(531 days)
No
The summary describes standard ultrasound technology and image processing without mentioning AI, ML, or related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or analysis using learned models). The performance studies section also focuses on standard safety and performance testing, not AI/ML model validation.
No
The device is intended for diagnostic ultrasound echo imaging, measurement, and analysis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body." Additionally, the "Device Description" section describes it as a "hand-held diagnostic ultrasound system."
No
The device description explicitly states that the system consists of a battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer, which is a hardware component responsible for emitting and receiving ultrasound waves. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications". This describes a device used for in vivo imaging (imaging within the living body), not in vitro testing (testing outside the body, typically on biological samples).
- Device Description: The description details how the device uses pulsed-echo technology to image tissues within the body. It describes a transducer that contacts the patient and emits and receives ultrasound waves.
- Modes of Operation: The listed modes (B-mode, BM-mode, Doppler modes) are all standard ultrasound imaging modes used for visualizing structures and blood flow in vivo.
- Anatomical Site: The specified anatomical sites (obstetrics, gynecology, general abdominal) are all locations within the human body.
- Performance Studies: The performance studies mentioned focus on electrical safety, electromagnetic compatibility, and performance safety related to ultrasound equipment, not on the analytical or clinical performance of a diagnostic test performed on a sample.
IVD devices are typically used to examine specimens such as blood, urine, or tissue samples to detect diseases, conditions, or infections. This ultrasound scanner operates by directly imaging the internal structures of the body.
N/A
Intended Use / Indications for Use
The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type CT, Type CL) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging. The part of this device to contact with the patient is the probe head.
Modes of operation:
- Pulsed-echo ultrasound
- Mode B (2D) scan
- · Mode BM scan
- · Doppler mode (COLOR)
- · Energy Doppler mode (PDI)
- · Pulse Doppler (PW)
Operator qualifications: The operator should be capable to understand the Instructions for Use, The operator must be an appropriately-trained healthcare professional or used under the supervision of the authority of a physician.
Device use settings: hospital or home use.
Product codes
IYN, IYO, ITX
Device Description
The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) is a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS operating system.
The mobile device for use with the Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) are those that utilizes the iOS operating system, i.e. all series of iPad or iPhone from Apple Inc.
The Wireless Probe Type Ultrasound Scanner is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS mobile device, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with iOS mobile devices, and (iv) the instructions for use manual, USB Cable for Charging.
The Wireless Probe Type Ultrasound Scanner utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
The device components are not supplied sterile and do not require sterilization prior to use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulsed-echo ultrasound
Anatomical Site
Human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging.
Indicated Patient Age Range
For use in all patients
Intended User / Care Setting
Operator qualifications: The operator should be capable to understand the Instructions for Use, The operator must be an appropriately-trained healthcare professional or used under the supervision of the authority of a physician.
Device use settings: hospital or home use.
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)
Clinical testing was not performed for Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) as part of the submission.
Non-Clinical Tests:
The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:
-
- Biocompatibility according to AAMI / ANSI / ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices - Part 5:Tests For In Vitro Cytotoxicity. (Biocompatibility) and AAMI / ANSI / ISO10993-10:2010/(R)2014, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility);
-
- Electrical Safety according to AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (Iec 60601-1:2005, Mod). (General II (ES/EMC));
-
- Electromagnetic Compatibility according to AAMI / ANSI / IEC 60601-1-2:2007/(R)2012, Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition3). (General II (ES/EMC));
-
- Performance Safety and Effectiveness according to IEC 60601-2-37 Edition 2.0 2007, Medical Electrical Equipment - Part 2-37: Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment. (Radiology);
-
- FCC Radio Frequency Testing: The Wireless Probe Type Ultrasound Scanner was tested according to FCC requirements and found to comply with the requirements of FCC CFR Title 47 Part 15 Subpart C Section 15.247: Frequency Hopping, Direct Spread Spectrum and Hybrid Systems that are in operation with the bands of 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz.
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.
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October 13, 2022
Image /page/0/Picture/1 description: The image contains the logo of 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name is "U.S. Food & Drug Administration".
Guangzhou Sonostar Technologies Co., Ltd. % Weizhong Cai General Manager 504#, C Building,#27 Yayingshi Road, Science Town Guangzhou. Guangdong 510665 CHINA
Re: K211321
Trade/Device Name: Wireless Probe Type Ultrasound Scanner (Model: CProbe: Type: Type C. Type L, Type CT, Type CL Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 9, 2022 Received: September 9, 2022
Dear Weizhong Cai:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (OS) 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
2
Indications for Use
510(k) Number (if known) K211321
Device Name
Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type CT, Type CL)
Indications for Use (Describe)
The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type CT, Type CL) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging. The part of this device to contact with the patient is the probe head.
Modes of operation:
- Pulsed-echo ultrasound
- Mode B (2D) scan
- · Mode BM scan
- · Doppler mode (COLOR)
- · Energy Doppler mode (PDI)
- · Pulse Doppler (PW)
Operator qualifications: The operator should be capable to understand the Instructions for Use, The operator must be an appropriately-trained healthcare professional or used under the supervision of the authority of a physician.
Device use settings: hospital or home use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| × Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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007_510(k) Summary
(As required by 21 CFR 807.92(a))
K211321
7.1 Submitter Information
- · Company: Guangzhou Sonostar Technologies Co., Ltd.
- · Address: 504#, C Building, #27 Yayingshi Road, Science Town,
Guangzhou, Guangdong, 510665, P.R.China
- ・ Phone: 086-20-32382095
- ・ Fax: 086-20-62614030
- Contact: Weizhong Cai, General Manager
- · Date: Oct. 01, 2020
7.2 Device Information
- · Trade/Device Name: Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type C, Type CT, Type CT, Type CL)
- Common Name: Diagnostic Ultrasound System and Transducer
- · Classification:
-
- Device: System, Imaging, Pulsed Echo, Ultrasonic Regulation Description: Ultrasonic pulsed echo imaging system
- · Review Panel: Radiology
- Product Code: IYN,IYO
- · Regulation Number: 21 CFR 892.1550
-
21 CFR 892.1560
- · Primary product code: IYN (associated regulation: 21 CFR 892.1550)
- · Device Class: 2
- 2) Device: Transducer, Ultrasonic, Diagnostic
Regulation Description: Diagnostic ultrasonic transducer
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Review Panel: Radiology
Product Code: ITX Regulation Number: 21 CFR 892.1570 Device Class: 2
7.3 Predicate Device Information
Primary predicate device: Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) submitted by Guangzhou Sonostar Technologies Co., Ltd. 510K Number: K172750 Reference Device: Vscan Air
submitted by GE VINGMED ULTRASOUND AS
(9900 Innovation Drive, wauwatosa, WI 53226)
510K Number: K202035
7.4 Device Description
The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) is a wirelessultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS operating system.
The mobile device for use with the Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) are those that utilizes the iOS operating system, i.e. all series of iPad or iPhone from Apple Inc.
The Wireless Probe Type Ultrasound Scanner is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS mobile device, (ii) the Wireless Probe
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Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with iOS mobile devices, and (iv) the instructions for use manual, USB Cable for Charging.
The Wireless Probe Type Ultrasound Scanner utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
The device components are not supplied sterile and do not require sterilization prior to use.
7.5 Indications for Use
The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging. The part of this device that is intended to contact with the patient is the probe head.
Modes of operation:
- Pulsed-echo ultrasound
- Mode B (2D) scan
- Mode BM scan
- · Doppler mode (COLOR)
- Energy Doppler mode (PDI)
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• Pulse Doppler (PV
Operator qualifications: The operator should be capable to understand the Instructions for Use; The operator must be an appropriately-trained healthcare professional or used under the supervision of the authority of a physician.
Device use settings: hospital or home use.
7.6 Comparison of Technological Characteristics with the Predicate Device
7.6.1 Comparison Table of Technological Characteristic with the
Predicate Device and Reference device for Model: CProbe
| Comparison
Items | Subject Device:
Wireless Probe
Type
Ultrasound
Scanner
(Model:
CProbe; Type:
Type C, Type
L, Type CT,
Type CL) | Primary
predicate
device:
Wireless Probe
Type
Ultrasound
Scanner
(Model:
UProbe-C)
(K172750) | Reference Device:
Vscan Air (K202035) |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Classification & Intended Use | | | |
| Classification | ITX & IYN & IYO | IYO & ITX | ITX & IYO & IYN |
| Class 2 | Class 2 | Class 2 | |
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| Guangzhou Sonostar Technologies Co., Ltd. | |||
|---|---|---|---|
| Intended Use | Intended for | ||
| diagnostic | |||
| ultrasound echo | |||
| imaging, | |||
| measurement, and | |||
| analysis of the | |||
| human body for | |||
| general clinical | |||
| applications | |||
| including obstetrics | |||
| (OB), gynecology | |||
| (GY) and general | |||
| (abdominal) | |||
| imaging. | Intended for | ||
| diagnostic | |||
| ultrasound echo | |||
| imaging, | |||
| measurement, and | |||
| analysis of the | |||
| human body for | |||
| general clinical | |||
| applications | |||
| including obstetrics | |||
| (OB), gynecology | |||
| (GY) and general | |||
| (abdominal) | |||
| imaging. | The device is enabling | ||
| visualization and | |||
| measurement of | |||
| anatomical structures | |||
| and fluid including | |||
| blood flow. |
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| Technological Characteristics | |||
|---|---|---|---|
| Environment of Use | Hospital, clinic, and | ||
| medical office | |||
| settings | Hospital, clinic, and | ||
| medical office | |||
| settings | Professional | ||
| healthcare facilities | |||
| (ex. Hospital, | |||
| clinic, medical | |||
| office), home | |||
| environment, | |||
| road/air ambulance | |||
| and other | |||
| environments | |||
| Acoustic Output | |||
| Levels | Below Track 3 | Below Track 3 | Below Track 3 |
| FDA limits in | FDA limits in | FDA limits in | |
| accordance | accordance | accordance | |
| with Sept. | with Sept. | with Sept. | |
| 2008 | 2008 | 2008 | |
| ultrasound | ultrasound | ultrasound | |
| systems | systems | systems | |
| guidance | guidance | guidance | |
| document | document | document | |
| Imaging Capacities | • Pulsed-echo | ||
| ultrasound | |||
| • Mode B (2D) scan | • Pulsed-echo | ||
| ultrasound | |||
| • Mode B (2D) | |||
| scan | |||
| • Mode BM | |||
| scan | • Black/ white (B- | ||
| mode) | |||
| • Harmonic | |||
| imaging modes | |||
| (PDI) | |||
| • Combined (B + | |||
| Color Doppler / | |||
| PW mode) | |||
| • Color flow (Color | |||
| doppler), | |||
| • Mode BM scan | |||
| • Doppler mode | |||
| (COLOR) | |||
| • Energy Doppler | |||
| mode (PDI) | |||
| • Pulse Doppler | |||
| (PW) | |||
| Feature function | • Biopsy guideline | ||
| • Harmonic | |||
| function | • Biopsy guideline | ||
| • Harmonic | |||
| function | • Biopsy guideline | ||
| • Harmonic | |||
| function | |||
| Guangzhou Sonostar Technologies Co., Ltd. | |||
| Patient Population | For use in all | ||
| patients | For use in all | ||
| patients | For use in all | ||
| patients | |||
| Principle /Mode of | |||
| Operation | Piezoelectric | ||
| material in the | |||
| transducer is used | |||
| as an ultrasound | |||
| source to transmit | |||
| soundwaves into | |||
| the body. Sound | |||
| waves are | |||
| reflected back to | |||
| the transducer | |||
| and converted to | |||
| electrical signals | |||
| that are processed | |||
| and displayed as | |||
| images of | |||
| anatomic | |||
| structures. | Piezoelectric | ||
| material in the | |||
| transducer is used | |||
| as an ultrasound | |||
| source to transmit | |||
| sound waves into | |||
| the body. Sound | |||
| waves are | |||
| reflected back to | |||
| the transducer and | |||
| converted to | |||
| electrical signals | |||
| that are processed | |||
| and displayed as | |||
| images of | |||
| anatomic | |||
| structures. | Medical | ||
| ultrasound images | |||
| are created by | |||
| computer and | |||
| digital memory | |||
| from the | |||
| transmission and | |||
| reception of | |||
| mechanical high- | |||
| frequency waves | |||
| applied through a | |||
| probe. The | |||
| mechanical | |||
| ultrasound waves | |||
| spread through the | |||
| body, producing | |||
| an echo where | |||
| density changes | |||
| occur. The echoes | |||
| return to the probe | |||
| where they are | |||
| converted back | |||
| into electrical | |||
| signals. | |||
| These echo | |||
| signals are | |||
| amplified and | |||
| processed by | |||
| several analog and | |||
| digital circuits | |||
| having filters with | |||
| many frequency | |||
| and time response | |||
| options, | |||
| transforming the | |||
| high-frequency | |||
| electrical signals | |||
| into a series of | |||
| digital image | |||
| signals which are | |||
| stored in memory. | |||
| Once in memory, | |||
| the image can be | |||
| displayed in real- | |||
| time on the | |||
| display device | |||
| Guangzhou Sonostar Technologies Co., Ltd. | |||
| Image Display Unit | Mobile device (4 to 13 inches approximately) | Mobile device (4 to 10 inches approximately) | Mobile device |
| Probe Characteristics | Convex, 3.5 MHz frequency; | Convex, 3.5 MHz frequency | Convex, 3.3MHz frequency |
| Probe Connectionto Display | Wireless | Wireless | Wireless |
| Off-the-shelf operating system | iOS / Android | iOS / Android | iOS / Android |
| 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 |
| System Components | • Commercial | ||
| • off-the-shelf iOS mobile device, | |||
| • Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, | |||
| • Wireless Probe Type Ultrasound Scanner battery-operated, hand-held ultrasound diagnostic transducer that communicates wirelessly with iOS or Android mobile devices | • Commercial off-the-shelf iOS mobile device, | ||
| • Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, | |||
| • Wireless Probe Type Ultrasound Scanner battery-operated, hand-held ultrasound diagnostic transducer that communicates wirelessly with iOS or Android mobile devices | • Mainframe | ||
| • Software | |||
| • Cable charger | |||
| Safety & Effectiveness | |||
| Patient- Contacting | |||
| Materials | Evaluated | ||
| according to FDA | |||
| recognized | |||
| standards - ISO | |||
| 10993-5 and ISO | |||
| 10993-10 | Evaluated | ||
| according to FDA | |||
| recognized | |||
| standards - ISO | |||
| 10993-5 and ISO | |||
| 10993-10 | Evaluated | ||
| according to FDA | |||
| recognized | |||
| standards - ISO | |||
| 10993-5 and ISO | |||
| 10993-10 | |||
| Electrical Safety | Evaluated | ||
| according to IEC | |||
| 60601-1 | Evaluated | ||
| according to IEC | |||
| 60601-1 | Evaluated | ||
| according to IEC | |||
| 60601-1 | |||
| EMC | Evaluated | ||
| according to IEC | |||
| 60601-1-2 | Evaluated | ||
| according to IEC | |||
| 60601-1-2 | Evaluated | ||
| according to IEC | |||
| 60601-1-2 | |||
| Performance Safety | Evaluated | ||
| according to IEC | |||
| 60601-2-37 | Evaluated | ||
| according to IEC | |||
| 60601-2-37 | Evaluated | ||
| according to IEC | |||
| 60601-2-37 |
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Brief Summary
First, the subject device (Model: CProbe) enjoys identical classification and intended use with the Primary predicate device and Reference device, which forms the foundation of their substantial equivalence.
Secondly, the subject device (Model: CProbe) boasts almost the same technological characteristics with the Primary predicate device. And their slight differences in imaging capacities, image display unit will not affect the coreusage of the two devices, thus will not affecting the substantial equivalence comparison between the two devices that the difference technological characteristics with the Reference Device on imaging capacities is covered. Such fact further supports that the two devices are substantial equivalent.
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Last but not least, the safety and effectiveness of the subject device (Model: CProbe) have been evaluated according to the same FDA recognized standards as the Primary predicate device and Reference Device, which ensures that the subject device will be safe and effective for usage as the predicate device, that the two devices are substantial equivalent.
As a result, it is reasonable to conclude that subject device (Model: CProbe) is substantial equivalent with Primary predicate device.
7.6.2 Clinical Test
Clinical testing was not performed for Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) as part of the submission.
7.6.3 Non-Clinical Tests
The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:
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- Biocompatibility according to AAMI / ANSI / ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices - Part 5:Tests For In Vitro Cytotoxicity. (Biocompatibility) and AAMI / ANSI / ISO10993-10:2010/(R)2014, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility);
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- Electrical Safety according to AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (Iec 60601-1:2005, Mod). (General II (ES/EMC));
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- Electromagnetic Compatibility according to AAMI / ANSI / IEC 60601-1-2:2007/(R)2012, Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition3). (General II (ES/EMC));
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- Performance Safety and Effectiveness according to IEC 60601-2-37 Edition 2.0 2007, Medical Electrical Equipment - Part 2-37: Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment. (Radiology);
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- FCC Radio Frequency Testing: The Wireless Probe Type Ultrasound Scanner was tested according to FCC requirements and found to comply with the requirements of FCC CFR Title 47 Part 15 Subpart C Section 15.247: Frequency Hopping, Direct Spread Spectrum and Hybrid Systems that are in operation with the bands of 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz.
7.7 Conclusion
From the above analysis, it is proper to conclude that the subject device (Model: CProbe) will be as safe and effective for usage as the listed predicate devices that have already been on the U.S. market.