(264 days)
SonoMe and SONOFINDER are indicated for examining the adult, pregnant woman, and children. These products are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. An appropriately trained healthcare professionals can have operator qualifications. The device use settings are intended in hospital clinic, and medical office settings. The general clinical applications include fetal/ obstetrics(OB), gynecology(GYN), abdominal, small organ and peripheral vessel imaging.
The SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) are a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a Tablet PC or Mobile Phone that utilizes the iOS, Android OS or Windows System.
The SonoMe Wireless Probe Type Ultrasound Scanner and SONOFINDER Wireless Probe Type Ultrasound Scanner are a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS, Android OS or Windows System, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and (iv) User Manual, USB charging cable and Wireless Charger (H5C10L only).
The Wireless Probe Type Ultrasound Scanner software can be downloaded to Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and utilizes an icon touch-based user interface.
The provided document is a 510(k) summary for the SonoMe and SONOFINDER Wireless Probe Type Ultrasound Scanners, indicating their clearance by the FDA based on substantial equivalence to predicate devices. It primarily focuses on demonstrating that the new devices meet established safety and performance standards through non-clinical testing and comparison with current ultrasound systems.
Crucially, the document explicitly states in Section 9. "Summary of Clinical Tests":
"The subject of this premarket submission, SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25), did not require clinical studies to support substantial equivalence."
Therefore, the following information regarding acceptance criteria, study design, and performance metrics for an AI-enabled device's clinical performance, as requested in the prompt, cannot be extracted from this document, because no clinical studies were performed or required for the 510(k) clearance of this ultrasound device. The device is purely a hardware ultrasound scanner, not an AI/ML software.
The document focuses on the equivalence of the device's technical specifications and safety standards (electrical, EMC, biocompatibility, acoustic output) to predicate devices, rather than on the performance of a diagnostic algorithm.
Despite the lack of clinical study information in the provided text, I will answer the questions based on the closest relevant information available regarding the device's characteristics and the general principles of medical device clearance, noting where specific details are not provided.
Acceptance Criteria and Device Performance (Based on provided information)
The acceptance criteria for this device are not framed as specific diagnostic performance metrics (e.g., sensitivity, specificity) derived from a clinical study for an AI algorithm. Instead, they are defined by compliance with recognized electrical, safety, and biocompatibility standards, and substantial equivalence in technical characteristics and intended use to legally marketed predicate ultrasound devices.
The "reported device performance" is implicitly that it successfully passed these non-clinical tests and was found substantially equivalent.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance/Compliance |
|---|---|---|
| Electrical Safety | IEC 60601-1:2005. AMD1:2012 (General requirements for basic safety and essential performance) | Evaluated according to IEC 60601-1; Complies |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2: 2014 (Electromagnetic disturbances - Requirements and tests) | Evaluated according to IEC 60601-1-2; Complies |
| Performance Safety (Ultrasound Specific) | IEC 60601-2-37: 2015 (Particular requirements for ultrasonic medical diagnostic and monitoring equipment) | Evaluated according to IEC 60601-2-37; Complies |
| Biocompatibility | ISO 10993-1: 2018 (Evaluation and testing within a risk management process) | Patient contact materials are biocompatible; Evaluated according to ISO 10993-5 and ISO 10993-10; Complies |
| ISO 10993-5: 2009 (Tests for in vitro cytotoxicity) | Complies | |
| ISO 10993-10: 2010 (Tests for irritation and skin sensitization) | Complies | |
| Risk Management | ISO 14971: 2007 (Application of risk management to medical devices) | Complies |
| Usability | IEC 60601-1-6: 2013 (Usability) | Complies |
| IEC 62366-1: 2015 (Application of usability engineering to medical devices) | Complies | |
| Labeling/Symbols | ISO15223-1:2016 (Symbols to be used with medical device labels) | Complies |
| Substantial Equivalence | Comparison to predicate devices (K172750, K151339, K171926, K170085) in intended use, principles of operation, technological characteristics, and safety and effectiveness. | Found "substantially equivalent" to predicate devices. |
Regarding an AI-enabled device's clinical performance, the following answers reflect the absence of such information in this specific 510(k) summary, as it explicitly states clinical studies were not required.
2. Sample size used for the test set and the data provenance:
- Not Applicable. No clinical test set or diagnostic study was performed. The evaluation was based on non-clinical engineering and bench testing, and comparison to predicate devices' specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical ground truth was established as no clinical study was performed for this device's clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set requiring adjudication was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. No MRMC study was conducted, as the device is an ultrasound scanner itself, not an AI-assisted diagnostic software affecting human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware ultrasound device, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No clinical ground truth was used or established for this submission, as per Section 9. The "ground truth" for the device's clearance pertains to its adherence to established electrical, performance, and biocompatibility standards.
8. The sample size for the training set:
- Not Applicable. This is a hardware device; thus, it does not have a "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. As above, this is a hardware device, so there is no training set or ground truth in the AI/ML sense.
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October 11, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Bionet Co., Ltd. % ChuelWon Lee RA Manager 5F, 61 Digital-ro 31-gil Guro-gu Seoul, 08375 REPUBLIC OF KOREA
Re: K220169
Trade/Device Name: SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 19, 2022 Received: September 20, 2022
Dear ChuelWon Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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 Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT 8C: 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
Enclosure
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Indications for Use
510(k) Number (if known) K220169
Device Name
SonoMe Wireless Probe Type Ultrasound Scamer (Model: 5C, 5CB, H5C, 10L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25)
Indications for Use (Describe)
SonoMe and SONOFINDER are indicated for examining the adult, pregnant woman, and children. These products are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. An appropriately trained healthcare professionals can have operator qualifications. The device use settings are intended in hospital clinic, and medical office settings. The general clinical applications include fetal/ obstetrics(OB), gynecology(GYN), abdominal, small organ and peripheral vessel imaging.
The modes of operation are B-mode, PDI(Power Doppler Imaging) mode, PW(Pulse Wave Spectral Doppler) mode and Harmonic mode.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in lowercase letters, with a stylized blue butterfly above the word. The word "bionet" is in a sans-serif font and is black. The butterfly is a light blue color and has a simple, elegant design.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided.
| 1. Submitter | |
|---|---|
| Submitter: | Bionet Co., LTD5F, 61 Digital-ro 31-gilGuro-gu, Seoul, Republic of Korea [08375] |
| Connect: | Primary Contact Person Name: ChuelWon Lee5F, 61 Digital-ro 31-gilGuro-gu, Seoul, Republic of Korea [08375]Tel: +82.70.7585.6459 or +82.10.2067.2442Email: cwlee@ebionet.comSecondary Contact Person Name: Robbin5F, 61 Digital-ro 31-gilGuro-gu, Seoul, Republic of Korea [08375]Tel: +82.10.2067.2442Email: shpark @ebionet.com |
| Date Prepared: | January 17, 2022 |
2. Proposed Device
| Device Name | Wireless Probe Type Ultrasound Scanner(Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) |
|---|---|
| Trade Name | SonoMe |
| Regulation Number | 21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 892.1570 |
| Regulation Name | Ultrasonic pulsed doppler imaging systemUltrasonic pulsed echo imaging systemDiagnostic ultrasonic transducer |
| Product Code | IYN, IYO, ITX |
| Regulatory Class | Class II |
| Device Name | Wireless Probe Type Ultrasound Scanner(Model: SF14L25) |
|---|---|
| Trade Name | SONOFINDER |
| Regulation Number | 21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 892.1570 |
| Regulation Name | Ultrasonic pulsed doppler imaging systemUltrasonic pulsed echo imaging systemDiagnostic ultrasonic transducer |
| Product Code | IYN, IYO, ITX |
| Regulatory Class | Class II |
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Image /page/4/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a sans-serif font, with a stylized blue butterfly above the word. The butterfly is positioned slightly to the left of the word "bionet". The overall design is simple and modern.
3. Predicate Device
| Type | Proposed Device | Predicate Device: |
|---|---|---|
| Convex | Model: 5C, 5CB, H5C | Wireless Probe Type Ultrasound Scanner /Model: UProbe-C (K172750)SONON Ultrasound Imaging System / Model:SONON 300C (K151339)C5 Diagnostic Ultrasound System (K171926) |
| Linear | Model: 10L, 14L, 10LB, H10L, SF14L25 | Wireless Probe Type Ultrasound Scanner /Model: UProbe-L (K172750)SONON Ultrasound Imaging System / Model:SONON 300L (K170085)C5 Diagnostic Ultrasound System (K171926) |
| Dual | Model: H5C10L | Wireless Probe Type Ultrasound Scanner /Model: UProbe-C (K172750)SONON Ultrasound Imaging System / Model:SONON 300C (K151339)C5 Diagnostic Ultrasound System (K171926)Wireless Probe Type Ultrasound Scanner /Model: UProbe-L (K172750)SONON Ultrasound Imaging System / Model:SONON 300L (K170085)C5 Diagnostic Ultrasound System (K171926) |
4. Device Description
The SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) are a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a Tablet PC or Mobile Phone that utilizes the iOS, Android OS or Windows System.
The SonoMe Wireless Probe Type Ultrasound Scanner and SONOFINDER Wireless Probe Type Ultrasound Scanner are a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS, Android OS or Windows System, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and (iv) User Manual, USB charging cable and Wireless Charger (H5C10L only).
The Wireless Probe Type Ultrasound Scanner software can be downloaded to Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and utilizes an icon touch-based user interface.
5. Indications for use
SonoMe and SONOFINDER are indicated for examining the adult, pregnant woman, and children. These products are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. An appropriately trained healthcare professionals can have operator qualifications. The device use settings are
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Image /page/5/Picture/0 description: The image shows the logo for Bionet. The logo features a light blue butterfly above the word "bionet" in a lowercase, sans-serif font. The butterfly is stylized with rounded wings, and the overall design is clean and modern.
intended in hospital clinic, and medical office settings. The general clinical applications include fetal/obstetrics(OB). gynecology(GYN), abdominal, small organ and peripheral vessel imaging, The modes of operation are B-mode, PDI(Power Doppler Imaging) mode, PW(Pulse Wave Spectral Doppler) mode and Harmonic mode.
6. Technology
The SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) employ the similar fundamental scientific technology as its predicate device(s).
7. Determination of Substantial Equivalence
The SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) are substantially equivalent to the predicate devices with regards to intended use, principles of operation, technological characteristics and safety and effectiveness.
As described below, the system has been evaluated for acoustic output, biocompatibility, thermal, electrical, and mechanical safety, and has been found to conform to applicable standards and product specifications that demonstrate that the SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) are substantially equivalent to the predicate devices.
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Image /page/6/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a sans-serif font, with the "b" in lowercase and the rest of the letters in lowercase. Above the word "bionet" is a stylized butterfly with a light blue color. The butterfly is positioned slightly to the left of the word "bionet".
Comparison Table:
Model: 5C, 5CB, H5C
| ComparisonItems | Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|---|
| Device Name /Model Name | Wireless Probe TypeUltrasound Scanner /Model: 5C(Under Review) | Wireless Probe TypeUltrasound Scanner /Model: 5CB(Under Review) | Wireless Probe TypeUltrasound Scanner /Model: H5C(Under Review) | Wireless Probe TypeUltrasound Scanner /Model: UProbe-C(K172750) | SONON UltrasoundImaging System /Model: SONON 300C(K151339) | C5 DiagnosticUltrasound System(K171926) |
| Manufacturer | Bionet Co., Ltd. | Bionet Co., Ltd. | Bionet Co., Ltd. | Guangzhou SonostarTechnologies Co.,Ltd. | Healcerion Co., Ltd. | Guangzhou SonostarTechnologies Co.,Ltd. |
| Product Code | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | IYO, ITX | IYO, ITX | IYN, IYO, ITX |
| Classification | Class 2 | Class 2 | Class 2 | Class 2 | Class 2 | Class 2 |
| Indication forUse | SonoMe is indicatedfor examining theadult, pregnantwoman, and children.This products isintended for use by, orby the order of, andunder the supervisionof, a licensedphysician who isqualified for direct useof medical devices. Anappropriately trainedhealthcareprofessionals can haveoperatorqualifications. Thedevice use settings areintended in hospitalclinic, and medicaloffice settings. Thegeneral clinicalapplications includefetal/obstetrics(OB),gynecology(GYN) | SonoMe is indicatedfor examining theadult, pregnantwoman, and children.This products isintended for use by, orby the order of, andunder the supervisionof, a licensedphysician who isqualified for direct useof medical devices. Anappropriately trainedhealthcareprofessionals can haveoperatorqualifications. Thedevice use settings areintended in hospitalclinic, and medicaloffice settings. Thegeneral clinicalapplications includefetal/obstetrics(OB),gynecology(GYN) | SonoMe is indicatedfor examining theadult, pregnantwoman, and children.This products isintended for use by, orby the order of, andunder the supervisionof, a licensedphysician who isqualified for direct useof medical devices. Anappropriately trainedhealthcareprofessionals can haveoperatorqualifications. Thedevice use settings areintended in hospitalclinic, and medicaloffice settings. Thegeneral clinicalapplications includefetal/obstetrics(OB),gynecology(GYN) | Intended fordiagnostic ultrasoundecho imaging,measurement, andanalysis of the humanbody for generalclinical applicationsincluding obstetrics(OB), gynecology(GYN) and general(abdominal) imaging. | Intended fordiagnostic ultrasoundecho imaging,measurement, andanalysis of the humanbody for generalclinical applicationsincluding obstetrics(OB), gynecology(GYN) and general(abdominal) imaging. | C5 DiagnosticUltrasound System isa general-purposeultrasonic imaginginstrument intendedfor use by a qualifiedphysician forevaluation for Fetal,Abdominal, Pediatric,Small Organ (breast,testes, thyroid), Trans-vaginal, PeripheralVascular, Musculo-skeletal (Conventionaland Superficial),Cardiac (neonatal andadult), OB/Gyn andUrology. |
| ComparisonItems | Subject Device | Predicate Device | ||||
| abdominal, smallorgan and peripheralvessel imaging.The modes ofoperation are B-mode,PDI(Power DopplerImaging) mode,PW(Pulse WaveSpectral Doppler)mode and Harmonicmode. | abdominal, smallorgan and peripheralvessel imaging.The modes ofoperation are B-mode,PDI(Power DopplerImaging) mode,PW(Pulse WaveSpectral Doppler)mode and Harmonicmode. | abdominal, smallorgan and peripheralvessel imaging.The modes ofoperation are B-mode,PDI(Power DopplerImaging) mode,PW(Pulse WaveSpectral Doppler)mode and Harmonicmode. | Hospital, clinic, andmedical office settings | Hospital, clinic, andmedical office settings | ||
| Environmentof Use | Hospital, clinic, andmedical office settings | Hospital, clinic, andmedical office settings | Hospital, clinic, andmedical office settings | Track 3 | Track 3 | |
| AcousticOutput Levels | Track 3 | Track 3 | Track 3 | B | B, M, **PW, Color,*PDI, CompoundImaging | |
| Display mode | B, B/M, Color, *PDI,**PW | B, B/M | B, B/M, Color, *PDI,**PW | For use in all patients | For use in all patients | |
| PatientPopulation | For use in all patients | For use in all patients | For use in all patients | General clinicalapplications, includingfetal/obstetrics,gynecology,abdominal | Fetal, Abdominal,Pediatric, Small Organ(breast, testes,thyroid), Trans-vaginal, PeripheralVascular, Musculo-skeletal (Conventionaland Superficial),Cardiac (neonatal andadult), OB/Gyn andUrology. | |
| Clinicalapplication | General clinicalapplications, includingfetal/obstetrics,gynecology,abdominal | General clinicalapplications, includingfetal/obstetrics,gynecology,abdominal | General clinicalapplications, includingfetal/obstetrics,gynecology,abdominal | Healthcareprofessionals | Healthcareprofessionals | |
| Users | Healthcareprofessionals | Healthcareprofessionals | Healthcareprofessionals | Piezoelectric materialin the transducer isused as an ultrasoundsource to transmitsound waves into the | The basic principle isthat system transmitsultrasonic energy intopatient body andimplements post | |
| Principle/Method ofOperation | Piezoelectric materialin the transducer isused as an ultrasoundsource to transmitsound waves into the | Piezoelectric materialin the transducer isused as an ultrasoundsource to transmitsound waves into the | Piezoelectric materialin the transducer isused as an ultrasoundsource to transmitsound waves into the | |||
| ComparisonItems | Subject Device | Predicate Device | ||||
| Image DisplayUnit | body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as image of anatomic structures.Mobile device (4 to 13 inches approximately) | body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as image of anatomic structures.Mobile device (4 to 13 inches approximately) | body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as image of anatomic structures.Mobile device (4 to 13 inches approximately) | body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as image of anatomic structures.Mobile device (4 to 13 inches approximately) | body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as image of anatomic structures.Mobile device (4 to 10 inches approximately) | processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.15-inch LCD monitor |
| ProbeCharacteristics | Convex, 3.2/5MHz frequency | Convex, 3.2/5MHz frequency | Convex, 3.2/5MHz frequency | Convex, 3.5MHz frequency | Convex, 3.5MHz frequency | Supporting Linear probes (7.5MHz & 6.5MHz) and convex array probes (3.5MHz & 5.0MHz) |
| ProbeConnection toDisplay | Wireless | Wireless | Wireless | Wireless | Wireless | Non wireless |
| Off-the-shelfoperationsystem | iOS / Android / Windows | iOS / Android / Windows | iOS / Android / Windows | iOS | iOS / Android | Linux |
| Software | Run as an app on off-the-shelf mobile device | Run as an app on off-the-shelf mobile device | Run as an app on off-the-shelf mobile device | Run as an app on off-the-shelf mobile device | Run as an app on off-the-shelf mobile device | Based on an embedded Linux Operating System |
| SystemComponents | Commercial off-the-shelf iOS mobile deviceWireless Probe Type Ultrasound Scanner software that runs as an app on the mobile deviceWireless Probe Type Ultrasound Scanner battery-operated, hand-held ultrasound diagnostic transducer that communicates | Commercial off-the-shelf iOS mobile deviceWireless Probe Type Ultrasound Scanner software that runs as an app on the mobile deviceWireless Probe Type Ultrasound Scanner battery-operated, hand-held ultrasound diagnostic transducer that communicates | Commercial off-the-shelf iOS mobile deviceWireless Probe Type Ultrasound Scanner software that runs as an app on the mobile deviceWireless Probe Type Ultrasound Scanner battery-operated, hand-held ultrasound diagnostic transducer that communicates | Commercial off-the-shelf iOS mobile deviceWireless Probe Type Ultrasound Scanner software that runs as an app on the mobile deviceWireless Probe Type Ultrasound Scanner battery-operated, hand-held ultrasound diagnostic transducer that communicates | Commercial off-the-shelf iOS or Android mobile deviceSONON Ultrasound Imaging System software that runs as an app on the mobile deviceSONON Ultrasound Imaging System battery-operated, hand-held ultrasound diagnostic transducer that communicates | The C5 Diagnostic Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging system |
| ComparisonItems | Subject Device | Predicate Device | ||||
| wirelessly with TabletPC or Mobile Phonewhich supports byiOS, Android OS orWindows System. | wirelessly with TabletPC or Mobile Phonewhich supports byiOS, Android OS orWindows System. | wirelessly with TabletPC or Mobile Phonewhich supports byiOS, Android OS orWindows System. | wirelessly with iOSmobile device | wirelessly with iOS orAndroid mobiledevice | All materials withpatient contact arebiocompatible and canbe disinfected | |
| PatientContactingMaterials | Patient contactmaterials arebiocompatible. | Patient contactmaterials arebiocompatible. | Patient contactmaterials arebiocompatible. | Evaluated accordingto FDA recognizedstandards - ISO10993-5 and ISO10993-10 | All materials withpatient contact arebiocompatible and canbe disinfected | All materials withpatient contact arebiocompatible and canbe disinfected |
| ElectricalSafety | Evaluated accordingto IEC 60601-1 | Evaluated accordingto IEC 60601-1 | ||||
| EMC | Evaluated accordingto IEC 60601-1-2 | Evaluated accordingto IEC 60601-1-2 | ||||
| PerformanceSafety | Evaluated accordingto IEC 60601-2-37 | Evaluated accordingto IEC 60601-2-37 |
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Image /page/7/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a lowercase, sans-serif font. Above the word is a stylized image of a butterfly with a gradient of blue colors. The butterfly is positioned so that it appears to be flying upwards and to the right.
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Image /page/8/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a sans-serif font, with the "b" in lowercase and the rest of the letters in lowercase as well. Above the word "bionet" is a stylized image of a butterfly in a light blue color. The butterfly is positioned so that its wings are spread out, and it appears to be in flight.
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Image /page/9/Picture/0 description: The image shows the logo for Bionet. The logo features a light blue butterfly above the word "bionet" in a lowercase, sans-serif font. The butterfly is stylized with rounded wings, and the overall design is simple and modern.
*PDI: Power Doppler Imaging, **PW: Pulse Wave Spectral Doppler
Model: 10L, 14L, SF14L25, 10LB, H10L
| ComparisonItems | Subject Device | Predicate Device | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Device Name /Model Name | Wireless ProbeTypeUltrasoundScanner /Model: 10L(Under Review) | Wireless ProbeTypeUltrasoundScanner /Model: 14L(Under Review) | Wireless ProbeTypeUltrasoundScanner /Model:SF14L25(Under Review) | Wireless ProbeTypeUltrasoundScanner /Model: 10LB(Under Review) | Wireless ProbeTypeUltrasoundScanner /Model: H10L(Under Review) | Wireless ProbeTypeUltrasoundScanner /Model: UProbe-L(K172750) | SONONUltrasoundImaging System/ Model:SONON 300L(K170085) | C5 DiagnosticUltrasoundSystem(K171926) | |
| Manufacturer | Bionet Co., Ltd. | Bionet Co., Ltd. | Bionet Co., Ltd. | Bionet Co., Ltd. | Bionet Co., Ltd. | GuangzhouSonostarTechnologiesCo., Ltd. | Healcerion Co.,Ltd. | GuangzhouSonostarTechnologiesCo., Ltd. | |
| Product Code | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | |
| Classification | Class 2 | Class 2 | Class 2 | Class 2 | Class 2 | Class 2 | Class 2 | Class 2 | |
| Indication forUse | SonoMe isindicated forexamining the | SonoMe isindicated forexamining the | SONOFINDERis indicated forexamining the | SonoMe isindicated forexamining the | SonoMe isindicated forexamining the | Intended fordiagnosticultrasound echo | Intended fordiagnosticultrasound echo | C5 DiagnosticUltrasoundSystem is a | |
| ComparisonItems | Subject Device | Predicate Device | |||||||
| adult, pregnantwoman, andchildren. Thisproducts isintended for useby, or by theorder of, andunder thesupervision of,a licensedphysician whois qualified fordirect use ofmedicaldevices. Anappropriatelytrainedhealthcareprofessionalscan haveoperatorqualifications.The device usesettings areintended inhospital clinic,and medical | adult, pregnantwoman, andchildren. Thisproducts isintended for useby, or by theorder of, andunder thesupervision of,a licensedphysician whois qualified fordirect use ofmedicaldevices. Anappropriatelytrainedhealthcareprofessionalscan haveoperatorqualifications.The device usesettings areintended inhospital clinic,and medical | adult, pregnantwoman, andchildren. Thisproducts isintended for useby, or by theorder of, andunder thesupervision of,a licensedphysician whois qualified fordirect use ofmedicaldevices. Anappropriatelytrainedhealthcareprofessionalscan haveoperatorqualifications.The device usesettings areintended inhospital clinic,and medical | adult, pregnantwoman, andchildren. Thisproducts isintended for useby, or by theorder of, andunder thesupervision of,a licensedphysician whois qualified fordirect use ofmedicaldevices. Anappropriatelytrainedhealthcareprofessionalscan haveoperatorqualifications.The device usesettings areintended inhospital clinic,and medical | adult, pregnantwoman, andchildren. Thisproducts isintended for useby, or by theorder of, andunder thesupervision of,a licensedphysician whois qualified fordirect use ofmedicaldevices. Anappropriatelytrainedhealthcareprofessionalscan haveoperatorqualifications.The device usesettings areintended inhospital clinic,and medical | imaging,measurement,and analysis ofthe human bodyfor generalclinicalapplicationsincluding smallorgan andperipheralvessel imaging. | imaging,measurement,and analysis ofthe human bodyfor generalclinicalapplicationsincludingmusculoskeletal(MSK),vascular, smallparts (breast,thyroid), andthoracic/pleuralmotion andfluid detectionimaging. | general-purposeultrasonicimaginginstrumentintended for useby a qualifiedphysician forevaluation forFetal, Abdominal,Pediatric, SmallOrgan (breast,testes, thyroid),Trans-vaginal,PeripheralVascular,Musculo-skeletal(Conventionaland Superficial),Cardiac (neonataland adult),OB/Gyn andUrology. | ||
| office settings.The generalclinicalapplicationsincludefetal/obstetrics(OB),gynecology(GYN), abdominal,small organ andperipheral | office settings.The generalclinicalapplicationsincludefetal/obstetrics(OB),gynecology(GYN), abdominal,small organ andperipheral | office settings.The generalclinicalapplicationsincludefetal/obstetrics(OB),gynecology(GYN), abdominal,small organ andperipheral | office settings.The generalclinicalapplicationsincludefetal/obstetrics(OB),gynecology(GYN), abdominal,small organ andperipheral | office settings.The generalclinicalapplicationsincludefetal/obstetrics(OB),gynecology(GYN), abdominal,small organ andperipheral | |||||
| ComparisonItems | Subject Device | Predicate Device | |||||||
| vessel imaging.The modes ofoperation are B-mode,PDI(PowerDopplerImaging) mode,PW(Pulse WaveSpectralDoppler) modeand Harmonicmode. | vessel imaging.The modes ofoperation are B-mode,PDI(PowerDopplerImaging) mode,PW(Pulse WaveSpectralDoppler) modeand Harmonicmode. | vessel imaging.The modes ofoperation are B-mode,PDI(PowerDopplerImaging) mode,PW(Pulse WaveSpectralDoppler) modeand Harmonicmode. | vessel imaging.The modes ofoperation are B-mode,PDI(PowerDopplerImaging) mode,PW(Pulse WaveSpectralDoppler) modeand Harmonicmode. | vessel imaging.The modes ofoperation are B-mode,PDI(PowerDopplerImaging) mode,PW(Pulse WaveSpectralDoppler) modeand Harmonicmode. | |||||
| Environmentof Use | Hospital, clinic,and medicaloffice settings | Hospital, clinic,and medicaloffice settings | Hospital, clinic,and medicaloffice settings | Hospital, clinic,and medicaloffice settings | Hospital, clinic,and medicaloffice settings | Hospital, clinic,and medicaloffice settings | Hospital, clinic,and medicaloffice settings | Hospital, clinic,and medicaloffice settings | |
| AcousticOutput Levels | Track 3 | Track 3 | Track 3 | Track 3 | Track 3 | Track 3 | Track 3 | Track 3 | |
| Display mode | B, B/M, Color,PDI,* PW | B, B/M, Color,PDI,* PW | B, B/M, Color,PDI,* PW | B, B/M | B, B/M, Color,PDI,* PW | B, B/M | B, Color | B, M, **PW,Color, *PDI,CompoundImaging | |
| PatientPopulation | For use in allpatients | For use in allpatients | For use in allpatients | For use in allpatients | For use in allpatients | For use in allpatients | For use in allpatients | For use in allpatients | |
| Clinicalapplication | General clinicalapplications,including smallorgan andperipheralvessel | General clinicalapplications,including smallorgan andperipheralvessel | General clinicalapplications,including smallorgan andperipheralvessel | General clinicalapplications,including smallorgan andperipheralvessel | General clinicalapplications,including smallorgan andperipheralvessel | General clinicalapplications,including smallorgan andperipheralvessel imaging. | General clinicalapplications,includingfetal/obstetrics,gynecology,abdominal | Fetal, Abdominal,Pediatric, SmallOrgan (breast,testes, thyroid),Trans-vaginal,PeripheralVascular,Musculo-skeletal(Conventionaland Superficial),Cardiac (neonataland adult),OB/Gyn andUrology. | |
| ComparisonItems | Subject Device | Predicate Device | |||||||
| Users | Healthcare | Healthcare | Healthcare | Healthcare | Healthcare | Healthcare | Healthcare | Healthcare | |
| professionals | professionals | professionals | professionals | professionals | professionals | professionals | professionals | ||
| Principle | Piezoelectric | Piezoelectric | Piezoelectric | Piezoelectric | Piezoelectric | Piezoelectric | Piezoelectric | The basic | |
| ofMethod | material in the | material in the | material in the | material in the | material in the | material in the | material in the | principle is that | |
| Operation | transducer is | transducer is | transducer is | transducer is | transducer is | transducer is | transducer is | system transmits | |
| used as an | used as an | used as an | used as an | used as an | used as an | used as an | ultrasonic energy | ||
| ultrasound | ultrasound | ultrasound | ultrasound | ultrasound | ultrasound | ultrasound | into patient body | ||
| source to | source to | source to | source to | source to | source to | source to | and implements | ||
| transmit sound | transmit sound | transmit sound | transmit sound | transmit sound | transmit sound | transmit sound | post processing | ||
| waves into the | waves into the | waves into the | waves into the | waves into the | waves into the | waves into the | of received | ||
| body. Sound | body. Sound | body. Sound | body. Sound | body. Sound | body. Sound | body. Sound | echoes to | ||
| waves are | waves are | waves are | waves are | waves are | waves are | waves are | generate onscreen | ||
| reflected back | reflected back | reflected back | reflected back | reflected back | reflected back | reflected back | display of | ||
| to the | to the | to the | to the | to the | to the | to the | anatomic | ||
| transducer and | transducer and | transducer and | transducer and | transducer and | transducer and | transducer and | structures and | ||
| converted to | converted to | converted to | converted to | converted to | converted to | converted to | fluid flow within | ||
| electrical | electrical | electrical | electrical | electrical | electrical | electrical | the body. | ||
| signals that are | signals that are | signals that are | signals that are | signals that are | signals that are | signals that are | |||
| processed and | processed and | processed and | processed and | processed and | processed and | processed and | |||
| displayed as | displayed as | displayed as | displayed as | displayed as | displayed as | displayed as | |||
| image of | image of | image of | image of | image of | image of | image of | |||
| anatomic | anatomic | anatomic | anatomic | anatomic | anatomic | anatomic | |||
| structures. | structures. | structures. | structures. | structures. | structures. | structures. | |||
| Image Display | Mobiledevice | Mobiledevice | deviceMobile | Mobile | Mobile device | Mobile device | Mobile device | 15-inch LCD | |
| Unit | (4 to 13 inches | (4 to 13 inches | (4 to 13 inches | (4 to 13 inches | (4 to 13 inches | (4 to 13 inches | (4 to 10 inches | monitor | |
| approximately) | approximately) | approximately) | approximately) | approximately) | approximately) | approximately ) | |||
| Probe | Linear. | Linear. | Linear. | Linear, | Linear. | Linear, 7.5MHz | Linear. | Supporting | |
| Characteristics | 7.5/10MHz | 10/14MHz | 10/14MHz | 7.5/10MHz | 7.5/10MHz | frequency | 5/7.5/10MHz | Linear probes | |
| frequency | frequency | frequency | frequency | frequency | frequency | (7.5MHz & | |||
| 6.5MHz) and | |||||||||
| convex array | |||||||||
| probes (3.5MHz | |||||||||
| & 5.0MHz) | |||||||||
| Probe | Wireless | Wireless | Wireless | Wireless | Wireless | Wireless | Wireless | Non wireless | |
| Connection to | |||||||||
| Display | |||||||||
| Operation | iOS / Android / | iOS / Android / | iOS / Android / | iOS / Android / | iOS / Android / | iOS | iOS / Android | Linux | |
| System | Windows | Windows | Windows | Windows | Windows | ||||
| ComparisonItems | Subject Device | Predicate Device | |||||||
| Software | Run as an appon off-the-shelfmobile device | Run as an appon off-the-shelfmobile device | Run as an appon off-the-shelfmobile device | Run as an appon off-the-shelfmobile device | Run as an appon off-the-shelfmobile device | Run as an appon off-the-shelfmobile device | Run as an appon off-the-shelfmobile device | Based on anembedded LinuxOperating System | |
| SystemComponents | Commercialoff-the-shelfiOS mobiledevice | Commercialoff-the-shelfiOS mobiledevice | Commercialoff-the-shelfiOS mobiledevice | Commercialoff-the-shelfiOS mobiledevice | Commercialoff-the-shelfiOS mobiledevice | Commercialoff-the-shelfiOS mobiledevice | Commercialoff-the-shelfiOS or Androidmobile device | The C5DiagnosticUltrasoundSystem is anintegratedpreprogrammedcolor ultrasoundimaging system,capable ofproducing highdetailresolutionintended forclinicaldiagnosticimaging system | |
| Wireless ProbeTypeUltrasoundScannersoftware thatruns as an appon the mobiledevice | Wireless ProbeTypeUltrasoundScannersoftware thatruns as an appon the mobiledevice | Wireless ProbeTypeUltrasoundScannersoftware thatruns as an appon the mobiledevice | Wireless ProbeTypeUltrasoundScannersoftware thatruns as an appon the mobiledevice | Wireless ProbeTypeUltrasoundScannersoftware thatruns as an appon the mobiledevice | Wireless ProbeTypeUltrasoundScannersoftware thatruns as an appon the mobiledevice | SONONUltrasoundImaging Systemsoftware thatruns as an appon the mobiledevice | |||
| Wireless ProbeTypeUltrasoundScannerbattery-operated, hand-held ultrasounddiagnostictransducer thatcommunicateswirelessly withTablet PC orMobile Phonewhich supportsby iOS,Android OS orWindowsSystem. | Wireless ProbeTypeUltrasoundScannerbattery-operated, hand-held ultrasounddiagnostictransducer thatcommunicateswirelessly withTablet PC orMobile Phonewhich supportsby iOS,Android OS orWindowsSystem. | Wireless ProbeTypeUltrasoundScannerbattery-operated, hand-held ultrasounddiagnostictransducer thatcommunicateswirelessly withTablet PC orMobile Phonewhich supportsby iOS,Android OS orWindowsSystem. | Wireless ProbeTypeUltrasoundScannerbattery-operated, hand-held ultrasounddiagnostictransducer thatcommunicateswirelessly withTablet PC orMobile Phonewhich supportsby iOS,Android OS orWindowsSystem. | Wireless ProbeTypeUltrasoundScannerbattery-operated, hand-held ultrasounddiagnostictransducer thatcommunicateswirelessly withTablet PC orMobile Phonewhich supportsby iOS,Android OS orWindowsSystem. | iOS mobiledevice | SONONUltrasoundImaging Systembattery-operated, hand-held ultrasounddiagnostictransducer thatcommunicateswirelessly withiOS or Androidmobile device | |||
| PatientContactingMaterials | Patient contactmaterials arebiocompatible. | Patient contactmaterials arebiocompatible. | Patient contactmaterials arebiocompatible. | Patient contactmaterials arebiocompatible. | Patient contactmaterials arebiocompatible. | Evaluatedaccording toFDArecognizedstandards - ISO | All materialswith patientcontact arebiocompatibleand can be | All materials withpatient contactare biocompatibleand can bedisinfected | |
| ComparisonItems | Subject Device | Predicate Device | |||||||
| 10993-5 andISO 10993-10 | disinfected | ||||||||
| ElectricalSafety | Evaluatedaccording toIEC 60601-1 | Evaluatedaccording toIEC 60601-1 | Evaluatedaccording toIEC 60601-1 | Evaluatedaccording toIEC 60601-1 | Evaluatedaccording toIEC 60601-1 | Evaluatedaccording toIEC 60601-1 | Evaluatedaccording toIEC 60601-1 | Evaluatedaccording to IEC60601-1 | |
| EMC | Evaluatedaccording toIEC 60601-1-2 | Evaluatedaccording toIEC 60601-1-2 | Evaluatedaccording toIEC 60601-1-2 | Evaluatedaccording toIEC 60601-1-2 | Evaluatedaccording toIEC 60601-1-2 | Evaluatedaccording toIEC 60601-1-2 | Evaluatedaccording toIEC 60601-1-2 | Evaluatedaccording to IEC60601-1-2 | |
| PerformanceSafety | Evaluatedaccording toIEC 60601-2-37 | Evaluatedaccording toIEC 60601-2-37 | Evaluatedaccording toIEC 60601-2-37 | Evaluatedaccording toIEC 60601-2-37 | Evaluatedaccording toIEC 60601-2-37 | Evaluatedaccording toIEC 60601-2-37 | Evaluatedaccording toIEC 60601-2-37 | Evaluatedaccording to IEC60601-2-37 |
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Image /page/10/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized blue butterfly above the word "bionet" in a lowercase, sans-serif font. The butterfly is positioned to the left of the word, creating a visually appealing and recognizable brand identity.
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Image /page/11/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized blue butterfly above the word "bionet" in a sans-serif font. The butterfly is a light blue color and appears to be in flight. The word "bionet" is in a darker shade of blue.
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Image /page/12/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a lowercase, sans-serif font. Above the word "bionet" is a stylized image of a butterfly with a light blue color. The butterfly is positioned so that it appears to be flying above the text.
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Image /page/13/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized blue butterfly above the word "bionet" in a lowercase, sans-serif font. The butterfly is positioned above and slightly to the left of the word "bionet."
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Image /page/14/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in lowercase, sans-serif font, with the "b" in black and the rest of the letters in a slightly lighter shade of black. Above the word "bionet" is a stylized image of a butterfly wing in a light blue color. The wing is positioned diagonally, giving the logo a sense of movement and lightness.
*PDI: Power Doppler Imaging, **PW: Pulse Wave Spectral Doppler
Model: H5C10L
| ComparisonItems | Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|---|
| Device Name /Model Name | Wireless Probe TypeUltrasound Scanner /Model: H5C10L(Under Review) | Wireless Probe TypeUltrasound Scanner /Model: UProbe-C(K172750) | SONON UltrasoundImaging System /Model: SONON 300C(K151339) | Wireless Probe TypeUltrasound Scanner /Model: UProbe-L(K172750) | SONON UltrasoundImaging System /Model: SONON 300L(K170085) | C5 DiagnosticUltrasound System(K171926) |
| Manufacturer | Bionet Co., Ltd. | Guangzhou SonostarTechnologies Co.,Ltd. | Healcerion Co., Ltd. | Guangzhou SonostarTechnologies Co.,Ltd. | Healcerion Co., Ltd. | Guangzhou SonostarTechnologies Co.,Ltd. |
| Product Code | IYN, IYO, ITX | IYO, ITX | IYO, ITX | IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX |
| Classification | Class 2 | Class 2 | Class 2 | Class 2 | Class 2 | Class 2 |
| Indication forUse | SonoMe is indicatedfor examining theadult, pregnantwoman, and children.This products isintended for use by, orby the order of, andunder the supervisionof, a licensedphysician who isqualified for direct useof medical devices. An | Intended fordiagnostic ultrasoundecho imaging,measurement, andanalysis of the humanbody for generalclinical applicationsincluding obstetrics(OB), gynecology(GYN) and general(abdominal) imaging. | Intended fordiagnostic ultrasoundecho imaging,measurement, andanalysis of the humanbody for generalclinical applicationsincluding obstetrics(OB), gynecology(GYN) and general(abdominal) imaging. | Intended fordiagnostic ultrasoundecho imaging,measurement, andanalysis of the humanbody for generalclinical applicationsincluding small organand peripheral vesselimaging. | Intended fordiagnostic ultrasoundecho imaging,measurement, andanalysis of the humanbody for generalclinical applicationsincludingmusculoskeletal(MSK), vascular,small parts (breast,thyroid), and | C5 DiagnosticUltrasound System isa general-purposeultrasonic imaginginstrument intendedfor use by a qualifiedphysician forevaluation for Fetal,Abdominal, Pediatric,Small Organ (breast,testes, thyroid), Trans-vaginal, Peripheral |
| ComparisonItems | Subject Device | Predicate Device | ||||
| appropriately trainedhealthcareprofessionals can haveoperatorqualifications. Thedevice use settings areintended in hospitalclinic, and medicaloffice settings. Thegeneral clinicalapplications includefetal/obstetrics(OB),gynecology(GYN),abdominal, smallorgan and peripheralvessel imaging.The modes ofoperation are B-mode,PDI(Power DopplerImaging) mode,PW(Pulse WaveSpectral Doppler)mode and Harmonicmode. | ||||||
| Environmentof Use | Hospital, clinic, andmedical office settings | Hospital, clinic, andmedical office settings | Hospital, clinic, andmedical office settings | Hospital, clinic, andmedical office settings | Hospital, clinic, andmedical office settings | Hospital, clinic, andmedical office settings |
| AcousticOutput Levels | Track 3 | Track 3 | Track 3 | Track 3 | Track 3 | Track 3 |
| Display mode | B, B/M, Color, *PDI,**PW | B, B/M | B | B, B/M | B, Color | B, M, **PW, Color,*PDI, CompoundImaging |
| PatientPopulation | For use in all patients | For use in all patients | For use in all patients | For use in all patients | For use in all patients | For use in all patients |
| Clinicalapplication | General clinicalapplications, includingfetal/obstetrics,gynecology,abdominal, small | General clinicalapplications, includingfetal/obstetrics,gynecology,abdominal | General clinicalapplications, includingfetal/obstetrics,gynecology,abdominal | General clinicalapplications, includingsmall organ andperipheral vesselimaging | General clinicalapplications, includingfetal/obstetrics,gynecology,abdominal | Fetal, Abdominal,Pediatric, Small Organ(breast, testes,thyroid), Trans-vaginal, Peripheral |
| thoracic/pleuralmotion and fluiddetection imaging. | Vascular, Musculo-skeletal (Conventionaland Superficial),Cardiac (neonatal andadult), OB/Gyn andUrology. | |||||
| ComparisonItems | Subject Device | Predicate Device | ||||
| organ and peripheralvessel imaging. | Vascular, Musculo-skeletal (Conventionaland Superficial),Cardiac (neonatal andadult), OB/Gyn andUrology. | |||||
| Users | Healthcareprofessionals | Healthcareprofessionals | Healthcareprofessionals | Healthcareprofessionals | Healthcareprofessionals | Healthcareprofessionals |
| PrincipleMethodofOperation | Piezoelectric materialin the transducer isused as an ultrasoundsource to transmitsound waves into thebody. Sound wavesare reflected back tothe transducer andconverted to electricalsignals that areprocessed anddisplayed as image ofanatomic structures. | Piezoelectric materialin the transducer isused as an ultrasoundsource to transmitsound waves into thebody. Sound wavesare reflected back tothe transducer andconverted to electricalsignals that areprocessed anddisplayed as image ofanatomic structures. | Piezoelectric materialin the transducer isused as an ultrasoundsource to transmitsound waves into thebody. Sound wavesare reflected back tothe transducer andconverted to electricalsignals that areprocessed anddisplayed as image ofanatomic structures. | Piezoelectric materialin the transducer isused as an ultrasoundsource to transmitsound waves into thebody. Sound wavesare reflected back tothe transducer andconverted to electricalsignals that areprocessed anddisplayed as image ofanatomic structures. | Piezoelectric materialin the transducer isused as an ultrasoundsource to transmitsound waves into thebody. Sound wavesare reflected back tothe transducer andconverted to electricalsignals that areprocessed anddisplayed as image ofanatomic structures. | The basic principle isthat system transmitsultrasonic energy intopatient body andimplements postprocessing of receivedechoes to generateonscreen display ofanatomic structuresand fluid flow withinthe body. |
| Image DisplayUnit | Mobile device (4 to 13inches approximately) | Mobile device (4 to 13inches approximately) | Mobile device (4 to 10inches approximately) | Mobile device (4 to 13inches approximately) | Mobile device (4 to 10inches approximately) | 15 inch LCD monitor |
| ProbeCharacteristics | Convex: 3.2MHz /5MHzLinear: 7.5MHz/10MHz | Convex: 3.5MHzfrequency | Convex, 3.5MHzfrequency | Linear, 7.5MHzfrequency | Linear, 5/7.5/10MHzfrequency | Supporting Linearprobes (7.5MHz &6.5MHz) and Convexarray probes (3.5MHz& 5.0MHz) |
| ProbeConnection toDisplay | Wireless | Wireless | Wireless | Wireless | Wireless | Non Wireless |
| OperationSystem | iOS / Android /Windows | iOS | iOS / Android | iOS | iOS / Android | Linux |
| Software | Run as an app on off-the-shelf mobiledevice | Run as an app on off-the-shelf mobiledevice | Run as an app on off-the-shelf mobiledevice | Run as an app on off-the-shelf mobiledevice | Run as an app on off-the-shelf mobiledevice | Based on anembedded LinuxOperating System |
| SystemComponents | Commercial off-the-shelf iOS mobile | Commercial off-the-shelf iOS mobile | Commercial off-the-shelf iOS or Android | Commercial off-the-shelf iOS mobile | Commercial off-the-shelf iOS or Android | The C5 DiagnosticUltrasound System is |
| ComparisonItems | Subject Device | Predicate Device | ||||
| deviceWireless Probe TypeUltrasound Scannersoftware that runs asan app on the mobiledeviceWireless Probe TypeUltrasound Scannerbattery-operated,hand-held ultrasounddiagnostic transducerthat communicateswirelessly with TabletPC or Mobile Phonewhich supports byiOS, Android OS orWindows System. | deviceWireless Probe TypeUltrasound Scannersoftware that runs asan app on the mobiledeviceWireless Probe TypeUltrasound Scannerbattery-operated,hand-held ultrasounddiagnostic transducerthat communicateswirelessly with iOSmobile device | mobile deviceSONON UltrasoundImaging Systemsoftware that runs asan app on the mobiledeviceSONON UltrasoundImaging Systembattery-operated,hand-held ultrasounddiagnostic transducerthat communicateswirelessly with iOS orAndroid mobiledevice | deviceWireless Probe TypeUltrasound Scannersoftware that runs asan app on the mobiledeviceWireless Probe TypeUltrasound Scannerbattery-operated,hand-held ultrasounddiagnostic transducerthat communicateswirelessly with iOSmobile device | mobile deviceSONON UltrasoundImaging Systemsoftware that runs asan app on the mobiledeviceSONON UltrasoundImaging Systembattery-operated,hand-held ultrasounddiagnostic transducerthat communicateswirelessly with iOS orAndroid mobiledevice | an integratedpreprogrammedcolor ultrasoundimaging system,capable of producinghigh detailresolution intended forclinical diagnosticimaging system. | |
| PatientContactingMaterials | Patient contactmaterials arebiocompatible. | Evaluated accordingto FDA recognizedstandards - ISO10993-5 and ISO10993-10 | All materials withpatient contact arebiocompatible and canbe disinfected | Evaluated accordingto FDA recognizedstandards - ISO10993-5 and ISO10993-10 | All materials withpatient contact arebiocompatible and canbe disinfected | All materials withpatient contact arebiocompatible and canbe disinfected |
| Electrical | Evaluated according | Evaluated according | Evaluated according | Evaluated according | Evaluated according | Evaluated according |
| Safety | to IEC 60601-1 | to IEC 60601-1 | to IEC 60601-1 | to IEC 60601-1 | to IEC 60601-1 | to IEC 60601-1 |
| EMC | Evaluated according | Evaluated according | Evaluated according | Evaluated according | Evaluated according | Evaluated according |
| to IEC 60601-1-2 | to IEC 60601-1-2 | to IEC 60601-1-2 | to IEC 60601-1-2 | to IEC 60601-1-2 | to IEC 60601-1-2 | |
| Performance | Evaluated according | Evaluated according | Evaluated according | Evaluated according | Evaluated according | Evaluated according |
| Safety | to IEC 60601-2-37 | to IEC 60601-2-37 | to IEC 60601-2-37 | to IEC 60601-2-37 | to IEC 60601-2-37 | to IEC 60601-2-37 |
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Image /page/15/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a lowercase, sans-serif font. Above the word "bionet" is a stylized butterfly icon in a light blue color. The butterfly is positioned above and slightly to the right of the word "bionet".
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Image /page/16/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized blue butterfly above the word "bionet" in a lowercase, sans-serif font. The butterfly is positioned to the left of the word, creating a visually appealing and recognizable brand identity.
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized blue butterfly above the word "bionet" in lowercase, black, sans-serif font. The butterfly is positioned to the left of the word, creating a simple and clean design. The overall impression is modern and professional.
*PDI: Power Doppler Imaging, **PW: Pulse Wave Spectral Doppler
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8. Summary of Non-Clinical Test
The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:
IEC 60601-1:2005. AMD1:2012 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 60601-2-37: 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicity
ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 14971: 2007 Medical devices - Application of risk management to medical devices
IEC 60601-1-6: 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62366-1: 2015 Medical devices - Part 1: Application of usability engineering to medical devices
ISO15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling. and information to be supplied - Part 1: General requirements
9. Summary of Clinical Tests
The subject of this premarket submission, SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25), did not require clinical studies to support substantial equivalence.
10. Conclusion
Bionet Co., Ltd. considers the SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) to be as safe, as effective, and performance is substantially equivalent to the predicate device.
§ 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.