(29 days)
No
The document describes a general-purpose ultrasound system and its various models, applications, and hardware components. There is no mention of AI or ML in the intended use, device description, or any other section provided. The processing described is standard ultrasound image formation.
No
The device is described as a "diagnostic ultrasound system" and its intended use is for "evaluation by ultrasound imaging," "diagnosis of patients," and "fluid flow analysis." There is no mention of it being used for treatment or therapy.
Yes
The "Device Description" explicitly states that the Sonosite Diagnostic Ultrasound Systems are "full featured, general purpose, software controlled, diagnostic ultrasound system." Additionally, the "Intended Use / Indications for Use" section for the Sonosite PX Ultrasound System specifies that it is "intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients."
No
The device description explicitly states that the Sonosite Diagnostic Ultrasound Systems are manufactured with hardware components, including a primary console and a range of compatible ultrasound transducers. This indicates it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The text clearly describes the Sonosite Ultrasound Systems as devices that acquire and display real-time ultrasound data by applying ultrasound waves to the human body. This is an in vivo (within the living body) imaging technique.
- Intended Use: The intended use is for "evaluation by ultrasound imaging of the human body" and "diagnosis of patients" through direct imaging of internal structures. This is not consistent with the testing of specimens outside the body.
The device is a diagnostic imaging system, but it operates in vivo, not in vitro.
N/A
Intended Use / Indications for Use
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 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.
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, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatic, Trans-esophageal (cardiac), Peripheral Vessel.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, OIJ, ITX, LLZ
Device Description
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 view with 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound Imaging
Anatomical Site
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, Trans-rectal, Neonatal Cephalic, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians and healthcare professionals / medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Relevant performance data does not apply to this submission. Design control measures described within the submission support a decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K200964, K180704, K162045, K171437, K183235, K130173
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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 Name
And Address | FUJIFILM Sonosite Inc
21919 30th Drive SE
Bothell, WA 98021-3904 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Anoush Frankian
Sr. Manager, Regulatory Affair
anoush.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 Doppler | ||
| Imaging System | 892.1550 | IYN |
| Ultrasonic Pulsed Echo Imaging | ||
| System | 892.1560 | IYO |
9
| Name | CFR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging | ||
| System | 892.1560 | OIJ |
| Diagnostic Ultrasound | ||
| Transducer | 892.1570 | ITX |
| Picture Archiving and | ||
| 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:
-
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 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: | |
| 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. | |
| Sonosite SII | 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 | |
| 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/GYN | |
| Abdominal | |
| Pediatric | |
| Small Organ (breast, thyroid, testicles, prostate) | |
| Musculo-skel. (Convent.) | |
| Musculo-skel. (Superfic.) | |
| Cardiac Adult | |
| Cardiac Pediatric | |
| Peripheral vessel | |
| 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: |
| 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 | |
| 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: |
| 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 | |
| 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 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 Adult, Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel. |
V. Indications for Use
11
12
Comparison of Technological Characteristics with the Predicate Device VI.
| Standard
Feature | Sonosite PX Ultrasound System
(Subject Device) | Sonosite PX Ultrasound System -
K200964
(Predicate Device) | Comparison |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | 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 or fluid flow
analysis 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
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:
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. | 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 (