Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)

{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 in blue. Underneath the FDA logo is the word "ADMINISTRATION". August 22, 2024 Beijing Konted Medical Technology Co.,Ltd % Xuexia Ren Official Correspondent (Chengdu Lizhu Technology Co., LTD) Room 111,1F, Building 3, No. 27 Yong Wang Road, Daxing Biological Pharmaceutical Base Daxing District, Beijing, 102629 PEOPLE'S REPUBLIC OF CHINA Re: K241979 Trade/Device Name: Pocket Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code(s): IYN, IYO, ITX Dated: July 4, 2024 Received: July 5, 2024 Dear Xuexia Ren: 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/cdrb/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). {1}------------------------------------------------ Your device is also subject to, among other requirements. the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Paramita Sengupta -2 For Yanna Kang Assistant Director 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K241979 Device Name Pocket Ultrasound System #### Indications for Use (Describe) The Pocket Ultrasound System 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 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Sum #### 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: 2024-07-02 #### II. Subject Device Device trade name: Pocket Ultrasound System Model: C10, C10TX, C10RL, C10RLpro Regulation number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Requlation class: II Panel: Radiology Product code: IYN, IYO, ITX #### III. Predicative Device Submission Number: K231354 Device Trade Name: Pocket Ultrasound System (C10) Applicant: Beijing Konted Medical Technology Co., Ltd Regulation number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Requlation class: II Panel: Radiology Product code: IYN, IYO, ITX #### IV. Device Description The Pocket Ultrasound System (Model: C10, C10TX, C10RLpro) 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 {4}------------------------------------------------ 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 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 / C10TX / C10RL / C10RLpro - The 4 models have no difference in composition and performance parameters, only the appearance and battery capacity are different. - Accessory: Wireless Battery Charger & Power Adapter Different type transducers are available for the Pocket Ultrasound System (Model: C10, C10TX, C10RL, C10RLpro), the frequencies are 2.5 MHz, 3.2 MHz and 7.5MHz respectively depending on different transducer. The Pocket Ultrasound System 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 Bmode, 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. M-mode 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 (Models: C10, C10TX, C10RLpro) 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: {5}------------------------------------------------ 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 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals. #### VI. Comparison to predicate device and conclusion The intended use, main materials, functional design, safety and performance characteristics of the subject device is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. | Elements of<br>Comparison | Subject Device | Predicate Device | Discussion | |-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Device Name | Pocket Ultrasound System | Pocket Ultrasound System (C10) | -- | | 510(k) Number | K241979 | K231354 | -- | | Model | C10, C10TX, C10RL, C10RLpro | C10 | -- | | Manufacture | Beijing Konted Medical Technology<br>Co., Ltd | Beijing Konted Medical Technology<br>Co., Ltd | Same | | Classification<br>Name: | Ultrasonic pulsed doppler imaging<br>system | Ultrasonic pulsed doppler imaging<br>system | SE | | Device<br>Classification: | II | II | SE | | Clinical characteristics | | | | | Indications for<br>Use | The Pocket Ultrasound System is<br>intended for diagnostic ultrasound<br>imaging in B (2D), Color Doppler,<br>Combined (B+M), and Pulsed Wave<br>modes. It is indicated for diagnostic<br>ultrasound imaging and fluid flow<br>analysis in the following applications<br>depending on different configuration of<br>array probes: | The Pocket Ultrasound System C10 is<br>intended for diagnostic ultrasound<br>imaging in B (2D), Color Doppler,<br>Combined (B+M), and Pulsed Wave<br>modes. It is indicated for diagnostic<br>ultrasound imaging and fluid flow<br>analysis in the following applications<br>depending on different configuration of<br>array probes: | SE | | Elements of<br>Comparison | Subject Device | Predicate Device | Discussion | | | Convex array probe - Fetal/Obstetrics,<br>Gynecological, Abdominal, Urology | Convex array probe - Fetal/Obstetrics,<br>Gynecological, Abdominal, Urology | | | | Linear array probe - Small Parts<br>(breast, thyroid), Carotid, Peripheral<br>Vessel, Muscular-Skeletal, Pediatric | Linear array probe - Small Parts<br>(breast, thyroid), Carotid, Peripheral<br>Vessel, Muscular-Skeletal, Pediatric | | | | Phase array probe - Cardiology,<br>Cardiac Fetal Echo. | Phase array probe - Cardiology,<br>Cardiac Fetal Echo. | | | | The Pocket Ultrasound System is a<br>transportable ultrasound system<br>intended for use in environments<br>where healthcare is provided by<br>healthcare professionals. | The Pocket Ultrasound System C10 is<br>a transportable ultrasound system<br>intended for use in environments<br>where healthcare is provided by<br>healthcare professionals. | | | Intended patient<br>population | For use in all patients | For use in all patients | SE | | Intended use<br>environment | Hospital, clinics, home for use by<br>healthcare professionals | Hospital, clinics, home for use by<br>healthcare professionals | SE | | | General technological characteristics | | | | | Principle of operation of the Pocket<br>Ultrasound System is based on<br>ultrasonic echo imaging, which is a<br>common medical imaging technology<br>to use the transmission speed of<br>ultrasound in different tissues and<br>reflection degree | Principle of operation of the Pocket<br>Ultrasound System is based on<br>ultrasonic echo imaging, which is a<br>common medical imaging technology<br>to use the transmission speed of<br>ultrasound in different tissues and<br>reflection degree | | | Working principle | differences, to get images through<br>computer processing for diagnosis and<br>treatment. | differences, to get images through<br>computer processing for diagnosis and<br>treatment. | SE | | | The transducers inside the probe are<br>responsible to emitting and receiving<br>ultrasonic waves. When a pulse with a<br>certain frequency and magnitude onto<br>the transducers, then ultrasonic waves<br>are generated through the inverse | The transducers inside the probe are<br>responsible to emitting and receiving<br>ultrasonic waves. When a pulse with a<br>certain frequency and magnitude onto<br>the transducers, then ultrasonic waves<br>are generated through the inverse | | | | piezoelectric effect and transmitted to<br>the human body tissue through the | piezoelectric effect and transmitted to<br>the human body tissue through the | | | Elements of<br>Comparison | Subject Device | Predicate Device | Discussion | | | probe. When the ultrasonic wave<br>meets the tissue interface, it will<br>generate echoes, which are scattered<br>in different tissues or blood flow and<br>received by the probe and converted<br>into electrical signals. The receiver<br>amplifies and processes these<br>electrical signals before transmitting<br>them to the processing unit. Based on<br>the signals received, the processing<br>unit will calculate the intensity and<br>timing of the echoes to form an image. | probe. When the ultrasonic wave<br>meets the tissue interface, it will<br>generate echoes, which are scattered<br>in different tissues or blood flow and<br>received by the probe and converted<br>into electrical signals. The receiver<br>amplifies and processes these<br>electrical signals before transmitting<br>them to the processing unit. Based on<br>the signals received, the processing<br>unit will calculate the intensity and<br>timing of the echoes to form an image. | | | Design | Autocorrelation for color processing<br>and FFT for pulse Doppler processing.<br>Supporting Linear, Convex and Phase<br>array probes.<br>Cine play back capability Image file<br>archive. | Autocorrelation for color processing<br>and FFT for pulse Doppler processing.<br>Supporting Linear, Convex and Phase<br>array probes.<br>Cine play back capability Image file<br>archive. | SE | | Operating<br>Controls | Convex: 90~305mm<br>Linear: 20~100mm<br>Cardiac: 90~160mm | Convex: 90~305mm<br>Linear: 20~100mm<br>Cardiac: 90~160mm | SE | | | Gain | Gain | SE | | | Focus | Focus | SE | | | Color box size/positive can be adjust | Color box size/positive can be adjust | SE | | | Baseline | Baseline | SE | | | Cline control: Toggling freeze key | Cline control: Toggling freeze key | SE | | Operation Mode | B mode<br>B/M mode<br>Color Doppler mode<br>Pulse Wave mode | B mode<br>B/M mode<br>Color Doppler mode<br>Pulse Wave mode | SE | | Elements of<br>Comparison | Subject Device | Predicate Device | Discussion | | Transducers | Convex Array; Phase Array; Linear<br>Array | Convex Array; Phase Array; Linear<br>Array | SE | | Frequency | Convex Array: 3.2MHz<br>Phase Array: 2.5MHz<br>Linear Array: 7.5MHz | Convex Array: 3.2MHz<br>Phase Array: 2.5MHz<br>Linear Array: 7.5MHz | SE | | Probe connection<br>to display unit | Wireless connection via Wi -Fi | Wireless connection via Wi -Fi | SE | | Power sourc and<br>power<br>requirement | Rechargeable battery(Li-ion)<br>DC 5V | Rechargeable battery(Li-ion)<br>DC 5V | SE | | Device and<br>Operating system<br>for the software<br>APP | A commercial off-the-shelf Android<br>device (COTS) | A commercial off-the-shelf Android<br>device (COTS) | SE | | Acoustic output<br>levels | Track 3<br>$Ispta.3≤720W/cm²$<br>$MI≤1.9$<br>$TI≤6.0$ | Track 3<br>$Ispta.3≤720W/cm²$<br>$MI≤1.9$<br>$TI≤6.0$ | SE | | Safety and Effectiveness | | | | | Patient contacting<br>material | Per ISO 10993-5 and ISO 10993-10 | Per ISO 10993-5 and ISO 10993-10 | SE | | Electrical Safety | Evaluated according to IEC 60601-1 | Evaluated according to IEC 60601-1 | SE | | EMC | Evaluated according to IEC 60601-1-2 | Evaluated according to IEC 60601-1-2 | SE | | Performance<br>Safety | Evaluated according to IEC 60601-2-<br>37 | Evaluated according to IEC 60601-2-<br>37 | SE | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ Comparison in Detail(s): {9}------------------------------------------------ As can be seen from the above comparison table, there is no difference between subject device and predicate device in terms of technical parameters and they are essentially equivalent. ### VII. Summary of Testing Three new models are added in this submission (C10TX / C10RLpro). The new models have no difference in composition and performance parameters from the original model, only the appearance and battery capacity are different. We have tested two types of batteries with different capacities to ensure that they are both qualified. Different models of devices have different colors in appearance, and safety tests have been conducted on the pigments that form different colors to ensure that they can come into contact with human skin. ### IX. Conclusions In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the subject device are substantially equivalent to the predicate device quoted above. The differences between the subject device and its predicat device do not introduce a new intended use and do no raise new issues of safety and effectiveness. Verification testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. It can be concluded that the subject device is substantially equivalent to the legally marketed predicate device.