(26 days)
The Sonosite PX Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Abdominal, Adult cephalic, Cardiac Adult, Cardiac Pediatric, Fetal - OB/GYN, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, Small Organ (breast, thyroid, testicles, prostate), Transvaginal, Transesophageal (cardiac), Transrectal, Needle Guidance. Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler Mode (B), M-Mode (M) (Including simultaneo (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (including Velocity Color Dopler), Tissue Harmonic Imaging (THI), Tissue Dopler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD. 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 PX 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 (including Simultaneous M-Mode and anatomical M-Mode), Pulsed Wave (PW) Doppler (including Pulsed Wave Tissue Doppler), Continuous Wave (CW) Doppler, Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging or in a combination of these modes. including Triplex imaging. The system includes a variety of accessories including optional needle guide starter kits. 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 does not contain information about acceptance criteria for a medical device or a study proving its performance against these criteria. Instead, it is a 510(k) summary for the FUJIFILM Sonosite PX Ultrasound System, establishing its substantial equivalence to previously cleared predicate devices.
The document focuses on:
- Indications for Use: Listing the clinical applications and exam types for which the ultrasound system is intended.
- Technological Characteristics: Comparing the subject device (Sonosite PX Ultrasound System) with its predicate devices (Sonosite PX Ultrasound System K200964 and SonoSite Edge II Ultrasound System K162045) in terms of features like intended use, indications for use (subsets of predicates), transducer types and frequencies, acoustic output, modes of operation, DICOM support, and safety certifications.
- Non-Clinical Tests: Stating that the device underwent evaluations for electrical, thermal, mechanical, and EMC safety, as well as cleaning/disinfection, biocompatibility, and acoustic output, conforming to applicable medical device safety standards. It also mentions compliance with specific ISO and IEC standards.
- Clinical Tests: Explicitly stating that clinical studies were not required to support the determination of substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving performance against them, as it is not present in the given text.
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December 27, 2021
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 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. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k SAINT PAUL MN 55114
Re: K213763
Trade/Device Name: Sonosite PX Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OIJ Dated: November 30, 2021 Received: December 1, 2021
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 (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
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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 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 (OS) 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 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,
For
Jessica Lamb, Ph.D. Assistant 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
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Indications for Use
510(k) Number (if known) K213763
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 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 |
| Transesophageal (cardiac) |
| Transrectal |
| Needle Guidance |
Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler
Mode (B), M-Mode (M) (Including simultaneo (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (including Velocity Color Dopler), Tissue Harmonic Imaging (THI), Tissue Dopler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD
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.
| 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)
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510(K) Summary
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 SEBothell, WA 98021-3904 |
|---|---|
| Corresponding Official: | Anoush Frankian |
| Sr. Manager, Regulatory Affairs | |
| E-mail: | anoush.frankian@fujifilm.com |
| Telephone: | (425) 951-6824 |
| Facsimile: | (425) 951-1201 |
| Date prepared: | October 18, 2021 |
| Regulatory Lead &Alternate Contact: | Medha Sateesh Bharadwaj |
| E-mail: | medha.bharadwaj@fujifilm.com |
| Telephone: | (631) 532-7229 |
| Facsimile: | (425) 951-1201 |
| 2) Device | |
| Trade Name: | Sonosite PX 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: | 21 CFR 892.155021 CFR 892.156021 CFR 892.1570 |
| Primary Product Code: | IYN |
| Secondary Product Codes: | IYOITXOIJ |
| Device Class: | Class II |
| Classification Panel: | Radiology |
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3) Predicate Device:
Primary Predicate: Sonosite PX Ultrasound System (K200964)
Reference Device: SonoSite Edge II Ultrasound System (K162045)
4) Device Description:
The Sonosite PX 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 (including Simultaneous M-Mode and anatomical M-Mode), Pulsed Wave (PW) Doppler (including Pulsed Wave Tissue Doppler), Continuous Wave (CW) Doppler, Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging or in a combination of these modes. including Triplex imaging.
The system includes a variety of accessories including optional needle guide starter kits. 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.
5) 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 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 Transesophageal (cardiac) Transrectal Needle Guidance
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Modes of operation include: B Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (CWD), Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD
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.
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6) Technological Characteristics:
The Sonosite PX Ultrasound System, subject device of this submission, is equivalent to the previously cleared Sonosite PX (K20096) and Edge II (K162045) Ultrasound Systems in terms of both the intended use and technological characteristics. The Sonosite PX (subject device) uses the same fundamental scientific technology as the predicate device.
| Feature | Sonosite PX UltrasoundSystem | Sonosite PX UltrasoundSystem | SonoSite Edge II UltrasoundSystem | Evaluation ofDifferences |
|---|---|---|---|---|
| (This submission) | (K200964) | (K162045) | ||
| Intended Use | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Diagnostic ultrasoundimaging or fluid flow analysisof the human body | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | The intended use ofthe Sonosite PX isidentical to thepredicate andreference devices. |
| Indications forUse | AbdominalAdult CephalicCardiac AdultCardiacPediatricFetal - OB/GYNMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)OphthalmicPediatricSmall Organ (breast, thyroid,testicle, prostate)TransvaginalPeripheral VesselTrans-RectalTrans-esophageal (cardiac)Needle guidance | AbdominalAdult CephalicCardiac AdultCardiacPediatricFetal - OB/GYNMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)OphthalmicPediatricSmall Organ (breast, thyroid,testicle, prostate)Peripheral VesselTransvaginalNeedle guidance | AbdominalAdultCephalicCardiac AdultCardiac PediatricFetal - OB/GYNMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)OphthalmicPediatricSmall Organ (breast, thyroid,testicle, prostate)TransvaginalPeripheral VesselNeedle guidanceNeonatalCephalicTrans-RectalTrans-esophageal (cardiac)Needle guidance | The Indications forUse are a subset ofSonosite PXUltrasound system(primary predicate-K200964) andSonosite Edge IIUltrasound system(reference device-K162045). |
| TransducerTypes | Linear ArrayCurved LinearArray Phased ArrayIntracavitaryTrans-esophageal | Linear ArrayCurved LinearArray Phased ArrayIntracavitary | Linear ArrayCurved Linear ArrayPhased ArrayIntracavitaryTrans-esophageal | Transducer types forSonosite PX are all asubset of SonositePX Ultrasoundsystem (primarypredicate) andSonosite Edge IIUltrasound system(referencedevice). |
| TransducerFrequency | 1.0-19.0 MHz | 1.0-19.0 MHz | 1.0 - 15.0 MHz | The frequency rangefor Sonosite PX isunchanged and thesame as the primarypredicate Sonosite PX(K200964) |
| Global | Ispta.3: 607 mW/cm^2 | Ispta.3: 607 mW/cm^2 | Ispta.3: 598.9 | Acoustic output is |
| MaximumOutputs/WorstCase Setting | (L12-3)TI Type: TIB (P5-1)TI Value: 4.87 (P5-1)MI: 1.72 (L12-3)Ipa.3@MI Max: 793mW/cm^2 (L15-4) | (L12-3)TI Type: TIB (P5-1)TI Value: 4.87 (P5-1) MI: 1.72 (L12-3)Ipa.3@MI Max: 793 mW/cm^2(L15-4) | (HFL50x)TI Type: TIB(rP19x)TI Value: 4.98(rP19x) MI: 1.7(rP19x)Ipa.3@MI Max: 776 (L38xi) | less than FDAestablished limits. |
| AcousticOutput Display& FDA Limits | Display Feature for HigherOutputs MI Output DisplayTI Output Display | Display Feature for HigherOutputs MI Output DisplayTI Output Display | Display Feature for HigherOutputs MI Output DisplayTI Output Display | MI & TI are alwaysdisplayed and a powermanagement systemensures that theynever exceed thederated FDA limits. |
| Modes ofOperation | ||||
| B-mode GrayscaleImaging | B-mode Grayscale Imaging | B-mode Grayscale Imaging | Modes of operationare a subset ofSonosite PXUltrasound system(primary predicate)and Sonosite Edge IIUltrasound system(reference device).The AMM imagingframe and transmitsequence is identicalto regularsimultaneous 2D/M-mode as seen onpredicate deviceSonosite PX(K200964). The onlydifference is the AMMline is extracted fromthe 2D image databased on the AMMline position the userspecified and thedisplay in the sweepfield of view. | |
| Tissue Harmonic Imaging | Tissue Harmonic Imaging | Tissue Harmonic Imaging | ||
| M-modeSimultaneous M- ModeAMM | M-modeSimultaneous M- Mode | M-mode Color M-Mode | ||
| Color Power DopplerZoom | Color Power Doppler Zoom | Color Power Doppler Zoom | ||
| Combination ModesPulsed Wave (PW)Doppler | Combination Modes PulsedWave (PW) Doppler | Combination ModesPulsed Wave (PW) Doppler | ||
| Continuous Wave (CW)Doppler | Continuous Wave (CW)Doppler | Continuous Wave (CW)Doppler | ||
| Speckle reduction algorithm(formerly branded asSonoHD2 Noise Reduction) | Speckle reduction algorithm(formerly branded asSonoHD2 Noise Reduction) | SonoHD2 Noise Reduction | ||
| SonoMB/MBe ImageCompounding | SonoMB/MBe ImageCompounding | SonoMB/MBe ImageCompounding | ||
| CW DopplerVelocity Color Doppler TissueDoppler Imaging (TDI) | CW DopplerVelocity Color DopplerTissue Doppler Imaging(TDI) | Steered CW Doppler VelocityColor DopplerTissue Doppler Imaging (TDI) | ||
| DICOM | DICOM 3.0Store and Offline Media | DICOM 3.0 Store, Print,Modality Worklist, PerformProcedure Step(PPS),Storage Commitment | DICOM 3.0 Store, Print,Modality Worklist, PerformProcedureStep (PPS),Storage Commitment | Includes a subsetof thisinformation |
| #TransmitChannels | 128 digital channels | 128 digital channels | 128 digital channels | - |
| #ReceiveChannels | 128 digital channels | 64 digital channels(128 digital channelsusingSyntheticAperture) | 64 digital channels(128 digital channels usingSynthetic Aperture) | - |
| PatientContactMaterials | Transducers:Silicone RubberPolysulfonePoly Vinyl Chloride(PVC)Silicone RTV AdhesiveSiliconePolymethyl-pentene EpoxyPaste AdhesivePolyurethaneFKM rubberThermoplasticpolyurethaneNeedle Guides: Acetalcopolymer Acrylonitrile-butadien-styrene (ABS) | Transducers:SiliconeRubberPolysulfone UDELP1700Poly Vinyl Chloride(PVC)Silicone RTVAdhesive SiliconeNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene(ABS) | Transducers:Acrylonitrile-butadien- styrene(ABS) Cycoloy Epoxy pasteadhesive Polyethylene (PE)lonomer Polyetheretherketone(PEEK)PolycarbonatePolysulfoneUDELPolyurethanePoly Vinyl Chloride (PVC)Silicone RTV AdhesiveSilicone Rubber UrethaneNeedle Guides:Acetal copolymer Acrylonitrile-butadien-styrene(ABS) | All patient contactmaterials have beentestedto ISO 10993-1.Materials used inSonositePX haveundergone identicalbiocompatibility andcleaning/disinfectiontesting to thepredicate devices.Bio-compatibilitysummary test resultsare provided inD00414, Bio-compatibility TestReport, included inAttachment 6 ofthissubmission. |
| ProductSafetyCertification | AAMI/ANSI ES60601-1:2005 (R2012)IEC 60601-2-37:2007+AMD 1:2015CAN/CSA-C22.2 No.60601-1:14 JSA JIS T0601-1:2017,JSA JIS T 0601-2-37 IEC61157:2007+AMD1:2013 | AAMI/ANSI ES60601-1:2005(R2012IEC 60601-2-37:2007+AMD 1:2015CAN/CSA-C22.2 No. 60601-1:14JSAJIS T 0601-1:2017,JSA JIS T 0601-2-37IEC 61157:2007+AMD1:2013 | AAMI/ANSI ES60601-1:2005 (R2012)IEC 60601-2-37:2007CAN/CSA C22.2 No. 60601-1:08NEMA UD2-2004 IEC62359:2010 | |
| IEC 62359:2010+AMD1:2017 | NEMA UD 2-2004 (R2009)IEC 62359:2010+AMD1:2017 | |||
| EMCCompliance | IEC 60601-1-2:2014CISPR 11:2015+AMD1:2016+AMD2:2019 IEC61000-4-2.IEC 61000-4-3IEC 61000-4-4.IEC 61000-4-5IEC 61000-4-6.IEC 61000-4-8IEC 61000-4-11 | IEC 60601-1-2:2014CISPR 11:2015+AMD1:2016+AMD2IEC 61000-4-2.IEC 61000-4-3IEC 61000-4-4.IEC 61000-4-5IEC 61000-4-6.IEC 61000-4-8IEC 61000-4-11 | AAMI / ANSI / IEC 60601-1-2:2007(R)2012 CISPR 11,Group 1,Class A | |
| DICOM | DICOM PS3.15 2011 | NEMA PS3.15 2003 | NEMA PS3.15 2003 | |
| AirborneEquipmentStandards | none applied | none applied | RTCA/DO160 (section 21) | Airborneequipmentstandards havenot been appliedto the SonositePXultrasoundsystem andlabeling will not claimto this. |
| System | Sonosite PX: | Sonosite PX: | Edge II: | Sonosite PX 2.0 |
| Characteristics | Beamformer 128/128 usingSA (configurable)12.1" Capacitive touchscreen interface19" LED LCD HD monitor256 gray shades on LED LCD | Beamformer 128/128 usingSA (configurable)12.1" Capacitive touchscreen interface19" LED LCD HD monitor256 gray shades on LED LCD | Beamformer 128/128using SA (configurable)Hand held display and controlSingle 12.1" Liquid CrystalDisplay (LCD)256 gray shades on LCD2 | includes a non-diagnostic ECGmodule.Likereference deviceEdge II ultrasoundsystem (K162045),this moduleprovides ECGtracing of the |
| 2 USB 3.04 USB 2.0 | 2 USB 3.04 USB 2.0 | USB ports | cardiac signalsynchronized withthe ultrasound | |
| Stand Base Dimensions:26.4" L x 21.2" WStand Height (max): 64"(monitor up)Stand Height (min): 42.2"(monitor down)Weight: 149.35 lbs (fullyconfigured w/ 3 transducersand stand baseWeight: 32.80 lbs(w/ 1 transducer) | Stand Base Dimensions:26.4" L x 21.2" WStand Height (max): 64"(monitor up)Stand Height (min): 42.2"(monitor down)Weight: 149.35 lbs (fullyconfigured w/ 3 transducersand stand baseWeight: 32.80 lbs (w/1transducer) | Dimensions: 12.8"(W) x12.1" (L) x 2.5"(H)Weight: 9.0 lbs | image. | |
| System operates via batteryor AC power | System operates via batteryor AC power | System operates viabattery or AC power | ||
| Battery life: 1 hour imaging- 10 days idle | Battery life: 1 hour imaging -10 days idle | Battery life: 1.5 - 4 houroperation per charge | ||
| Input: 100 - 240 VAC, 50/60HzOutput 1: 26.7VDC output,220 W maxSystem on stand: | Input: 100 - 240 VAC, 50/60HzOutput 1: 26.7VDC output, 220W maxSystem on stand: | 100 - 240V options, 50/60Hz,15VDC output | ||
| Input: 100 - 240 VAC, 50/60HzOutput 1: 26.7VDC output,220 W maxOutput 2: 100-240VAC, 50-60Hz(AC Printer) | Input: 100 - 240 VAC, 50/60HzOutput 1: 26.7VDC output, 220W maxOutput 2: 100-240VAC, 50-60Hz(AC Printer) | |||
| Various obstetrical, cardiac,volume, M-mode,PW andCW Doppler measurementand calculation packages | Various obstetrical,cardiac, volume, M-mode,PW and CW Dopplermeasurement andcalculation packages | Various obstetrical, cardiac,volume, M- mode, PW and CWDoppler measurement andcalculation packages | ||
| Non-diagnostic ECG tracing | Non-diagnostic ECG tracing,CW/PW Doppler Audio SpectralDoppler Audioand image storage onremovable media | |||
| Wireless 802.11 (a/b/g/n) | Wireless 802.11(a/b/g/n) support forimage transfer | Wireless 802.11 (b/g/n) supportfor image transfer | ||
| Additional system features:Assisted CardiacOutput (ACO) -Available on Sonosite PXsystem | Additional system features:Assisted Cardiac Output (ACO)- Available onSonosite PX system | Additional system features:Assisted Cardiac Output (ACO) –Available on Edge II system | ||
| 510(k) Track | Track 3 | Track 3 | Track 3 |
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7) Determination of Substantial Equivalence:
Summary of Technological Comparison to Predicate Devices:
The Sonosite PX Ultrasound System, subject device of this submission, is enhanced implementation of previous FDA Cleared predicate devices Sonosite PX (K200964) and Sonosite Edge II Ultrasound System (K162045). The technological characteristics and physical design are unchanged from the primary predicate Sonosite PX (K200964) and reference device Edge II (K162045) ultrasound systems. The primary function of Sonosite PX Ultrasound System and the predicate devices is diagnostic ultrasound imaging or fluid flow analysis of the human body. The Sonosite PX Ultrasound System employs the same fundamental scientific characteristics as the currently marketed predicate devices. The Sonosite PX 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 PX Ultrasound System) and its predicates.
- Addition of T8-3 transducer, which is substantially equivalent to the TEExi transducer . previously cleared on Edge II (K153626).
- Addition of C10-3 transducer, which is substantially equivalent to the C5-1 and C35x . transducers previously cleared on Sonosite PX (K200964) and Edge II (K162045) respectively.
- . Addition of two new clinical indications: trans-esophaqeal and trans-rectal, which are the same indications cleared on Edge II (K162045).
- Addition of non-diagnostic ECG module which provides ECG tracing of the cardiac signal synchronized with the ultrasound image, similar to the module cleared on Edge II (K162045).
- Addition of compatible OEM Needle Guide for use with C10-3 transducer. The needle ● guidance has been cleared (K093713).
- Addition of PIV exam type (preset) to work with L12-3 transducer. The PIV exam type ● (preset) is already available on predicated device Sonosite PX (K200964) transducer L19-5.
- Addition of Anatomical M-Mode available on P5-1 and T8-3 probes in cardiac exams. ● Anatomical M-Mode (AMM) is a display option in simultaneous 2D-Mode, which is available in Sonosite PX (K200964). The AMM uses 2D data instead of M-mode data.
- . Addition of Cleaning Mode for device, which locks the user interface touch screen so that user can wipe the screen without accidentally touching or moving controls.
- Addition of carotid exam and measurements. The carotid exam type and measurements have the same imaging optimization as the arterial exam type on predicate Sonosite PX (K200964). The carotid exam type provides carotid blood flow calculations using either the right or left side. This is similar to what is seen in arterial exam for the reference device (K162045). However the subject device provides the user with the ability to evaluate fluid responsiveness for calculating stenosis in the carotid specifically.
- Addition of Qview. The Qview feature provides a communication pathway with QPathE. To ● access the reporting capability of QPathE, the user can access the product through the Sonosite PX system by opening the Qview feature. Both Qview and QPathE are products of Telexy Healthcare.
- . Addition of Customized Exam Setting. This allows for the customer to use the exams
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provided to them on the Sonosite PX and customize the settings to have their most preferred or used exams placed in an order based on the use of the system and exam presets. This does not change the function of the device or exam types. Rather allows for preferences for exams to be customized through this settings tool.
The transducer types for the subject device are all a subset of the primary predicate (Sonosite PX -K200964) and reference device (Sonosite Edge II - K162045). The transducer frequency range is unchanged and the same as the primary predicate Sonosite PX (K200964). The transducers have been tested to performance standards and the acoustic output is less than FDA established limits. Similar to the predicates, 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 PX leverage existing technological characteristics and features available on both the primary predicate (K200964) and 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 PX Ultrasound System has been evaluated for electrical, thermal, mechanical, and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, 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, Clinical Validation. All patient contact materials are biocompatible.
The Sonosite PX Ultrasound System is designed to comply with the following FDA recognized standards.
| 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 |
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| 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 | 5-40 | ANSI AAMI ISO 14971:2007/(R) 2010 - Medical devices- Application of risk management to medical devices |
| IEC 62359 | 12-316 | IEC 62359:2010+AMD1:2017Ultrasonics - Field characterization - Test methods forthe determination of thermal and mechanical indicesrelated to medical diagnostic ultrasonic fields. |
Summary of Clinical Tests:
The Sonosite PX Ultrasound System and transducers, subject of this submission, did not reguire clinical studies to support the determination of substantial equivalence.
Conclusion
The Sonosite PX Ultrasound System meets FDA requirements for Track 3 devices, shares indications for use with the primary predicate and reference device. With successful verification and validation testing and conformance to applicable electromedical device safety standards as well as compliance verified through independent evaluation as part of the nonclinical testing summarized above, FUJIFILM Sonosite considers the proposed Sonosite PX Ultrasound System to be as safe, as effective and performance that is substantially equivalent to the primary predicate.
§ 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.