KOLO Evolution XHD Series Ultrasound Diagnostic System

K221568 · Kolo Medical (Suzhou) Co., Ltd. · IYN · Sep 12, 2022 · Radiology

Device Facts

• Record ID: K221568
• Device Name: KOLO Evolution XHD Series Ultrasound Diagnostic System
• Applicant: Kolo Medical (Suzhou) Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Sep 12, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Evolution XHD Series Ultrasound Diagnostic System is a high frequency general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.

Device Story

High-frequency, software-controlled ultrasound diagnostic system; laptop console with integrated keyboard and LCD display. Uses linear array transducers (15-50MHz) to acquire real-time ultrasound data; main unit processes acoustic signals and displays images. Operated by qualified physicians in hospital environments. Supports B-mode, Color Doppler, Power Doppler, and PW Doppler. Provides measurement tools (distance, area, volume, angle, length trace, curve). Output used by clinicians for diagnostic imaging and analysis of human body and fluid. Benefits include high-resolution imaging for various clinical applications; 128 transmit channels provide improved image quality compared to predicate.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including acoustic output, biocompatibility (ISO 10993), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance verification.

Technological Characteristics

Laptop-based ultrasound console; 128 transmit/64 receive digital channels. Transducers: 256-element linear array (15-50MHz). Materials meet ISO 10993-1. Connectivity: DICOM 3.0. Power: Integrated battery or external supply. Software: IEC 62304 compliant. Safety standards: ANSI/AAMI ES60601-1, IEC 60601-2-37, IEC 60601-1-2.

Indications for Use

Indicated for adult and pediatric patients for ultrasound imaging, measurement, and analysis in clinical applications including: Pediatric, Small parts (breast, thyroid, testicles, prostate), Peripheral vessel, Dermatological, Musculoskeletal (conventional), and Musculoskeletal (superficial).

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 (K190476)

Submission Summary (Full Text)

{0}------------------------------------------------

September 12, 2022

Image /page/0/Picture/1 description: The image shows 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Kolo Medical (Suzhou) Co., Ltd % Mike Su RA Manager Room 303-305 and 504. Building A5, No. 218 Xinghu Street Suzhou. Jiangsu 215123 CHINA

#### Re: K221568

Trade/Device Name: Evolution XHD Series Ultrasound Diagnostic Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX, IYO Dated: August 12, 2022 Received: August 15, 2022

#### Dear Mike Su:

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Yanna Kang, Ph.D.

Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K221568

Device Name

Evolution XHD Series Ultrasound Diagnostic System

Indications for Use (Describe)

The Evolution XHD Series Ultrasound Diagnostic System is a high frequency general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.

The systems support the following clinical applications:

The Evolution XHD Series Diagnostic Ultrasound System is applicable for adult and pediatric. It is intended for use in Pediatric, Small parts (breast, thyroid, testicles, prostate), Peripheral vessel, Dermatological, Musculoskeletal (conventional), Musculoskeletal (superficial).

Modes of operation include: B Mode, Color Doppler, Power Doppler, Combined modes: B+Color Doppler, B+Power Doppler, B+PW Doppler.

| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> <span style="vertical-align: middle;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="vertical-align: middle;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "KOLO" in blue letters. The "K" has a small orange accent mark on the top left. The letters are large and bold, and the word is centered in the image. The background is white.

#### 510(k) Summary K221568

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

| Date Prepared: | Aug 11, 2022 |
|-----------------|---------------------------------------------|
| Manufacturer: | Kolo Medical (Suzhou) Co., Ltd |
| | Room 303-305 and 504, Building A5, No. 218 |
| | Xinghu Street, Biobay, Industry Park, China |
| | (Jiangsu) Pilot Free Trade Zone, Suzhou, |
| | 215123 Jiangsu, P.R. China |
| Contact Person: | Mike SU |
| | Regulatory Affair Mananger |
| | Kolo Medical (Suzhou) Co., Ltd |
| | Tel: [phone] |
| | [e-mail] |

#### ldentification of the Device:

| Proprietary/Trade Name: | KOLO Evolution XHD Series |
|-------------------------|------------------------------|
| Classification Name: | Ultrasound Diagnostic System |
| Regulatory Number: | 21 CFR 892.1550, 1560, 1570 |
| Product Code: | IYN, ITX, IYO |
| Device Class: | Class II |
| Review Panel: | Radiology |

#### Identification of the Legally Marketed Predicate Device:

| Trade Name: | FUJIFILM SonoSite Vevo MD Imaging System |
|--------------------------|------------------------------------------|
| Classification Name: | Ultrasound Diagnostic System |
| Regulatory Number: | 21 CFR 892.1550, 1560, 1570 |
| Product Code: | IYN, ITX, IYO |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Submitter/510(k) Holder: | FUJIFILM SonoSite, Inc. |
| Clearance: | K190476 (cleared March 15, 2019) |

{4}------------------------------------------------

### Device Description:

The Evolution XHD Series device is a high frequency general purpose, software controlled, diagnostic imaging system used to acquire and display high-resolution, real-time ultrasound data. The Evolution XHD Series device is comprised of transducers responsible for ultrasound signal generation, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

The main unit is a laptop ultrasound console with integrated keyboard, a color video LCD type display and operates from an integrated battery or separate power supply/charger.

Evolution XHD Ultrasound Diagnostic System integrated 4 linear probe transducers: L22-8 K2, L28-12K2, L38-22K2, L62-38K2.

| Probe Model | Probe Type | Intended Use | Applicable<br>Body Part |
|-------------|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| L22-8K2 | Linear | Pediatric,<br>Dermatological,<br>Small parts (breast, thyroid, testicles,<br>prostate),<br>musculoskeletal (conventional),<br>musculoskeletal (superficial),<br>Peripheral vessels | Surface |
| L28-12K2 | Linear | Pediatric,<br>Dermatological,<br>Small parts (breast, thyroid, testicles,<br>prostate),<br>musculoskeletal (superficial),<br>Peripheral vessels | Surface |

Intend use of each probe on Evolution XHD Ultrasound Diagnostic System listed as below table:

{5}------------------------------------------------

### 510(k) Premarket Notification Submission

| L38-22K2 | Linear | Pediatric,<br>Dermatological,<br>musculoskeletal (superficial),<br>Peripheral vessels | Surface |
|----------|--------|---------------------------------------------------------------------------------------|---------|
| L62-38K2 | Linear | Pediatric,<br>Dermatological | Surface |

Evolution XHD Ultrasound Diagnostic System has 6 models: Evolution XHD 80, Evolution XHD 70, Evolution XHD 65, Evolution XHD 60, Evolution XHD 55, Evolution XHD 50. The different models of ultrasonic diagnosis system as below table:

| Model | Probe | Mode | SW Function of<br>Auto Optimize<br>(one-key optimize) |
|------------------|------------------------------------------|------------------|-------------------------------------------------------|
| Evolution XHD 50 | L22-8K2+ L38-22K2+ L62-38K2 | B/C/PW | Not support |
| Evolution XHD 55 | L22-8K2+ L38-22K2+ L62-38K2 | B/C/PW/Power | Not support |
| Evolution XHD 60 | L22-8K2+ L28-12K2+ L38-22K2+<br>L62-38K2 | B/C/PW | Not support |
| Evolution XHD 65 | L22-8K2+ L28-12K2+ L38-22K2+<br>L62-38K2 | B/C/PW/Power | Not support |
| Evolution XHD 70 | L22-8K2+ L28-12K2+ L38-22K2+<br>L62-38K2 | B/C/PW | Support |
| Evolution XHD 80 | L22-8K2+ L28-12K2+ L38-22K2+<br>L62-38K2 | B/C/PW/<br>Power | Support |

#### Indications for Use:

The Evolution XHD Series Ultrasound Diagnostic System is a high frequency general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the word "KOLO" in blue letters. The "K" has an orange accent mark above it. The letters are large and bold, and the word is centered in the image. The background is white.

The systems support the following clinical applications:

The Evolution XHD Series Diagnostic Ultrasound System is applicable for adult and pediatric. It is intended for use in Pediatric, Small parts (breast, thyroid, testicles, prostate), Peripheral vessel, Dermatological, Musculoskeletal (conventional), Musculoskeletal (superficial).

Modes of operation include: B Mode, Color Doppler, Power Doppler, PW Doppler, Combined modes: B+Color Doppler, B+Power Doppler, B+PW Doppler.

#### Comparison with Predicate Device:

The Evolution XHD series Ultrasound Diagnostic System and its predicate device, the FUJIFILM SonoSite Vevo MD Imaging System (K190476), have the same intended use, and similar physical characteristics.

{7}------------------------------------------------

## 510(k) Premarket Notification Submission

| Description | Subject Device<br>KOLO Evolution XHD<br>Ultrasound Diagnostic<br>System | Predicate Device<br>FUJIFILM SonoSite Vevo<br>MD Imaging System<br>(K190476) |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic<br>ultrasound imaging,<br>measurement, display and<br>analysis of the human body<br>and fluid. | Diagnostic<br>ultrasound imaging<br>or fluid flow analysis<br>of the human body. |
| Indications for<br>use | Specific clinical applications<br>and exam types include:<br>Pediatric, Small<br>parts(breast, thyroid,<br>testicles, prostate),<br>Peripheral vessel,<br>Dermatological,<br>Musculoskeletal<br>(conventional),<br>Musculoskeletal<br>(superficial). | Specific clinical applications<br>and exam types include:<br>Abdominal<br>Dermatological<br>Musculoskeletal<br>(conventional)<br>Musculoskeletal (superficial)<br>Neonatal Cephalic<br>Ophthalmic<br>Pediatric<br>Peripheral vessel<br>Small Organ (breast,<br>thyroid, testicles, prostate) |
| User | Qualified and trained<br>physician | Qualified and trained<br>physician |
| Environment | Hospital environment | Hospital environment |
| Transducer<br>Types<br>Available | Linear Array | Linear Array |
| Transducer<br>Center<br>Frequency | 15-50MHz | 15-49MHz |
| Transducer<br>Element | 256-element linear array<br>detector | 256-element linear array<br>detector |
| Modes of<br>Operation | B Mode, Color<br>Doppler,<br>Power Doppler, PW<br>Doppler | 2D Mode, Color<br>Doppler, M-Mode,<br>Power Doppler, PW<br>Doppler |
| DICOM | DICOM 3.0 | DICOM 3.0 |
| Description | Subject Device<br>KOLO Evolution XHD<br>Ultrasound Diagnostic System | Predicate Device<br>FUJIFILM SonoSite Vevo MD Imaging System<br>(K190476) |
| #Transmit<br>Channels | 128 digital channels | 64 digital channels |
| #Receive<br>Channels | 64 digital channels | 64 digital channels |
| Patient Contact<br>Materials | Material meet ISO 10993-1<br>and FDA guidance | Material meet ISO 10993-1<br>and FDA guidance |
| Acoustic Output within<br>FDA<br>guidelines | Track 3; | Track 3; |
| general safety<br>and<br>effectiveness<br>information | ANSI/AAMI ES60601-1<br>IEC60601-2-37<br>IEC60601-1-2<br>ISO 10993-1 | ANSI/AAMI ES60601-1<br>IEC60601-2-37<br>IEC60601-1-2<br>ISO 10993-1 |
| Labeling | Conforms to 21 CFR Part 801 | Conforms to 21 CFR Part 801 |
| SW functions | • Zoom,<br>• Dual Display<br>• Annotation<br>• Bodymark,<br>• Report<br>• DICOM | • Zoom<br>• Dual Window<br>• Annotation<br>• Bodymark,<br>• Report<br>• DICOM. |
| Measurement | • Distance<br>• Area<br>• Volume<br>• Angle<br>• Length trace<br>• Curve | • Linear<br>• Area<br>• Volume<br>• Angle<br>• Traced Distance<br>• Curve<br>• IMT |

{8}------------------------------------------------

## 510(k) Premarket Notification Submission

{9}------------------------------------------------

## Technology:

The Evolution XHD Series employs the same fundamental scientific technology as its predicated device.

## Determination of substantial equivalence:

The Proposed Evolution XHD Series system are substantially equivalent to the predicate the FUJIFILM SonoSite Vevo MD Imaging System (K190476) with regards to intended use, indication for use, image capabilities, technological characteristics, image mode, and safety effectiveness.

The following is an overview of the differences between the proposed Evolution XHD Series and its predicate device.

Comparison Analysis:

## Note 1:

Indication for use:

The Indication for use of subject device does not support Abdominal, Neonatal Cephalic, Ophthalmic. It is less than Predicate device. They can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

## Note 2:

The subject device does not support M mode. The mode of operation is less than Predicate device. They can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected. Note 3:

Transmit Channels: The subject device is 128 channels, and predicted device is 64 channels. The performance is better on image quality of subject device as the channels more than predicted one.

## Summary of Non-clinical test:

The Evolution XHD Series were evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standard, The Evolution XHD Series complies with voluntary standards:

- 1. AAMI/ANSI ES60601-1: Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance, 2005/A2:2012
- 2. IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Disturbance - Requirements and tests, 2014
- 3. IEC 60601-2-37 Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the word "KOLO" in a sans-serif font. The letters are a light blue color, except for a small orange line above the top left corner of the "K". The letters are large and bold, taking up most of the image space. The background is white.

medical diagnostic and monitoring equipment, Ed2.1, 2015

- 4. ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, 2018
- 5. ISO 10993-5 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity
- 6. ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization
- 7. IEC62359, Ultrasonics-Field characterization- Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017.
- 8. ISO 14971 Medical Devices Applications of Risk Management to Medical Devices, 2019
- 9. NEMA PS3.1-3.20, Digital Imaging and Communications in Medicine (DICOM) Set.(radiology), 2016.
- 10. IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
- 11. IEC 62366 Consolidated Version Medical Devices Application of Usability Engineering to Medical Devices
- 12. IEC 62304 Medical Device Software Software Life Cycle Processes

The following quality assurance measures are applied to the development of the system:

Risk Management Requirement review and Design reviews Integration testing (system verification) Performance testing (Verification) Safety testing (Verification)

The new transducers have no different technological characteristics from those with the predicate device. The new transducers were tested with ultrasound console for electrical safety, EMC, performance, verification and validation. The biocompatibility was evaluated and meets the ISO10993 series standard and FDA guidance.

#### Summary of Clinical Tests:

The subject of this premarket submission, did not require clinical studies to support substantial equivalence.

#### Conclusion:

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the word "KOLO" in a sans-serif font. The letters are a light blue color. There is a small orange line above the "K" in the word.

KOLO Considers the Evolution XHD Series Ultrasound Diagnostic System to be as safe, as effective, and performance is substantially equivalent to the predicate device.