(57 days)
No
The document does not mention AI, ML, or any related terms in the device description, intended use, or performance studies. The focus is on standard ultrasound imaging modes and features.
No.
The device is indicated for the visualization of structures and dynamic processes using ultrasound and to provide image information for diagnosis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "to provide image information for diagnosis." Furthermore, the "Device Description" clearly identifies the systems as "mobile diagnostic ultrasound systems."
No
The device is described as a "mobile diagnostic ultrasound system" and explicitly mentions employing "a wide array of probes," which are hardware components essential for ultrasound imaging.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body. They are used to diagnose diseases or other conditions.
- Device Function: The description clearly states that this device is a "Diagnostic Ultrasound System" used for "visualization of structures, and dynamic processes with the human body using ultrasound." This involves using sound waves to create images of internal body parts within the living patient.
- No Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient. The device operates by interacting directly with the patient's body.
Therefore, based on the provided information, this device falls under the category of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Diagnostic Ultrasound System Aplio a550 Model CUS-AA550,Aplio a450 Model CUS-AA450 and Aplio a Model CUS-AA000 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, intraoperative (abdominal), pediatric, small organs (including thyroid, breast, testicle), 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, CWD, Power) (blood-flow spectrum), Combined (B/M; B/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 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.
Product codes
IYN, IYO, ITX
Device Description
The Aplio a550 Model CUS-AA550, Aplio a450 Model CUS-AA450 and Aplio a Model CUS-AA000 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 2 MHz to 20 MHz.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fetal, abdominal, intraoperative (abdominal), pediatric, small organs (including thyroid, breast, testicle), trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural.
Indicated Patient Age Range
neonatal, adult, pediatric
Intended User / Care Setting
Physicians or legally qualified persons who have received the appropriate training.
Hospital and clinical settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk Analysis and Verification/Validation testing conducted through the bench testing which is included in this submission demonstrate that the requirements for the new and improved features have been met. Additional performance testing, using test data and volunteer studies, were conducted to assess improvements to existing features. Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K191467, K182277, K180572, K181485
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
October 15, 2020
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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below that.
Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K202364
Trade/Device Name: Aplio a550, Aplio a, Diagnostic Ultrasound System, Software V5.1 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: August 17, 2020 Received: August 19, 2020
Dear Mr. Tadeo:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K202364
Device Name
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V5.1
Indications for Use (Describe)
The Diagnostic Ultrasound System Aplio a550 Model CUS-AA550,Aplio a450 Model CUS-AA450 and Aplio a Model CUS-AA000 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, intraoperative (abdominal), pediatric, small organs (including thyroid, breast, testicle), 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, CWD, Power) (blood-flow spectrum), Combined (B/M; B/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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K202364 510(k) SUMMARY
-
- SUBMITTER'S NAME: Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550
-
- OFFICIAL CORRESPONDENT Hideo Saeki
-
- ESTABLISHMENT REGISTRATION: 9614698
4. CONTACT PERSON:
Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459
-
- DATE PREPARED:
August 17, 2020
- DATE PREPARED:
6. DEVICE NAME: Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V5.1
7. TRADE NAME(S):
Diagnostic Ultrasound System Aplio a550 Model CUS-AA550 Diagnostic Ultrasound System Aplio a450 Model CUS-AA450 Diagnostic Ultrasound System Aplio a Model CUS-AA000
8. COMMON NAME:
System, Diagnostic Ultrasound
9. 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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10. PREDICATE DEVICE:
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| Aplio a550 and a450, Software V4.0 Diagnostic Ultrasound System | |||
| (Primary Predicate Device) | Canon Medical Systems USA, Inc | K191663 | September 18, 2019 |
| Aplio i900/i800/i700, Software V4.0 Diagnostic Ultrasound System | |||
| (Reference Predicate Device) | Canon Medical Systems USA, Inc | K191467 | July 19, 2019 |
| Versana Premier | |||
| (Reference Predicate Device) | GE Healthcare | K182277 | November 21, 2018 |
| AIXPLORER® MACH Ultrasound Diagnostic Systems | |||
| (Reference Predicate Device) | Super Imagine | K180572 | May 29, 2018 |
| Epiq 7 | |||
| (Reference Predicate Device) | Philips Medical Systems | K181485 | July 27, 2018 |
11. DEVICE DESCRIPTION:
The Aplio a550 Model CUS-AA550, Aplio a450 Model CUS-AA450 and Aplio a Model CUS-AA000 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 2 MHz to 20 MHz.
12. INDICATIONS FOR USE:
The Diagnostic Ultrasound Systems Aplio a550 Model CUS-AA550, Aplio a450 Model CUS-AA450 and Aplio a Model CUS-AA000 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, transvaginal, 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 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 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.
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13. SUBSTANTIAL EQUIVALENCE:
The purpose of this submission is the modification of cleared Aplio a550, and Aplio a, Diagnostic Ultrasound System, V4.0, 510(k) cleared per K191663, marketed by Canon Medical Systems USA, Inc. to which the subject device is substantially equivalent. The Aplio a450, and Aplio a, V5.1 employ the same fundamental scientific technology as the predicate devices, and functions in a manner similar to and is intended for the same use as the predicate devices. The subject device includes modifications to the cleared device which improves upon existing features.
This submission also includes details regarding new features determined to be substantially equivalent to features cleared under the predicate devices referenced within this submission. The Aplio a550, Aplio a450 and Aplio a, V5.1 and predicate Aplio a550, Aplio a450, and Aplio a,
- . V4.0 have the same clinical intended use and the same imaging modes, except that Thoracic/Pleural is now available on several transducers on Aplio a550, and Aplio a, V5.1, and Shear Wave Elastography mode was expanded to include musculo-skeletal clinical use.
- . The transducers supported in the subject Aplio a550, and Aplio a and predicate Aplio a550, Aplio a450 and Aplio a are identical, except for the addition of the new transducer PST-65BT which was previously cleared with reference predicate Aplio i900/i800/i700, V4.0, K191467 and shares the same fundamental technological and biocompatibility characteristics as existing transducers supported by the subject system.
- The software features supported in subject Aplio a550, and Aplio a and predicate Aplio a550, Aplio a450, and Aplio a are identical except the following main, new features:
- o LI-RADS Checklist (Contrast Enhanced Ultrasound (CEUS) Liver Imaging Reporting and Data System), a new feature predicated on the RADS kit feature, which includes the BI-RADS Checklist (Breast Imaging Reporting and Data System) and TI-RADS Checklist (Thyroid lmaging Reporting and Data System), which is also introduced on Aplio a550, Aplio a450, and Aplio a, V5.1 and was previously cleared on reference predicate device Aplio i900/i800/i700, V4.0 (K191467). LI-RADS Checklist supports the standardization of liver characterization based on American College of Radiology (ACR) guidelines, BI-RADS Checklist supports the standardization of breast mass characterization according to ACR guidelines, and TI-RADS Checklist supports the standardization of thyroid mass characterization according to ACR guidelines.
- o Workflow Navigator, a new feature predicated on existing workflow functionality available on predicate Aplio a550, Aplio a450, and Aplio a which provides workflow and reporting support based on American Society of Echocardiography (ASE) guidelines for specific medical conditions.
- Smart Optimization, a new feature similar to "Whizz" on the reference predicate device O Versana Premier by GE Healthcare (K182277) which is intended to improve image quality, targeting the abdominal region.
- O Prostate Biopsy Report, a new feature which adds functionality existing on predicate
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Made For life
Aplio a550, Aplio a450, and Aplio a, to provide a workflow panel for biopsy procedures and 3D modeling for visualization during these procedures.
- In addition to these new features, several existing features have been modified for improved functionality on the subject device:
- Smart Body Mark, an improvement to manual breast scan workflow by incorporation of O previously cleared functionality
- MSK Protocol movie, to support the display of musculo-skeletal (MSK) instructional movies O with existing functionality
- Wide View support, an expansion of the scan range available with convex transducers O
- Sensor 3D, modified to support improved resolution O
- Obstetric Image quality, modified to support improved visualization O
- The following features were migrated to the subject Aplio a550, aplio a450, and Aplio a, from reference predicate, Aplio iSeries (K191467)
- O Multi Parametric Report, allows the review of results of up to five applications on a single worksheet
- 2D Wall Motion Tracking Fetal kit, enables the analysis of second trimester fetal hearts O
14. SAFETY:
The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device 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.
15. TESTING
Risk Analysis and Verification/Validation testing conducted through the bench testing which is included in this submission demonstrate that the requirements for the new and improved features have been met. Additional performance testing, using test data and volunteer studies, were conducted to assess improvements to existing features. Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended. FDA guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducer", issued June 27, 2019 was referenced for this submission, along with Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005. 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 also referenced for this submission.
Additionally, 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.
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16. CONCLUSION
The Aplio a550 Model CUS-AA550, Aplio a450 Model CUS-AA450 and Aplio a Model CUS-AA000, V5.1 are substantially equivalent to the predicate devices. The subject devices function in a manner similar to and are intended for the same use as the predicate devices, as described in the labeling. Based upon the bench testing, clinical evaluation, 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 performance, and is substantially equivalent to the predicate devices.