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), 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.

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.

AI/ML Overview

This document describes the premarket notification for the Aplio a550, Aplio a450, and Aplio a Diagnostic Ultrasound System, Software V6.5 (K212960).

The provided information focuses on substantial equivalence to a predicate device (Aplio a550, Aplio a450, and Aplio a, V5.1, K202364) and improvements to existing features. Crucially, the document states: "No clinical studies were required to demonstrate safety and efficacy of the Aplio a550, and Aplio a, V6.5 system." This implies that formal acceptance criteria with reported device performance based on a new clinical study are not directly applicable in the traditional sense for this submission as a standalone device.

However, the document does mention "Additional performance testing, using phantoms and volunteer data, were conducted in order to demonstrate that the requirements for the improved features were met." It also discusses the expansion of marketing language for features supported by Artificial Intelligence (AI) and Machine Learning (ML), such as "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."

Given the information provided, it's not possible to extract specific acceptance criteria and detailed device performance metrics from a dedicated clinical study for this 510(k) submission. The substantial equivalence argument relies on the predicate device's existing clearance and improvements to its features, with performance demonstrated through technical testing rather than a new clinical trial with pre-defined acceptance criteria.

Therefore, the following points address the questions based on the available text:

A table of acceptance criteria and the reported device performance:
- This information is not provided in the document as part of a formal clinical study with pre-defined acceptance criteria for the new submission. The submission is based on demonstrating substantial equivalence to a predicate device and showing improvements through technical testing.
Sample size used for the test set and the data provenance:
- The document mentions "additional performance testing, using phantoms and volunteer data." However, the specific sample size (number of phantoms or volunteers) and the provenance of this data are not provided in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. As no clinical study is explicitly described for establishing ground truth, the involvement of experts for this purpose is not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- An MRMC comparative effectiveness study is not explicitly mentioned as being performed for this submission. While the document talks about "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)," it does not detail a study demonstrating the effect size of human reader improvement with AI assistance. The AI/ML aspects are presented as improvements to existing functionalities rather than a new comparative effectiveness claim requiring an MRMC study in this context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that AI/ML capabilities are for "automated initial contour tracing" and "Auto Ejection Fraction." While this suggests algorithmic performance, the document does not present a standalone performance study with specific metrics for the algorithm only. The context is generally about supporting existing features.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The type of ground truth used for "additional performance testing, using phantoms and volunteer data" is not explicitly stated. For phantom data, the "ground truth" would typically be derived from the known properties of the phantom. For volunteer data, it is not specified how ground truth was established, particularly for the AI/ML features in question.
The sample size for the training set:
- The document does not provide information regarding the sample size for any training set used for the AI/ML features mentioned.
How the ground truth for the training set was established:
- The document does not provide information on how ground truth was established for any training set.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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 ycook@us.medical.canon

1. 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 andAplio a, Diagnostic UltrasoundSystem, Software V5.1	Canon MedicalSystems USA, Inc.	K202364	October 15, 2020

9. REASON FOR SUBMISSION

Modification of a cleared device.

10. DEVICE DESCRIPTION

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.

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.

Regulation Number and Section

§ 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.