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K Number
K183575
Device Name
ACUSON S3000, S2000 Diagnostic Ultrasound System
Manufacturer
Siemens Healthineers
Date Cleared
2019-03-20

(89 days)

Product Code
IYN,ITX,IYO,OBJ
Regulation Number
892.1550
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
K181547,K103411,K172162,K131164
Predicate For
K191922
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, transesophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The AcuNav Catheter is intended for intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediative patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The Quantitative Ultrasound (OUS) software provides the ability to measure the attenuation coefficient in dB/cm-MHz at 3 MHz and the backscatter coefficient in dB/cm-str at 3 MHz in a 3-cm region of interest in the liver. Quantitative Ultrasound also includes the Ultrasonically-Derived Fat Fraction (UDFF) software which provides a 3-cm by 3-cm region of interest measurement tool to report an index that can be useful as an aid to the physician in managing adult patients with hepatic steatosis.

Device Description

The ACUSON S2000, S3000 Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

All of the transducers and the catheter based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON S-Family systems (K172162).

Only the VTQ application has been modified, all other hardware and software features of the Diagnostic Ultrasound device remain unchanged. Only the ACUSON S2000 and S3000 systems will be updated with the software update to VE11A upon customer purchase of the Quantitative Ultrasound (QUS) application, which will be license controlled. The S1000 system does not support the VTQ application, therefore, will not be configured to support the QUS application.

AI/ML Overview

The ACUSON S3000, S2000 Diagnostic Ultrasound System includes Quantitative Ultrasound (QUS) software that provides the ability to measure the attenuation coefficient (AC) and backscatter coefficient (BSC) at 3 MHz in a 3-cm region of interest in the liver. It also includes Ultrasonically-Derived Fat Fraction (UDFF) software for a 3-cm by 3-cm region of interest measurement that can aid in managing adult patients with hepatic steatosis.

Acceptance Criteria and Device Performance:

The provided document does not explicitly list numerical acceptance criteria for the QUS features (AC, BSC, UDFF) but describes their performance. The acceptance criteria for the QUS functionality appear to be demonstrated by its correlation with established methods and its intended clinical utility.

MetricAcceptance CriteriaReported Device Performance
Attenuation Coefficient (AC) Accuracy & Precision (Phantom Study)Within +/- 20% of nominal valuesWithin +/- 20% of nominal values
Backscatter Coefficient (BSC) Accuracy & Precision (Phantom Study)Within +/- 20% of nominal valuesWithin +/- 20% of nominal values
UDFF Index (Clinical Study)Correlation between acoustic property measurements and MRI-PDFF measurements and a trend of increasing UDFF with increasing steatosis grade."The UDFF index is based on a least squares fit (estimation) between the acoustic property measurements and the corresponding MRI Proton Density Fat Fraction (PDFF %) measurements. ... Patients with lower steatosis grade had lower values of UDFF and MRI-PDFF, and patients with higher steatosis grade had larger values of UDFF and MRI-PDFF."

Study Details:

  1. Sample Size and Data Provenance for Test Set:

    • Clinical Study Test Set: 101 participants.
    • Data Provenance: The document doesn't explicitly state the country of origin but refers to an "external clinical study." It is a prospective study as it involved acquiring acoustic property measurements from participants.
    • Phantom Study Test Set: Phantoms with known attenuation and backscatter coefficients. The number of phantoms or measurements is not specified.

  2. Number of Experts and Qualifications for Ground Truth:

    • The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study.
    • For the UDFF index, the ground truth reference was MRI Proton Density Fat Fraction (MRI-PDFF), an objective imaging biomarker.
    • For steatosis grading (0, 1, 2, 3), it refers to "% hepatocytes," implying histological assessment, which is typically done by pathologists. No specific number or qualifications are given.

  3. Adjudication Method for Test Set:

    • The document does not describe an adjudication method for the test set. For the UDFF index, it relies on a "least squares fit" to MRI-PDFF. For steatosis grades, it appears to rely on histological assessment without mentioning a specific adjudication process among experts.

  4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    • No MRMC comparative effectiveness study is mentioned for the QUS features (AC, BSC, UDFF). The study focuses on the standalone performance and correlation with reference methods.

  5. Standalone Performance Study:

    • Yes, a standalone study was performed. The QUS software, including AC, BSC, and UDFF measurements, was evaluated independently.
    • The phantom study assessed the accuracy and precision of AC and BSC measurements.
    • The clinical study assessed the acoustic property measurements (AC and BSC) and the derived UDFF index in relation to MRI-PDFF and histological steatosis grades.

  6. Type of Ground Truth Used:

    • Phantom Study: Known nominal values of attenuation and backscatter coefficients.
    • Clinical Study for UDFF: MRI Proton Density Fat Fraction (MRI-PDFF %) measurements were used as the reference standard to establish the UDFF index via a least squares fit.
    • Clinical Study for Steatosis Grading: Histological assessment (percentage of hepatocytes) was used to define steatosis grades (S0, S1, S2, S3), which were then correlated with UDFF and MRI-PDFF values.

  7. Sample Size for Training Set:

    • The document does not explicitly specify a separate training set size for the QUS software. The clinical study with 101 participants appears to be used for the development and evaluation of the UDFF index, which is based on a "least squares fit" to MRI-PDFF measurements. This suggests the clinical data was used to train/calibrate the UDFF algorithm.

  8. How Ground Truth for Training Set Was Established:

    • Assuming the clinical study data (101 participants) served as the primary data for establishing the UDFF index:
      • MRI-PDFF: This is an objective measurement obtained from magnetic resonance imaging.
      • Steatosis Grade: Defined by the percentage of hepatocytes, which is determined through histological examination (pathology).

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March 20, 2019

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Siemens Healthineers % Ms. Christine Dunbar Sr. Regulatory Affairs Specialist 22010 SE 51 Street ISSAQUAH WA 98029

Re: K183575

Trade/Device Name: ACUSON S3000, S2000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ Dated: February 17, 2019 Received: February 19, 2019

Dear Ms. Dunbar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination. product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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

{1}------------------------------------------------

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Michael D'Hara For

Thalia Mills, 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K183575

Device Name

ACUSON S3000, S2000 Diagnostic Ultrasound System

Indications for Use (Describe)

The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, transesophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The AcuNav Catheter is intended for intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediative patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The Quantitative Ultrasound (OUS) software provides the ability to measure the attenuation coefficient in dB/cm-MHz at 3 MHz and the backscatter coefficient in dB/cm-str at 3 MHz in a 3-cm region of interest in the liver. Quantitative Ultrasound also includes the Ultrasonically-Derived Fat Fraction (UDFF) software which provides a 3-cm by 3-cm region of interest measurement tool to report an index that can be useful as an aid to the physician in managing adult patients with hepatic steatosis.

The Transducer Indications for Use on the attached pages.

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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Page 31 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

ACUSON S3000, S2000 Diagnostic Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPPBMDCNote 2,3,4,5,7,8,10,11,13
AbdominalPPPPPPBMDCNote 2,3,4,5,6, 7,8,10,11,13,16,17,18,20,21
Intraoperative(Note 9)PPPPPPBMDCNote 2,3,4,5,7,8,10,11,14
IntraoperativeNeurologicalPPPPPPBMDCNote 2,3,4,5,7,8,10,11,14
PediatricPPPPPPBMDCNote 2,3,4,5,6,7,8,10,11
Small Organ(Note 1)PPPPPPBMDCNote 2,3,4,5,6, 7,8,10,11,14,16,18,19,20
Neonatal CephalicPPPPPPBMDCNote 2,3,4,5,7,8,10
Adult CephalicPPPPPPBMDCNote 2,3,4,5,7,8,10
CardiacPPPPPPBMDCNote 2,3,4,5,7,8,10,15
Trans-esophagealPPPPPPBMDCNote 4
TransrectalPPPPPPBMDCNote 2,3,4,5,6, 7,8,10,11,14
TransvaginalPPPPPPBMDCNote 2,3,4,5,7,8,10,11
Transurethral
Intravascular
Peripheral vesselPPPPPPBMDCNote2,3,4,5,7,8,10,11,14,15
Laparoscopic
Musculo-skeletalConventionalPPPPPPBMDCNote 2,3,4,5,7,8,10, 11,14
Musculo-skeletalSuperficialPPPPPPBMDCNote 2,3,4,5,7,8,10, 11,14
Other (specify)Neonatal cardiacPPPPPPBMDCNote 3,4,10,17

N = new indication; P = previously cleared by K172162; K130739 (VTI); K131164(VTQ); K130881 (VTIQ)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

  • Note 3 SieClear multi-view spatial compounding

  • Note 5 3-Scape real-time 3D imaging

  • Note 7 B&W SieScape panoramic imaging

  • For example: vascular, abdominal Note 9 Note 11 Advanced Sieclear spatial compounding

  • Note 14 eSie™ Touch elasticity imaging / FTI

  • Note 16 Custom Tissue Imaging

  • Note 18 VTI

  • Note 20 VTQ

  • Note 6 Cadence contrast agent imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE technology Note 13 STIC Note 15 AHP Note 17 eSie Fusion
    Ensemble tissue harmonic imaging Tissue Equalization Technology

  • Note 19 VTIQ
    Note 2

Note 4

  • Note 21 QUS (Quantitative Ultrasound)
    (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510(k)_

  • 02.17.2019

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510 (k) Number (if known):

Device Name:CW2 Probe
Intended Use:Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalP
AbdominalP
Intraoperative(Note 9)P
IntraoperativeNeurological
PediatricP
Small Organ(Note 1)P
Neonatal CephalicP
Adult CephalicP
CardiacP
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselP
Laparoscopic
Musculo-skeletalConventionalP
Musculo-skeletalSuperficialP
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

For example: vascular, abdominal Note 9

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-----------------------------------------------------------
510(k)
----------

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510 (k) Number (if known):

Device Name:CW5 Probe
Intended Use:Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalP
AbdominalP
Intraoperative(Note 9)P
IntraoperativeNeurologicalP
PediatricP
Small Organ(Note 1)P
Neonatal CephalicP
Adult CephalicP
CardiacP
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselP
Laparoscopic
Musculo-skeletalConventionalP
Musculo-skeletalSuperficialP
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 9 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Page 34 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:EC9-4 Curved Array Transducer
Intended Use:Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPBMDCNote 2,3,4,5,7,8,10,11
AbdominalPPPPPBMDCNote2,3,4,5,6,7,8,10,11,17
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)PPPPPBMDCNote 2,3,4,5,7,8,10,11,14
Neonatal CephalicPPPPPBMDCNote 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
TransrectalPPPPPBMDCNote2,3,4,5,6,7,8,10,11,14
TransvaginalPPPPPBMDCNote 2,3,4,5,7,8,10,11
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

Note 17 eSie™ Fusion

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Page 35 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:Intended Use:9L4 Linear Array TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPPBMDCNote 2,3,4,5,7,8,10,11
AbdominalPPPPPPBMDCNote 6,18,20
Intraoperative
IntraoperativeNeurological
PediatricPPPPPPBMDCNote 2,3,4,5,6, 7,8,10,11
Small Organ(Note 1)PPPPPPBMDCNote2,3,4,5,6,7,8,10,11,14,16,18,19,20
Neonatal CephalicPPPPPPBMDCNote 2,3,4,5,7,8,10,11
Adult CephalicPPPPPP
CardiacPPPPPPBMDCNote 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPBMDCNote 2,3,4,5,7,8,10,11,14,15
Laparoscopic
Musculo-skeletalConventionalPPPPPPBMDCNote 2,3,4,5,7,8,10,11,14
Musculo-skeletalSuperficialPPPPPPBMDCNote 2,3,4,5,7,8,10,11,14
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

  • SieClear multi-view spatial compounding Note 3
  • 3-Scape real-time 3D imaging Note 5

Note 7 B&W SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

Note 19 VTIQ

Note 2 Ensemble tissue harmonic imaging

Note 4

te 6 Cadence contrast agent imaging

te 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear

Note 15 AHP

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510(k)

  • Tissue Equalization Technology
    Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 18 VTI Note 20 VTQ

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510 (k) Number (if known):

Device Name: Intended Use:

14L5BV Multi-D Array Transducer for use on S2000

Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)PPPPPBMDCNote2,3,4,5,7,8,10,11,14,16
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K081148

Additional Comments:

  • Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
  • Ensemble tissue harmonic imaging Note 2
  • Note 3 SieClear multi-view spatial compounding
  • Tissue Equalization Technology Note 4
  • 3-Scape real-time 3D imaging Note 5
  • Note 6 Cadence contrast agent imaging
  • B&W SieScape panoramic imaqinq Note 7
  • Note 8 Power SieScape panoramic imaging
  • Note 10 Clarify VE vascular enhancement technology
  • Note 11 Advanced Sieclear spatial compounding
  • Note 14 eSie™ Touch elasticity imaging / FTI
  • Note 16 Custom Tissue Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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{10}------------------------------------------------

510 (k) Number (if known):

Device Name:Intended Use:4P1 Phased Array TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPPBMDCNote 2,3,4,5,7,8,10
AbdominalPPPPPPBMDCNote 2,3,4,5,7,8,10
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult CephalicPPPPPPBMDCNote 2,3,4,5,7,8,10
CardiacPPPPPPBMDCNote 2,3,4,5,7,8,10
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaqinq

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices

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Page 38 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

6C2 Curved Array Transducer

Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPBMDCNote2,3,4,5,7,8,10,11
AbdominalPPPPPBMDCNote2,3,4,5,7,8,10,11,14,16,17
Intraoperative
IntraoperativeNeurological
PediatricPPPPPBMDCNote2,3,4,5,7,8,10,11
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote2,3,4,5,7,8,10,11
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

  • Note 2 Ensemble tissue harmonic imaqinq
    Tissue Equalization Technology Note 4

B&W SieScape panoramic imaqinq Note 7

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

Note 17 eSie Fusion

Note 3 SieClear multi-view spatial compounding

3-Scape real-time 3D imaging Note 5

Power SieScape panoramic imaqinq Note 8

Note 11 Advanced Sieclear spatial compounding

Note 16 Custom Tissue Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Division Sign-Off - Office of In Vitro Diagnostic Devices

{12}------------------------------------------------

510 (k) Number (if known):

Device Name:4C1 Curved Array TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPPBMDCNote2,3,4,5,7,8,10,11,18,19,20
AbdominalPPPPPPBMDCNote2,3,4,5,6,7,8,10,11,14,16,17
Intraoperative
IntraoperativeNeurological
PediatricPPPPPPNote 6
Small OrganPPPPPPBMDC
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPBMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPBMDC
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

  • Note 2 Ensemble tissue harmonic imaqinq

  • Note 4 Tissue Equalization Technology

  • Note 6 Cadence contrast agent imaging

  • Note 8 Power SieScape panoramic imaging

  • Note 11 Advanced Sieclear spatial compounding

  • Note 16 Custom Tissue Imaging

  • Note 18 VTI

  • Note 20 VTQ

  • SieClear multi-view spatial compounding Note 3
    Note 5 3-Scape real-time 3D imaginq

  • B&W SieScape panoramic imaging Note 7

  • Note 10 Clarify VE vascular enhancement technology

  • Note 14 eSie™ Touch elasticity imaging / FTI

  • Note 17 eSie Fusion

  • Note 19 VTIQ

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)

{13}------------------------------------------------

Page 40 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:Intended Use:6C1HD Curved Array Transducer HDUltrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPPPBMDCNote2,3,4,5,7,8,10,11
AbdominalPPPPPPPBMDCNote2,3,4,5,6,7,8,10,11,14,16,17,18,19,20,21
Intraoperative
IntraoperativeNeurological
PediatricPPPPPPPBMDCNote 6
Small OrganPPPPPPPBMDC
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPPBMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPPBMDC
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

  • Note 2 Ensemble tissue harmonic imaging
  • Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

  • Note 8 Power SieScape panoramic imaging

  • Note 11 Advanced Sieclear spatial compounding

  • Note 16 Custom Tissue Imaging

  • Note 18 VTI

  • Note 20 VTQ

  • Note 3 SieClear multi-view spatial compounding
    Note 5 3-Scape real-time 3D imaging

  • Note 7 B&W SieScape panoramic imaging

  • Note 10 Clarify VE vascular enhancement technology

  • Note 14 eSie™ Touch elasticity imaging / FTI

  • Note 17 eSie Fusion

  • Note 19 VTIQ

Note 21 QUS (Quantitative Ultrasound)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510 (k) Number (if known):

Device Name:8C3HD Curved Array Transducer for use with ACUSON S3000
Intended Use:Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPBMDCNote2,3,4,5,7,8,10,11
AbdominalPPPPPBMDCNote2,3,4,5,7,8,10,11,14,16
Intraoperative
IntraoperativeNeurological
PediatricPPPPPBMDCNote2,3,4,5,7,8,10,11
Small OrganPPPPPBMDC
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote2,3,4,5,7,8,10,11
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

  • Note 2 Ensemble tissue harmonic imaging
  • SieClear multi-view spatial compounding Note 3
  • Note 4 Tissue Equalization Technology
  • Note 5 3-Scape real-time 3D imaging
  • Cadence contrast agent imaging Note 6
  • Note 7 B&W SieScape panoramic imaging
  • Note 8 Power SieScape panoramic imaging
  • Note 10 Clarify VE vascular enhancement technology
  • Note 11 Advanced Sieclear spatial compounding
  • Note 14 eSie™ Touch elasticity imaging / FTI
  • Note 16 Custom Tissue Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

{15}------------------------------------------------

510 (k) Number (if known):

Device Name:4V1 Phased Array Transducer
Intended Use:Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPBMDCNote 2,3,4,5,7,8,10
AbdominalPPPPPBMDCNote2,3,4,5,7,8,10,14,16,17,18,19,20
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

  • Note 4 Tissue Equalization Technology
    B&W SieScape panoramic imaging Note 7

  • Note 10 Clarify VE vascular enhancement technology
    Note 14 eSie™ Touch elasticity imaging / FTI

Note 17 eSie Fusion

  • Note 19 VTIQ
  • Note 3 SieClear multi view spatial compounding
    Note 5 3-Scape real-time 3D imaging

Power SieScape panoramic imaging Note 8

Note 11 Advanced Sieclear spatial compounding

  • Note 16 Custom Tissue Imaging
  • Note 18 VTI Note 20 VTQ

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Division Sign-Off - Office of In Vitro Diagnostic Devices

510(k)_

02.17.2019

{16}------------------------------------------------

510 (k) Number (if known):

Device Name:Intended Use:10V4 Phased Array TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPPPBMDCNote 2,3,4,5,7,8,10
AbdominalPPPPPPPBMDCNote 2,3,4,5,7,8,10
Intraoperative
IntraoperativeNeurological
PediatricPPPPPPPBMDCNote 2,3,4,5,7,8,10
Small Organ
Neonatal CephalicPPPPPPPBMDCNote 2,3,4,5,7,8,10
Adult Cephalic
CardiacPPPPPPPBMDCNote 3,4
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPPBMDCNote 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaqinq

Note 3 SieClear multi view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)

510(k)

{17}------------------------------------------------

510 (k) Number (if known):

Device Name:14L5 SP Linear Array Transducer
Indications For Use:Diagnostic imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 9)PPPPPBMDCNote 2,3,4,5,7,8,10
IntraoperativeNeurologicalPPPPPBMDCNote2,3,4,5,7,8,10,11
Pediatric
Small Organ(Note 1)PPPPPBMDCNote2,3,4,5,7,8,10,11,14,16
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPBMDCNote 15
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote2,3,4,5,7,8,10,11,14,15
Laparoscopic
Musculo-skeletalConventionalPPPPPBMDCNote2,3,4,5,7,8,10,11,14
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaqing

Note 8 Power SieScape panoramic imaging

For example: vascular, abdominal Note 9

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)

Note 15 AHP Note 16 Custom Tissue Imaging

Page 14 of 26

02.17.2019

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510 (k) Number (if known):

Device Name:Intended Use:7CF2 Curved array mechanical 3D transducerUltrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPPBMDCNote2,3,4,5,7,8,10,11,13
AbdominalPPPPPPBMDCNote2,3,4,5,7,8,10,11,13
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaqinq

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)

{19}------------------------------------------------

Page 46 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

9EVF4 Curved Array Transducer

Device Name: Intended Use:

Fetal

Abdominal

Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation Color Amplitude Color Combined Other Clinical Application A B PWD CWD M Velocity (Specify) Doppler Doppler (Specify) Imaging Ophthalmic Note P P P P b BMDC 2,3,4,5,7,8,10,11,13

Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal CephalicPPPPPBMDCNote2,3,4,5,7,8,10,11
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
TransvaginalPPPPPBMDCNote2,3,4,5,7,8,10,11
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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{20}------------------------------------------------

510 (k) Number (if known):

Device Name:Intended Use:V5Ms Multiplane TEE TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophagealPPPPPPPPBMDCNote 4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 4 Tissue Equalization Technology

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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{21}------------------------------------------------

510 (k) Number (if known):

Device Name:18L6 HD Linear Array Transducer
Intended Use:Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)PPPPPPBMDCNote2,3,4,5,7,8,10,11,14,16
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPBMDCNote 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPBMDCNote2,3,4,5,7,8,10,11,14,15
Laparoscopic
Musculo-skeletalConventionalPPPPPPBMDCNote2,3,4,5,7,8,10,11,14
Musculo-skeletalSuperficialPPPPPPBMDCNote2,3,4,5,7,8,10,11,14
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

  • For example: breast, testes, thyroid, penis, prostate, etc. Note 1
  • Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

  • Tissue Equalization Technology Note 4
  • Note 5 3-Scape real-time 3D imaging
  • B&W SieScape panoramic imaging Note 7
  • Note 8 Power SieScape panoramic imaging
  • Note 10 Clarify VE vascular enhancement technology
  • Note 11 Advanced Sieclear spatial compounding
  • Note 14 eSie™ Touch elasticity imaging / FTI

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510(k)

Note 15 AHP Note 16 Custom Tissue Imaging

02.17.2019

{22}------------------------------------------------

510 (k) Number (if known):

Device Name: Intended Use: 8V3 Phased Array Transducer

Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPPBMDCNote 2,3,4,5,7,8,10
Abdominal
Intraoperative
IntraoperativeNeurological
PediatricPPPPPPBMDCNote 2,3,4,5,7,8,10
Small Organ
Neonatal CephalicPPPPPPBMDCNote 2,3,4,5,7,8,10
Adult Cephalic
CardiacPPPPPPBMDCNote 3,4
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)Neonatal CardiacPPPPPPBMDCNote 3,4

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510(k)_

{23}------------------------------------------------

510 (k) Number (if known):

Device Name:Intended Use:4V1c Phased Array TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPPBMDCNote 2,3,4,5,7,8,10
AbdominalPPPPPPBMDCNote 2,3,4,5,7,8,10
IntraoperativePPPPPPBMDCNote 2,3,4,5,7,8,10
IntraoperativeNeurologicalPPPPPPBMDCNote 2,3,4,5,7,8,10
PediatricPPPPPPBMDCNote 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic
Adult CephalicPPPPPPBMDCNote 2,3,4,5,7,8,10
CardiacPPPPPPBMDCNote2,3,4,5,7,8,10,15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPBMDCNote 2 3 4 5 7 8 10 15
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)Neonatal CardiacPPPPPPBMDCNote 2,3,4,5,7,8,10

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 15 AHP

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510(k)_

{24}------------------------------------------------

510 (k) Number (if known):

Device Name:Intended Use:EV8C4 TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPPPBMDCNote 2,3,4,5,7,8,10
AbdominalPPPPPPPBMDCNote2,3,4,5,6,7,8,10
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
TransvaginalPPPPPPPBMDCNote 2,3,4,5,7,8,10
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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{25}------------------------------------------------

Page 52 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: V7M TEE Transducer Ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application CWD Combined B M PWD Color Power Color Harmonic Other Doppler (Amplitude) Velocity (Specify) * Imaging A (Specify) Doppler Imaging Ophthalmic Fetal P P P P P P P Note 4 Abdominal P Intraoperative Intraoperative Neurological Pediatric P P P P P P P P Note 4 Small Organ (specify)* Neonatal Cephalic Adult Cephalic Cardiac P P P P P P P P Note 4 Trans-esophageal P P P P P P P b Note 4 Transrectal Transvaginal Transurethral Intravascular Peripheral Vessel Laparoscopic Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,

B+M+POWER DOPPLER, B+PWD+POWER DOPPLER, B+CWD+POWER DOPPLER, B+CLARIFY VE

  • Note 2 Ensemble tissue harmonic imaging
  • Note 4 Tissue Equalization Technology

Note 10 Clarify VE vascular enhancement technology

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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{26}------------------------------------------------

510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 8F Ultrasound Catheter

›uCatheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerPower(Amplitude)DopplerColorVelocityImagingCombined(Specify) *Other:HarmonicImaging
Ophtalmic
Fetal
Abdominal
Intraoperative
Intraoperative(Neurological)
PediatricPPPPPPP
Small Organ(Specify)**
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPP
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-LuminalPPPPPPP
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)PPPPPPP

P=Previously cleared by the FDA K172162

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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{27}------------------------------------------------

510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 10F Ultrasound Catheter ›uCatheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerPower(Amplitude)DopplerColorVelocityImagingCombined(Specify) *Other:HarmonicImaging
Ophtalmic
Fetal
Abdominal
Intraoperative
Intraoperative(Neurological)
PediatricPPPPPPP
Small Organ(Specify)**
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPP
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-LuminalPPPPPPP
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)PPPPPPP

P=Previously cleared by the FDA K172162

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510(k)_

{28}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known): Device Name: Intended Use:

MC9-4 Transducer

Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
FetalPPPPPBMDCNote 2,3,4,5,7,8,10,11
AbdominalPPPPPBMDCNote 2,3,4,5,7,8,10,11
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ (note1)PPPPPBMDCNote2,3,4,5,7,8,10,11,14
Neonatal CephalicPPPPPBMDCNote 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
TransrectalPPPPPBMDCNote2,3,4,5,7,8,10,11,14
TransvaginalPPPPPBMDCNote 2,3,4,5,7,8,10,11
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc.

Note 3 SieClear multi-view spatial compounding

Siescape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Note 10 Clarify VE Vascular enhancement technology

Note 14 eSie Touch elasticity imaging/FTI

  • Note 2 Ensemble tissue harmonic imaging
    Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear spatial compounding

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices

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Page 56 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known): Device Name: Intended Use:

14L5 Transducer

Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ (note1)PPPPPPBMDCNote2,3,4,5,7,8,10,11,14,16
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPBMDCNote2,3,4,5,6,7,8,10,11,14
Laparoscopic
Musculo-skeletalConventionalPPPPPPBMDCNote2,3,4,5,7,8,10,11,14
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc.

Note 3 SieClear multi-view spatial compounding

Note 5 Siescape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 10 Clarify VE Vascular enhancement technology

Note 14 eSie Touch elasticity imaging/FTI

  • Note 2 For example: vascular, abdominal
    Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear spatial compounding

Note 16 Custom Tissue Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices

510(k)_

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510(k) SummaryPrepared December 16, 2018Updated February 17, 2019K183575
Sponsor:Siemens Medical Solutions USA, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043
Contact Person:Christine DunbarTel: (925) 374-2045
Device Name:ACUSON S3000TM, S2000TM Diagnostic Ultrasound System
Common Name:Diagnostic Ultrasound System with Accessories
Classification:Regulatory Class:Review Category:Classification Panel:IITier II90, Radiology
Ultrasonic Pulsed Doppler Imaging System892.155090-IYN
Ultrasonic Pulsed Echo Imaging System892.156090-IYC
Diagnostic Ultrasound Transducer892.157090-ITX
Diagnostic Intravascular Catheter892.120090-OB

Legally Marketed Predicate Devices 3.

The modified ACUSON S3000, S2000 Diagnostic Ultrasound Systems are substantially equivalent to the company's own ACUSON S3000, S2000 and S1000 system cleared under K172162, which is the primary predicate device.

The second predicate is the Siemens Virtual Touch Quantification (VTQ) feature, as currently cleared under K131164. The VTQ software under modification includes the new Quantitative Ultrasound (OUS) feature.

The Echosens Fibroscan system with Controlled Attenuation Parameter (CAP) for measurements of the ultrasound coefficient of attenuation serves as a reference predicate system, specifically for QUS measurements of the Attenuation Coefficient (AC).

The second reference predicate is the GE IDEAL Software for magnetic resonance imaging proton density fat fraction (MRI-PDFF). The Ultrasonically-derived Fat Fraction (UDFF)

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index provides a clinical utility similar to that of MRI-PDFF as an aid for managing patients with hepatic steatosis.

Device Description 4.

The ACUSON S2000, S3000 Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

All of the transducers and the catheter based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON S-Family systems (K172162).

5. Intended Use

The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The AcuNav Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The Quantitative Ultrasound (QUS) software provides the ability to measure the attenuation coefficient in dB/cm-MHz at 3 MHz and the backscatter coefficient in dB/cm-str at 3 MHz in a 3-cm by 3-cm region of interest in the liver. Quantitative Ultrasound also includes the Ultrasonically-Derived Fat Fraction (UDFF) software which provides a 3-cm by 3-cm region

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of interest measurement tool to report an index that can be useful as an aid to the physician in managing adult patients with hepatic steatosis.

6. Summary of Technological Characteristics

The ACUSON S2000 and S3000 Diagnostic Ultrasound Systems with software version VE11A are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to the company's own products, the ACUSON S1000, 2000 and S3000 VE10A (K172162) and the ACUSON S2000 and S3000 (K131164 with VTQ feature) with regard to both intended use and technological characteristics.

The subject ultrasound systems and the currently cleared primary predicate ultrasound systems function in the same manner and with the same list of transducers including cardiac catheters.

Only the VTQ application has been modified, all other hardware and software features of the Diagnostic Ultrasound device remain unchanged. Only the ACUSON S2000 and S3000 systems will be updated with the software update to VE11A upon customer purchase of the Quantitative Ultrasound (QUS) application, which will be license controlled. The S1000 system does not support the VTQ application, therefore, will not be configured to support the QUS application.

The ACUSON S2000 and S3000 with software version VE11A are substantially equivalent to the predicate devices with regard to both intended use, indications for use and technological characteristics. The table below compares the technological characteristics between the submission device and the predicated devices.

Feature / CharacteristicSubmissionDevicePrimaryPredicateK172162SecondaryPredicateK131164(VTQ)ReferencePredicateFibroscanK181547ReferencePredicateGE MRIDEALK103411
Indications for Use
■ Fetal✓✓✓--
■ Abdominal✓✓✓✓-
■ Intraoperative abdominaland vascular✓✓✓--
■ Intraoperative neurological-----
■ Pediatric✓✓✓--
■ Small Organ✓✓✓--
■ Neonatal cephalic✓✓✓--
■ Adult Cephalic✓✓✓--
■ Cardiac✓✓✓--
Feature / CharacteristicSubmissionDevicePrimaryPredicateK172162SecondaryPredicateK131164(VTQ)ReferencePredicateFibroscanK181547ReferencePredicateGE MRIDEALK103411
■ Trans-esophageal✓✓✓--
■ Transrectal✓✓✓--
■ Transvaginal✓✓✓--
■ Peripheral vessel✓✓✓--
■ Laparoscopic------
■ Musculo-skeletal(conventional)✓✓✓--
■ Musculo-skeletal(superficial)✓✓✓--
Center Frequencies Supported
■ 2.0 MHz✓✓✓--
■ 2.5 MHz-----
■ 3.0 MHz✓✓✓--
■ 3.2 MHz✓✓✓--
■ 3.3 MHz✓✓✓--
■ 3.5 MHz---✓-
■ 4.2 MHz✓✓✓--
■ 4.4 MHz✓✓✓--
■ 4.8 MHz✓✓✓--
■ 5.0 MHz✓✓✓--
■ 5.2 MHz✓✓✓--
■ 6.0 MHz✓✓✓--
■ 6.5 MHz✓✓✓--
■ 6.9 MHz✓✓✓--
■ 9.5 MHz✓✓✓--
■ 10.0 MHz✓✓✓--
Modes
■ B✓✓✓--
■ Parallel processing in Bmode✓✓✓--
■ M✓✓✓--
Feature / CharacteristicSubmissionDevicePrimaryPredicateK172162SecondaryPredicateK131164(VTQ)ReferencePredicateFibroscanK181547ReferencePredicateGE MRIDEALK103411
■ PWD (Pulsed WaveDoppler)✓✓✓--
■ CWD (Continuous WaveDoppler)✓✓✓--
■ D (Color Doppler)✓✓✓--
■ Amplitude Doppler✓✓✓✓-
■ Combined (BMDC)✓✓✓--
Features
Quad processing in color✓✓✓--
■ Native™ tissue harmonicimaging✓✓✓--
■ SieScape™ panoramicimaging✓✓✓--
■ Color SieScape™panoramic imaging✓✓✓--
■ 3-Scape™ real-time 3Dimaging✓✓✓--
■ fourSight™ 4D transducertechnology✓✓✓--
■ TEQ™ ultrasoundtechnology✓✓✓--
■ Cardiac Imagingphysiological signal display✓✓✓--
■ syngo ® Auto OBmeasurements✓✓✓--
■ Advanced SieClear™spatial compounding✓✓✓--
■ STIC (Fetal Heart Imaging)✓✓✓--
■ Amnioscopic rendering✓✓✓--
■ Cadence contrast agentimaging✓✓✓--
■ Contrast Dynamics✓✓✓--
■ Clarify™ vascularenhancement technology✓✓✓--
■ eSie™ Touch elasticityimaging✓✓✓--
Feature / CharacteristicSubmission DevicePrimary Predicate K172162Secondary Predicate K131164 (VTQ)Reference Predicate Fibroscan K181547Reference Predicate GE MR IDEAL K103411
syngo ® Auto Left heartTested to ISO 10993-1Tested to ISO 10993-1✓--
syngo ® Velocity Vector Imaging✓✓✓--
Semi Auto-segmentation (eSie Calc)✓✓✓--
Custom Tissue Imaging / Speed of Sound✓✓✓--
Virtual Touch Imaging (VTI) (S2000, S3000)✓✓---
Virtual Touch Quantification (VTQ) (S2000, S3000)✓✓✓Shear wave Speed-
Virtual Touch Imaging Quantification (VTIQ) (S2000, S3000)✓✓---
Quantitative Ultrasound (QUS)New--✓-
ACAC at 3.0 MHz--CAP at 3.5 MHz-
BSCBSC at 3.0 MHz----
UDFF IndexIndex based on acoustic physical tissue properties---MRI Proton Density Fat Fraction (MRI-PDFF)
AHP✓✓✓--
Monitor: 19" FPD✓✓✓--
eSie Fusion✓✓---
Output Display Standard (Track 3)✓✓✓✓-
Patient Contact MaterialsTested to ISO 10993-1Tested to ISO 10993-1Tested to ISO 10993-1--
UL 60601-1 Certified✓✓✓--

Table 1: Comparison of Technological Characteristics

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7. A brief discussion of nonclinical tests submitted. referenced, or relied on in the 510(k) for a determination of substantial equivalence.

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety and have been found to conform to applicable medical device safety standards.

Cleared patient contact materials, electrical and mechanical safety are unchanged. Testing was performed to verify the software release.

The ACUSON S2000 and S3000 Ultrasound systems comply with the following standards:

  • UL 60601-1:2006, Medical electrical equipment, Part 1: General requirements for safety .
  • IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements For Basic ● Safety And Essential Performance (IEC 60601-1:2005, (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012)
  • IEC 60601-1-2: 2007(Third Edition), Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
  • IEC 60601-2-37:2007+A1:2015, Medical electrical equipment Part 2-37: Particular ● requirements for the basic safety and essential performance of ultrasound medical diagnostic and monitoring equipment. IEC 60601-2-18 Medical electrical equipment - part 2-18: particular requirements for basic safety and essential performance of endoscopic equipment.
  • AIUM/NEMA UD-3:2004. Standard for Real Time Display of Thermal and Mechanical ● Acoustic Output Indices on Diagnostic Ultrasound Equipment.
  • AIUM/NEMA UD-2:2004. Acoustic Output Measurement Standard for Diagnostic ● Ultrasound Equipment.
  • ISO 10993-1:2009, Biological evaluation of Medical Devices ●
  • IEC 62366:2014, Medical Devices Application of Usability ●
  • IEC 62359:2010, Ultrasonics Field characterization Test Methods for the ● determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields.

8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.

Phantom Study: The accuracy and precision of the device was obtained based on tests performed on phantoms with known attenuation and backscatter coefficients. The overall range of values of AC and BSC are within +/-20% of the nominal values of the phantoms.

Clinical Study: Acoustic property measurements including the AC and BSC were obtained from the liver of one hundred and one (101) participants in an external clinical study. The UDFF index is based on a least squares fit (estimation) between the acoustic property measurements and the corresponding MRI Proton Density Fat Fraction (PDFF %) measurements.

Table 2 summarizes baseline demographic information from the clinical study including sex, age, BMI, race, and ethnicity. There were no adverse effects or complications in the

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acquisition of the ultrasound clinical data. The QUS software has identical safety considerations as compared to conventional ultrasound B-mode imaging.

CharacteristicValue
Sex
Male39 of 101 (39)
Female62 of 101 (61)
Age
mean ± SD$52.02\pm13.5$
Range19-74
BMI
mean ± SD$30.6\pm5.1$
Range17.6-43.3
Racial Category
White50 of 101 (49)
Black2 of 101 (2.0)
Asian12 of 101 (12)
American Indian1 of 101 (1.0)
Hawaiian or Pacific Islander1 of 101 (1.0)
Unknown35 of 101 (35)
Ethnic Category
Hispanic/Latino39 of 101 (39)
Non-Hispanic60 of 101 (59)
Other2 of 101 (2)
Steatosis Grade
0; <5% hepatocytes6 of 90 (7)
1: 5%-33% hepatocytes39 of 90 (43)
2; 33%-66% hepatocytes33 of 90 (36)
3; >66% hepatocytes12 of 90 (13)
MRI-PDFF (%)
mean ± SD$13.8\pm8.9$
Range0.6-40.6

Table 2:Participant Characteristics

Note: Numbers in parentheses are percentages.

The results of the clinical study indicate that BMI does not have a statistically significant effect on measurements of the AC and BSC. Patients with lower steatosis grade had lower values of UDFF and MRI-PDFF, and patients with higher steatosis grade had larger values of UDFF and MRI-PDFF.

The trends for patients with less than 5% MRI-PDFF scores (steatosis grade S0) and with more than 30% MRI-PDFF scores (steatosis grade S3) were not clear given the small number of samples in these ranges.

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Reference Studies: In addition to the phantom and external clinical studies, peer-reviewed journal articles in studies utilizing Siemens ACUSON S3000 Diagnostic Ultrasound Systems were used to support the claim for the safety and effectiveness of quantitative ultrasound for assessing hepatic steatosis. The references below offer further reading on the performance of quantitative ultrasound.

9. Summary

Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms to 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance.

The S2000 and S3000 Diagnostic ultrasound systems have accumulated a long history of safe and effective performance. The software modification of the S2000 / S3000 Diagnostic Ultrasound VTQ feature raises no new issues of safety and effectiveness.

Therefore, it is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON S2000 and S3000 systems including the new Quantitative Ultrasound (QUS) feature is substantially equivalent with respect to safety and effectiveness to the currently cleared predicate devices for the U.S. market.

10. References

  • [1] S. C. Lin, E. Heba, T. Wolfson, B. Ang, A. Gamst, A. Han, J. W. Erdman, W. D. O' Brien, M. P. Andre, C. B. Sirlin and others, "Noninvasive diagnosis of nonalcoholic fatty liver disease and quantification of liver fat using a new quantitative ultrasound technique," Clinical Gastroenterology and Hepatology, vol. 13, pp. 1337-1345, 2015.
  • [2] J. S. Paige, G. S. Bernstein, E. Heba. E. A. C. Costa, M. Fereirra. T. Wolfson, A. C. Gamst, M. A. Valasek, G. Y. Lin, A. Han and others, "A Pilot Comparative Study of Quantitative Ultrasound, Conventional Ultrasound, and MRI for Predicting Histology-Determined Steatosis Grade in Adult Nonalcoholic Fatty Liver Disease," American Journal of Roentgenology, vol. 208, pp. W168--W177, 2017.
  • [3] A. Han, M. P. Andre, J. W. Erdman, R. Loomba, C. B. Sirlin and W. D. O'Brien, "Repeatability and Reproducibility of a Clinically Based QUS Phantom Study and Methodologies," IEEE transactions on ultrasonics, ferroelectrics, and frequency control, vol. 64, pp. 218-231, 2017.
  • [4] A. Han, Y. Labyed, M. P. Andre, J. W. Erdman, R. Loomba, C. B. Sirlin and W. D. O'Brien, "Inter-sonographer Reproducibility of Quantitative Ultrasound Outcomes and Shear Wave Speed Measured in the Right Lobe of the Liver in Adults with Known or Suspected Nonalcoholic Fatty Liver Disease," Accepted for publication in European Radiology, 2018.

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§ 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.