Pocket Ultrasound System (C10)

K231354 · Beijing Konted Medical Technology Co.,Ltd · IYN · Dec 20, 2023 · Radiology

Device Facts

• Record ID: K231354
• Device Name: Pocket Ultrasound System (C10)
• Applicant: Beijing Konted Medical Technology Co.,Ltd
• Product Code: IYN · Radiology
• Decision Date: Dec 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Pocket Ultrasound System C10 is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+M), and Pulsed Wave modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications depending on different configuration of array probes: Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology Linear array probe - Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric Phase array probe - Cardiology, Cardiac Fetal Echo. The Pocket Ultrasound System C10 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

Device Story

Pocket Ultrasound System (C10) is a portable, software-controlled diagnostic ultrasound system. It consists of wireless transducers (convex, linear, or phased array) and the 'MY USG' software application running on a COTS Android smartphone/tablet. The system uses ultrasonic echo imaging; transducers emit ultrasonic waves via the inverse piezoelectric effect; echoes are received, amplified, and processed to form images. The system supports B-mode, B+M mode, Color Doppler, and Pulsed Wave Doppler. Data is transmitted from the transducer to the Android device via direct Wi-Fi. Healthcare professionals (doctors, nurses, sonographers) operate the system via the Android touch screen to acquire, display, measure, and store real-time ultrasound images. The device aids in clinical decision-making by providing visual diagnostic information for various anatomical structures and blood flow. It benefits patients by enabling portable, point-of-care diagnostic imaging.

Clinical Evidence

No clinical studies were performed. Substantial equivalence was demonstrated through bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), wireless coexistence (ANSI C63.27), biocompatibility (ISO 10993), and software validation.

Technological Characteristics

Portable ultrasound system using wireless transducers (convex, linear, phased array) communicating via Wi-Fi (IEEE 802.11n) to a COTS Android device. Operates in B, B+M, Color Doppler, and Pulsed Wave modes. Materials are biocompatible per ISO 10993. Safety evaluated per IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37. Power provided by rechargeable Li-ion battery. Software is Android-based.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring fetal/obstetrics, gynecological, abdominal, urological, small parts (breast, thyroid), carotid, peripheral vessel, musculoskeletal, pediatric, or cardiac/cardiac fetal echo examinations. Intended for use by qualified healthcare professionals in hospital, clinic, or home environments.

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

• Lumify Ultrasound System (K162549)

Reference Devices

• Pocket Ultrasound System (K211746)

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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 22, 2024

Beijing Konted Medical Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 CHINA

Re: K231354

Trade/Device Name: Pocket Ultrasound System (C10) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX

Dear Ivy Wang:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 20, 2023. Specifically, FDA is updating this SE Letter for a typo in the Indications for Use (IFU) statement as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yanna Kang, OHT8: Office of Radiological Health, 301-796-6704, [e-mail].

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

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Image /page/1/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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Beijing Konted Medical Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai. Shanghai 200122 CHINA

#### Re: K231354

Trade/Device Name: Pocket Ultrasound System (C10) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 10, 2023 Received: November 15, 2023

Dear Ivy Wang:

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.

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).

December 20, 2023

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Your device is also subject to, among other requirements, the Quality System (QS) 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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## Indications for Use

510(k) Number (if known) K231354

Device Name Pocket Ultrasound System (C10)

#### Indications for Use (Describe)

The Pocket Ultrasound System C10 is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+M), and Pulsed Wave modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications depending on different configuration of array probes:

Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology

Linear array probe - Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric Phase array probe - Cardiology, Cardiac Fetal Echo.

The Pocket Ultrasound System C10 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## SECTION 2

## 510(k) Summary

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## 510(k) Summary

#### I. SUBMITTER

Name: Beijing Konted Medical Technology Co., Ltd.

Address: Room 111,1F, Building 3, No. 27, Yong wang Road, Daxing Biological

Pharmaceutical Industry Base, Daxing District, Beijing, 102629 PEOPLE'S

REPUBLIC OF CHINA

Name of contact person: Deyi Zhu

Tel: [phone]

Fax: [phone]

E-Mail: [e-mail]

Submission date: 2024-01-12

#### II. Subject Device

Device trade name: Pocket Ultrasound System (Model: C10) Regulation number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation class: II Panel: Radiology Product code: IYN, IYO, ITX

## III. Primary Predicative Device & Reference Device Primary Predicative Device

Submission Number: K162549 Device Trade Name: Lumify Ultrasound System Applicant: Philips Healthcare Regulation number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation class: II Panel: Radiology Product code: IYN, IYO, ITX

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#### Reference Device

Submission Number: K211746 Device Trade Name: Pocket Ultrasound System Applicant: GuangDong Youkey Medical Co., Ltd. Regulation number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation class: II Panel: Radiology Product code: IYN, IYO, ITX

#### IV. Device Description

The Pocket Ultrasound System C10 is designed to be a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display highresolution, real-time ultrasound data through an off-the-shelf (OTS) Android device. the system mainly includes the ultrasound equipment and software application components. The ultrasound equipment is used to complete the ultrasonic imaging function and the software application components are used to complete the image display, measurement, patient information management as well as image storage etc. The Pocket Ultrasound System comprises a series of wireless transducers employing Wi-Fi-based technology to communicate with smartphone devices via direct Wi-Fi. One of the software application components is a software APP (MY USG), which is deployed on Android devices which supported Wi-Fi wireless communication. The other one is the software contained in the ultrasound equipment to control operation of the equipment and transfer images via Wi-Fi to the smartphone devices. This allows the user to export ultrasound images and display them across a range of portable personal devices. The communication protocol between the software APP and the other software contained in the equipment is specially defined for unique connection.

The system is only intended for use by qualified healthcare practitioners (e.g., doctors, nurses, sonographers) who are trained in the use of ultrasound imaging technology. The Pocket Ultrasound System comprises the following:

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• A commercial off-the-shelf (COTS) Android smartphone/tablet device.

· the software application (MY USG) running as an App on the COTS device with Android system.

• The ultrasound equipment/Transducers: C10

• Accessory: Wireless Battery Charger & Power Adapter

Different type transducers are available for the Pocket Ultrasound System C10, the frequencies are 2.5 MHz and 7.5MHz respectively depending on different transducer. The Pocket Ultrasound System C10 is designed with four ultrasound modes of operation, including B-mode, Combination Mode (B+M mode), Color Doppler mode and Pulsed Wave Doppler mode.

Real time image and dynamic changes of tissues, organs or vessels will be showed in the image under B-mode, while coloring blood flow can be seen under Color Doppler mode and Pulsed Wave Doppler mode. Combination mode B+M-mode is the combination of the B-mode and M-mode of operation, superimposed on the display. Mmode is defined as time motion display of the ultrasound wave along a chosen ultrasound line, so it's usually applied in diagnosis of cardiovascular diseases.

The system provides real-time images for tissues, organs or blood flow via touch screen of the COTS Android smartphone/tablet device, which, in combination with the embedded software system contained in the ultrasound device, provides users a friendly and convenient graphical interface and makes users be able to easily control the whole system.

#### V. Indication For Use

The Pocket Ultrasound System C10 is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+M), and Pulsed Wave modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications depending on different configuration of array probes:

Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology

Page 4 of 18

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Linear array probe - Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric

Phase array probe - Cardiology, Cardiac Fetal Echo.

The Pocket Ultrasound System C10 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

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## VI. Comparison of Technological Characteristics with The Primary Predicate Device

The subjective device and the primary predicate device have intended use. The subject device and the primary predicate device have similar technological characteristics as evidenced by the differences in technological characteristics do not raise new questions regarding safety or effectiveness of the subject device.

| Attribute | Subject device | Primary (K162549) | Predicative device | Reference device (K211746) | Discussion/ Conclusion |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Product picture | | | | | / |
| Manufacturer | Beijing Konted Medical Technology Co., Ltd. | Philips Healthcare | | GuangDong Youkey Medical Co., Ltd. | / |
| Proprietary name, model | Pocket Ultrasound System C10 | Lumify Ultrasound System | | Pocket Ultrasound System | / |
| Regulation name | Ultrasonic pulsed doppler imaging system | Ultrasonic pulsed doppler imaging system | | Ultrasonic pulsed doppler imaging system | Same |
| Regulatory | Class II | Class II | | Class II | Same |
| Attribute | Subject device | Primary Predicative device (K162549) | Reference device (K211746) | Discussion/Conclusion | |
| Class | | | | | |
| Product code | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | Same | |
| Clinical characteristics | | | | | |
| Indications for Use | The Pocket Ultrasound System C10 is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+M), and Pulsed Wave modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications depending on different configuration of array probes: Fetal/Obstetrics, Gynecological, Cardiac Fetal Echo, Abdominal, Small Parts (breast, thyroid), Cardiology, Carotid, Peripheral Vessel, Muscular-Skeletal, Urology and Pediatric.<br>Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology<br>Linear array probe - Small Parts (breast, thyroid), Carotid | Philips Lumify Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B + Color), and M modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac. Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals. | Pocket Ultrasound System (Model: P50, P51, P52, P53, P54, P55, P56) is intended for use by an appropriately trained, qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: Abdominal, Obstetrics, Gynaecology, Small Parts (breast, thyroid, etc), Peripheral Vascular, Urology. This system is suitable for use in hospital and clinical settings. | Same | |
| Attribute | Subject device | Primary<br>(K162549) | Predicative device | Reference device (K211746) | Discussion/<br>Conclusion |
| | Peripheral Vessel, Muscular-<br>Skeletal, Pediatric<br>Phase array probe - Cardiology,<br>Cardiac Fetal Echo.<br>The Pocket Ultrasound System<br>C10 is a transportable ultrasound<br>system intended for use in<br>environments where healthcare is<br>provided by healthcare<br>professionals. | | | | |
| Intended<br>patient<br>population | For use in all patients | For use in all patients | | For use in all patients | Same |
| Intended use<br>environment | Hospital, clinics, home for use by<br>healthcare professionals | Hospital, clinics, home and<br>transport for use by healthcare<br>professionals | | Hospitals, clinics | Different, see<br>discussion 1 |
| General technological characteristics | | | | | |
| Working<br>principle | Principle of operation of the<br>Pocket Ultrasound System is based<br>on ultrasonic echo imaging, which<br>is a common medical imaging<br>technology to use the transmission | The system and transducers function<br>in a manner identical to all<br>ultrasound systems and transducers.<br>The system circuitry generates an<br>electronic voltage pulse, which is | | The transducers inside the probe are<br>responsible to emitting and<br>receiving ultrasonic waves. When<br>the host pushes pulse with a certain<br>frequency and magnitude onto the | Same |
| Attribute | Subject device | Primary<br>(K162549) | Predicative device | Reference device (K211746) | Discussion/<br>Conclusion |
| | speed of ultrasound in different<br>tissues and reflection degree<br>differences, to get images through<br>computer processing for diagnosis<br>and treatment. | transmitted to the transducer. In the | transducer, a piezo-electric array<br>converts the electronic pulse into an<br>ultrasonic pressure wave. When<br>coupled to the body, the pressure<br>wave transmits through body<br>tissues. The differing acoustic<br>properties of the tissues in the body<br>reflect some of the transmitted<br>energy back to the transducer, where<br>it is converted back to electrical<br>signals and sent back to the system.<br>In the system, advanced signal<br>processing technologies convert the<br>returned signals into images of the<br>tissues. The Doppler functions of<br>this system process the Doppler shift<br>frequencies from the echoes of<br>moving targets (such as blood), to | transducers, a short burst of<br>ultrasound is emitted from<br>transducers and directed into tissue.<br>Echoes are produced as a result of<br>the interaction of sound with tissue,<br>and some of back to the transducers.<br>Echoes come back is then converted<br>into electric signals by transducers<br>and handed to host for further<br>process.<br>The host is mainly responsible for<br>the following: data processing, in<br>response to user instructions. By<br>receiving the echo pulse<br>transmitting time and timing<br>between the transducer and the echo<br>signal can be calculated by the<br>distance between the structure, form<br>the brightness degree of adjacent | |
| | The transducers inside the probe<br>are responsible to emitting and<br>receiving ultrasonic waves. When<br>a pulse with a certain frequency<br>and magnitude onto the<br>transducers, then ultrasonic waves<br>are generated through the inverse<br>piezoelectric effect and<br>transmitted to the human body<br>tissue through the probe. When the<br>ultrasonic wave meets the tissue<br>interface, it will generate echoes,<br>which are scattered in different<br>tissues or blood flow and received | | | | |
| Attribute | Subject device | Primary Predicative device (K162549) | Reference device (K211746) | Discussion/ Conclusion | |
| | by the probe and converted into<br>electrical signals. The receiver<br>amplifies and processes these<br>electrical signals before<br>transmitting them to the<br>processing unit. Based on the<br>signals received, the processing<br>unit will calculate the intensity and<br>timing of the echoes to form an<br>image. | detect and graphically display the<br>Doppler shifts of these tissues as<br>flow. | image materials. The inherent<br>acoustic impedance difference in the<br>image are different. And through the<br>WIFI transmission and instruction<br>imaging data. | | |
| Design | Autocorrelation for color<br>processing and FFT for pulse<br>Doppler processing.<br>Supporting Linear, Convex and<br>Phase array probes.<br>Cine play back capability Image<br>file archive. | Autocorrelation for color processing<br>and FFT for pulse Doppler<br>processing.<br>Supporting Linear, Curve, Phase<br>array and Volume probes.<br>Cine play back capability Image file<br>archive. | Not specified | Same | |
| Operating<br>Controls | Convex: 90~305mm<br>Linear: 20~100mm<br>Cardiac: 90~160mm<br>Gain | Depth Range: 0.003 to >30 cm<br>Gain | Not specified | Different, see<br>discussion 2<br>Same…