(28 days)
No
The document describes standard ultrasound imaging modes and image processing techniques (speckle reduction, compounding) but does not mention any features or algorithms that are characteristic of AI or ML, such as automated detection, classification, or quantitative analysis powered by learned models. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a "diagnostic ultrasound system" intended for "evaluation by ultrasound imaging of the human body" and "diagnosis of patients," rather than for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Sonosite LX system is intended to be used in medical practices, clinical environments... for diagnosis of patients." Additionally, the "Device Description" section refers to it as a "diagnostic ultrasound system."
No
The device description explicitly states it is an "integrated unit with its kiosk-style stand" and includes hardware components like transducers, USB ports, an Ethernet port, and an ECG-specific port. It is powered by battery or AC electrical power and requires a transducer to obtain images.
Based on the provided text, the Sonosite LX ultrasound system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Intended Use of Sonosite LX: The Sonosite LX is described as a "general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or the human body." It uses ultrasound waves to create images of internal structures within the body.
- No mention of specimen analysis: The description focuses entirely on imaging the human body directly, not on analyzing samples taken from the body.
Therefore, the Sonosite LX is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sonosite LX ultrasound system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or the human body. Specific clinical applications and exam types include:
Abdominal Adult Cephalic Neonatal Cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral vessel Small Organ (breast, thyroid, testicles, prostate) Transesophageal (cardiac) Transrectal Transvaginal Needle Guidance
Modes of operation include: B Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler (PWD) (including High Pulse Repetition Frequency (HPRF) and simultaneous PWD for certain exam types), Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Color Power Doppler, Velocity Color Doppler, Color Variance, Tissue Harmonic Imaging (THI), Multi-beam imaging, Steep Needle Profiling, Trapezoid, and combined modes, including duplex and triplex imaging: B+M, B+PWD, B+C, (B+C)+PWD, (B+C)+CWD.
This device is indicated for Prescription Use Only.
The Sonosite LX 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 system is used with a transducer attached and is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient's body where needed to obtain the desired ultrasound image.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Sonosite LX Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler (CPD), and color Doppler (Color) or in a combination of these modes. The Sonosite LX is designed as an integrated unit with its kiosk-style stand.
The system includes a variety of accessories including needle guide starter kits. The system includes USB host support for peripherals such as input devices, storage devices, and an Ethernet port. Input devices include wired and wireless devices. The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal Adult Cephalic Neonatal Cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral vessel Small Organ (breast, thyroid, testicles, prostate) Transesophageal (cardiac) Transrectal Transvaginal Needle Guidance
Indicated Patient Age Range
Adult
Neonatal
Pediatric
Fetal
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)
The Sonosite LX Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.
Summary of Non-Clinical Tests:
The Sonosite LX Ultrasound System has been evaluated for electrical, thermal, mechanical, and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated for Sonosite LX, and the device has been found to conform to applicable medical device safety standards.
Assurance of quality was established by employing the following elements of product development: Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, and Clinical Validation. All patient contact materials are biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
December 6, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is 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. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive Suite 510k SAINT PAUL MN 55114
Re: K233597
Trade/Device Name: Sonosite LX Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 8, 2023 Received: November 8, 2023
Dear Prithul Bom:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233597
Device Name
FUJIFILM Sonosite LX Ultrasound System (Sonosite LX)
Indications for Use (Describe)
The Sonosite LX ultrasound system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or the human body. Specific clinical applications and exam types include:
Abdominal Adult Cephalic Neonatal Cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral vessel Small Organ (breast, thyroid, testicles, prostate) Transesophageal (cardiac) Transrectal Transvaginal Needle Guidance
Modes of operation include: B Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler (PWD) (including High Pulse Repetition Frequency (HPRF) and simultaneous PWD for certain exam types), Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Color Power Doppler, Velocity Color Doppler, Color Variance, Tissue Harmonic Imaging (THI), Multi-beam imaging, Steep Needle Profiling, Trapezoid, and combined modes, including duplex and triplex imaging: B+M, B+PWD, B+C, (B+C)+PWD, (B+C)+CWD.
This device is indicated for Prescription Use Only.
The Sonosite LX 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 system is used with a transducer attached and is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient's body where needed to obtain the desired ultrasound image.
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.
3
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4
510(K) Summary
K233597
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1) Submitter:
| Manufacturer Name:
Address: | FUJIFILM SonoSite, Inc
21919 30th Drive SE
Bothell, WA 98021-3904 |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Corresponding Official: | Anoush Frankian
Director, Regulatory Affairs |
| Email:
Telephone:
Facsimile
Date prepared: | anoush.frankian@fujifilm.com
(425) 951-6824
(425) 951-1201
October 04, 2023 |
| Regulatory Leads &
Alternate Contacts:
Emails: | Akanksha Kulshreshtha and Anjana Varier
akanksha.kulshreshtha@fujifilm.com
and anjana.varier@fujifilm.com |
| Telephone: | (425)951-6897
(425)686-6519 |
| Facsimile: | (425) 951-1201 |
| 2) Device | |
|---|---|
| Trade Name: | Sonosite LX Ultrasound System |
| Common Name: | Diagnostic Ultrasound System and Transducers with |
| Accessories | |
| Regulation Name: | Ultrasonic Pulsed Doppler Imaging System |
| Ultrasonic Pulsed Echo Imaging System | |
| Diagnostic Ultrasound Transducer | |
| Regulation Number: | 892.1550 |
| 892.1560 | |
| 892.1570 |
Page 1 of 15
5
IYN Primary Product Code:
Secondary Product Codes: IYO ITX
Device Class: Class II
Classification Panel: Radiology
3) Predicate Device:
Primary Predicate: Sonosite PX Ultrasound System (K213763)
Reference Device: SonoSite Edge II Ultrasound System (K162045)
4) Device Description:
The Sonosite LX Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler (CPD), and color Doppler (Color) or in a combination of these modes. The Sonosite LX is designed as an integrated unit with its kiosk-style stand.
The system includes a variety of accessories including needle guide starter kits. The system includes USB host support for peripherals such as input devices, storage devices, and an Ethernet port. Input devices include wired and wireless devices. The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.
6
5) Intended Use/Indications for Use:
The Sonosite LX 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 Neonatal Cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral vessel Small Organ (breast, thyroid, testicles, prostate) Transesophageal (cardiac) Transrectal Transvaginal Needle Guidance
Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler (PWD) (including High Pulse Repetition Frequency (HPRF) and simultaneous PWD for certain exam types). Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Color Power Doppler, Velocity Color Variance, Tissue Harmonic Imaging (THI), Multi-beam imaging, Steep Needle Profiling, Trapezoid, and combined modes, including duplex and triplex imaging: B+M. B+PWD. B+C. (B+C)+PWD. (B+C)+CWD.
This device is indicated for Prescription Use Only.
The Sonosite LX 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 system is used with a transducer attached and is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient's body where needed to obtain the desired ultrasound image.
7
6) Technological Characteristics:
The Sonosite LX Ultrasound System, subject device of this submission, is equivalent to the previously cleared Sonosite PX (K213763) and Edge II (K162045) Ultrasound Systems in terms of both the intended use and technological characteristics. The Sonosite LX (subject device) uses the same fundamental scientific technology as the predicate device.
| Feature | Sonosite LX Ultrasound
System
(K233597) | Sonosite PX Ultrasound
System
(K213763) | Sonosite Edge II
Ultrasound System
(K162045) | Evaluation of
Differences |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound imaging or fluid
flow analysis of the human body | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Diagnostic ultrasound
imaging or fluid flow
analysis of the human body | The intended use of the
Sonosite LX is identical
to the predicate and
reference devices. |
| Indications for
Use | AbdominalAdult Cephalic
Neonatal Cephalic
Cardiac Adult
Cardiac Pediatric
Fetal – OB/GYN
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Ophthalmic
Pediatric
Peripheral vessel
Small Organ (breast, thyroid, testicle,
prostate)
Transrectal
Transvaginal
Trans-esophageal (cardiac)
Needle Guidance | Abdominal
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Fetal – OB/GYN
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Ophthalmic
Pediatric
Peripheral Vessel
Small Organ (breast, thyroid,
testicle, prostate)
Transrectal
Transvaginal
Trans-esophageal (cardiac)
Needle guidance | Abdominal
Adult Cephalic
Neonatal Cephalic
Cardiac Adult
Cardiac Pediatric
Fetal – OB/GYN
Musculo-skeletal
(Conventional) Musculo-
skeletal (Superficial)
Ophthalmic
Pediatric
Small Organ (breast,
thyroid, testicle, prostate)
Transvaginal
Peripheral Vessel
Needle guidance
Trans-Rectal
Trans-esophageal (cardiac)
Needle guidance | The Indications for
Use are a subset of
Sonosite PX
Ultrasound system
(primary predicate-
K213763) and
Sonosite Edge II
Ultrasound system
(reference device-
K162045). |
| Transducer
Types | Linear Array
Curved Linear Array
Phased Array | Linear Array
Curved Linear Array
Phased Array | Linear Array
Curved Linear Array
Phased Array | Transducer types for
Sonosite LX are all a
subset of Sonosite
PX Ultrasound |
| | | | | |
| | Intracavitary
Trans-esophageal | Intracavitary
Trans-esophageal | Array
Intracavitary
Trans-esophageal | system (primary predicate) and
Sonosite Edge II Ultrasound system
(reference device) |
| Transducer
Frequency | 1.0-19.0 MHz | 1.0-19.0 MHz | 1.0 – 15.0 MHz | The frequency range
for Sonosite LX is
unchanged and the
same as the primary
predicate Sonosite PX
(K213763) |
| Global Maximum
Outputs/Worst
Case Setting | lspta.3: 607 mW/cm^2 (L12-3)
TI Type: TIB (P5-1) TI Value: 4.87 (P5-
- MI: 1.72 (L12-3)
lpa.3@MI Max: 793 mW/cm^2 (L15-4) | lspta.3: 607 mW/cm^2 (L12-3)
TI Type: TIB (P5-1) TI Value: 4.87
(P5-1) MI: 1.72 (L12-3)
lpa.3@MI Max: 793 mW/cm^2
(L15-4) | lspta.3: 598.9 (HFL50x)
TI Type: TIB (rP19x)
TI Value: 4.98
(rP19x) MI: 1.7 (rP19x)
Ipa.3@MI Max: 776 (L38xi) | Acoustic output is less
than FDA established
limits. |
| Acoustic Output
Display & FDA
Limits | Display Feature for Higher Outputs MI
Output Display TI Output Display | Display Feature for Higher Outputs
MI Output Display TI Output
Display | Display Feature for Higher
Outputs MI Output Display
TI Output Display | MI & TI are always
displayed and a power
management system
ensures that they never
exceed the derated
FDA limits. |
| Modes of
Operation | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Simultaneous M-Mode
Anatomical M-Mode
Color Doppler (C)
Color Power Doppler (CPD)
Zoom
Color Velocity Doppler (CVD)
Color Variance (Var) | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Simultaneous M-Mode
Anatomical M-Mode
Color Doppler (C)
Color Power Doppler (CPD)
Zoom
Color Velocity Doppler (CVD)
Color Variance (Var) | B-mode Grayscale
Imaging Tissue Harmonic
Imaging M-mode
Color M-Mode | Modes of operation are
a subset of Sonosite
PX Ultrasound system
(primary predicate) and
Sonosite Edge II
Ultrasound system
(reference device). |
8
9
| Combination Modes | Combination Modes |
|---|---|
| Pulsed Wave (PW) Doppler | Pulsed Wave (PW) Doppler |
| Continuous Wave (CW) Doppler | Continuous Wave (CW) Doppler |
| Speckle reduction algorithm (formerly branded as SonoHD2 Noise Reduction) | Speckle reduction algorithm (formerly branded as SonoHD2 Noise Reduction) |
| SonoMB/MBe Image Compounding | SonoMB/MBe Image Compounding |
| CW Doppler | CW Doppler |
| Tissue Doppler Imaging (TDI) | Tissue Doppler Imaging (TDI) |
| DICOM | DICOM 3.0
Store, Modality Worklist, Modality
Perform Procedure Step (MPPS),
Storage Commitment, Structured
reports, offline media | DICOM 3.0
Store, Modality Worklist, Modality
Perform Procedure Step (MPPS),
Storage Commitment, Structured
reports, offline media | DICOM 3.0
Store, Print, Modality
Worklist, Modality Perform
Procedure Step (MPPS),
Storage Commitment,
offline media | Includes a subset of this
information |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| #Transmit
Channels | 128 digital channels | 128 digital channels | 128 digital channels | - |
| #Receive
Channels | 128 digital channels | 128 digital channels | 64 digital channels
(128 digital channels using
Synthetic Aperture) | - |
10
| Patient Contact
Materials | Transducers:
Silicone Rubber
Polysulfone
PolyVinylChloride (PVC)
Silicone RTV Adhesive
Silicone
Polymethyl-pentene
Epoxy Paste Adhesive
Polyurethane
FKM rubber
Thermoplastic
polyurethane
Needle Guides: Acetal copolymer
Acrylonitrile-butadien- styrene (ABS) | Transducers:
Silicone Rubber
Polysulfone
PolyVinylChloride (PVC)
Silicone RTV Adhesive Silicone
Polymethyl-pentene
Epoxy Paste Adhesive
Polyurethane
FKM rubber
Thermoplastic polyurethane
Needle Guides: Acetal copolymer
Acrylonitrile-butadien- styrene
(ABS) | Transducers:
Acrylonitrile-butadien-
styrene (ABS)
Cycoloy
Epoxy paste adhesive
Polyethylene (PE)
Ionomer
Polyetheretherketone
(PEEK)
Polycarbonate
Polysulfone
UDEL
Polyurethane
PolyVinylChloride (PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien- styrene
(ABS) | All patient contact
materials have been
tested to ISO 10993-
1.
Materials used in
Sonosite LX have
undergone identical
biocompatibility and
cleaning/disinfection
testing to the
predicate devices. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Safety
Certification | AAMI/ANSI ES60601- 1:2005 (R2012)
IEC 60601-2- 37:2007+AMD1:2015
CAN/CSA-C22.2 No. 60601-1:14
JSA JIS T
0601-1:2017,
JSA JIS T 0601-2-37
IEC 61157:2007+AMD1:2013
IEC 62359:2010+AMD1:2017 | AAMI/ANSI ES60601- 1:2005
(R2012)
IEC 60601-2-
37:2007+AMD1:2015
CAN/CSA-C22.2 No. 60601-1:14
JSA JIS T
0601-1:2017,
JSA JIS T 0601-2-37 | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No.
60601-1:08
NEMA UD2-2004 IEC
62359:2010 | |
| EMC
Compliance | IEC 60601-1-2:2014 (Edition 4.0)
IEC 60601-1-2:2014+A1:2020 (Edition
4.1)
CISPR 11:2015+AMD1:2016
+A2:2019
IEC 61000-3-2:2018
IEC 61000-3-
3:2013+A1:2017
IEC 61000-4-2:2008
IEC 61000-4-3:2020
IEC 61000-4-4::2012
IEC 61000-4-
5:2014+A1:2017
IEC 61000-4-6:2013
IEC 61000-4-
11:2020+AC:2020+AC:2022
IEC 61000-4-8:2009
IEC 61000-4-39:2017 | IEC 60601-1-2:2014 (Edition 4.0)
CISPR 11:2015+AMD1:2016
IEC 61000-3-2:2018
IEC 61000-3-
3:2013+A1:2017
IEC 61000-4-2:2008
IEC 61000-4-3:2010
IEC 61000-4-4::2012
IEC 61000-4-
5:2014+A1:2017
IEC 61000-4-6:2013
IEC 61000-4-
11:2004+A1:2017
IEC 61000-4-8:2009 | AAMI / ANSI / IEC
60601- 1-
2:2007(R)2012 CISPR 11,
Group 1, Class A | The changes in the
standards did not affect
the EMC testing
performed for the
subject device,
Sonosite LX and the
primary predicate,
Sonosite PX
(K213763). |
| DICOM | DICOM PS3.15 | DICOM PS3.15 | DICOM PS3.15 | |
| Airborne
Equipment
Standards | None applied | None applied | RTCA/DO160
(section 21) | Airborne equipment
standards have not
been applied to the
Sonosite LX
Ultrasound System. |
IEC 61157:2007+AMD1:2013 IEC 62359:2010+AMD1:2017
11
12
| System
| Characteristics | Sonosite LX: | Sonosite PX: | Edge II: | The features |
|---|---|---|---|---|
| Beamformer 128/128 | Beamformer 128/128 | Beamformer | ||
| 128/128 using SA | ||||
| (configurable) | introduced are | |||
| equivalent to Sonosite | ||||
| PX Ultrasound system | ||||
| 21.3" Projected Capacitive (PCAP) | ||||
| touch screen interface | 15.6" capacitive screen | |||
| interface | (K213763) and | |||
| Sonosite Edge II | ||||
| Ultrasound system | ||||
| Storage bin capacity: 11 lbs. (5 kg) | ||||
| Stand depth: 25.4 in. (64.5 cm) | ||||
| Stand width: 23.0 in. (58.4 cm) | ||||
| Height range: max with monitor up 68 | ||||
| in. (172.7 cm); min with monitor down | ||||
| 49 in. (124.5 cm) | ||||
| Weight (system and accessories | ||||
| including safe working load): 151.68 | ||||
| lbs. (68.8 kg) |
2 USB 2.0 Ports
2 USB 3.0 Ports
1 USB port for optional printer | Storage bin capacity: 11 lbs
Stand depth: 25.4 in (64.5 cm)
Stand width: 23.0 in. (58.4)
Height: 45 in. (114.3 cm)
maximum, 33 in. (83.8 cm)
minimum
Weight: 17.92 lbs (8.13 kg) with
the L15-4 transducer and battery
installed
Total Stand weight with systems
and peripherals: 118 lbs (53.6 kg)
maximum
2 USB 3.0 ports
4 USB 2.0 ports | Hand held display and
control Single 12.1" Liquid
Crystal Display (LCD)
256 gray shades on LCD
Dimensions: 12.8"(W) x
12.1" (L) x 2.5"(H)
Weight: 9.0 lbs
2 USB ports | (K162045).
The variation in the
system characteristics
is due to the changes
in the form factor
between Sonosite LX
and the primary
predicate, Sonosite PX
(K213763). The
configuration of
Sonosite LX as a kiosk-
style system has 5
USB ports, while the
Sonosite PX (K213763)
has 6 USB ports. The
USB port types are all
the same as the ones |
| | | | | available on Sonosite |
| | Stand battery | Stand battery | | PX (K213763). |
| | Length: 19 in. (48.26 cm)
Width: 4 in. (10.16 cm)
Depth: 2.2 in. (5.59 cm)
Weight: 6 lbs (2.72 kg) | Length: 19 in. (48.26 cm)
Width: 4 in. (10.16 cm)
Depth: 2.2 in. (5.59 cm)
Weight: 6 lbs (2.72 kg) | System operates
via battery or AC
power | HPRF included in
Sonosite LX is a setting
for PW Doppler that
allows measurement of
higher velocities by |
| | Battery Life: 3 hours | Battery life: 1 hour imaging
- 10 days idle | Battery life: 1.5 - 4-hour
operation per charge | adding multiple sample
gates. Trapezoid
imaging feature on |
| Ratings:
Stand
Input: 100-240 VAC, 50-60 Hz, 6.0-
2.5 A | Ratings:
Portable power supply
Input: 100-240 VAC, 50-60
Hz, 3.4-1.3 A
Output: 26.7 VDC, 8.24 A,
220 W max; Class I,
continuous use. | Ratings:
100 – 240V options,
50/60 Hz, 15VDC output | Sonosite LX expands
the field of view of both
linear and curved
transducers to assist in
the measurement and
assessment of large
structures.
Cardiac triplex is an
imaging feature for
scanning in
simultaneous PW
Doppler mode, and is
equivalent to the triplex
feature on arterial and
venous exam types
already cleared on
Sonosite PX
(K213763). | |
| Stand battery
21.6 VDC, 12000mAh, 259.2Wh
Input: 26.7 VDC, 8.24 A (max 220
W)
Output: 26.7 VDC, 8.24 A (max
220 W) from power supply or 21.6
VDC, 12000 mAh, 259.2 Wh from
battery | Stand rating
Input: 100-240 VAC, 50-60
Hz, 6.0–2.5 A
Output: 100-240 VAC, 50–
60 Hz, 2.5-1.0 A
Stand battery rating | | | |
| Various obstetrical, cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages
Non-diagnostic ECG tracing
Wireless 802.11 (a/b/g/n) support for image transfer
Additional system features: Assisted Cardiac Output (ACO), Anatomical M-Mode, Trapezoid imaging, Label and Measurement in Review (LiMR), High Pulse Repetition Frequency (HPRF), Cardiac Triplex, Voice Assist. | 21.6 VDC, 12000 mAh, 259.2 Wh
Input: 26.7 VDC, 8.24 A (max 220 W)
Output: 26.7 VDC, 8.24 A (max 220 W) from power supply or 21.6 VDC, 12000 mAh, 259.2 Wh from battery | Various obstetrical, cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages
Non-diagnostic ECG tracing
Wireless 802.11 (a/b/g/n) support for image transfer
Additional system features: Assisted Cardiac Output (ACO), Anatomical M-Mode, SonoMB, Pulse Repetition Frequency (PRF), Measurement and Calculations, Triplex. | Various obstetrical, cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages
Non-diagnostic ECG tracing, CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable media
Wireless 802.11 (b/g/n) support for image transfer
Additional system features: Assisted Cardiac Output (ACO) – Available on Edge II system | Label and Measure in Review (LMiR) feature provides the user with the ability to label and make measurements and calculations on saved images. The feature is substantially equivalent to the analysis (measurement and calculations) and annotations features already cleared on Sonosite PX (K213763).
The Voice assist feature on Sonosite LX is intended for hands-free system control, which includes specific commands that allow the most common interactions. The interactions included with Voice assist are the same that can be performed by using the tactile control panel or previously cleared Sonosite PX (K213763). |
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|---|---|---|---|
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7) Determination of Substantial Equivalence:
Summary of Technological Comparison to Predicate Devices:
The Sonosite LX Ultrasound System, subject device of this submission, is enhanced implementation of previous FDA Cleared predicate devices Sonosite PX (K213763) and Sonosite Edge II Ultrasound System (K162045).
The technological characteristics are unchanged from the primary predicate Sonosite PX (K213763) and reference device. Edge II (K162045) ultrasound systems. The primary function of Sonosite LX Ultrasound System and the predicate device is diagnostic ultrasound imaging or fluid flow analysis of the human body. The Sonosite LX Ultrasound System employs the same fundamental scientific characteristics as the currently marketed predicate devices. The Sonosite LX Ultrasound device and predicates share indications for use, share modes of operation and have biosafety equivalence.
The following lists an overview of differences between the proposed subject device (Sonosite LX Ultrasound System) and its predicates.
- Addition of L13-6 transducer, which is substantially equivalent to the L19-5 transducer and HSL25x transducer, previously cleared on Sonosite PX (K213763) and Edge II (K162045), respectively.
- . Addition of P11-3 transducer, which is substantially equivalent to the P10x transducer previously cleared on Edge II (K162045).
- . Addition of a new clinical indication: Neonatal cephalic, which is the same indication cleared on P10x transducer with Edge II (K162045).
- . Addition of High Pulse Repetition Frequency (HPRF), which is based on the same PRF functionality available for PW mode on Sonosite PX (K213763).
- Addition of Trapezoidal imaging feature to assist with the measurement by using large field ● of view of both linear and curved transducers. The images captured with the trapezoid feature is the same as Sonosite PX (K213763), but it allows for an expanded image base.
- . Addition of Cardiac Triplex which is an imaging feature for scanning in simultaneous PW and Doppler mode, and is equivalent to the triplex feature on arterial and venous exam types already cleared on Sonosite PX (K213763).
- . Addition of Label and Measure in Review (LMiR) feature to provide the user with the ability to label and make measurements and calculations on saved images. The feature is substantially equivalent to the analysis (measurement and calculations) and annotations features already cleared on Sonosite PX (K213763).
- Addition of Voice Assist feature that is intended for hands-free system control and includes . specific commands that allow the most common interactions. The interactions included with Voice assist are the same that can be performed by using the tactile control panel on previously cleared Sonosite PX (K213763).
The transducer types for the subject device are all a subset of the primary predicate (Sonosite PX -K213763) and reference device (Sonosite Edge II - K162045). The transducer frequency range is unchanged and the same as the primary predicate Sonosite PX (K213763). The transducers have been tested to performance standards and the acoustic output is less than FDA established limits.
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Similar to both predicate and the reference devices. MI and TI values are always displayed, and a power management system ensures that they never exceed the derated FDA limits.
The changes implemented on the Sonosite LX leverage existing technological characteristics and features available on both the primary predicate (K213763) and the reference device (K162045). The submission device is substantially equivalent to the predicates with respect to the intended use and technological characteristics.
Summary of Non-Clinical Tests:
The Sonosite LX Ultrasound System has been evaluated for electrical, thermal, mechanical, and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated for Sonosite LX, and the device has been found to conform to applicable medical device safety standards.
Assurance of quality was established by employing the following elements of product development: Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, and Clinical Validation. All patient contact materials are biocompatible.
| Reference No. | Recognition
No. | Title |
|----------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1 | 2-258 | ISO 10993-1:2018, Biological evaluation of medical
devices -- Part 1: Evaluation and testing within a risk
management process |
| IEC 60601-1 | 19-4 | AAMI / ANSI ES60601- 1:2005/(R)2012 and A1:2012,
C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated
Text) Medical electrical equipment -- Part 1: General
requirements for basic safety and essential performance
(IEC 60601-1:2005, MOD) |
| IEC 60601-1-2 | 19-8 | ANSI AAMI IEC 60601-1-2:2014
Medical electrical equipment -- Part 1-2: General
requirements for basic safety and essential performance
-- Collateral Standard: Electromagnetic disturbances --
Requirements and tests |
| IEC 60601-1-6 | 5-89 | IEC 60601-1-6 Edition 3.1 2013-10
Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance
- Collateral standard: Usability |
| IEC 60601-2-37 | 12-293 | IEC 60601-2-37 Edition 2.1 2015
Medical electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and
monitoring equipment |
| IEC 62304 | 13-79 | ANSI AAMI IEC 62304:2006/A1:2016
Medical device software - Software life cycle processes
[Including Amendment 1 (2016) |
| ISO 14971 | 5-125 | ANSI AAMI ISO 14971:2019 Medical devices - Application of risk management to medical devices |
The Sonosite LX Ultrasound System is designed to comply with the following FDA recognized standards.
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| IEC 62359 | 12-316 | IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION - Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields |
|---|---|---|
| ----------- | -------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Summary of Clinical Tests:
The Sonosite LX Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.
Conclusion
Intended uses and other key features are consistent with traditional clinical practice and FDA quidance entitled "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", issued February 2023. The Sonosite LX Ultrasound device and predicates conform to applicable electromedical device safety standards with compliance verified through independent evaluation. The Sonosite LX Ultrasound device and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence and are manufactured using the same ISO 13485 and 21 CFR 820 quality system. FUJIFILM SonoSite, Inc. believes that the Sonosite LX Ultrasound System is substantially equivalent with regard to safety and effectiveness to the primary predicate device.