(28 days)
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.
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.
The provided text is a 510(k) summary for the FUJIFILM SonoSite LX Ultrasound System. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it explicitly states that no clinical studies were required to support the determination of substantial equivalence for this device. Therefore, the device's acceptance criteria and studies proving it meets those criteria based on clinical performance metrics (like sensitivity, specificity, or reader improvement) are not detailed in this document.
The "acceptance criteria" discussed in the document are primarily related to technical and safety standards compliance rather than clinical performance based on a study.
Here's a breakdown of the requested information based on the provided text, with an emphasis on what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
As no clinical study was conducted for performance claims, there is no direct table of acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) and corresponding reported device performance from such a study.
The provided document focuses on compliance with recognized medical device safety and performance standards. The "acceptance criteria" in this context are adherence to these standards, and the "reported device performance" is a statement of compliance.
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| ISO 10993-1:2018 (Biological evaluation of medical devices) | All patient contact materials are biocompatible. Materials used have undergone identical biocompatibility testing to predicate devices. |
| IEC 60601-1 (General requirements for basic safety and essential performance) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| IEC 60601-1-2 (Electromagnetic disturbances) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| IEC 60601-1-6 (Usability) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| IEC 60601-2-37 (Basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| IEC 62304 (Medical device software - Software life cycle processes) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| ISO 14971 (Application of risk management to medical devices) | Assured quality by employing Design Phase Reviews, Risk Assessment. |
| IEC 62359 (Test methods for determining thermal and mechanical indices for diagnostic ultrasonic fields) | Acoustic output is less than FDA established limits. MI & TI values are always displayed, and a power management system ensures they never exceed derated FDA limits. |
| FDA Guidance: "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" | Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. |
| ISO 13485 and 21 CFR 820 (Quality system) | Device is manufactured using the same ISO 13485 and 21 CFR 820 quality system as predicates. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not available as no clinical studies were performed. The non-clinical tests involved evaluations against engineering standards and internal verification processes, not a dataset of patient cases.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not available as no clinical studies were performed requiring expert ground truth establishment for a test set.
4. Adjudication Method for the Test Set
This information is not available as no clinical studies were performed requiring an adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The document explicitly states: "The Sonosite LX Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This device is a general-purpose ultrasound system, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is an ultrasound system, not a standalone algorithm, and no clinical studies were conducted for substantial equivalence.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not available as no clinical studies were performed requiring a type of ground truth. For the non-clinical tests, the "ground truth" was adherence to established engineering and safety standards.
8. The Sample Size for the Training Set
This information is not available as no clinical studies were performed. The device is an ultrasound system with software, but the document does not indicate it uses machine learning/AI models that would require a dedicated "training set" in the diagnostic performance sense. The software development follows IEC 62304 standards, which involve verification and validation but not necessarily clinical "training sets."
9. How the Ground Truth for the Training Set Was Established
This information is not available as no training set (in the context of clinical performance for an algorithm) was discussed or used in the provided documentation for establishing substantial equivalence.
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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).
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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
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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.
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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, Inc21919 30th Drive SEBothell, WA 98021-3904 |
|---|---|
| Corresponding Official: | Anoush FrankianDirector, Regulatory Affairs |
| Email:Telephone:FacsimileDate prepared: | anoush.frankian@fujifilm.com(425) 951-6824(425) 951-1201October 04, 2023 |
| Regulatory Leads &Alternate Contacts:Emails: | Akanksha Kulshreshtha and Anjana Varierakanksha.kulshreshtha@fujifilm.comand 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 withAccessories |
| Regulation Name: | Ultrasonic Pulsed Doppler Imaging SystemUltrasonic Pulsed Echo Imaging SystemDiagnostic Ultrasound Transducer |
| Regulation Number: | 892.1550892.1560892.1570 |
Page 1 of 15
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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.
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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.
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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 UltrasoundSystem(K233597) | Sonosite PX UltrasoundSystem(K213763) | Sonosite Edge IIUltrasound System(K162045) | Evaluation ofDifferences |
|---|---|---|---|---|
| Intended Use | Diagnostic ultrasound imaging or fluidflow analysis of the human body | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Diagnostic ultrasoundimaging or fluid flowanalysis of the human body | The intended use of theSonosite LX is identicalto the predicate andreference devices. |
| Indications forUse | AbdominalAdult CephalicNeonatal CephalicCardiac AdultCardiac PediatricFetal – OB/GYNMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)OphthalmicPediatricPeripheral vesselSmall Organ (breast, thyroid, testicle,prostate)TransrectalTransvaginalTrans-esophageal (cardiac)Needle Guidance | AbdominalAdult CephalicCardiac AdultCardiac PediatricFetal – OB/GYNMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)OphthalmicPediatricPeripheral VesselSmall Organ (breast, thyroid,testicle, prostate)TransrectalTransvaginalTrans-esophageal (cardiac)Needle guidance | AbdominalAdult CephalicNeonatal CephalicCardiac AdultCardiac PediatricFetal – OB/GYNMusculo-skeletal(Conventional) Musculo-skeletal (Superficial)OphthalmicPediatricSmall Organ (breast,thyroid, testicle, prostate)TransvaginalPeripheral VesselNeedle guidanceTrans-RectalTrans-esophageal (cardiac)Needle guidance | The Indications forUse are a subset ofSonosite PXUltrasound system(primary predicate-K213763) andSonosite Edge IIUltrasound system(reference device-K162045). |
| TransducerTypes | Linear ArrayCurved Linear ArrayPhased Array | Linear ArrayCurved Linear ArrayPhased Array | Linear ArrayCurved Linear ArrayPhased Array | Transducer types forSonosite LX are all asubset of SonositePX Ultrasound |
| IntracavitaryTrans-esophageal | IntracavitaryTrans-esophageal | ArrayIntracavitaryTrans-esophageal | system (primary predicate) andSonosite Edge II Ultrasound system(reference device) | |
| TransducerFrequency | 1.0-19.0 MHz | 1.0-19.0 MHz | 1.0 – 15.0 MHz | The frequency rangefor Sonosite LX isunchanged and thesame as the primarypredicate Sonosite PX(K213763) |
| Global MaximumOutputs/WorstCase Setting | 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: 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 lessthan FDA establishedlimits. |
| Acoustic OutputDisplay & FDALimits | Display Feature for Higher Outputs MIOutput Display TI Output Display | Display Feature for Higher OutputsMI Output Display TI OutputDisplay | Display Feature for HigherOutputs MI Output DisplayTI Output Display | MI & TI are alwaysdisplayed and a powermanagement systemensures that they neverexceed the deratedFDA limits. |
| Modes ofOperation | B-mode Grayscale ImagingTissue Harmonic ImagingM-modeSimultaneous M-ModeAnatomical M-ModeColor Doppler (C)Color Power Doppler (CPD)ZoomColor Velocity Doppler (CVD)Color Variance (Var) | B-mode Grayscale ImagingTissue Harmonic ImagingM-modeSimultaneous M-ModeAnatomical M-ModeColor Doppler (C)Color Power Doppler (CPD)ZoomColor Velocity Doppler (CVD)Color Variance (Var) | B-mode GrayscaleImaging Tissue HarmonicImaging M-modeColor M-Mode | Modes of operation area subset of SonositePX Ultrasound system(primary predicate) andSonosite Edge IIUltrasound system(reference device). |
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| 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 3.0Store, Modality Worklist, ModalityPerform Procedure Step (MPPS),Storage Commitment, Structuredreports, offline media | DICOM 3.0Store, Modality Worklist, ModalityPerform Procedure Step (MPPS),Storage Commitment, Structuredreports, offline media | DICOM 3.0Store, Print, ModalityWorklist, Modality PerformProcedure Step (MPPS),Storage Commitment,offline media | Includes a subset of thisinformation |
|---|---|---|---|---|
| #TransmitChannels | 128 digital channels | 128 digital channels | 128 digital channels | - |
| #ReceiveChannels | 128 digital channels | 128 digital channels | 64 digital channels(128 digital channels usingSynthetic Aperture) | - |
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| Patient ContactMaterials | Transducers:Silicone RubberPolysulfonePolyVinylChloride (PVC)Silicone RTV AdhesiveSiliconePolymethyl-penteneEpoxy Paste AdhesivePolyurethaneFKM rubberThermoplasticpolyurethaneNeedle Guides: Acetal copolymerAcrylonitrile-butadien- styrene (ABS) | Transducers:Silicone RubberPolysulfonePolyVinylChloride (PVC)Silicone RTV Adhesive SiliconePolymethyl-penteneEpoxy Paste AdhesivePolyurethaneFKM rubberThermoplastic polyurethaneNeedle Guides: Acetal copolymerAcrylonitrile-butadien- styrene(ABS) | Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyEpoxy paste adhesivePolyethylene (PE)IonomerPolyetheretherketone(PEEK)PolycarbonatePolysulfoneUDELPolyurethanePolyVinylChloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien- styrene(ABS) | All patient contactmaterials have beentested to ISO 10993-1.Materials used inSonosite LX haveundergone identicalbiocompatibility andcleaning/disinfectiontesting to thepredicate devices. |
|---|---|---|---|---|
| Product SafetyCertification | AAMI/ANSI ES60601- 1:2005 (R2012)IEC 60601-2- 37:2007+AMD1:2015CAN/CSA-C22.2 No. 60601-1:14JSA JIS T0601-1:2017,JSA JIS T 0601-2-37IEC 61157:2007+AMD1:2013IEC 62359:2010+AMD1:2017 | AAMI/ANSI ES60601- 1:2005(R2012)IEC 60601-2-37:2007+AMD1:2015CAN/CSA-C22.2 No. 60601-1:14JSA JIS T0601-1:2017,JSA JIS T 0601-2-37 | AAMI/ANSI ES60601-1:2005 (R2012)IEC 60601-2-37: 2007CAN/CSA C22.2 No.60601-1:08NEMA UD2-2004 IEC62359:2010 | |
| EMCCompliance | IEC 60601-1-2:2014 (Edition 4.0)IEC 60601-1-2:2014+A1:2020 (Edition4.1)CISPR 11:2015+AMD1:2016+A2:2019IEC 61000-3-2:2018IEC 61000-3-3:2013+A1:2017IEC 61000-4-2:2008IEC 61000-4-3:2020IEC 61000-4-4::2012IEC 61000-4-5:2014+A1:2017IEC 61000-4-6:2013IEC 61000-4-11:2020+AC:2020+AC:2022IEC 61000-4-8:2009IEC 61000-4-39:2017 | IEC 60601-1-2:2014 (Edition 4.0)CISPR 11:2015+AMD1:2016IEC 61000-3-2:2018IEC 61000-3-3:2013+A1:2017IEC 61000-4-2:2008IEC 61000-4-3:2010IEC 61000-4-4::2012IEC 61000-4-5:2014+A1:2017IEC 61000-4-6:2013IEC 61000-4-11:2004+A1:2017IEC 61000-4-8:2009 | AAMI / ANSI / IEC60601- 1-2:2007(R)2012 CISPR 11,Group 1, Class A | The changes in thestandards did not affectthe EMC testingperformed for thesubject device,Sonosite LX and theprimary predicate,Sonosite PX(K213763). |
| DICOM | DICOM PS3.15 | DICOM PS3.15 | DICOM PS3.15 | |
| AirborneEquipmentStandards | None applied | None applied | RTCA/DO160(section 21) | Airborne equipmentstandards have notbeen applied to theSonosite LXUltrasound System. |
IEC 61157:2007+AMD1:2013 IEC 62359:2010+AMD1:2017
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| SystemCharacteristics | Sonosite LX: | Sonosite PX: | Edge II: | The features |
|---|---|---|---|---|
| Beamformer 128/128 | Beamformer 128/128 | Beamformer128/128 using SA(configurable) | introduced areequivalent to SonositePX Ultrasound system | |
| 21.3" Projected Capacitive (PCAP)touch screen interface | 15.6" capacitive screeninterface | (K213763) andSonosite Edge IIUltrasound 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 68in. (172.7 cm); min with monitor down49 in. (124.5 cm)Weight (system and accessoriesincluding safe working load): 151.68lbs. (68.8 kg)2 USB 2.0 Ports2 USB 3.0 Ports1 USB port for optional printer | Storage bin capacity: 11 lbsStand 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)minimumWeight: 17.92 lbs (8.13 kg) withthe L15-4 transducer and batteryinstalledTotal Stand weight with systemsand peripherals: 118 lbs (53.6 kg)maximum2 USB 3.0 ports4 USB 2.0 ports | Hand held display andcontrol Single 12.1" LiquidCrystal Display (LCD)256 gray shades on LCDDimensions: 12.8"(W) x12.1" (L) x 2.5"(H)Weight: 9.0 lbs2 USB ports | (K162045).The variation in thesystem characteristicsis due to the changesin the form factorbetween Sonosite LXand the primarypredicate, Sonosite PX(K213763). Theconfiguration ofSonosite LX as a kiosk-style system has 5USB ports, while theSonosite PX (K213763)has 6 USB ports. TheUSB port types are allthe 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 operatesvia battery or ACpower | HPRF included inSonosite LX is a settingfor PW Doppler thatallows measurement ofhigher velocities by | |
| Battery Life: 3 hours | Battery life: 1 hour imaging- 10 days idle | Battery life: 1.5 - 4-houroperation per charge | adding multiple samplegates. Trapezoidimaging feature on | |
| Ratings:StandInput: 100-240 VAC, 50-60 Hz, 6.0-2.5 A | Ratings:Portable power supplyInput: 100-240 VAC, 50-60Hz, 3.4-1.3 AOutput: 26.7 VDC, 8.24 A,220 W max; Class I,continuous use. | Ratings:100 – 240V options,50/60 Hz, 15VDC output | Sonosite LX expandsthe field of view of bothlinear and curvedtransducers to assist inthe measurement andassessment of largestructures.Cardiac triplex is animaging feature forscanning insimultaneous PWDoppler mode, and isequivalent to the triplexfeature on arterial andvenous exam typesalready cleared onSonosite PX(K213763). | |
| Stand battery21.6 VDC, 12000mAh, 259.2WhInput: 26.7 VDC, 8.24 A (max 220W)Output: 26.7 VDC, 8.24 A (max220 W) from power supply or 21.6VDC, 12000 mAh, 259.2 Wh frombattery | Stand ratingInput: 100-240 VAC, 50-60Hz, 6.0–2.5 AOutput: 100-240 VAC, 50–60 Hz, 2.5-1.0 AStand battery rating | |||
| Various obstetrical, cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packagesNon-diagnostic ECG tracingWireless 802.11 (a/b/g/n) support for image transferAdditional 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 WhInput: 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 packagesNon-diagnostic ECG tracingWireless 802.11 (a/b/g/n) support for image transferAdditional 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 packagesNon-diagnostic ECG tracing, CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable mediaWireless 802.11 (b/g/n) support for image transferAdditional 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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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. | RecognitionNo. | Title |
|---|---|---|
| ISO 10993-1 | 2-258 | ISO 10993-1:2018, Biological evaluation of medicaldevices -- Part 1: Evaluation and testing within a riskmanagement 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 (ConsolidatedText) Medical electrical equipment -- Part 1: Generalrequirements for basic safety and essential performance(IEC 60601-1:2005, MOD) |
| IEC 60601-1-2 | 19-8 | ANSI AAMI IEC 60601-1-2:2014Medical electrical equipment -- Part 1-2: Generalrequirements 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 2013-10Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance- Collateral standard: Usability |
| IEC 60601-2-37 | 12-293 | IEC 60601-2-37 Edition 2.1 2015Medical electrical equipment - Part 2-37: Particularrequirements for the basic safety and essentialperformance of ultrasonic medical diagnostic andmonitoring equipment |
| IEC 62304 | 13-79 | ANSI AAMI IEC 62304:2006/A1:2016Medical 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 |
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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.
§ 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.