(29 days)
The Sonosite PX 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: 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 Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
The SonoSite SII 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: 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
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
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
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
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, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatic, Trans-esophageal (cardiac), Peripheral Vessel.
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 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.
The provided document is a 510(k) Summary for multiple FUJIFILM Sonosite Diagnostic Ultrasound Systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. The document explicitly states: "Relevant performance data does not apply to this submission. Design control measures described within the submission support a decision of substantial equivalence."
Therefore, the document does not include a study or acceptance criteria related to a new device or algorithm performance evaluation. Instead, it relies on the predicate devices' established safety and effectiveness. The modifications mentioned are primarily "Additional user labeling ... for patients with coronavirus disease 2019 (COVID-19)" based on existing methods or society guidelines, not a new AI-powered diagnostic feature.
Given this, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, experts, or MRMC studies, as these types of studies were explicitly stated as not applicable to this submission.
{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)
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 NameAnd Address | FUJIFILM Sonosite Inc21919 30th Drive SEBothell, WA 98021-3904 |
|---|---|
| Contact Information: | Anoush FrankianSr. Manager, Regulatory Affairanoush.frankian@fujifilm.com(425) 951-6824(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 DopplerImaging System | 892.1550 | IYN |
| Ultrasonic Pulsed Echo ImagingSystem | 892.1560 | IYO |
{9}------------------------------------------------
| Name | CFR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Echo ImagingSystem | 892.1560 | OIJ |
| Diagnostic UltrasoundTransducer | 892.1570 | ITX |
| Picture Archiving andCommunications 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:
-
a primary console (e.g., workstation, tablet with touchscreen) with built-in software components, features, and various clinical applications, and
-
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 byqualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluidflow analysis of the human body. Specific clinical applications and exam types include: |
| AbdominalAdult cephalicCardiac AdultCardiac PediatricFetal - OB/GYNMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)OphthalmicPediatricPeripheral VesselSmall Organ (breast, thyroid, testicles, prostate)TransvaginalNeedle Guidance | |
| This device is indicated for Prescription Use Only.The Sonosite PX Ultrasound System is intended to be used in medical practices, clinicalenvironments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care fordiagnosis of patients. | |
| Sonosite SII | The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use byqualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluidflow analysis of the human body. Specific clinical applications and exam types include: |
| OphthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast, thyroid, testicle, prostate)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricPeripheral 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:Fetal – OB/GYNAbdominalPediatricSmall Organ (breast, thyroid, testicles, prostate)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)Cardiac AdultCardiac PediatricPeripheral vesselOphthalmic |
| 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:OphthalmicFetal – OB/GYNAbdominalPediatricSmall Organ (breast, thyroid, testicles, prostate)Neonatal CephalicAdult CephalicTrans-vaginalMusculo-skel. (Convent.)Musculo-skel. (Superfic.)Cardiac AdultCardiac PediatricTrans-esophageal (card.)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:OphthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast, thyroid, testicle, prostate)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac Pediatric |
| Device | Indication for Use |
| Trans-esophageal (cardiac)Peripheral Vessel | |
| Sonosite Maxx | The SonoSite Maxx Ultrasound System is a general purpose ultrasound system intended for use bya qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the humanbody. 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,Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal(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.
| StandardFeature | Sonosite PX Ultrasound System(Subject Device) | Sonosite PX Ultrasound System -K200964(Predicate Device) | Comparison |
|---|---|---|---|
| Indications forUse | The Sonosite PX Ultrasound Systemis a general purpose ultrasoundsystem intended for use by qualifiedphysicians and healthcareprofessionals for evaluation byultrasound imaging or fluid flowanalysis of the human body. Specificclinical applications and exam typesinclude:AbdominalAdult CephalicCardiac AdultCardiac PediatricFetal - OB/GYNMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)OphthalmicPediatricPeripheral vesselSmall Organ (breast, thyroid,testicles, prostate)TransvaginalNeedle GuidanceThis device is indicated forPrescription Use Only. | The Sonosite PX Ultrasound System isa general purpose ultrasound systemintended for use by qualifiedphysicians and healthcareprofessionals for evaluation byultrasound imaging or fluid flowanalysis of the human body. Specificclinical applications and exam typesinclude:AbdominalAdult CephalicCardiac AdultCardiac PediatricFetal - OB/GYNMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)OphthalmicPediatricPeripheral vesselSmall Organ (breast, thyroid, testicles,prostate)TransvaginalNeedle GuidanceThis device is indicated forPrescription 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 ArrayCurved ArrayPhased ArrayIntracavitary | Linear ArrayCurved ArrayPhased ArrayIntracavitary | 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 |
| StandardFeature | Sonosite SII Ultrasound System(Subject Device) | Sonosite SII Ultrasound System -K183235 (Predicate Device) | Comparison |
| Indications forUse | The SonoSite SII Ultrasound Systemis a general purpose ultrasoundsystem intended for use by qualifiedphysicians and healthcareprofessionals for evaluation byultrasound imaging or fluid flowanalysis of the human body. Specificclinical applications and exam typesinclude:OphthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast, thyroid, testicle,prostate)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricPeripheral Vessel | The SonoSite SII Ultrasound Systemis a general purpose ultrasoundsystem intended for use by qualifiedphysicians and healthcareprofessionals for evaluation byultrasound imaging or fluid flowanalysis of the human body. Specificclinical applications and exam typesinclude:OphthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast, thyroid, testicle,prostate)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricPeripheral Vessel | Identical |
| Reusable? | Yes | Yes | Identical |
| Duration ofUse | Limited (<24 hours) | Limited (<24 hours) | Identical |
| ScientificTechnology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| OperatingPrinciple | The ultrasound beam originates frommechanical oscillations of numerouscrystals in a transducer, which isexcited by electrical pulses(piezoelectric effect). The ultrasoundwaves (pulses of sound) are sentfrom the transducer, propagatethrough different tissues, and thenreturn to the transducer as reflectedechoes. The returned echoes areconverted back into electricalimpulses by the transducer crystalsand are further processed to form theultrasound image presented on thescreen. | The ultrasound beam originates frommechanical oscillations of numerouscrystals in a transducer, which isexcited by electrical pulses(piezoelectric effect). The ultrasoundwaves (pulses of sound) are sentfrom the transducer, propagatethrough different tissues, and thenreturn to the transducer as reflectedechoes. The returned echoes areconverted back into electricalimpulses by the transducer crystalsand are further processed to form theultrasound image presented on thescreen. | Identical |
| StandardFeature | Sonosite SII Ultrasound System(Subject Device) | Sonosite SII Ultrasound System -K183235 (Predicate Device) | Comparison |
| Type ofPreviouslyClearedTransducers | Linear ArrayCurved Linear ArrayPhased ArrayIntracavitary | Linear ArrayCurved Linear ArrayPhased ArrayIntracavitary | Identical |
| AcousticOutputs withinRange? | Yes | Yes | Identical |
| PreviouslyClearedImagingModes? | 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:Fetal – OB/GYNAbdominalPediatricSmall Organ (breast, thyroid, testicles, prostate)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)Cardiac AdultCardiac PediatricPeripheral vesselOphthalmic | 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:Fetal – OB/GYNAbdominalPediatricSmall Organ (breast, thyroid, testicles, prostate)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)Cardiac AdultCardiac PediatricPeripheral vesselOphthalmic | Identical |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (<24 hours) | Limited (<24 hours) | Identical |
{16}------------------------------------------------
| StandardFeature | Sonosite iViZ Ultrasound System(Subject Device) | Sonosite iViz Ultrasound System -K180704 (Predicate Device) | Comparison |
|---|---|---|---|
| ScientificTechnology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| OperatingPrinciple | The ultrasound beam originates frommechanical oscillations of numerouscrystals in a transducer, which isexcited by electrical pulses(piezoelectric effect). The ultrasoundwaves (pulses of sound) are sentfrom the transducer, propagatethrough different tissues, and thenreturn to the transducer as reflectedechoes. The returned echoes areconverted back into electricalimpulses by the transducer crystalsand are further processed to form theultrasound image presented on thescreen. | The ultrasound beam originates frommechanical oscillations of numerouscrystals in a transducer, which isexcited by electrical pulses(piezoelectric effect). The ultrasoundwaves (pulses of sound) are sentfrom the transducer, propagatethrough different tissues, and thenreturn to the transducer as reflectedechoes. The returned echoes areconverted back into electricalimpulses by the transducer crystalsand are further processed to form theultrasound image presented on thescreen. | Identical |
| Type ofPreviouslyClearedTransducers | Linear ArrayCurved ArrayPhased Array | Linear ArrayCurved ArrayPhased Array | Identical |
| AcousticOutputsWithin Range? | Yes | Yes | Identical |
| PreviouslyClearedImagingModes? | Yes | Yes | Identical |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Identical |
Table 4: Technological Comparison of Subject Device (Sonosite X-Porte Ultrasound System) and Predicate Device
| StandardFeature | Sonosite X-Porte UltrasoundSystem(Subject Device) | Sonosite X-Porte UltrasoundSystem - K171437(Predicate Device) | Comparison |
|---|---|---|---|
| Indications forUse | The SonoSite X-Porte UltrasoundSystem is a general purposeultrasound system intended for useby qualified physicians andhealthcare professionals forevaluation by ultrasound imaging orfluid flow analysis of the humanbody. Specific clinical applicationsand exam types include: | The SonoSite X-Porte UltrasoundSystem is a general purposeultrasound system intended for useby qualified physicians andhealthcare professionals forevaluation by ultrasound imaging orfluid flow analysis of the humanbody. Specific clinical applicationsand exam types include: | Identical |
| Standard Feature | Sonosite X-Porte Ultrasound System(Subject Device) | Sonosite X-Porte Ultrasound System - K171437(Predicate Device) | Comparison |
| OphthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast, thyroid, testicles, prostate)Neonatal CephalicAdult CephalicTrans-vaginalMusculo-skel. (Convent.)Musculo-skel. (Superfic.)Cardiac AdultCardiac PediatricTrans-esophageal (card.)Peripheral Vessel | OphthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast, thyroid, testicles, prostate)Neonatal CephalicAdult CephalicTrans-vaginalMusculo-skel. (Convent.)Musculo-skel. (Superfic.)Cardiac AdultCardiac PediatricTrans-esophageal (card.)Peripheral Vessel | ||
| 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 numerouscrystals in a transducer, which isexcited by electrical pulses(piezoelectric effect). The ultrasoundwaves (pulses of sound) are sentfrom the transducer, propagatethrough different tissues, and thenreturn to the transducer as reflectedechoes. The returned echoes areconverted back into electricalimpulses by the transducer crystalsand are further processed to form theultrasound image presented on thescreen. | The ultrasound beam originates from mechanical oscillations of numerouscrystals in a transducer, which isexcited by electrical pulses(piezoelectric effect). The ultrasoundwaves (pulses of sound) are sentfrom the transducer, propagatethrough different tissues, and thenreturn to the transducer as reflectedechoes. The returned echoes areconverted back into electricalimpulses by the transducer crystalsand are further processed to form theultrasound image presented on thescreen. | Identical |
| Type of PreviouslyClearedTransducers | Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayStatic ProbesTrans-esophageal | Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayStatic ProbesTrans-esophageal | Identical |
| Acoustic OutputsWithin Range? | Yes | Yes | Identical |
| PreviouslyCleared | Yes | Yes | Identical |
| StandardFeature | Sonosite X-Porte UltrasoundSystem(Subject Device) | Sonosite X-Porte UltrasoundSystem - K171437(Predicate Device) | Comparison |
| ImagingModes? | |||
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Identical |
{17}------------------------------------------------
{18}------------------------------------------------
Table 5: Technological Comparison of Subject Device (Sonosite Edge II Ultrasound System) and Predicate Device
| StandardFeature | Sonosite Edge II UltrasoundSystem(Subject Device) | Sonosite Edge II UltrasoundSystem - K162045(Predicate Device) | Comparison |
|---|---|---|---|
| Indications forUse | The SonoSite Edge II UltrasoundSystem is a general purposeultrasound system intended for useby qualified physicians andhealthcare professionals forevaluation by ultrasound imaging orfluid flow analysis of the humanbody. Specific clinical applicationsand exam types include:OphthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast, thyroid, testicle,prostate)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral Vessel | The SonoSite Edge II UltrasoundSystem is a general purposeultrasound system intended for useby qualified physicians andhealthcare professionals forevaluation by ultrasound imaging orfluid flow analysis of the humanbody. Specific clinical applicationsand exam types include:OphthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast, thyroid, testicle,prostate)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral Vessel | Identical |
| Reusable? | Yes | Yes | Identical |
| Duration ofUse | Limited (<24 hours) | Limited (<24 hours) | Identical |
| ScientificTechnology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| OperatingPrinciple | The ultrasound beam originates frommechanical oscillations of numerouscrystals in a transducer, which isexcited by electrical pulses(piezoelectric effect). The ultrasoundwaves (pulses of sound) are sentfrom the transducer, propagate | The ultrasound beam originates frommechanical oscillations of numerouscrystals in a transducer, which isexcited by electrical pulses(piezoelectric effect). The ultrasoundwaves (pulses of sound) are sentfrom the transducer, propagate | Identical |
{19}------------------------------------------------
| Standard | Sonosite Edge II UltrasoundSystem | Sonosite Edge II UltrasoundSystem - K162045 | Comparison |
|---|---|---|---|
| Feature | (Subject Device) | (Predicate Device) | |
| through different tissues, and thenreturn to the transducer as reflectedechoes. The returned echoes areconverted back into electricalimpulses by the transducer crystalsand are further processed to form theultrasound image presented on thescreen. | through different tissues, and thenreturn to the transducer as reflectedechoes. The returned echoes areconverted back into electricalimpulses by the transducer crystalsand are further processed to form theultrasound image presented on thescreen. | ||
| Type ofPreviouslyClearedTransducers | Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayTrans-esophageal | Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayTrans-esophageal | Identical |
| AcousticOutputsWithin Range? | Yes | Yes | Identical |
| PreviouslyClearedImagingModes? | Yes | Yes | Identical |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Identical |
Table 6: Technological Comparison of Subject Device (Sonosite Maxx Ultrasound System) and Predicate Device
| StandardFeature | Sonosite Maxx Ultrasound System(Subject Device) | Sonosite Maxx Ultrasound System- K130173(Predicate Device) | Comparison |
|---|---|---|---|
| Indications forUse | The SonoSite Maxx UltrasoundSystem is a general-purposeultrasound system intended for useby a qualified physician forevaluation by ultrasound imaging orfluid flow analysis of the humanbody. Specific clinical applicationsinclude:Ophthalmic, Fetal - OB/GYN,Abdominal, Intraoperative(abdominal organs and vascular),Intra-operative (Neuro.), Pediatric,Small Organ (breast, thyroid, testicle,prostate), Neonatal Cephalic, AdultCephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal(Conventional), Musculo-skeletal(Superficial), Cardiac Adult, CardiacPediatric, Trans-esophageal(cardiac). Peripheral Vessel. | The SonoSite Maxx UltrasoundSystem is a general-purposeultrasound system intended for useby a qualified physician forevaluation by ultrasound imaging orfluid flow analysis of the humanbody. Specific clinical applicationsinclude:Ophthalmic, Fetal - OB/GYN,Abdominal, Intraoperative(abdominal organs and vascular),Intra-operative (Neuro.), Pediatric,Small Organ (breast, thyroid, testicle,prostate), Neonatal Cephalic, AdultCephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal(Conventional), Musculo-skeletal(Superficial), Cardiac Adult, CardiacPediatric, Trans-esophageal(cardiac). Peripheral Vessel. | Identical |
| StandardFeature | Sonosite Maxx Ultrasound System(Subject Device) | Sonosite Maxx Ultrasound System- K130173(Predicate Device) | Comparison |
| Reusable? | Yes | Yes | Identical |
| Duration ofUse | Limited (<24 hours) | Limited (<24 hours) | Identical |
| ScientificTechnology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| OperatingPrinciple | The ultrasound beam originates frommechanical oscillations of numerouscrystals in a transducer, which isexcited by electrical pulses(piezoelectric effect). The ultrasoundwaves (pulses of sound) are sentfrom the transducer, propagatethrough different tissues, and thenreturn to the transducer as reflectedechoes. The returned echoes areconverted back into electricalimpulses by the transducer crystalsand are further processed to form theultrasound image presented on thescreen. | The ultrasound beam originates frommechanical oscillations of numerouscrystals in a transducer, which isexcited by electrical pulses(piezoelectric effect). The ultrasoundwaves (pulses of sound) are sentfrom the transducer, propagatethrough different tissues, and thenreturn to the transducer as reflectedechoes. The returned echoes areconverted back into electricalimpulses by the transducer crystalsand are further processed to form theultrasound image presented on thescreen. | Identical |
| Type ofPreviouslyClearedTransducers | Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayStatic ProbesTrans-esophageal | Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayStatic ProbesTrans-esophageal | Identical |
| AcousticOutputsWithin Range? | Yes | Yes | Identical |
| PreviouslyClearedImagingModes? | Yes | Yes | Identical |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Identical |
{20}------------------------------------------------
VII. Standards Compliance
The standards compliance of the devices included in this application remains unchanged from the previously cleared devices. The expansion in labeling does not necessitate new testing or impact standards compliance in any way. A declaration of conformity that lists the recognized standards that the Sonosite suite of Ultrasound systems comply with is included with this submission.
{21}------------------------------------------------
VIII. Performance Testing
Relevant performance data does not apply to this submission. Design control measures described within the submission support a decision of substantial equivalence.
IX. Conclusions
There are no changes in software, hardware, and intended uses of the subject devices compared to the predicates. Additional user labeling has been included for the subject devices, including information about lung and cardiac ultrasound imaging, based on established methods or the latest society guidelines, for patients with coronavirus disease 2019 (COVID-19). The results of the design controls activity support a determination that the subject devices do not raise new questions of safety or effectiveness and are substantially equivalent to the predicate devices.
§ 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.