(224 days)
No
The summary describes a standard ultrasound system with software for image display, measurement, and management. There is no mention of AI or ML capabilities for image analysis, interpretation, or other functions.
No.
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic ultrasound imaging." It does not mention any therapeutic functions or applications.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Pocket Ultrasound System C10 is intended for diagnostic ultrasound imaging..." and "It is indicated for diagnostic ultrasound imaging and fluid flow analysis...". The "Device Description" also mentions it is a "diagnostic ultrasound system".
No
The device description explicitly states that the system includes "the ultrasound equipment and software application components" and that "The ultrasound equipment is used to complete the ultrasonic imaging function". This indicates the presence of hardware components essential to the device's primary function.
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. This testing is done outside of the body (in vitro).
- Device Function: The Pocket Ultrasound System C10 is a diagnostic ultrasound system. It uses sound waves to create images of internal body structures within the body (in vivo). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "diagnostic ultrasound imaging" and "fluid flow analysis" within the body for various anatomical sites.
- Device Description: The description details how it acquires and displays real-time ultrasound data from within the body.
Therefore, the Pocket Ultrasound System C10 falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / 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.
Product codes
IYN, IYO, ITX
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:
• 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Gynecological, Abdominal, Urology, Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric, Cardiology, Cardiac Fetal Echo.
Indicated Patient Age Range
For use in all patients
Intended User / Care Setting
healthcare professionals / environments where healthcare is provided by healthcare professionals (Hospital, clinics, home for use by healthcare professionals)
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 testing for Pocket Ultrasound System C10 was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance based on current applicable standards, and to demonstrate substantial equivalence to the primary predicate device. The following tests were performed.
- A Electric Safety and Electromagnetic Compatibility
- Safety test for Rechargeable Li-ion battery
- A Usability Evaluation
- Software validation
- Cybersecurity
- A Wireless Coexistence
- Biocompatibility Safety A
- Non-clinical Performance
No clinical studies are available for the subject device. Clinical testing was not required to demonstrate the substantial equivalence of the subject device to its primary predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
0
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, Yanna.Kang@fda.hhs.gov.
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
1
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
2
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
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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4
SECTION 2
510(k) Summary
5
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: +86 10-60219113
Fax: +86 10-60219213
E-Mail: 3245132464@qq.com
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
6
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:
7
• 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
8
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.
9
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. | ||||
| Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology | |||||
| 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 | |||
| (K162549) | Predicative device | Reference device (K211746) | Discussion/ | ||
| Conclusion | |||||
| 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. | |||||
| Intended | |||||
| patient | |||||
| population | For use in all patients | For use in all patients | For use in all patients | Same | |
| Intended use | |||||
| environment | Hospital, clinics, home for use by | ||||
| healthcare professionals | Hospital, clinics, home and | ||||
| transport for use by healthcare | |||||
| professionals | Hospitals, clinics | Different, see | |||
| discussion 1 | |||||
| General technological characteristics | |||||
| Working | |||||
| principle | Principle of operation of the | ||||
| Pocket Ultrasound System is based | |||||
| on ultrasonic echo imaging, which | |||||
| is a common medical imaging | |||||
| technology to use the transmission | The system and transducers function | ||||
| in a manner identical to all | |||||
| ultrasound systems and transducers. | |||||
| The system circuitry generates an | |||||
| electronic voltage pulse, which is | The transducers inside the probe are | ||||
| responsible to emitting and | |||||
| receiving ultrasonic waves. When | |||||
| the host pushes pulse with a certain | |||||
| frequency and magnitude onto the | Same | ||||
| Attribute | Subject device | Primary | |||
| (K162549) | Predicative device | Reference device (K211746) | Discussion/ | ||
| Conclusion | |||||
| speed of ultrasound in different | |||||
| tissues and reflection degree | |||||
| differences, to get images through | |||||
| computer processing for diagnosis | |||||
| and treatment. | transmitted to the transducer. In the | transducer, a piezo-electric array | |||
| converts the electronic pulse into an | |||||
| ultrasonic pressure wave. When | |||||
| coupled to the body, the pressure | |||||
| wave transmits through body | |||||
| tissues. The differing acoustic | |||||
| properties of the tissues in the body | |||||
| reflect some of the transmitted | |||||
| energy back to the transducer, where | |||||
| it is converted back to electrical | |||||
| signals and sent back to the system. | |||||
| In the system, advanced signal | |||||
| processing technologies convert the | |||||
| returned signals into images of the | |||||
| tissues. The Doppler functions of | |||||
| this system process the Doppler shift | |||||
| frequencies from the echoes of | |||||
| moving targets (such as blood), to | transducers, a short burst of | ||||
| ultrasound is emitted from | |||||
| transducers and directed into tissue. | |||||
| Echoes are produced as a result of | |||||
| the interaction of sound with tissue, | |||||
| and some of back to the transducers. | |||||
| Echoes come back is then converted | |||||
| into electric signals by transducers | |||||
| and handed to host for further | |||||
| process. | |||||
| The host is mainly responsible for | |||||
| the following: data processing, in | |||||
| response to user instructions. By | |||||
| receiving the echo pulse | |||||
| transmitting time and timing | |||||
| between the transducer and the echo | |||||
| signal can be calculated by the | |||||
| distance between the structure, form | |||||
| the brightness degree of adjacent | |||||
| The transducers inside the probe | |||||
| are responsible to emitting and | |||||
| receiving ultrasonic waves. When | |||||
| a pulse with a certain frequency | |||||
| and magnitude onto the | |||||
| transducers, then ultrasonic waves | |||||
| are generated through the inverse | |||||
| piezoelectric effect and | |||||
| transmitted to the human body | |||||
| tissue through the probe. When the | |||||
| ultrasonic wave meets the tissue | |||||
| interface, it will generate echoes, | |||||
| which are scattered in different | |||||
| tissues or blood flow and received | |||||
| Attribute | Subject device | Primary Predicative device (K162549) | Reference device (K211746) | Discussion/ Conclusion | |
| by the probe and converted into | |||||
| electrical signals. The receiver | |||||
| amplifies and processes these | |||||
| electrical signals before | |||||
| transmitting them to the | |||||
| processing unit. Based on the | |||||
| signals received, the processing | |||||
| unit will calculate the intensity and | |||||
| timing of the echoes to form an | |||||
| image. | detect and graphically display the | ||||
| Doppler shifts of these tissues as | |||||
| flow. | image materials. The inherent | ||||
| acoustic impedance difference in the | |||||
| image are different. And through the | |||||
| WIFI transmission and instruction | |||||
| imaging data. | |||||
| Design | Autocorrelation for color | ||||
| processing and FFT for pulse | |||||
| Doppler processing. | |||||
| Supporting Linear, Convex and | |||||
| Phase array probes. | |||||
| Cine play back capability Image | |||||
| file archive. | Autocorrelation for color processing | ||||
| and FFT for pulse Doppler | |||||
| processing. | |||||
| Supporting Linear, Curve, Phase | |||||
| array and Volume probes. | |||||
| Cine play back capability Image file | |||||
| archive. | Not specified | Same | |||
| Operating | |||||
| Controls | Convex: 90~305mm | ||||
| Linear: 20~100mm | |||||
| Cardiac: 90~160mm | |||||
| Gain | Depth Range: 0.003 to >30 cm | ||||
| Gain | Not specified | Different, see | |||
| discussion 2 | |||||
| Same | |||||
| Attribute | Subject device | Primary Predicative device (K162549) | Reference device (K211746) | Discussion/ Conclusion | |
| Focus | Focus | Not specified | Same | ||
| Color box size/position can be adjust | Color box size/position can be adjust | Not specified | Same | ||
| Baseline | N/A | Not specified | Same | ||
| Cine control: drag scroll bar | Cine control: drag scroll bar, press |
| Not specified | Same | |
| | Freeze control: Toggling freeze key | Freeze control: Toggling freeze key | Not specified | Same | |
| Operation Mode | B mode | B mode | B mode | Different, see discussion 3 | |
| | B/M mode | M mode | M mode | | |
| | Color Doppler Mode | Color Doppler Mode | Color Doppler | | |
| | Pulsed Wave mode | B+C mode | Power Doppler
PWD and Combined (B+M; B+CD; B+PD; B+PWD mode) | | |
| Transducers | Convex Array; Phase Array; Linear Array; | Convex Array, Phased Array, Linear Array | Convex Array, Linear Array, Phase Array, Intracavity | Same | |
| Frequency | 2.5MHz (phase); 3.2MHz(convex); 7.5MHz(linear) | curvilinear 5-2MHz; linear 12-4MHz | 3.5-7.5MHz | Difference, see discussion 4 | |
| Probe connection to display unit | Wireless connection via Wi-Fi | Wire connection via USB | Wire connection via USB or Wireless connection via Wi-Fi | Difference, see discussion 5 | |
| Attribute | Subject device | Primary
Predicative device
(K162549) | Reference device (K211746) | Discussion/
Conclusion | |
| Device and
Operating
system for the
software APP | A commercial off-the-shelf
Android device (COTS) | A commercial off-the-shelf Android
device (COTS) | A commercial off-the-shelf (COTS)
Android mobile device
A commercial off-the-shelf (COTS)
Windows device | Same | |
| Image display
unit | CPU Clock Speed: ≥2GHz;
Memory: ≥2G
Screen size: ≥4.7 inch;
Screen resolution: ≥1334x750
Brightness: capable of ambient
light detection and brightness
correction.
Android version 8.0 or newer | Minimum 50 MB of storage space
(plus more for patient data storage)
• Color display, minimum 14 cm
(5.5 in)
• Touch interface
• Internally mounted speakers
• 1280 x 800 resolution (minimum)
• Android 5.0 or later operating
system | Windows environment (13.3
inches);
Android environment (9.6 inches) | Difference,
see discussion
6 | |
| Wireless
network
capability | Communication via Wi-Fi (IEEE
802.11n, 2.4 GHz & 5 G ISM
band) | Wireless or cellular networking
capability | Wi-Fi | Difference,
see discussion
7 | |
| Acoustic
output levels | Track 3
Ispta.3 ≤ 720mW/cm2
MI ≤ 1.9
TI ≤ 6.0 | Track 3
Ispta.3 ≤ 720mW/cm2
MI ≤ 1.9
TI ≤ 6.0 | Track 3
Ispta.3 = 720mW/cm2
MI max.= 1.9
MI display
TI display | Same | |
| Power source
and power
requirement | Rechargeable battery (Li-ion)
DC 5V | AC :100V-240V,
Frequenzy:50-60Hz | Rechargeable battery (Li-ion)
DC 5V | Difference,
see discussion
8 | |
| Attribute | Subject device | Primary Predicative device
(K162549) | Reference device (K211746) | Discussion/
Conclusion | |
| Operating
environment | Operating temperature: 0-40 °C;
relative humidity 30-85%;
Barometric pressure:700 to 1060 hPa | Operatingtemperature:5-40 °C;
relative humidity 15-95%;
Barometric pressure:700 to 1060 hPa | Not specified | Difference,
see discussion
9 | |
| Ingress
Protection
degree | Host part of the ultrasound device:
IP22
probe part of the ultrasound
device: IP27 | probe part of the ultrasound device:
IP47 | Not specified | Difference,
see discussion
10 | |
| Safety and Effectiveness | | | | | |
| Patient
contacting
material | Per ISO 10993-5 and ISO 10993-
10 | Per ISO 10993-5 and ISO 10993-10 | Per ISO 10993-5 and ISO 10993-10 | Same | |
| Electrical
Safety | Evaluated according to IEC
60601-1 | Evaluated according to IEC 60601-
1 | Evaluated according to IEC 60601-
1 | Same | |
| EMC | Evaluated according to IEC
60601-1-2 | Evaluated according to IEC 60601-
1-2 | Evaluated according to IEC 60601-
1-2 | Same | |
| Performance
Safety | Evaluated according to IEC
60601-2-37 | Evaluated according to IEC 60601-
2-37 | Evaluated according to IEC 60601-
2-37 | Same | |
10
11
12
13
14
15
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Discussion on differences between the subject device and the primary predicate device
Discussion 1: The subject device is not intended to be used in the transport condition, which is applicable in the primary predicate device. As the subject device has restricted use condition the primary predicate device, such difference will not affect clinical performance and safety of the
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subject device.
Discussion 2: The depth range of the subject device is different from the primary predicate device. As the depth size is depending on the type of the probe and the image is able to be enlarged and shunk by adjusting the depth. Such difference will not affect clinical performance and safety of the subject device.
Discussion 3: The subject device has the B-M mode while the primary predicate device has no such two modes, while both B-M mode and PW mode are well-established ultrassund modes on the market, like the reference device and all modes have been tested acording to standard IEC 60601-2-37. Therefore, will not affect clinical performance and safety of the subject device. Discussion 4: Quality of the image is mainly determined by the array number of transducer elements in principle. There is no image quality when the same body site is detected via the same array elements under specific frequency range 2-5MHz for convex array or 4-12MHz range for linear array. As frequency of the subject device are within the frequency range of the primary predicate device, such difference will not affect clinical performance and safety of the subject device.
Discussion 5: Although the subject device is connection while the primary predicate device is connected via USB wire connection, all wireless connection performance and safety have been evaluated accordingly. Therefore will not affect clinical performance and safety of the subject device.
Discussion 6: Although requirement for image display unit of the subject device is different from the min. resolution requirement for both devices is same in actual use, touch screen/speaker function is same, better memory performance and higher operating system is used on the subject device than the primary predicate devill not impact image quality as zoom and focus functions
18
are available. Therefore, such difference will not affect clinical performance and safety of the subject device.
Discussion 7: Although wireless network capability of the subject device is different from the primary predicate device, all wireless comection performance and safety have been evaluated accordingly. Therefore, will not affect clinical performance and safety of the subject device.
Discussion 8: The subject device is supplied by rechareable battery while the primary predicate device is supplied by power adapter. All safety requirement for the power adapter and battery used have been tested respectively according to applicable standards, such difference will affect clinical performance and safety of the subject device.
Discussion 9: Operating temperature and relaive humice is sightly different from the primary predicate device, while the safety and essential performance of the been evaluated under specific operational environment. Therefore, such difference will not affect clinical performance and safety of the subject device.
Discussion 10: IP degree for the subject device probe is IP27, which is different from IP47 of the primary probe, while both devices are intended to be used for indoor condition, ingress protect against dust with IP2X is enough. As for ingress water protection, both devices are in conformity with IPX degree. Therefore, such difference will not affect clinical performance and safety of the subject device.
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VII. Summary of Non-clinical Performance
Non-clinical testing for Pocket Ultrasound System C10 was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance based on current applicable standards, and to demonstrate substantial equivalence to the primary predicate device. The following tests were performed.
- A Electric Safety and Electromagnetic Compatibility
- AAMI/IEC 60601-1:2005 + AMD 1:2012 Medical electrical equipment Part . 1 : General requirements for basic safety and essential performance
- IEC 60601-1-2: 2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances – Requirements and tests
- IEC 60601-1-11: 2015 Medical electrical equipment. Part 1-11: General requirements for basic safety and essential performance. Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
-
Safety test for Rechargeable Li-ion battery
- . IEC 62133-2: 2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
- A Usability Evaluation
- . IEC 60601-1-6: 2010 + A1:2013 Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- . IEC 62366-1: 2014 + A1: 2020 Medical devices - Application of usability engineering to medical devices
-
Software validation
Software validation was conducted with a moderate concern according to the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Document issued on: May 11, 2005).
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> Cybersecurity
Cybersecurity is evaluated according to the FDA draft guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (Document issued on October 2, 2014)
-
A Wireless Coexistence
Wireless Coexistence of the subject device is evaluated according to the following two standards: -
. ANSI C63.27: 2017 American National Standard for Evaluation of Wireless Coexistence
-
AAMI TIR69: 2017 Risk Management of Radio-frequency Wireless . Coexistence for Medical Devices and Systems
-
Biocompatibility Safety A
Biocompatibility Safety is evaluated according to the following standards and guidance:
- . Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (Document issued on: September 4, 2020)
- . ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity
- ISO 10993-10: 2010, Biological evaluation of medical devices Part 10: Tests . for irritation and sensitization
-
Non-clinical Performance
- IEC 60601-2-37: 2007 + A1:2015 Medical electrical equipment Part 2-37: . Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- . Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Document issued on: June 27, 2019)
- Performance Data Animal >
N/A, no animal studies are available for the subject device.
VIII. Summary of Clinical Performance
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No clinical studies are available for the subject device. Clinical testing was not required to demonstrate the substantial equivalence of the subject device to its primary predicate device.
IX. Conclusions
In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the subject device substantially equivalent to the primary predicate device quoted above. The differences between the subjective device and its primary predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device is substantially equivalent to the legally marketed primary predicate device.