The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900,Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-Al700 are 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(thyroid, breast and testicle), trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatic), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and Thoracic/Pleural. This system provides high-quality ultrasound images in the following modes B mode, M mode, Continuous Wave, Color Doppler, Power Doppler , Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.

In addition to the aforementioned indications for use, when EUS transducer GF-UCT 180 is connected, Aplio i800 Model TUS-AI800 /E3 provides image information for diagnosis of the upper gastromtestinal tract and surrounding organs.

Device Description

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700, V8.1 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 33 MHz.

AI/ML Overview

The provided document details the 510(k) summary for the Aplio i900, Aplio i800, and Aplio i700 Software V8.1 Diagnostic Ultrasound System. The report primarily focuses on demonstrating substantial equivalence to a predicate device (Aplio i900/i800/i700, Diagnostic Ultrasound System, V7.0, K223017) by highlighting new and improved features and the testing conducted to support their safety and effectiveness.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes "pre-specified performance criteria" being passed for new and improved features. While specific quantitative acceptance criteria are not explicitly laid out in a table format in the provided text, the outcome of the tests indicates that these criteria were met. The general acceptance criterion for all new and improved features appears to be: "perform equivalently to the predicate device, and as described in labeling." and "meet established specifications and perform as intended".

For Left Atrial Appendage (LAA) Analysis, the acceptance criteria appear to be the ability to:

Produce equivalent measurement results as existing manual measurements.
Achieve workflow improvements compared to existing manual workflows.
Provide measurement results useful for the planning of transcatheter LAAO.

For Strain Ratio Measurement, the acceptance criterion appears to be the ability to:

Calculate strain ratio equivalent to the known elasticity values.

For Ultra Wideview for Mecha4D, the acceptance criterion appears to be:

Capability of the scan range for 4D mode to be increased with Mecha4D transducer model, PVT-675MVS, for which availability of the existing Ultra Wideview feature is expanded.

For Olympus EUS Transducer integration, the acceptance criterion appears to be:

Successful integration of the cleared Olympus Medical Systems Corporation manufactured EUS transducer model, GF-UCT180, with the Aplio i800 Model TUS-AI800A/E3, V8.1, in accordance with requirements pre-specified by Olympus Medical Systems Corporation.

Feature/Functionality	Acceptance Criteria (Inferred from text)	Reported Device Performance (as stated in text)
LAA Analysis (Non-clinical)	Produce equivalent measurement results as existing manual measurements.	"demonstrated the ability of LAA Analysis to produce equivalent measurement results as the existing manual measurements."
LAA Analysis (Clinical)	1. Workflow improvements compared to existing manual workflow. 2. Provide measurement results useful for planning transcatheter LAAO.	"confirmed workflow improvements compared to existing manual workflow in the establishment of a shape model of the left atrial appendage, as well as the ability of LAA Analysis to provide measurement results which are useful for the planning of transcatheter LAAO."
Strain Ratio Measurement	Calculate strain ratio equivalent to the known elasticity values.	"demonstrated the ability of Strain Ratio Measurement to calculate strain ratio equivalent to the known elasticity values."
Ultra Wideview for Mecha4D	Capability of scan range increase for 4D mode with Mecha4D transducer.	"demonstrated the capability of the scan range for 4D mode to be increased with Mecha4D transducer model, PVT-675MVS, for which availability of the existing Ultra Wideview feature is expanded."
Olympus EUS Transducer	Successful integration with Aplio i800 Model TUS-AI800A/E3, V8.1, in accordance with Olympus Medical Systems Corporation's pre-specified requirements.	"demonstrated the successful integration of the cleared Olympus Medical Systems Corporation manufactured EUS transducer model, GF-UCT180, with the Aplio i800 Model TUS-AI800A/E3, V8.1, in accordance with requirements pre-specified by Olympus Medical Systems Corporation."

Overall Acceptance Statement: "By passing all prespecified performance criteria, it was demonstrated that the new and improved features included in this submission perform equivalently to the predicate device, and as described in labeling."

Study Information

The document describes several studies conducted as "Non-clinical Testing" and "Clinical Testing".

Sample sizes used for the test set and data provenance:
- LAA Analysis (Non-clinical): 10 clinical data sets. Data provenance is not specified (e.g., country of origin, retrospective/prospective).
- LAA Analysis (Clinical): 10 in-vivo cine data. Data provenance is not specified.
- Strain Ratio Measurement: Elasticity phantoms used. Not patient data.
- Ultra Wideview for Mech4D: Not specified as involving specific patient data sets; likely internal technical validation.
- Olympus EUS Transducer integration: Not specified as involving specific patient data sets; likely internal technical validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the Clinical LAA Analysis study, the evaluation was "by a cardiologist". The specific number of cardiologists (e.g., one or multiple) and their years of experience/specific qualifications are not provided.
- For other studies (Non-clinical LAA Analysis, Strain Ratio Measurement, Ultra Wideview, EUS Integration), no external expert ground truth establishment is mentioned; ground truth likely derived from existing manual measurements, known phantom values, or engineering specifications.
Adjudication method for the test set:
- No adjudication method (e.g., 2+1, 3+1) is described for any of the studies mentioned. For the clinical LAA study, it states "evaluated by a cardiologist," implying a single assessment unless explicitly stated otherwise.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No MRMC comparative effectiveness study is mentioned. The clinical LAA study only mentions evaluation by "a cardiologist" and "workflow improvements compared to existing manual workflow," but it does not quantify human reader improvement with AI vs. without AI assistance in an MRMC setting.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The description of "LAA Analysis (Non-clinical)" and "Strain Ratio Measurement" where the device's output is compared to "manual measurements" or "known elasticity values" suggests a form of standalone performance evaluation for those specific functionalities, though "algorithm only" is not explicitly stated. The LAA clinical study describes assisting the human workflow.
The type of ground truth used:
- LAA Analysis (Non-clinical): "existing manual measurements" for comparison.
- LAA Analysis (Clinical): Implicitly, the "cardiologist's" assessment and established clinical utility for "planning of transcatheter LAAO" served as the reference for confirming clinical usefulness and workflow improvement.
- Strain Ratio Measurement: "known elasticity values" from elasticity phantoms.
- For other functionalities, ground truth seems to be based on technical specifications and successful integration ("requirements pre-specified"). There is no mention of pathology or broader outcomes data for ground truth.
The sample size for the training set:
- The document does not specify any training set size for the AI/software features. The information provided is solely on the testing phase to demonstrate equivalence and performance. This is common for this type of submission (510k for a software update to an existing device).
How the ground truth for the training set was established:
- Since no training set is mentioned or described, the method for establishing its ground truth is also not provided.

Summary

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January 24, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K233195

Trade/Device Name: Aplio i900, Aplio i800 and Aplio i700 Software V8.1 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: December 28, 2023 Received: December 28, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 S. Kang -S

Yanna Kang 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

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Indications for Use

510(k) Number (if known) K233195

Device Name

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

Indications for Use (Describe)

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 K233195

SUBMITTER'S NAME 1. 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 (657) 270-5595

4. DATE PREPARED September 27, 2023

5. DEVICE NAME/TRADE NAME

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

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 i900/i800/i700 DiagnosticUltrasound System, SoftwareV7.0 (Primary predicate)	Canon MedicalSystems USA, Inc.	K223017	March 31, 2023
OLYMPUS GF TYPE UC180,OLYMPUS GF TYPE UCT180 EVISEXERA II ULATRASOUNDGASTROVIDEOSCOPE(Reference device)	Olympus MedicalSystemsCorporation	K093395	June 17, 2010

9. REASON FOR SUBMISSION

Modification of a cleared device.

10. DEVICE DESCRIPTION

11. INDICATIONS FOR USE

The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900,Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-Al700 are 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(thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal 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 B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler , Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.

In addition to the aforementioned indications for use, when EUS transducer GF-UCT180 is connected, Aplio i800 Model TUS-Al800 /E3 provides image information for diagnosis of the upper gastrointestinal tract and surrounding organs.

12. SUBSTANTIAL EQUIVALENCE

The subject devices, Aplio i900, Aplio i700 Software V8.1 Diagnostic Ultrasound System are substantially equivalent to the predicate devices Aplio i900/i800/i700, Diagnostic Ultrasound System, V7.0 (K223017). The subject devices employ the same fundamental scientific

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technology as the predicate devices and function in a manner similar to, and are intended for the same use as the predicate devices. The subject devices include new features, as well as improvements to existing features and functionality. This submission includes details which demonstrate the substantial equivalence of the new and improved features and functionality, to those currently cleared with the predicate devices. Differences between the subject devices and the cleared predicate devices do not raise any new questions about the safety and effectiveness of the subject devices. This submission includes evidence to demonstrate the substantial equivalence of the subject devices to the predicate devices.

. The subject devices have the same clinical intended use and use the same imaging modes as the predicate devices
The transducers supported by the subject and predicate devices are identical with the exception of the addition of transducer model GF-UCT180, manufactured by Olympus Medical Systems Corporation, exclusively for Aplio i800 Model TUS-AI800/E3
- The indicated uses available with the subject devices are pre-existing with the o predicate devices, with the exception of added imaging of upper gastrointestinal tract and surrounding organs, enabled for Aplio i800 Model TUS-AI800/E3 by GF-UCT180
The software features supported in the subject and predicate devices are identical except for the following new features and improvements to features or functionality available with the predicate devices:
- o Left Atrial Appendage (LAA) Analysis, a new feature which enables the assessment of dimensions for certain user specified parameters, as well as provides a shape model of the left atrial appendage
- Strain Ratio Measurement, an improvement to existing strain elastography O functionality which enables the calculation of strain ratio for strain elastography images
- O Ultra Wideview Support for Mecha4D, an improvement to the existing Wideview feature, enabling its use with Mecha4D transducer model, PVT-675MVS
- CEUS viewer, an improvement to existing functionality which enables a viewer for o stored contrast exam images

14. SAFETY

The subject devices are designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. These devices are in conformance with the applicable parts of the AAMI/ANSI ES60601-1: 2005/(R)2012 & A1:2012, C1:2009/(R)2012& A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC 60601-1-2:2020, IEC 60601-2-37:2015, IEC 62304:2015, IEC 62359:2017, and ISO 10993-1:2018 standards.

15. TESTING

Risk Analysis and verification and validation activities demonstrate that the established specifications for these devices have been met. Additional performance testing included in the submission was conducted in order to demonstrate that the requirements for the new and improved features and functionality were met. The results of all of these studies demonstrate that the subject devices meet established specifications and perform as intended and in accordance with labeling. The following provides a summary of the testing conducted in support of the new and improved features:

Non-clinical Testing:

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Left Atrial Appendage (LAA) Analysis – This study was applied to 10 clinical data sets acquired for the accompanying clinical evaluation of this feature, and demonstrated the ability of LAA Analysis to produce equivalent measurement results as the existing manual measurements.

Strain Ratio Measurement – This study was conducted using elasticity phantoms and demonstrated the ability of Strain Ratio Measurement to calculate strain ratio equivalent to the known elasticity values.

Ultra Wideview for Mech4D – This study demonstrated the capability of the scan range for 4D mode to be increased with Mecha4D transducer model, PVT-675MVS, for which availability of the existing Ultra Wideview feature is expanded.

Olympus EUS Transducer integration – This study demonstrated the successful integration of the cleared Olympus Medical Systems Corporation manufactured EUS transducer model, GF-UCT180, with the Aplio i800 Model TUS-AI800A/E3, V8.1, in accordance with requirements pre-specified by Olympus Medical Systems Corporation.

Clinical Testing:

Left Atrial Appendage (LAA) Analysis – This study, evaluated by a cardiologist and applied to 10 invivo cine data, confirmed workflow improvements compared to existing manual workflow in the establishment of a shape model of the left atrial appendage, as well as the ability of LAA Analysis to provide measurement results which are useful for the planning of transcatheter LAAO.

By passing all prespecified performance criteria, it was demonstrated that the new and improved features included in this submission perform equivalently to the predicate device, and as described in labeling.

FDA guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", issued February 21, 2023 was referenced for this submission, along with "Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023.

Additionally, cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued on October 02, 2014, is included in this submission.

Testing of these devices 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 i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System are substantially equivalent to the Aplio i900/i800/i700, Diagnostic Ultrasound System, V7.0, K223017. The subject devices function in a manner similar to and are intended for the same use as the predicate devices, as described in labeling. The evidence provided in this submission demonstrate the Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System are safe and effective for their intended use, and perform with substantial equivalence to the predicate devices.

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.