wirelessly with | transducer that | |
| | iOS mobile | communicates | |
| | devices | wirelessly with | |
| | | iOS or Android | |
| | | mobile devices | |
| Safety & Effectiveness | | | |
| Patient-Contactin | Evaluated | All materials | All materials |
| g Materials | according to | with patient | with patient |
| | FDA recognized | contact are | contact are |
| | standards - ISO | biocompatible | biocompatible |
| | 10993-5 and ISO | and can be | |
| | 10993-10 | disinfected | |
| Electrical Safety | Evaluated | Evaluated | Unknown |
| | according to IEC | according to IEC | |
| | 60601-1 | 60601-1 | |
| EMC | Evaluated
according to IEC
60601-1-2 | Evaluated
according to IEC
60601-1-2 | Unknown |
| Performance
Safety | Evaluated
according to IEC
60601-2-37 | Evaluated
according to IEC
60601-2-37 | Unknown |

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Image /page/14/Picture/0 description: The image features the logo for SonoStar. The logo consists of a five-pointed star in a light green color, positioned to the left of the company name. The text "SonoStar" is written in a bold, sans-serif font, also in a matching shade of green, creating a cohesive and recognizable brand identity.

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Image /page/15/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star on the left side, with the word "SonoStar" written in green, bold font to the right of the star. The star has a slight gradient effect, with the top point being a lighter shade of green.

16

Image /page/16/Picture/0 description: The image features the logo for SonoStar. The logo consists of a five-pointed star in a light green color, positioned to the left of the text "SonoStar". The text is also in a green color, complementing the star. The overall design is simple and clean, with a focus on the brand name and a symbolic star element.

17

Image /page/17/Picture/0 description: The image features the logo for SonoStar. The logo consists of a green star with a thick outline and the word "SonoStar" in a bold, green font. The star is positioned to the left of the text, and the overall design is simple and clean.

18

Image /page/18/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, and the overall design is simple and clean.

Brief Summary

First, the subject device (Model: UProbe-L) enjoys similar classification and intended use with predicate device 2. The classification and intended use of the subject device (Model: UProbe-L) is covered by those of the predicate device 2 which has a broader usage scope, which forms the foundation of the substantial equivalence between the two devices.

Secondly, the subject device (Model: UProbe-L) boasts similar technological characteristics with predicate device 2. They have the same environment of use, acoustic output levels, patient population, users and principle/method of operation; they have similar anatomic structure, probe characteristics and probe connection to display, i.e. those 3 aspects of the subject device (Model: UProbe-L) is covered by those of the predicate device 2 which has a broader usage scope; they have similar imaging capacities, i.e. some imaging capacities of subject device (Model: UProbe-L) are covered by that of the predicate device 2, and the different imaging capacities of subject device (Model: UProbe-L) - Model BM Scan is commonly used, not newly developed imaging capacity, thus will not bringing new safety and effectiveness concerns to the substantial equivalence comparison between the two device; although the subject device (Model: UProbe-L) has different image display unit, off-the-shelf operating system, software and system components compared with the predicate device 2, such characteristics have already been adopted by Page 13 of 19

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Image /page/19/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, sans-serif font.

predicate device 1, not newly developed, which will bring no new safety and effectiveness concerns. All those facts further supports that the subject device (Model: UProbe-L) and predicate device 2 are substantially equivalent.

Last but not least, the safety and effectiveness of the subject device (Model: UProbe-L) have been further ensured by the following FDA recognized standards - ISO 10993-5 & ISO 10993-10, IEC 60601-1 & IEC 60601-1-2 and IEC 60601-2-37, which shows that the subject device will be safe and effective for usage as the device that has already been on the market.

As a result, it is reasonable to conclude that subject device (Model: UProbe-L) is substantial equivalent with predicate device 2.

7.6.3 Comparison Table of Technological Characteristic with the

Comparison Items	Subject Device:	Predicate Device 3:
	Wireless Probe Type	Palm Bladder Scanner
	Ultrasound Scanner	- PBSV4.1
	(Model: BProbe)	(K130229)
Classification & Intended Use
Classification	IYO & ITX	IYO & ITX
	Class 2	Class 2
Intended Use	Intended to project	Intended to project
	ultrasound energy	ultrasound energy
	through the lower	through the lower
	abdomen of the	abdomen of the
	nonpregnant patient to	nonpregnant patient to
	obtain an image of the	obtain an image of the
		bladder and uses that
image to calculate the
bladder volume
non-invasively.	bladder and uses that
image to calculate the
bladder volume
non-invasively.
Technological Characteristics
Mode of Operation		B	B
Transducer
Characteris
tics	Type	3.5MHz Mechanical
Sector Scan	2.6MHz Mechanical
Sector Scan
	Time
from 3D
Scan
Initiation
to Result
Display	4 seconds	4 seconds
	Penetrati
on Depth	≥150mm	≥140mm
Range of Measurement		10-999ml	0-999ml
Accuracy		±10%	•±25% (60ml≤ volume ≤ 150ml)
•±15% (150mlSafety and Effectiveness
Patient-Contacting
Materials		Evaluated according to
ISO 10993-5 and ISO
10993-10	Evaluated according to
ISO 10993-5 and ISO
10993-10
Electrical Safety		Evaluated according to
IEC 60601-1	Evaluated according to
IEC 60601-1
EMC		Evaluated according to
IEC 60601-1-2	Evaluated according to
IEC 60601-1-2
Performance Safety		Evaluated according to
IEC 60601-2-37	Evaluated according to
IEC 60601-2-37
FCC Radio Frequency
Testing		Tested to FCC
requirements and found
to comply with the
requirements of FCC
CFR Title 47 Part 15
Subpart C Section
15.247	Not applicable.

Predicate Device for Model: BProbe

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Image /page/20/Picture/0 description: The image contains 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.

21

Image /page/21/Picture/0 description: The image features the logo for SonoStar. The logo consists of a five-pointed star in a light green color, positioned to the left of the text "SonoStar". The text is written in a bold, sans-serif font, also in a darker shade of green. The overall design is clean and modern, with the star adding a touch of visual interest to the brand name.

Brief Summary

22

Image /page/22/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a yellow outline on the left side. To the right of the star, the word "SonoStar" is written in green, with the "S" in "Sono" being slightly larger than the rest of the letters.

First, the subject device (Model: BProbe) enjoys the same classification and intended use with the predicate device 3, which forms the foundation of the substantial equivalence between the two devices.

Secondly, the subject device (Model: BProbe) boasts similar technological characteristics with the predicate device 3, for example, they have the same mode of operation, transducer type (i.e.Mechanical Sector Scan), target population and anatomical sites. Though they differ in transducer specification, range of measurement, accuracy, operation condition and screen display, such slight difference will not affect the core usage of the subject device (Model: BProbe), thus will not affecting the substantial equivalence between the two devices. Although they do not have the same power supply and acoustic output index, such difference has been verified by FDA recognized standards - IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-37. And though they have different probe connection to display, the wireless connection adopted by the subject device (Model: BProbe) is not newly developed technology, it has already bee adopted by predicate device 1, and its safety has been further ensured by FCC requirements, which will not bring new concerns to the subject device's safety and effectiveness, thus will not affecting the substantial equivalence comparison between the two devices. All of those facts further supports that the two devices are substantial equivalent.

Last but not least, the safety and effectiveness of the subject device (Model: BProbe) have been further ensured by the following FDA recognized standards - ISO 10993-5 & ISO 10993-10, IEC 60601-1 & IEC 60601-1-2 and IEC 60601-2-37, and FCC requirements, which shows that the subject device will be as safe and effective for usage as the device that has already been on the market.

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Image /page/23/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 first letter capitalized.

As a result, it is reasonable to conclude that subject device (Model: BProbe) is substantial equivalent with predicate device 3.

7.7 Discussion of Tests Performed

7.7.1 Clinical Test

Clinical testing was not performed for Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) as part of the submission.

7.7.2 Non-Clinical Tests

The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:

Biocompatibility according to AAMI / ANSI / ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility) and AAMI / ANSI / ISO 10993-10:2010/(R)2014, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility); 2) Electrical Safety according to AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (lec 60601-1:2005, Mod). (General II (ES/EMC)):
Electromagnetic Compatibility according to AAMI / ANSI / IEC 60601-1-2:2007/(R)2012, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition 3). (General II (ES/EMC));
Performance Safety and Effectiveness according to IEC 60601-2-37 Edition 2.0 2007, Medical Electrical Equipment - Part 2-37: Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment. (Radiology);

Page 18 of 19

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Image /page/24/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 first letter of each word capitalized. The logo is simple and clean, with a focus on the company name and a star symbol.

FCC Radio Frequency Testing: The Wireless Probe Type Ultrasound Scanner was tested according to FCC requirements and found to comply with the requirements of FCC CFR Title 47 Part 15 Subpart C Section 15.247: Frequency Hopping, Direct Spread Spectrum and Hybrid Systems that are in operation with the bands of 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz.

7.8 Conclusion

From the above analysis, it is proper to conclude that the subject device (Model: UProbe-C; UProbe-L; BProbe) will be as safe and effective for usage as the listed predicate devices that have already been on the U.S. market.