ACUSON S2000 AND S3000

K130881 · Siemens Medical Solutions USA, Inc. · IYN · Oct 11, 2013 · Radiology

Device Facts

• Record ID: K130881
• Device Name: ACUSON S2000 AND S3000
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Oct 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 Acuson Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

Device Story

The S2000 and S3000 are mobile, software-controlled diagnostic ultrasound systems. They acquire harmonic ultrasound echo data to display B-Mode, Pulsed/Continuous Wave Doppler, Color Doppler, Amplitude Doppler, and 3D/4D imaging. The systems include the Virtual Touch IQ (VTIQ) feature, which performs shear wave elasticity imaging to provide localized quantitative shear wave velocity measurements of tissue. The device is operated by clinicians in clinical settings. The system processes ultrasound signals to generate images and measurements, including anatomical calculations and the Arterial Health Package (AHP) for intima-media thickness. These outputs assist physicians in clinical diagnosis and patient communication. VTIQ uses focused push beams and detection beams to estimate tissue stiffness, providing quality, time, and displacement maps to aid interpretation. The system is substantially equivalent to previous Siemens S2000/S3000 models and the Supersonic Imagine Aixplorer.

Clinical Evidence

No clinical data required. Substantial equivalence is based on technological characteristics and bench testing, including acoustic output, biocompatibility, and electrical/mechanical safety standards.

Technological Characteristics

Mobile diagnostic ultrasound system; supports multiple modes (B, M, PWD, CWD, Color/Amplitude Doppler, 3D/4D). Materials tested to ISO 10993-1. Connectivity includes flat panel display and physiological signal display. Software-controlled with various imaging technologies (e.g., SieClear, TEQ, VTIQ). Sterilization/disinfection per manufacturer guidelines. Safety compliance: UL 60601-1, IEC 60601-2-37, AIUM/NEMA UD-2/UD-3.

Indications for Use

Indicated for fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications in adult and pediatric patients.

Regulatory Classification

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.

Predicate Devices

• Acuson S2000 (K111674)
• Acuson S3000 (K121138)
• Supersonic Imagine Shearwave Elastography (K111674, K121138, K112255, K121329)

Submission Summary (Full Text)

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K130881
Page 1 of 8

\$2000 and S3000 Virtual Touch IC 510(k) Submission

#### 510(k) Summarv Prepared March 26, 2013 1. Sponsor: Siemens Medical Solutions, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043 Contact Person: Shelly Pearce Telephone: [phone] [phone] Fax: Acuson S2000 and S3000 Diagnostic Ultrasound Systems 2. Device Name: Common Name: Diagnostic Ultrasound System Classification: OCT 1 1 2013 Regulatory Class: = Review Category: Tier II Classification Panel: Radiology Ultrasonic Pulsed Doppler Imaging System FR # 892.1550 Product Code 90-IYN Ultrasonic Pulsed Echo Imaging System FR # 892.1560 Product Code 90-IYO

#### 3. Legally Marketed Predicate Devices

Diagnostic Ultrasound Transducer Diagnostic Ultrasound Catheter

The Acuson S2000 and S3000 Ultrasound Systems are substantially equivalent to the company's own S2000 and S3000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K111674, K121138, K112255, K121329)

FR # 892.1570

FR # 870.1200

#### 4. Device Description:

The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. It is substantially equivalent to the S2000 (K111674) and S3000 system (K121138) which are legally marketed devices.

#### 5. Intended Use

The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

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Product Code 90-ITX

Product Code OBJ

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The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 Acuson Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

| Feature / Characteristic | Submission Device S2000 | Submission Device S3000 | Acuson S3000 K121138 | Acuson S2000 K111674 | Supersonic Imagine K112255 / K121329 |
|----------------------------------------------|-------------------------------|-------------------------------|----------------------------|----------------------------|-----------------------------------------------|
| <b>Indications for Use:</b> | | | | | |
| Fetal | √ | √ | √ | √ | |
| Abdominal | √ | √ | √ | √ | √ |
| Intraoperative abdominal and vascular | √ | √ | √ | √ | |
| Intraoperative neurological | -- | -- | -- | -- | -- |
| Pediatric | √ | √ | √ | √ | √ |
| Small Organ | √ | √ | √ | √ | √ |
| Neonatal cephalic | √ | √ | √ | √ | |
| Adult Cephalic | √ | √ | √ | √ | |
| Cardiac | √ | √ | √ | √ | |
| Trans-esophageal | √ | √ | √ | √ | |
| Transrectal | √ | √ | √ | √ | √ |
| Transvaginal | √ | √ | √ | √ | √ |
| Peripheral vessel | √ | √ | √ | √ | √ |
| Laparoscopic | -- | -- | -- | -- | -- |
| Musculo-skeletal (conventional) | √ | √ | √ | √ | √ |
| Musculo-skeletal (superficial) | √ | √ | √ | √ | √ |
| <b>Center Frequencies Supported:</b> | | | | | |
| 2.0 MHz | √ | √ | √ | √ | √ |
| 3.0 MHz | √ | √ | √ | √ | √ |
| 3.2 MHz | √ | √ | √ | √ | √ |
| Feature / Characteristic | Submission Device S2000 | Submission Device S3000 | Acuson S3000 K121138 | Acuson S2000 K111674 | Supersonic Imagine K112255/ K121329 |
| 3.3 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 B mode | √ | √ | √ | √ | √ |
| M | √ | √ | √ | √ | |
| PWD (Pulsed Wave Doppler) | √ | √ | √ | √ | √ |
| CWD (Continuous Wave Doppler) | √ | √ | √ | √ | √ |
| D (Color Doppler) | √ | √ | √ | √ | √ |
| Amplitude Doppler | √ | √ | √ | √ | √ |
| Combined (BMDC) | √ | √ | √ | √ | √ |
| Features: | | | | | |
| Quad processing in color | √ | √ | | √ | |
| Native™ tissue harmonic imaging | √ | √ | √ | √ | |
| SieScape™ panoramic imaging | √ | √ | √ | √ | |
| Color SieScape™ panoramic imaging | √ | √ | √ | √ | |
| 3-Scape™ real-time 3D imaging | √ | √ | √ | √ | |
| fourSight™ 4D transducer technology | √ | √ | √ | √ | |
| TEQ™ ultrasound technology | √ | √ | √ | √ | |
| Extend imaging technology | √ | √ | √ | √ | |
| Cardiac Imaging physiological signal display | √ | √ | √ | √ | |
| syngo ® Auto OB measurements | √ | √ | √ | √ | |
| Advanced SieClear™ spatial compounding | √ | √ | √ | √ | |
| STIC (Fetal Heart Imaging) | √ | √ | √ | √ | |
| Amnioscopic rendering | √ | √ | √ | √ | |
| Cadence contrast agent imaging | √ | √ | √ | √ | |
| Clarify™ vascular enhancement technology | √ | √ | √ | √ | |
| eSie™ Touch elasticity imaging | √ | √ | √ | √ | √ |
| syngo ® Auto Left heart | √ | √ | √ | √ | |
| syngo ® Velocity Vector Imaging | √ | √ | √ | √ | |
| Semi Auto-segmentation (eSie Calc) | √ | √ | √ | √ | |
| Feature / Characteristic | Submission<br>Device<br>S2000 | Submission<br>Device<br>S3000 | Acuson<br>S3000<br>K121138 | Acuson<br>S2000<br>K111674 | Supersonic<br>Imagine<br>K112255 /<br>K121329 |
| ● Custom Tissue Imaging / Speed of<br>Sound | √ | √ | √ | √ | |
| ● AHP | √ | √ | √ | √ | |
| ● VTIQ | √ | √ | | | √ |
| ● 18L6HD Transducer | √ | √ | √ | √ | |
| ● 6C1HD Transducer | √ | √ | √ | √ | |
| ● 8C3HD Transducer | √ | √ | √ | √ | |
| ● Monitor: FPD | √ | √ | √ | √ | √ |
| Output Display Standard (Track 3) | √ | √ | √ | √ | √ |
| Patient Contact Materials | Tested to ISO<br>10993-1 | Tested to ISO<br>10993-1 | Tested to ISO<br>10993-1 | Tested to ISO<br>10993-1 | Tested to ISO<br>10993-1 |
| UL 60601-1 Certified | √ | √ | √ | √ | √ |

# 6. Summary of Technological Characteristics - New Device Compared to Predicate

the submit the state of the same of the same of the subject of

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# S2000 and S3000 Virtual Touch IQ 510(k) Submission

S2000/3000 510(k) Submission

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# S2000 and S3000 Virtual Touch IQ 510(k) Submission

| | | Supersonic<br>Imagine | |
|---------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shear Wave Elasticity Imaging Software | VTIQ | Aixplorer | Comments |
| Comparable Exam Types | Breast,<br>Thyroid | Breast,<br>Thyroid | |
| Transducer for same Exam Types | 9L4 Multi-D<br>Linear Array | 10L2, 15L4<br>Linear Array | |
| Operating Mode | Single Frame | Low Frame<br>Rate Real<br>Time | Note 1 |
| Cool Down period before live imaging<br>resumes | Yes (variable,<br>~3-6 sec) | No | Note 1 |
| Push Pulse beam density | High<br>(variable with<br>FOV size) | Low (variable<br>with FOV<br>size)<br>Reference<br>Figure 13 in<br>Supersonic<br>White Paper | Note 1 |
| Multiple Push Pulse Focal Zones | Yes | "Mach Cone" | In both cases, multiple push pulse focal zones in<br>depth are used for the purpose of increasing<br>radiation force uniformity with depth. "Mach<br>Cone" is the Supersonic term for compound<br>transmit focusing, similar to Siemens. |
| Two Dimensional Display with Elasticity<br>Region of Interest | Yes | Yes | |
| Localized Quantitative Shear Wave<br>Velocity measurement | Yes | Yes -<br>Predicate not<br>cleared in the<br>U.S.A | |
| Localized Quantitative Young's Modulus<br>measurement | No | Yes -<br>Predicate not<br>cleared in the<br>U.S.A. | Supersonic Imagine has implemented the shear<br>wave velocity scale in the color bar which<br>indicates relative shear wave speed in the image<br>and has been cleared in the U.S. Young's<br>modulus is not cleared. Siemens VTIQ is<br>equivalent to Supersonic except Siemens is<br>requesting clearance for point measurements in<br>addition to displaying shear wave velocity on the<br>color bar. When Young's modulus is displayed<br>(kPa). assumptions are made regarding tissue<br>density and viscosity that may not be correct in a<br>wide range of biological tissues and is therefore<br>an indirect measurement. Shear wave velocity is<br>a direct measurement. |
| Shear Wave Velocity Display Mode | Yes | Yes | The Shear Wave Quality display assists the user<br>in interpreting possible shear wave velocity<br>estimate artifacts in the Shear Wave Velocity<br>image by indicating in a color coded display the<br>shear wave magnitude and signal to noise ratio<br>(SNR) of the shear wave form. This display can<br>reduce the number of false negative indications<br>with shear wave imaging in lesions with very high<br>shear modulus that attenuate the shear wave. |
| Shear Wave Quality Display Mode | Yes | No | |
| Shear Wave Travel Time Display Mode | Yes | No | Shear Wave Travel Time display improves the<br>dynamic range of the shear wave image in focal<br>regions of high shear wave velocity as illustrated<br>in figures 1 and 2 below. |
| Shear Wave Displacement Display Mode | Yes | No | The Shear Wave displacement image provides<br>information to the user about relative shear wave<br>amplitudes throughout the shear wave image and<br>can be useful to correlate regions of high shear<br>wave attenuation within regions of high shear<br>modulus to the Shear Wave Quality image. The<br>Shear Wave Displacement image can also assist<br>in identifying lesion boundaries. |
| Shear Wave Propagation "Movie" (clip) | No | Yes | Siemens approach to visualizing shear wave<br>characteristics are the Shear Wave Quality, Time<br>and Displacement maps. The Supersonic shear<br>wave propagation movie provides information<br>specific to their implementation of shear wave<br>imaging, as noted in Note 1. |
| Shear Wave Velocity Measurement Range | 0.5-10 m/sec | 0.1-10 m/sec | Siemens has chosen a lower velocity cutoff of 0.5<br>m/s to avoid potential artifacts. In in-vivo studies,<br>shear wave velocities below 0.5 m/s have not<br>been encountered so there is no impact on<br>clinical efficacy. |
| "See through to B mode" when no shear<br>wave detected | Yes | Yes | |
| Color Coded Shear Wave Velocity Display | Yes | Yes | |
| Adjustable Maximum and Minimum<br>Velocity Scale | Yes | Yes | |
| In Color Code. Red is 'stiff' and blue is<br>'soft' | Yes | Yes | |
| Color map is transparent over B mode<br>display | Yes | Yes | |
| Other system features: | | | |
| B Mode Imaging | Yes | Yes | |
| Pulse Wave Doppler Imaging | Yes | Yes | |
| Color Flow Doppler Imaging | Yes | Yes | |
| Spatial Compound Imaging | Yes | Yes | |
| Speckle Reduction Image Processing | Yes | Yes | |
| Tissue Harmonic Imaging | Yes | Yes | |

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:

# S2000 and S3000 Virtual Touch IQ 510(k) Submission

S2000/3000 510(k) Submission

·

Page 11 of 66

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# S2000 and S3000 Virtual Touch IQ 510(k) Submission

### Note 1:

There are differences in push pulse sequencing and shearwave detection between the predicate device (Supersonic Aixplorer) and Siemens VTIQ. Siemens uses closely spaced focused push beams and a large number of closely spaced focused detection beams resulting in higher signal to noise ratio in shearwave imaging than the predicate device. We attribute this to several factors, including wide spacing of push beams on the Aixplorer, plane wave detection of shearwaves over a wide area on the Aixplorer resulting in signal to noise limitations and a higher frequency transducer (15L4 on Aixplorer vs 9L4 on VTIQ) that results in higher shearwave attenuation with the predicate device. Additionally, a reduced push beam mechanical index is used on the Aixplorer as compared to the constant value of 1.7 with VTIQ. which allows pseudo-real time operation on the Aixplorer of approximately 1 frame per second. The user is required to compound the image at the region of interest over several seconds with the Aixplorer to allow the image to "build up" over several frames to improve signal to noise ratio. VTIQ is a single frame image acquisition that allows higher signal to noise ratio without image compounding and generates a more consistent shearwave velocity estimation based on our experience in in-vivo studies. Using VTIQ and Supersonic Aixplorer in the same lesions on the same subjects, we have encountered many cases where maximum shearwave velocity with VTIQ was higher and more completely filled in with shearwave information throughout the lesion than with the predicate device in biopsy proven breast cancers. In many cases the maximum velocity on the predicate device fell far below the threshold cutoff of 80 kPa (~5.2 m/s) indicated in the Supersonic BE1 study for malignancy as indicated in the 25 example cases submitted (refer to tab 1.7.5.10 D).

Image /page/5/Picture/5 description: The image shows two ultrasound images comparing SW Velocity and SW Time. The top image shows a lesion boundary in SW Velocity, while the bottom image shows a lesion boundary in SW Time. The text on the right side of the image indicates that the images are related to ILC anterior to a breast implant. The image is labeled as "Figure 1".

S2000/3000 510(k) Submission

Page 12 of 66

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Image /page/6/Figure/2 description: The image shows a diagram of a wave source with two detection points, T1 and T2, along with a graph illustrating the relationship between velocity and travel time. The formula for velocity (v) is given as v = (x2-x1) / (T2-T1). The graph shows two curves, one for T1 and one for T2, plotting velocity against travel time, indicating an inverse relationship where high velocity corresponds to low travel time and vice versa. The text explains that in shear wave velocity imaging, the distance between detection locations is constant, and the inverse relationship between velocity and travel time means that travel time display has a high dynamic range at low velocity, while velocity display has a high dynamic range at high velocity.

Relationship of SW Velocity and SW Travel Time Displays

Figure 2

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

The devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:

- UL 60601-1, Safety Requirements for Medical Equipment .
- . IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment . .
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical ● Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound .
- . 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment
- · EN/IEC 60601-1
- . EN/IEC 60601-1-1
- . EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power ■
- . ISO 10993-1 Biocompatibility

Cleared patient contact materials, electrical and mechanical safety are unchanged.

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

The S2000. \$3000 and Aixplorer use the same technology and principles as existing devices. clinical data is not required.

# 9. Summarv

Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms with 21 CFR

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Page 8 of 8

# S2000 and S3000 Virtual Touch IQ 510(k) Submission

.

820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the devices are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three parallel lines curving upwards and to the right.

# Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 11, 2013

Siemens Medical Solutions, Inc. % Ms Shelly Pearce Regulatory Affairs 1230 Shorebird Way MOUNTAIN VIEW CA 94043

Re: K130881

Trade/Device Name: Acuson S2000 and S3000 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: October 3, 2013 Received: October 4, 2013

Dear Ms. Pearce:

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.

This determination of substantial equivalence applies to the following transducers intended for use with the Acuson S2000 Diagnostic Ultrasound Systems, as described in your premarket notification:

# Transducer Model Number

CW2 9L4 Linear Array 6C2 Curved Array 4V1 Phased Array 7CF2 Curved Array 8V3 Phased Array EV8C4 V7M TEE

CWS 14L5 Multi-D Array 4C1 Curved Array 10V4 Phased Array 9EVF4 Curved Array 4V1c Phased Array 8C3HD Curved Array AcuNav 8F

EC9-4 Curved Array 4P1 Phased Array 6C1HD Curved Array 141.5 SP Linear Array V5Ms Multiplane TEE 613 18L6 HD Linear Array AcuNav 10F

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Page 2-Ms. Pearce

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note

the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sm.h.7)

for

Janine M. Morris 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 1.3

# A. 510(k) Number (if known): K130881

Device Name: S2000 and S3000 Diagnostic Ultrasound Systems

#### Indications for Use:

The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Supericial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculoskeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 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 Acuson Acunav Ultrasound Catheter is intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

AND/OR

Prescription Use _ × (Part 21CFR 801 Subpart D)

Over-The-Counter
(21 CFR 801

Over-The-Counter Use (21 CFR 801 Subpart C)

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.

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| 1.3 Indications for Use Forms | Diagnostic Ultrasound Indications for Use Form | | | | | | | | | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------|
| 510 (k) Number (if known): | | | | | | | | | | |
| Device Name:<br>Intended Use: | ACUSON S2000/S3000 Ultrasound Systems<br>Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | P | P | P | P | P | P | P | | | Note 2,3,4,5,7,8,10 |
| Fetal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11, 13 |
| Abdominal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11, 13 |
| Intraoperative<br>(Note 9) | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11, 14 |
| Intraoperative<br>Neurological | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11, 14 |
| Pediatric | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Small Organ<br>(Note 1) | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11,14, 16, 18 |
| Neonatal Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Cardiac | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,6,7,8,10,15 |
| Trans-esophageal | P | P | P | P | P | P | P | | BMDC | Note 4 |
| Transrectal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11,14 |
| Transvaginal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11,14,15 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11,14, 18 |

N = new indication; P = previously cleared by FDA K111674, 121138

P

P

P

P

P

P

P

P

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

Note 3 SieClear multi-view spatial compounding

3-Scape real-time 3D imaging Nate 5 B&W SieScape panoramic imaging

Note 7 Note 9 For example: vascular, abdominal

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

Custom Tissue Imaging Note 16

Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology

Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology Note 13 STIC

BMDC

BMDC

te 15 AHP

Note 15 AHP
Note 18 VTIQ

P

P

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P

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Musculo-skeletal

Neonatal Cardiac

Other (specify)

Superficial

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Note 2,3,4,5,7,8,10.

11,14, 18

Note 3,4,6, 10

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510 (k) Number (if known):

| Device Name: | | | | | | | CW2 Probe for use with ACUSON S2000/S3000 | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|-------------------------------------------|------------------------------|-------------------------------------------------------------------------|--------------------|--|--|
| Intended Use: | | | | | | | | | Ultrasound imaging or fluid flow analysis of the human body as follows: | | | |
| | Mode of Operation | | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | P | | | | | | | |
| Abdominal | | | | | P | | | | | | | |
| Intraoperative<br>(Note 9) | | | | | P | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | P | | | | | | | |
| Small Organ<br>(Note 1) | | | | | P | | | | | | | |
| Neonatal Cephalic | | | | | P | | | | | | | |
| Adult Cephalic | | | | | P | | | | | | | |
| Cardiac | | | | | P | | | | | | | |
| Trans-esophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | P | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | P | | | | | | | |
| Other (specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K# 111674, 121138

Additional Comments:

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

For example: vascular, abdominal Note 9

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510 (k) Number (if known):

Device Name: Intended Use:

# CW5 Probe for use with ACUSON S2000/3000

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

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | P | | | | | |
| Abdominal | | | | | P | | | | | |
| Intraoperative<br>(Note 9) | | | | | P | | | | | |
| Intraoperative<br>Neurological | | | | | P | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ<br>(Note 1) | | | | | P | | | | | |
| Neonatal Cephalic | | | | | P | | | | | |
| Adult Cephalic | | | | | P | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | P | | | | | |
| Musculo-skeletal<br>Superficial | | | | | p | | |…