Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System

{0}------------------------------------------------ October 16, 2020 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 acronym along with the full name of the agency on the right. The FDA acronym and the words "U.S. FOOD & DRUG" are in a blue sans-serif font, with "ADMINISTRATION" in a smaller font below. Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780 Re: K202737 Trade/Device Name: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, 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: September 15, 2020 Received: September 18, 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202737 ## Device Name Aplio i900/i800/i700/i600 Diagnostic Ultrasound System Indications for Use (Describe) The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 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, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## 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 PRAStaff @fda.hhs.gov "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." {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202737 Device Name Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System Indications for Use (Describe) 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, intraoperative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------|-----------------------------------------------------------| | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) | ## 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 PRAStaff @fda.hhs.gov "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." {4}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202737 ### Device Name Xario200G and Xario100G, Diagnostic Ultrasound System ## Indications for Use (Describe) The Diagnostic Ultrasound System Xario200G Model CUS-X200G and Xario100G Model CUS-X100G 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), laparoscopic, pediatric, small organs, neonatic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac pediatric, trans-esoph(cardiac) and peripheral vessel. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |-------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## 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 PRAStaff @fda.hhs.gov "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." {5}------------------------------------------------ # MEDICAL SYSTEMS USA, INC. ## 510(k) SUMMARY - 1. SUBMITTER'S NAME Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550 - OFFICIAL CORRESPONDENT 2. Fumiaki Teshima Sr. Manager, Quality Assurance Department - ESTABLISHMENT REGISTRATION 3. 9614698 #### CONTACT PERSON 4. Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459 - ട. DATE PREPARED September 15, 2020 #### 6. DEVICE NAME(S) Aplio i900/i800/i700/i600 Diagnostic Ultrasound System Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System Xario200G and Xario100G, Diagnostic Ultrasound System #### 7. TRADE NAME(S) Diagnostic Ultrasound System Aplio i900 Model TUS-AI900 Aplio i800 Model TUS-AI800 Aplio i700 Model TUS-AI700 Aplio i600 Model TUS-AI600 Aplio a550 Model CUS-AA550 Aplio a450 Model CUS-AA450 Aplio a Model CUS-AA000 Xario200G Model CUS-X200G Xario100G Model CUS-X100G {6}------------------------------------------------ #### 8. COMMON NAME Diagnostic Ultrasound System and Transducers #### 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 ## 10. PREDICATE DEVICE | Product | Marketed by | 510(k) Number | Clearance Date | |----------------------------------------------------------------------------|------------------------------|---------------|--------------------| | Aplio i900/i800/i700/i600<br>Diagnostic Ultrasound System, V4.0 | Canon Medical<br>Systems USA | K191467 | July 19, 2019 | | Aplio a550, Aplio a450, and Aplio a,<br>Diagnostic Ultrasound System, V4.0 | Canon Medical<br>Systems USA | K191663 | September 18, 2019 | | Xario200G and Xario100G,<br>Software V1.1 Diagnostic Ultrasound System | Canon Medical<br>Systems USA | K182596 | November 02, 2018 | #### REASON FOR SUBMISSION 11. Modification of labeling for a cleared device. #### 12. DEVICE DESCRIPTION The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are mobile, compact diagnostic ultrasound systems which implement the latest technologies. 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 30 MHz. 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. The Xario200G Model CUS-X200G and Xario100G Model CUS-X100G 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 12 MHz. #### 13. INDICATIONS FOR USE ## Aplio i900/i800/i700/i600 Diagnostic Ultrasound System The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 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, trans-rectal, neonatal cephalic, {7}------------------------------------------------ adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculoskeletal (both conventional and superficial) and laparoscopic. ## Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System 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, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic. ## Xario200G and Xario100G, Diagnostic Ultrasound System The Diagnostic Ultrasound System Xario200G Model CUS-X200G and Xario100G Model CUS-X100G 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), laparoscopic, pediatric, small organs, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel. #### 14. SUBSTANTIAL EQUIVALENCE The purpose of this submission is the modification of the labeling for Aplio i900/i800 Diagnostic Ultrasound System, V4.0, K191467; Aplio a450, and Aplio a, Diagnostic Ultrasound System, V4.0, K191663; and Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System, K182596, marketed by Canon Medical Systems USA, to which the subject devices are substantially equivalent. The subject devices, Aplio i900/i700/i600 Diagnostic Ultrasound System; Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System; and Xario200G and Xario100G, Diagnostic Ultrasound System, each employ the same fundamental scientific technology as their respective predicate device, and function in the same manner and are intended for the same use as their respective predicate device. This submission includes a modification to the cleared devices to expand labeling for lung and cardiac imaging functionality. The subject devices are otherwise unchanged from their respective predicate device, and are determined to be substantially equivalent. - The subject devices and their respective predicate employ the same operating principle and have the same imaging modes. - . The transducers supported in the subject devices and their respective predicate are identical, and share the same fundamental technological and biocompatibility characteristics. - . The software features supported in the subject devices and their respective predicate device are identical. - The hardware components of the subject devices and their respective predicate device are identical. {8}------------------------------------------------ #### 15. TESTING Performance data is not required for this submission. Design control measures are discussed within the submission. #### 16. CONCLUSION The major change to the devices is to expand the labeling to include information about lung and cardiac imaging, based upon societal guidelines, for patients who have been diagnosed with the novel coronavirus disease 2019 (COVID-19). This labeling update is being provided without changes to the software, hardware and intended use of the subject devices. This labeling change did not impact the previous design controls for the subject devices.