Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System

{0}------------------------------------------------ September 1, 2020 Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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. FUJIFILM SonoSite Inc. % Anoush Frankian Senior Manager, Regulatory Affairs 21919 30th Drive SE BOTHELL WA 98021 # Re: K202160 Trade/Device Name: Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System. Sonosite Maxx Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, OIJ, ITX, LLZ Dated: August 3, 2020 Received: August 3, 2020 # Dear Anoush Frankian: 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 {1}------------------------------------------------ 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 (QS) 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 {2}------------------------------------------------ #### Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ## 510(k) Number (if known) ### K202160 #### Device Name #### Sonosite PX Ultrasound System #### Indications for Use (Describe) The Sonosite PX Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthicare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Abdominal Adult cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral Vessel Small Organ (breast, thyroid, testicles, prostate) Transvaginal Needle Guidance This device is indicated for Prescription Use Only. The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthicare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients. 区Prescription Use (Part 21 CFR 801 Subpart D) _ 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 OfficerPaperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {3}------------------------------------------------ ### "DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K202160 #### Device Name SonoSite SII Ultrasound System Indications for Use (Describe) The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthicare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel #### Type of Use (Select one or both, as applicable) 区Prescription Use (Part 21 CFR 801 Subpart D) □ 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 6699 {4}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K202160 Device Name SonoSite iViz Ultrasound System Indications for Use (Describe) The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include: | Fetal - OB/GYN | | |----------------------------------------------------|--| | Abdominal | | | Pediatric | | | Small Organ (breast, thyroid, testicles, prostate) | | | Musculo-skel. (Convent.) | | | Musculo-skel. (Superfic.) | | | Cardiac Adult | | | Cardiac Pediatric | | | Peripheral vessel | | | Ophthalmic | | Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D) _ 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." {5}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K202160 Device Name SonoSite X-Porte Ultrasound System Indications for Use (Describe) The SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: | Ophthalmic | | |----------------------------------------------------|--| | Fetal – OB/GYN | | | Abdominal | | | Pediatric | | | Small Organ (breast, thyroid, testicles, prostate) | | | Neonatal Cephalic | | | Adult Cephalic | | | Trans-vaginal | | | Musculo-skel. (Convent.) | | | Musculo-skel. (Superfic.) | | | Cardiac Adult | | | Cardiac Pediatric | | | Trans-esophageal (card.) | | | Peripheral Vessel | | 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) ## 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 {6}------------------------------------------------ # DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K202160 #### Device Name SonoSite Edge II Ultrasound System Indications for Use (Describe) The SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: | Ophthalmic | |---------------------------------------------------| | Fetal - OB/GYN | | Abdominal | | Pediatric | | Small Organ (breast, thyroid, testicle, prostate) | | Neonatal Cephalic | | Adult Cephalic | | Trans-rectal | | Trans-vaginal | | Musculo-skeletal (Conventional) | | Musculo-skeletal (Superficial) | | Cardiac Adult | | Cardiac Pediatric | | Trans-esophageal (cardiac) | | Peripheral Vessel | ### Type of Use (Select one or both, as applicable) 区Prescription Use (Part 21 CFR 801 Subpart D) □ 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." {7}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration **Indications for Use** #### Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K202160 #### Device Name Sonosite Maxx Ultrasound System Indications for Use (Describe) The SonoSite Maxx Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatic, Trans-esophageal (cardiac), Peripheral Vessel. Type of Use (Select one or both, as applicable) 区Prescription Use (Part 21 CFR 801 Subpart D) _ 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. {8}------------------------------------------------ # 510(k) SUMMARY - K202160 # FUJIFILM Sonosite Diagnostic Ultrasound Systems This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. # Date Prepared: July 30th, 2020 #### I. Submitter | Manufacturer Name<br>And Address | FUJIFILM Sonosite Inc<br>21919 30th Drive SE<br>Bothell, WA 98021-3904 | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Contact Information: | Anoush Frankian<br>Sr. Manager, Regulatory Affair<br>anoush.frankian@fujifilm.com<br>(425) 951-6824<br>(425) 659-0186 | #### II. Device # Common/Usual Name: Diagnostic Ultrasound System with Accessories # Proprietary Name: Sonosite PX Ultrasound System Sonosite SII Ultrasound System Sonosite iViz Ultrasound System Sonosite Edge II Ultrasound System Sonosite X-Porte Ultrasound System Sonosite Maxx Ultrasound System # Device Classification and Product Code: | Name | CFR Number | Product Code | |---------------------------------------------|------------|--------------| | Ultrasonic Pulsed Doppler<br>Imaging System | 892.1550 | IYN | | Ultrasonic Pulsed Echo Imaging<br>System | 892.1560 | IYO | {9}------------------------------------------------ | Name | CFR Number | Product Code | |------------------------------------------------|------------|--------------| | Ultrasonic Pulsed Echo Imaging<br>System | 892.1560 | OIJ | | Diagnostic Ultrasound<br>Transducer | 892.1570 | ITX | | Picture Archiving and<br>Communications System | 892.2050 | LLZ | #### Predicate Device: III. Sonosite PX Ultrasound System (K200964) Sonosite iViz Ultrasound System (K180704) Sonosite Edge II Ultrasound System (K162045) Sonosite X-Porte Ultrasound System (K171437) Sonosite SII Ultrasound System (K183235) Sonosite Maxx Ultrasound System (K130173) #### Device Description IV. The Sonosite Diagnostic Ultrasound Systems are full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. They are intended to be used for general purpose ultrasound examination, cardiac imaging, fetal imaging and OB/GYN applications, vascular imaging and trans-rectal applications and fluid flow analysis among others. Some Sonosite Ultrasound Systems (Sonosite PX) also have needle guidance capabilities. They are intended to be used by qualified physicians and trained professionals in various patient care settings including hospitals, clinics, and point-of-care settings. Software modes/applications, scanning protocols, and pre-installed settings or functionality to create dedicated settings for imaging of specific anatomy are available with the subject Sonosite Ultrasound Systems and may vary among the different model configurations. The Sonosite Ultrasound Systems work on either battery or AC power. Some Sonosite Diagnostic Ultrasound Systems support Bluetooth and wireless connectivity for image transfer and over-the-air (OTA) software updates. The diagnostic ultrasound systems are manufactured with hardware components which consist of: 1) a primary console (e.g., workstation, tablet with touchscreen) with built-in software components, features, and various clinical applications, and 2) a range of compatible ultrasound transducers. A suite of compatible transducers are offered with the Sonosic Ultrasound Systems. These include linear array, curved array, phased array, intra-cavitary, static probes and trans-esophageal transducers. Linear array transducers (prefixed with the letter L) produce a rectangular field of view with uniform beam density throughout and are useful for imaging shallow structures and small parts. Curved array transducers (prefixed with the letter C) allow for a wider field of vith decreased line density at depth and reduced lateral resolution. They are the ideal probe for lung ultrasound imaging. Phased array transducers (prefixed with the letter P) are small faced transducers allowing for imaging in small spaces. They are able to change the focus of {10}------------------------------------------------ the ultrasound beam. It is the optimal transducer recommended for cardiac imaging. Trans-esophageal transducers (prefixed with the letters TE) are commonly used for evaluation of cardiac and aortic structures. Intra-cavitary transducers (prefixed with the letters IC) are used for trans-rectal ultrasounds. Some models may have additional previously-cleared accessories, or components which are manufactured by other manufacturers. | Device | Indication for Use | |------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sonosite PX | The Sonosite PX Ultrasound System is a general purpose ultrasound system intended for use by<br>qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid<br>flow analysis of the human body. Specific clinical applications and exam types include: | | | Abdominal<br>Adult cephalic<br>Cardiac Adult<br>Cardiac Pediatric<br>Fetal - OB/GYN<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Ophthalmic<br>Pediatric<br>Peripheral Vessel<br>Small Organ (breast, thyroid, testicles, prostate)<br>Transvaginal<br>Needle Guidance | | | This device is indicated for Prescription Use Only.<br>The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical<br>environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for<br>diagnosis of patients. | | Sonosite SII | The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by<br>qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid<br>flow analysis of the human body. Specific clinical applications and exam types include: | | | Ophthalmic<br>Fetal - OB/GYN<br>Abdominal<br>Pediatric<br>Small Organ (breast, thyroid, testicle, prostate)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Cardiac Adult<br>Cardiac Pediatric<br>Peripheral Vessel | | Device | Indication for Use | | Sonosite iViz | The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include:<br>Fetal – OB/GYN<br>Abdominal<br>Pediatric<br>Small Organ (breast, thyroid, testicles, prostate)<br>Musculo-skel. (Convent.)<br>Musculo-skel. (Superfic.)<br>Cardiac Adult<br>Cardiac Pediatric<br>Peripheral vessel<br>Ophthalmic | | Sonosite X-Porte | The SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:<br>Ophthalmic<br>Fetal – OB/GYN<br>Abdominal<br>Pediatric<br>Small Organ (breast, thyroid, testicles, prostate)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-vaginal<br>Musculo-skel. (Convent.)<br>Musculo-skel. (Superfic.)<br>Cardiac Adult<br>Cardiac Pediatric<br>Trans-esophageal (card.)<br>Peripheral Vessel | | Sonosite Edge II | The SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:<br>Ophthalmic<br>Fetal - OB/GYN<br>Abdominal<br>Pediatric<br>Small Organ (breast, thyroid, testicle, prostate)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Cardiac Adult<br>Cardiac Pediatric | | Device | Indication for Use | | | Trans-esophageal (cardiac)<br>Peripheral Vessel | | Sonosite Maxx | The SonoSite Maxx Ultrasound System is a general purpose ultrasound system intended for use by<br>a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human<br>body. Specific clinical applications include:<br>Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-<br>operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic,<br>Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal<br>(Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel. | #### V. Indications for Use {11}------------------------------------------------ {12}------------------------------------------------ #### Comparison of Technological Characteristics with the Predicate Device VI. | Standard<br>Feature | Sonosite PX Ultrasound System<br>(Subject Device) | Sonosite PX Ultrasound System -<br>K200964<br>(Predicate Device) | Comparison | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Indications for<br>Use | The Sonosite PX Ultrasound System<br>is a general purpose ultrasound<br>system intended for use by qualified<br>physicians and healthcare<br>professionals for evaluation by<br>ultrasound imaging or fluid flow<br>analysis of the human body. Specific<br>clinical applications and exam types<br>include:<br><br>Abdominal<br>Adult Cephalic<br>Cardiac Adult<br>Cardiac Pediatric<br>Fetal - OB/GYN<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Ophthalmic<br>Pediatric<br>Peripheral vessel<br>Small Organ (breast, thyroid,<br>testicles, prostate)<br>Transvaginal<br>Needle Guidance<br><br>This device is indicated for<br>Prescription Use Only. | The Sonosite PX Ultrasound System is<br>a general purpose ultrasound system<br>intended for use by qualified<br>physicians and healthcare<br>professionals for evaluation by<br>ultrasound imaging or fluid flow<br>analysis of the human body. Specific<br>clinical applications and exam types<br>include:<br><br>Abdominal<br>Adult Cephalic<br>Cardiac Adult<br>Cardiac Pediatric<br>Fetal - OB/GYN<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Ophthalmic<br>Pediatric<br>Peripheral vessel<br>Small Organ (breast, thyroid, testicles,<br>prostate)<br>Transvaginal<br>Needle Guidance<br><br>This device is indicated for<br>Prescription Use Only. | Identical | | Standard Feature | Sonosite PX Ultrasound System (Subject Device) | Sonosite PX Ultrasound System - K200964 (Predicate Device) | Comparison | | | The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients. | The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients. | | | Reusable? | Yes | Yes | Identical | | Duration of Use | Limited (<24 hours) | Limited (<24 hours) | Identical | | Scientific Technology | Ultrasound Imaging | Ultrasound Imaging | Identical | | Operating Principle | The ultrasound beam originates from mechanical oscillations of numerous crystals in a transducer, which is excited by electrical pulses (piezoelectric effect). The ultrasound waves (pulses of sound) are sent from the transducer, propagate through different tissues, and then return to the transducer as reflected echoes. The returned echoes are converted back into electrical impulses by the transducer crystals and are further processed to form the ultrasound image presented on the screen. | The ultrasound beam originates from mechanical oscillations of numerous crystals in a transducer, which is excited by electrical pulses (piezoelectric effect). The ultrasound waves (pulses of sound) are sent from the transducer, propagate through different tissues, and then return to the transducer as reflected echoes. The returned echoes are converted back into electrical impulses by the transducer crystals and are further processed to form the ultrasound image presented on the screen. | Identical | | Type of Previously Cleared Transducers | Linear Array<br>Curved Array<br>Phased Array<br>Intracavitary | Linear Array<br>Curved Array<br>Phased Array<br>Intracavitary | Identical | | Acoustic Outputs Within Range? | Yes | Yes | Identical | | Previously Cleared Imaging Modes? | Yes | Yes | Identical | | Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Identical | | Standard<br>Feature | Sonosite SII Ultrasound System<br>(Subject Device) | Sonosite SII Ultrasound System -<br>K183235 (Predicate Device) | Comparison | | Indications for<br>Use | The SonoSite SII Ultrasound System<br>is a general purpose ultrasound<br>system intended for use by qualified<br>physicians and healthcare<br>professionals for evaluation by<br>ultrasound imaging or fluid flow<br>analysis of the human body. Specific<br>clinical applications and exam types<br>include:<br><br>Ophthalmic<br>Fetal - OB/GYN<br>Abdominal<br>Pediatric<br>Small Organ (breast, thyroid, testicle,<br>prostate)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Cardiac Adult<br>Cardiac Pediatric<br>Peripheral Vessel | The SonoSite SII Ultrasound System<br>is a general purpose ultrasound<br>system intended for use by qualified<br>physicians and healthcare<br>professionals for evaluation by<br>ultrasound imaging or fluid flow<br>analysis of the human body. Specific<br>clinical applications and exam types<br>include:<br><br>Ophthalmic<br>Fetal - OB/GYN<br>Abdominal<br>Pediatric<br>Small Organ (breast, thyroid, testicle,<br>prostate)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Cardiac Adult<br>Cardiac Pediatric<br>Peripheral Vessel | Identical | | Reusable? | Yes | Yes | Identical | | Duration of<br>Use | Limited (<24 hours) | Limited (<24 hours) | Identical | | Scientific<br>Technology | Ultrasound Imaging | Ultrasound Imaging | Identical | | Operating<br>Principle | The ultrasound beam originates from<br>mechanical oscillations of numerous<br>crystals in a transducer, which is<br>excited by electrical pulses<br>(piezoelectric effect). The ultrasound<br>waves (pulses of sound) are sent<br>from the transducer, propagate<br>through different tissues, and then<br>return to the transducer as reflected<br>echoes. The returned echoes are<br>converted back into electrical<br>impulses by the transducer crystals<br>and are further processed to form the<br>ultrasound image presented on the<br>screen. | The ultrasound beam originates from<br>mechanical oscillations of numerous<br>crystals in a transducer, which is<br>excited by electrical pulses<br>(piezoelectric effect). The ultrasound<br>waves (pulses of sound) are sent<br>from the transducer, propagate<br>through different tissues, and then<br>return to the transducer as reflected<br>echoes. The returned echoes are<br>converted back into electrical<br>impulses by the transducer crystals<br>and are further processed to form the<br>ultrasound image presented on the<br>screen. | Identical | | Standard<br>Feature | Sonosite SII Ultrasound System<br>(Subject Device) | Sonosite SII Ultrasound System -<br>K183235 (Predicate Device) | Comparison | | Type of<br>Previously<br>Cleared<br>Transducers | Linear Array<br>Curved Linear Array<br>Phased Array<br>Intracavitary | Linear Array<br>Curved Linear Array<br>Phased Array<br>Intracavitary | Identical | | Acoustic<br>Outputs within<br>Range? | Yes | Yes | Identical | | Previously<br>Cleared<br>Imaging<br>Modes? | Yes | Yes | Identical | | Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Identical | # Table 1: Technological Comparison of Subject Device (Sonosite PX Ultrasound System) and Predicate Device {13}------------------------------------------------ {14}------------------------------------------------ # Table 2: Technological Comparison of Subject Device (Sonosite SII Ultrasound System) and Predicate Device {15}------------------------------------------------ # Table 3: Technological Comparison of Subject Device (Sonosite iViz Ultrasound System) and Predicate Device | Standard Feature | Sonosite iViZ Ultrasound System (Subject Device) | Sonosite iViz Ultrasound System - K180704 (Predicate Device) | Comparison | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Indications for Use | The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include:<br>Fetal – OB/GYN<br>Abdominal<br>Pediatric<br>Small Organ (breast, thyroid, testicles, prostate)<br>Musculo-skel. (Convent.)<br>Musculo-skel. (Superfic.)<br>Cardiac Adult<br>Cardiac Pediatric<br>Peripheral vessel<br>Ophthalmic | The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include:<br>Fetal – OB/GYN<br>Abdominal<br>Pediatric<br>Small Organ (breast, thyroid, testicles, prostate)<br>Musculo-skel. (Convent.)<br>Musculo-skel. (Superfic.)<br>Cardiac Adult<br>Cardiac Pediatric<br>Peripheral vessel<br>Ophthalmic | Identical | | Reusable? | Yes | Yes | Identical | | Duration of Use | Limited (<24 hours) | Limited (<24 hours) | Identical | {16}------------------------------------------------ | Standard<br>Feature | Sonosite iViZ Ultrasound System<br>(Subject Device) | Sonosite iViz Ultrasound System -<br>K180704 (Predicate Device) | Comparison | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Scientific<br>Technology | Ultrasound Imaging | Ultrasound Imaging | Identical | | Operating<br>Principle | The ultrasound beam originates from<br>mechanical oscillations of numerous<br>crystals in a transducer, which is<br>excited by electrical pulses<br>(piezoelectric effect). The ultrasound<br>waves (pulses of sound) are sent<br>from the transducer, propagate<br>through different tissues, and then<br>return to the transducer as reflected<br>echoes. The returned echoes are<br>converted back into electrical<br>impulses by the transducer crystals<br>and are further processed to form the<br>ultrasound image presented on the<br>screen. | The ultrasound beam originates from<br>mechanical oscillations of numerous<br>crystals in a transducer, which is<br>excited by electrical pulses<br>(piezoelectric effect). The ultrasound<br>waves (pulses of sound) are sent<br>from the transducer, propagate<br>through different tissues, and then<br>return to the transducer as reflected<br>echoes. The returned echoes are<br>converted back into electrical<br>impulses by the transducer crystals<br>and are further processed to form the<br>ultrasound image presented on the<br>screen. | Identical | | Type of<br>Previously<br>Cleared<br>Transducers | Linear Array<br>Curved Array<br>Phased Array | Linear Array<br>Curved Array<br>Phased Array | Identical | | Acoustic<br>Outputs<br>Within Range? | Yes | Yes | Identical | | Previously<br>Cleared<br>Imaging<br>Modes? | Yes | Yes…