Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

K212960 · Canon Medical Systems Corporation · IYN · Mar 22, 2022 · Radiology

Device Facts

• Record ID: K212960
• Device Name: Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
• Applicant: Canon Medical Systems Corporation
• Product Code: IYN · Radiology
• Decision Date: Mar 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Intended Use

The Diagnostic Ultrasound System Aplio a550 Model CUS-AA550, Aplio a450 Model CUSAA450 and Aplio a Model CUS-AA000 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (including thyroid, breast, testicle), transrectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural. This system provides high-quality ultrasound images in the following modes of operation: B (2D), M, Color Doppler (blood-flow imaging), Doppler (PWD, CWD, Power) (blood-flow spectrum), Combined (B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD), Precision Imaging, Apli Pure, Micro Pure, BEAM, TDI, Shear wave, Elastography, SMI (ADF), 2D Wall Motion Tracking, Smart 3D, Smart Sensor3D, 3D Color (Volume color), 4D, STIC, STIC, STIC Color, Fusion, Smart Navigation, ATI, CHI (Per FDA approved contrast agent prescribing information), Shadow Glass. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.

Device Story

Mobile diagnostic ultrasound system; uses various probes (linear, convex, sector) with 2-20 MHz frequency range. Inputs: ultrasound echoes; transforms signals into B-mode, M-mode, Doppler, and advanced imaging modes (e.g., Elastography, 2D Wall Motion Tracking, Smart 3D). Used in hospital/clinical settings by trained physicians/qualified personnel. Output: real-time ultrasound images and measurements for diagnostic visualization. Features include AI/ML-supported automated contour tracing for 2D Wall Motion Tracking (left ventricle) and Auto Ejection Fraction. Enhancements in V6.5 include improved network storage, Tricefy DICOM transfer, Smart Body Mark for abdomen, expanded Shear Wave Elastography (SWE) range, lung presets, and liver/breast examination packages. Clinicians use output for diagnostic assessment of anatomy and dynamic processes; aids in clinical decision-making by providing high-quality visualization and automated measurements.

Clinical Evidence

Bench testing only. No clinical studies were required. Performance verified using phantoms and volunteer data to validate improved features and software functionality.

Technological Characteristics

Mobile ultrasound system; 2-20 MHz probes (linear, convex, sector). Imaging modes: B, M, Doppler, Elastography, 2D Wall Motion Tracking, 3D/4D, Fusion, ATI. Connectivity: Network storage, DICOM via Tricefy. Software: V6.5. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 10993-1. Cybersecurity controls included.

Indications for Use

Indicated for visualization of structures and dynamic processes in fetal, abdominal, intra-operative, pediatric, small organs, transrectal, neonatal/adult cephalic, cardiac, peripheral vascular, transesophageal, musculoskeletal, laparoscopic, and thoracic/pleural applications.

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

• Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, Software V5.1 (K202364)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Canon Medical Systems Corporation % Yoshiaki Cook Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

march 22, 2022

Re: K212960

Trade/Device Name: Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: February 16, 2022 Received: February 18, 2022

Dear Yoshiaki Cook:

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

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

Sincerely,

Jessica Lamb, Ph.D. Assistant 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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# Indications for Use

510(k) Number (if known)

K212960

#### Device Name

Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

#### Indications for Use (Describe)

The Diagnostic Ultrasound System Aplio a550 Model CUS-AA550, Aplio a450 Model CUSAA450 and Aplio a Model CUS-AA000 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (including thyroid, breast, testicle), transrectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural.

This system provides high-quality ultrasound images in the following modes of operation: B (2D), M, Color Doppler (blood-flow imaging), Doppler (PWD, CWD, Power) (blood-flow spectrum), Combined (B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD), Precision Imaging, Apli Pure, Micro Pure, BEAM, TDI, Shear wave, Elastography, SMI (ADF), 2D Wall Motion Tracking, Smart 3D, Smart Sensor3D, 3D Color (Volume color), 4D, STIC, STIC, STIC Color, Fusion, Smart Navigation, ATI, CHI (Per FDA approved contrast agent prescribing information), Shadow Glass. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.

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

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| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.3333 2H2.66667C2.29848 2 2 1.70152 2 1.33333V2.66667C2 3.03485 2.29848 3.33333 2.66667 3.33333H13.3333C13.7015 3.33333 14 3.03485 14 2.66667V1.33333C14 0.965147 13.7015 2 13.3333 2ZM13.3333 14H2.66667C2.29848 14 2 13.7015 2 13.3333V14.6667C2 15.0348 2.29848 15.3333 2.66667 15.3333H13.3333C13.7015 15.3333 14 15.0348 14 14.6667V13.3333C14 12.9651 13.7015 14 13.3333 14ZM13.3333 8H2.66667C2.29848 8 2 7.70152 2 7.33333V8.66667C2 9.03485 2.29848 9.33333 2.66667 9.33333H13.3333C13.7015 9.33333 14 9.03485 14 8.66667V7.33333C14 6.96515 13.7015 8 13.3333 8Z" fill="black"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 510(k) SUMMARY

K212960

- 1. SUBMITTER'S NAME Fumiaki Teshima Sr. Manager, Quality Assurance Dept. Quality, Safety and Regulation Center Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550
- ESTABLISHMENT REGISTRATION 2. 9614698

#### 3. OFFICIAL CORRESPONDENT/CONTACT PERSON Yoshiaki Cook Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin, CA 92780 [e-mail]

- 4. DATE PREPARED
Sept. 14, 2021

#### 5. DEVICE NAME/TRADE NAME

Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

#### COMMON NAME 6.

System, Diagnostic Ultrasound

#### 7. DEVICE CLASSIFICATION

Class II

Ultrasonic Pulsed Doppler Imaging System – Product Code: 90-IYN [per 21 CFR 892.1550] Ultrasonic Pulsed Echo Imaging System – Product Code: 90-IYO [per 21 CFR 892.1560] Diagnostic Ultrasonic Transducer – Product Code: 90-ITX [per 21 CFR 892.1570]

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#### 8. PREDICATE DEVICE

| Product | Marketed by | 510(k) Number | Clearance Date |
|---------------------------------------------------------------------------------------|------------------------------------|---------------|------------------|
| Aplio a550, Aplio a450 and<br>Aplio a, Diagnostic Ultrasound<br>System, Software V5.1 | Canon Medical<br>Systems USA, Inc. | K202364 | October 15, 2020 |

## 9. REASON FOR SUBMISSION

Modification of a cleared device.

## 10. DEVICE DESCRIPTION

The Aplio a550 Model CUS-AA550, Aplio a450 Model CUS-AA450, and Aplio a Model CUS-AA000, V6.5 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2MHz to 20 MHz.

#### 11. INDICATIONS FOR USE

The Diagnostic Ultrasound System Aplio a550 Model CUS-AA550,Aplio a450 ModelCUSAA450 and Aplio a Model CUS-AA000 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (including thyroid, breast, testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural.

This system provides high-quality ultrasound images in the following modes of operation: B (2D), M, Color Doppler (blood-flow imaging), Doppler (PWD, Power) (blood-flow spectrum), Combined (B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD), Precision lmaging, Apli Pure, Micro Pure, BEAM, TDI, Shear wave, Elastography, SMI (ADF), 2D Wall Motion Tracking, Smart 3D, Smart Sensor3D, 3D Color (Volume color), 4D, STIC, STIC Color, Fusion, Smart Navigation, ATI, CHI (Per FDA approved contrast agent prescribing information), Shadow Glass. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.

#### 12. SUBSTANTIAL EQUIVALENCE

The Aplio a550 Model CUS-AA550, Aplio a450 Model CUS-AA450, and Aplio a Model CUS-AA000, V6.5 is substantially equivalent to the Aplio a550, Aplio a450, and Aplio a, V5.1 Diagnostic Ultrasound Systems (K202364). The subject device employs the same fundamental scientific technology as the predicate device and functions in a manner similar to, and is intended for the same use as the predicate device. The subject device includes modifications to the cleared predicate device, to improve upon existing features. This submission includes details which demonstrate the substantial equivalence of the improved features, to those currently cleared with the predicate device.

- . The subject Aplio a550, Aplio a450, and Aplio a, V6.5 and predicate Aplio a550, Aplio a450, and Aplio a, V5.1 use the same imaging modes and support identical transducers

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- The software features supported in the subject Aplio a550, Aplio a450, and Aplio a, V6.5 and predicate Aplio a550, Aplio a450, and Aplio a, V5.1 are identical
- . The following features or functionality available with predicate Aplio a550, and Aplio a, V5.1 have been improved in the subject device:
- o Network Storage, an improvement to existing functionality, enabling storage of raw data directly into Network Attached Storage
- Tricefy Access, an improvement to existing functionality, enabling transfer of O DICOM data through firewall to the Tricefy server
- Smart Body Mark for Abdomen, an improvement which extends support of existing O Smart Body Mark functionality for abdominal use
- SWE Hard, an improvement to the existing SWE Hard feature, expanding the upper O limit and range of shear wave elastography
- o Lung Preset, an improvement to existing preset and body mark functionality by expanding its applicability to lung imaging
- Liver Package Basic, an improvement which packages existing features which have O utility for liver examinations
- O Apligate and Apligate Soft, an improvement to existing image transfer capability by enabling the ability to share deidentified images
- Breast Package and Breast Package Soft, an improvement which packages existing O features which have utility for breast examinations
- SmartFetal2D, an improvement to existing feature, 2D Wall Motion Tracking for O Fetal Heart, to candidate heart cycle selection functionality
- O Reference mode, improved by support of MicroPure mode
- O Smart fusion, improved by support of SWE
- Obstetric (OB) 4D image quality, improved by optimization of ROI sampling and O filter application
- OB measurement summary, improved by single page display format O
- Operability improvement by which zoom position is retained despite depth O changes
- Addition of two user selectable settings in Exam Review o
- . The expansion of marketing language for several previously 510(k) cleared features is also proposed in the subject submission, including the promotion of the support by artificial intelligence (AI) and/or machine learning (ML) of the automated initial contour tracing capability of 2D Wall Motion Tracking for left ventricle (2D WMT) and Auto Ejection Fraction for left ventricle (Auto EF), marketed by Canon as 2D WMT with Full-assist function and Auto EF with Full-assist function, respectively.
- . The support of the expansion of marketing language for previously 510(k) cleared liver analysis features, Attenuation imaging (ATI) and Shear wave elastography (SWE), as well as an expansion within the existing clinical MSK use for the previously 510(k) cleared feature, SWE Hard, by referenced publications, are proposed in the subject submission.

## 14. SAFETY

The subject device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This devices is in conformance with the applicable parts of the AAMI/ANSI ES60601-1:2012, IEC 60601-1-2 (2014), IEC 60601-2-37 (2015), IEC 62304 (2015), IEC 62359 (2017) and ISO 10993-1 (2009) standards.

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#### 15. TESTING

Risk Analysis and verification and validation activities demonstrate that the established specifications for this device have been met. Additional performance testing, using phantoms and volunteer data, were conducted in order to demonstrate that the requirements for the improved features were met. The results of these studies demonstrate that the improved features meet established specifications and perform as intended.

No clinical studies were required to demonstrate safety and efficacy of the Aplio a550, and Aplio a, V6.5 system.

FDA guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", issued June 27, 2019 was referenced for this submission, along with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005.

Additionally, cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued on October 18, 2018, was included in this submission.

Testing of this device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and UL systems.

#### 16. CONCLUSION

The Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 is substantially equivalent to the Aplio a550, Aplio a450, and Aplio a, V5.1, K202364. The subject device functions in a manner similar to and is intended for the same use as the predicate device, as described in the labeling. Based upon the bench testing, successful completion of software validation, and application of risk management and design controls, it is concluded that this device is safe and effective for its intended use and performs with substantial equivalence to the predicate device.