Paragon XHD Diagnostic Ultrasound System

K191347 · Shenzhen Wisonic Medical Technology Co. , Ltd. · IYN · Feb 7, 2020 · Radiology

Device Facts

• Record ID: K191347
• Device Name: Paragon XHD Diagnostic Ultrasound System
• Applicant: Shenzhen Wisonic Medical Technology Co. , Ltd.
• Product Code: IYN · Radiology
• Decision Date: Feb 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Diagnostic Ultrasound System is applicable for adults and pediatric patients. It is intended for use in pediatric, small organ (breast, thyroid, testicles, prostate), musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and dermatological exams.

Device Story

Mobile, software-controlled diagnostic ultrasound system; acquires and displays ultrasound data in B-Mode, Color Flow Doppler, Power/Dirpower mode, or combinations. System comprises main unit, ultrasound probe, power adapter, and cables. Operated by healthcare professionals in clinical settings to visualize anatomical structures. Provides software analysis packages for measurements (area, angle, volume, velocity). Output displayed to clinician for diagnostic decision-making. Benefits include non-invasive imaging for assessment of small organs, musculoskeletal, vascular, and dermatological conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1, -5, -10), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing (IEC 60601-2-37) to evaluate measurement accuracy and system sensitivity.

Technological Characteristics

Mobile ultrasound system; B-Mode, Color Flow Doppler, Power/Dirpower modes. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-37 (ultrasonic performance). Probes and materials biocompatible per ISO 10993. Software-controlled with measurement/calculation packages.

Indications for Use

Indicated for adult and pediatric patients undergoing diagnostic ultrasound exams of small organs (breast, thyroid, testicles, prostate), musculoskeletal (conventional and superficial), peripheral vessels, and dermatological structures.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• FUJIFILM SonoSite Vevo MD Imaging System (K160674)
• Clover 50/Clover60/Clover70 Diagnostic Ultrasound System (K163712)

Submission Summary (Full Text)

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Shenzhen Wisonic Medical Technology Co., Ltd. % Jiang Xiaosan Regulatory Engineer 1st, 2nd & 5th Floor, No. 6 Building, Pingshan Tech. Park, Taoyuan Street, Nanshan Shenzhen, Guangdong 518055 CHINA

Re: K191347

Trade/Device Name: Paragon XHD Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 4, 2020 Received: January 9, 2020

### Dear Jiang Xiaosan:

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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K191347

Device Name

Paragon XHD Diagnostic Ultrasound System

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

Indications for Use (Describe)

The Diagnostic Ultrasound System is applicable for adults and pediatric patients. It is intended for use in pediatric, small organ (breast, thyroid, testicles, prostate), musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and dermatological exams.

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information unless it displays a currently valid OMB number."

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# 510(k) Summary

K191347

In accordance with 21 CFR 807.92 the following summary of information is provided:

### 1. Identification of Sponsor

Shenzhen Wisonic Medical Technology Co., LTD.

1st, 2nd & 5th Floor, NO.6 Building, Pingshan Technology Park, Address: Taoyuan Street, Nanshan, Shenzhen. Guangdong, 518055, P.R. CHINA

Contact Person: Jiang Xiaosan

Tel: [phone]

Fax: [phone]

Jan 30, 2019 Date prepared

### 2. Identification of Proposed Device

| Device Name: | Paragon XHD Diagnostic Ultrasound System |
|----------------------|---------------------------------------------|
| Common/Usual Name: | Diagnostic Ultrasound System |
| Regulation number: | 21 CFR 892.1550 |
| Regulation Name: | Ultrasonic pulsed doppler imaging system |
| Regulation Class: | Class II |
| Product Code: | IYN, ITX, IYO |
| Classification Name: | System, Imaging, Pulsed Doppler, Ultrasonic |
| Model: | Paragon XHD |

### 3. Identification of Predicate Device

Primary Predicate Device:

K160674, FUJIFILM SonoSite Vevo MD Imaging System

Secondary Predicate Device:

K163712, Clover 50/Clover60/Clover70 Diagnostic Ultrasound System

### 4 Device Description

The Paragon XHD Diagnostic Ultrasound System is a mobile software controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, Color Flow Doppler, Power/Dirpower mode or the combination of these modes. The system can also measure anatomical structures and offer software analysis

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packages performance to provide information based on which the competent health care professionals can make the diagnosis.

The Paragon XHD Diagnostic Ultrasound System consists of the main unit, an ultrasound probe, power adapter, connecting cable.

### 5. Intended Use

The Diagnostic Ultrasound System is applicable for adults and pediatric patients. It is intended for use in pediatric, small organ (breast, thyroid, testicles, prostate), musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and dermatological exams.

### 6. Substantial Equipment

The Paragon XHD Diagnostic Ultrasound System is comparable with and substantially equivalent to the following predicate devices:

| Predicate<br>Device | Manufacturer | Model | 510(k) Control<br>Number |
|------------------------|----------------------|-----------------------------|--------------------------|
| Primary<br>Predicate | FUJIFILM<br>SonoSite | Vevo MD | K160674 |
| Secondary<br>Predicate | Wisonic | Clover 50/Clover60/Clover70 | K163712 |

### Compared of indications:

Indications of the predicate device (FUJIFILM SonoSite /Vevo MD/K160674) and the subject device (WISONIC/Paragon XHD) are the same.

### Compared of Technological Characteristics:

The proposed device has the similar type probes and similar technical characteristics, including design, operation controls, display modes, operation modes, measurement items and image parameters as the predicate device Vevo MD(K160674).

The proposed device has the same connector port as the predicate device Clover 50/Clover 60/Clover 70(K163712).

The proposed device has the same capability in term of measurements and calculation functions as predicate device, except for adding area (ellipse, circle), angle and volume measurements in B-mode, C-mode, PW-mode and combined mode, and velocity in PW-mode. These measurements are substantially equivalent with the predicate device Clover 50/Clover 60/Clover 70(K163712).

The acoustic power level of proposed device Paragon XHD is below the limit of FDA, which is the same as the predicated device Clover 60/Clover 60/Clover 70(K163712).

All the above differences in technological characteristics do not rise different questions of safety and effectiveness as compared to the predicate device.

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# wisor

### 7. Non-clinical data

The following non-clinical data were provided in support of the substantial equivalence determination.

### Biocompatibility testing

The biocompatibility evaluation for the Paragon XHD Diagnostic Ultrasound System was conducted in accordance with the International Standard ISO 10993-1:2009/ (R)2013, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:

- Cytotoxicity
- Sensitization
- Skin Irritation

The ultrasonic probes and glue of the Diagnostic Ultrasound System are considered to contact directly with human body for a duration of less than 24 hours. The test results of cytotoxicity, sensitization and skin irritation complied with ISO 10993-5:2009. Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity and ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. It demonstrates substantial equivalences to the predicate device.

### Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Diagnostic Ultrasound System. The device complies with the IEC 60601-1:2005/A1:2012, standard for safety and the IEC 60601-1-2:2014, standard for EMC. It demonstrates substantial equivalences to the predicate device.

### Performance testing

The Diagnostic Ultrasound System, was tested according to IEC 60601-2-37:2015 Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, and met the same standard, Performance testing was conducted on the Paragon XHD Diagnostic Ultrasound System, to evaluate the clinic measurement accuracy and system sensitivity, and all of the tested parameters met the predefined acceptance criteria. The comparisons of performance of Paragon XHD Diagnostic Ultrasound System to predicate devices are listed in the table below.

The performance of the device was compared with the predicate devices, and it is concluded that the proposed device is substantially equivalent to the predicate device.

### Software Verification and Validation Testing

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# wison

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. It demonstrates substantial equivalences to the predicate device.

# Animal Study

The subject of this premarket submission, the Paragon XHD Diagnostic Ultrasound System, does not require animal studies to support substantial equivalence.

# 8. Clinical data

The subject of this premarket submission, the Paragon XHD Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence.

# 9. Conclusion

The non-clinical data support the safety of the device and the performance testing report demonstrate that the Paragon XHD Diagnostic Ultrasound System should perform as intended in the specified use conditions and conform to applicable medical device safety standards. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification. Shenzhen Wisonic concludes that the Paragon XHD Diagnostic Ultrasound System is as safe and as effective as the predicate devices.