(19 days)
The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or thuid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel
The SonoSite SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.
This document is a 510(k) premarket notification for the SonoSite SII Ultrasound System. It aims to demonstrate substantial equivalence to previously cleared predicate devices, not to present a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity for a particular medical condition.
Therefore, many of the requested elements for describing acceptance criteria and a study proving their fulfillment are not applicable or cannot be extracted from this type of regulatory submission. The document focuses on demonstrating safety and technological equivalence, not clinical performance for a diagnostic task.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense. This document does not present clinical performance acceptance criteria (e.g., specific sensitivity or specificity thresholds) because it is a 510(k) submission for an ultrasound system, not a device interpreting ultrasound images to make a diagnosis. The "performance" discussed relates to technical specifications and compliance with safety standards rather than diagnostic accuracy.
- The closest "acceptance criteria" are compliance with various safety and performance standards (e.g., ISO, IEC, NEMA) and demonstrating similar technological characteristics and intended uses to predicate devices. The "reported device performance" is the conclusion that the device conforms to these standards and is technologically equivalent.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document explicitly states: "The SonoSite SII Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." Therefore, there is no clinical test set, sample size, or data provenance from such a study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As no clinical studies were performed, there was no test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical 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
- Not Applicable. This device is an ultrasound system itself, not an AI or CAD (Computer-Aided Detection/Diagnosis) software designed to assist human readers. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is an ultrasound imaging device, not an algorithm for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No clinical ground truth was established as no clinical studies were conducted to assess diagnostic accuracy. The "ground truth" for this submission concerns compliance with engineering standards and performance specifications, demonstrated through non-clinical testing.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that would require a training set for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. No training set for an algorithm.
Summary from the document regarding acceptance criteria and study:
The acceptance criteria for the SonoSite SII Ultrasound System, as described in this 510(k) submission, are primarily focused on safety, technological equivalence to predicate devices, and compliance with recognized industry standards.
The "study" or justification for meeting these criteria involved:
- Non-Clinical Tests: Evaluation of electrical, thermal, mechanical, and EMC safety. Cleaning/disinfection, biocompatibility, and acoustic output were also evaluated.
- Compliance with Standards: The device was designed to comply with a list of FDA-recognized standards, including:
- ISO 10993-1 (Biological evaluation of medical devices)
- IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
- IEC 60601-1-2 (Electromagnetic compatibility)
- IEC 60601-1-6 (Usability)
- IEC 60601-2-37 (Particular requirements for ultrasonic medical diagnostic and monitoring equipment)
- IEC 62304 (Medical device software - Software life cycle processes)
- IEC 62359 (Ultrasonics - Field characterization - Test methods)
- ISO 14971 (Application of risk management to medical devices)
- NEMA UD 2-2004 (Acoustic Output Measurement Standard)
- Quality Assurance Processes: Assurance of quality was established through Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation.
- Substantial Equivalence Argument: The document argues that the SII system shares the same intended uses and fundamental scientific technology as the predicate devices (SonoSite Edge II and SonoSite S Series Ultrasound Systems), with a detailed comparison table showing technological characteristics.
The report explicitly states, "The SonoSite SII Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means that the regulatory pathway for this device did not necessitate clinical performance data demonstrating diagnostic accuracy against a ground truth.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, stacked on top of each other, with a flowing design below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2016
FUJIFILM SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K160734
Trade/Device Name: SonoSite SII Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 16, 2016 Received: March 17, 2016
Dear Mr. Job:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) TBD K160734
Device Name SonoSite SII Ultrasound System
Indications for Use (Describe)
The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or thuid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
| Research Use Only (R&D) 21 CFR 201.122 | Some Therapeutic Use (21 CFR Part 312) |
|---|---|
| --------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------- |
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's name, address, telephone number, contact person:
FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904
| Corresponding Official: | Patricia Liau |
|---|---|
| Manager, Regulatory Affairs | |
| E-mail: | Patricia.Liau@sonosite.com |
| Telephone: | (425) 951-6870 |
| Facsimile: | (425) 951-1201 |
| Date prepared: | March 2, 2016 |
2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/ Usual Name
Diagnostic Ultrasound System with Accessories Proprietary Name
SonoSite SII Ultrasound System (subject to change)
Classification Names
| Name | FR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
3) Identification of the predicate or legally marketed device:
| SonoSite Edge II Ultrasound System | K153626 |
|---|---|
| SonoSite S Series (Maxx Series) Ultrasound System | K130173 |
4) Device Description:
The SonoSite SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.
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5) Intended Use:
The FUJIFILM SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
- Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel
6) Technological Characteristics:
SonoSite Edge II and S Series Ultrasound Systems are both Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.
| Feature | SonoSite SII UltrasoundSystem(This submission) | SonoSite Edge IIUltrasound System(K153626) | SonoSite S SeriesUltrasound System(K130173) |
|---|---|---|---|
| Intended Use | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody |
| Indications forUse | OpthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast, thyroid,testicle, prostate)Neonatal CephalicAdult CephalicTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricPeripheral VesselNeedle guidance | OpthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast, thyroid,testicle, prostate)Neonatal CephalicAdult CephalicTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral VesselNeedle guidance | OpthalmicFetal - OB/GYNAbdominalIntra-operative (Abdominal organsand vascular)Intra-operative (Neuro.)LaparoscopicPediatricSmall Organ (breast, thyroid,testicle, prostate)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral VesselNeedle guidance |
| TransducerTypes | Linear ArrayCurved Linear ArrayIntracavitaryPhased Array | Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayTrans-esophageal | Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayStatic ProbesTrans-esophageal |
| TransducerFrequency | 1.0 — 15.0 MHz | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz |
| Feature | SonoSite SII UltrasoundSystem(This submission) | SonoSite Edge IIUltrasound System(K153626) | SonoSite S SeriesUltrasound System(K130173) |
| Modes ofOperation | B-mode Grayscale ImagingTissue Harmonic Imaging | B-mode Grayscale ImagingTissue Harmonic Imaging | B-mode Grayscale Imaging3D/4D Grayscale ImagingTissue Harmonic Imaging |
| M-modeColor M-ModeColor Power DopplerZoomCombination Modes | M-modeColor M-ModeColor Power DopplerZoomCombination ModesPulsed Wave (PW) DopplerContinuous Wave (CW) Doppler | M-modeAnatomical M-ModeColor M-ModeColor Power DopplerZoomCombination ModesPulsed Wave (PW) DopplerContinuous Wave (CW) Doppler | |
| SonoHD2 Noise ReductionSonoMB/MBe ImageCompoundingVelocity Color Doppler | SonoHD2 Noise ReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging (TDI) | SonoRes/SonoHD NoiseReductionSonoMB Image CompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging (TDI) | |
| PW Doppler | Not available | Available | Available |
| CW Doppler | Not available | Available | Available |
| PatientContact | Transducers: | Transducers: | Transducers:Acrylonitrile-butadien-styrene(ABS) |
| Materials | Cycoloy | CycoloyEpoxy paste adhesivePolyethylene (PE) IonomerPolyetheretherketone (PEEK) | CycoloyDow Medical Adhesive, Type AEpoxy paste adhesivePolyethylene (PE) IonomerPolyetheretherketone (PEEK) |
| PolycarbonatePolysulfone UDEL P1700Poly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene | PolycarbonatePolysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene | PolycarbonatePolysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene | |
| SystemCharacteristics | (ABS)SII:Beamformer 128/128 using SA(configurable)Hand held display and controlSingle 12.1" Liquid Crystal Display(LCD)256 gray shades on LCD | (ABS)Edge II:Beamformer 128/128 using SA(configurable)Hand held display and controlSingle 12.1" Liquid Crystal Display(LCD)256 gray shades on LCD | (ABS)S Series:Beamformer 128/128 using SA(configurable)Hand held display and controlSingle 10.4" Liquid Crystal Display(LCD)256 gray shades on LCD |
| 3 USB ports | 2 USB ports | 3 USB ports | |
| Dimension: 11.5"(W) x 17.6" (L) x4.8"(H) | Dimensions: 12.8"(W) x 12.1" (L) x2.5"(H) | Dimensions: 11.6"(W) x 15.1" (L) x6.1"(H) | |
| Weight: 12.6 lbs | Weight: 9.0 lbs | Weight: 8.5 lbs | |
| System operates via battery or ACpower100 - 240V options, 50/60 Hz,15VDC output | System operates via battery or ACpower100 - 240V options, 50/60 Hz,15VDC output | System operates via battery or ACpower100 - 240V options, 50/60 Hz,15VDC output | |
| Various obstetrical, cardiac,volume, and M-modemeasurement and calculation | Various obstetrical, cardiac,volume, M-mode, PW and CWDoppler measurement and | Various obstetrical, cardiac,volume, and M-modemeasurement and calculation | |
| Feature | SonoSite SII UltrasoundSystem(This submission) | SonoSite Edge IIUltrasound System(K153626) | SonoSite S SeriesUltrasound System(K130173) |
| packages | calculation packagesECG acquisition and displaycapabilitiesCW/PW Doppler AudioSpectral Doppler Audio and imagestorage on removable media | packages | |
| Wireless 802.11 support for imagetransfer | Wireless 802.11 support for imagetransfer | Wireless 802.11 support for imagetransfer | |
| 510(k) Track | Track 3 | Track 3 | Track 3 |
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7) Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The SonoSite SII 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 mandatory medical device safety standards. Assurance of quality was established by employing the following elements of product development but were not limited to: Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation.
The SonoSite SII Ultrasound System is designed to comply with the following FDA recognized standards.
| Reference No. | Title |
|---|---|
| ISO 10993-1 | AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process |
| IEC 60601-1 | AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance (IEC 60601-1:2005, MOD) |
| IEC 60601-1-2 | AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance - Collateralstandard: Electromagnetic compatibility - Requirements and tests (Edition 3) |
| IEC 60601-1-6 | IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance - Collateral standard:Usability |
| IEC 60601-2-37 | IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment – Part 2-37:Particular requirements for the basic safety and essential performance of ultrasonicmedical diagnostic and monitoring equipment |
| IEC 62304 | AAMI / ANSI / IEC 62304:2006, Medical device software - Software life cycleprocesses |
| IEC 62359 | IEC 62359 Edition 2.0 2010-10-10, Ultrasonics - Field characterization - Testmethods for the determination of thermal and mechanical indices related to medicaldiagnostic ultrasonic fields [Including: Technical corrigendum 1 (2011)] |
| ISO 14971 | ISO 14971:2007, Medical devices - Application of risk management to medicaldevices |
| NEMA UD 2-2004 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment |
Summary of Clinical Tests:
The SonoSite SII Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.
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8) Conclusion:
Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The SonoSite SII system and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and conform to applicable electromedical device safety standards. FUJIFILM SonoSite, Inc. believes that the SonoSite SII Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate devices.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.