ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
Device Facts
| Record ID | K130739 |
|---|---|
| Device Name | ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Jun 6, 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 adiunctively 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 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. Virtual Touch Imaging and eSie Touch Elastography provide qualitation of relative stiffness between tissues with different elastic properties.
Device Story
Multi-purpose mobile diagnostic ultrasound systems; acquire harmonic ultrasound echo data; display in B-Mode, PW/CW/Color/Amplitude Doppler, 3D/4D, and harmonic imaging. Operated by clinicians in clinical settings. Features include Arterial Health Package (AHP) for Intima Media Thickness measurement, Virtual Touch Imaging (VTI), and eSie Touch Elastography for tissue stiffness qualification. Output displayed on flat panel monitor; used adjunctively with other medical data for clinical diagnosis. Benefits include non-invasive visualization of anatomy/physiology and assessment of vascular health/tissue properties.
Clinical Evidence
Bench testing only. No clinical data required. Testing included acoustic output, biocompatibility (ISO 10993-1), cleaning/disinfection, and thermal/electrical/mechanical safety (UL 60601-1, IEC 60601-2-37). VTI reproducibility validated via intra-operator and inter-operator studies using phantom images, demonstrating consistent contrast-to-noise ratio and inclusion visualization compared to existing elastography benchmarks.
Technological Characteristics
Mobile ultrasound system; flat panel display; supports multiple transducers (linear, curved, phased array, TEE, catheter). Materials tested to ISO 10993-1. Connectivity: standard ultrasound interfaces. Software-controlled; includes harmonic imaging, spatial compounding (SieClear), panoramic imaging (SieScape), and elasticity imaging (VTI/eSie Touch). Safety standards: 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)
Reference Devices
- Acuson S3000 (K122825)
- Acuson Antares (K063138)
Related Devices
- K131164 — ACUSON · Siemens Medical Solutions USA, Inc. · Dec 24, 2013
- K132804 — ACUSON S1000 / S2000 / S3000 · Siemens Medical Solutions USA, Inc. Ultrasound Gro · Oct 24, 2013
- K123001 — ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Oct 26, 2012
- K121699 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Jun 22, 2012
- K130619 — ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Mar 21, 2013
Submission Summary (Full Text)
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## 510(k) Summary Prepared March 12, 2013
JUN 6 2013
1. Sponsor: Siemens Medical Solutions, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043
| Contact Person: | Shelly Pearce<br>Telephone:<br>Fax: | (650) 694-5988<br>(650) 694-5580 |
|-----------------|-------------------------------------|----------------------------------|
|-----------------|-------------------------------------|----------------------------------|
- 2. Device Name: Acuson S2000 and S3000 Diagnostic Ultrasound Systems
- Common Name: Diagnostic Ultrasound System
## Classification:
Regulatory Class: ll 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 |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
| Diagnostic Ultrasound Catheter | FR # 870.1200 | Product Code OBJ |
# 3. Legally Marketed Predicate Devices
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)
## 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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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 adiunctively 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 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.
Virtual Touch Imaging and eSie Touch Elastography provide qualitation of relative stiffness between tissues with different elastic properties.
| | Feature / Characteristic | Submission<br>Device<br>S2000 | Submission<br>Device<br>S3000 | Acuson<br>S3000<br>K122825 | Acuson<br>S2000<br>K111674 | Acuson<br>Antares<br>K063138 |
|---------------------------------------------------|------------------------------------------|-------------------------------|-------------------------------|----------------------------|------------------------------|------------------------------|
| | Indications for Use: | | | | | |
| ■ | Fetal | √ | √ | √ | √ | √ |
| ■ | Abdominal | √ | √ | √ | √ | √ |
| ■ | Intraoperative abdominal and<br>vascular | √ | √ | √ | √ | √ |
| | Intraoperative neurological | -- | -- | -- | -- | -- |
| ■ | Pediatric | √ | √ | √ | √ | √ |
| ■ | Small Organ | √ | √ | √ | √ | √ |
| ■ | Neonatal cephalic | √ | √ | √ | √ | √ |
| ■ | Adult Cephalic | √ | √ | √ | √ | √ |
| ■ | Cardiac | √ | √ | √ | √ | √ |
| ■ | Trans-esophageal | √ | √ | √ | √ | √ |
| ■ | Transrectal | √ | √ | √ | √ | √ |
| ■ | Transvaginal | √ | √ | √ | √ | √ |
| | Peripheral vessel | √ | √ | √ | √ | √ |
| ■ | Laparoscopic | -- | -- | -- | -- | -- |
| ■ | Musculo-skeletal (conventional) | √ | √ | √ | √ | √ |
| ■ | Musculo-skeletal (superficial) | √ | √ | √ | √ | √ |
| | Center Frequencies Supported: | | | | | |
| ■ | 2.0 MHz | √ | √ | √ | √ | √ |
| Feature / Characteristic | Submission<br>Device<br>S2000 | Submission<br>Device<br>S3000 | Acuson<br>S3000<br>K122825 | Acuson<br>S2000<br>K111674 | Acuson<br>Antares<br>K063138 | |
| ■ 3.0 MHz | √ | √ | √ | √ | √ | |
| ■ 3.2 MHz | √ | √ | √ | √ | √ | |
| ■ 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<br>imaging | √ | √ | √ | √ | √ | |
| ■ 3-Scape™ real-time 3D imaging | √ | √ | √ | √ | √ | |
| ■ fourSight™ 4D transducer<br>technology | √ | √ | √ | √ | √ | |
| ■ TEQ™ ultrasound technology | √ | √ | √ | √ | √ | |
| ■ Extend imaging technology | √ | √ | √ | √ | √ | |
| ■ Cardiac Imaging<br>physiological signal display | √ | √ | √ | √ | √ | |
| syngo ® Auto OB measurements | √ | √ | √ | √ | √ | |
| ■ Advanced SieClear™ spatial<br>compounding | √ | √ | √ | √ | √ | |
| ■ STIC (Fetal Heart Imaging) | √ | √ | √ | √ | √ | |
| ■ Amnioscopic rendering | √ | √ | √ | √ | √ | |
| ■ Cadence contrast agent imaging | √ | √ | √ | √ | √ | |
| ■ Clarify™ vascular enhancement<br>technology | √ | √ | √ | √ | √ | |
| ■ eSie™ Touch elasticity imaging | √ | √ | √ | √ | √ | |
| ■ eSie Fusion | | √ | √ | | | |
| Feature / Characteristic | Submission<br>Device<br>S2000 | Submission<br>Device<br>S3000 | Acuson<br>S3000<br>K122825 | Acuson<br>S2000<br>K111674 | Acuson<br>Antares<br>K063138 | |
| • syngo ® Velocity Vector Imaging | √ | √ | √ | √ | √ | |
| • Semi Auto-segmentation (eSie<br>Calc) | √ | √ | √ | √ | √ | |
| • Custom Tissue Imaging / Speed of<br>Sound | √ | √ | √ | √ | √ | |
| • AHP | √ | √ | √ | √ | √ | |
| • VTI | √ | √ | √ | √ | √ | |
| • 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
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# S2000 and S3000 Virtual Touch Imaging 510(k) Submission
.
:
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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 devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, 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 비
- 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 60601-1-1 .
- . 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.
Additional testing was performed to compare El to VTI by validating intra-operator and interoperator reproducibility of VTI using El as a benchmark. Visual comparison of phantom images generated with El and VTI demonstrate more consistent contrast to noise ratio and clearer inclusion visualization with VTI than with EI.
## 8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
The S2000 and S3000 use the same technology and principles as existing devices, clinical data is not required.
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## 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 with 21 CFR 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/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 human figure with three arms or wings extending upwards.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June.6, 2013
Siemens Medical Solutions USA. Inc. % Ms. Shelly Pearce Regulatory Affairs 685 East Middlefield Road MOUNTAIN VIEW CA 94043
Re: K130739
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: 1YN, IYO, ITX, OBJ Dated: March 14, 2013 Received: March 21, 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 and S3000 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
CW5 14L5 Multi-D Array 4C1 Curved Array 10V4 Phased Array 9EVF4 Curved Array 4VIc Phased Array 8C3HD Curved Array AcuNav 8F
EC9-4 Curved Array 4P1 Phased Array 6C1HD Curved Array 14L5 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 (OS) 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 toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours;
Sinh.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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#### 1.3 Indications for Use
#### A. 510(k) Number (if known): K130739
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, 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, 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 intended for 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.
Virtual Touch Imaging and eSie Touch Elastography provide qualization of relative stiffness between tissues with different elastic properties.
Prescription Use X (Part 21CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh.7).
Division Sign-Off
Division of Radiological Health
· Office of In Vitro Diagnostics and Radiological Health
510(k) == K130739 Page 1 of
S2000/3000 510(k) Submission
Page 1 of 26
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## S2000 and S3000 Virtual Touch Imaging 510(k) Submission
#### 1.3 Indications for Use Forms
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
ACUSON S2000/S3000 Ultrasound Systems
| Device Name:<br>ACUSON S2000/S3000 Ultrasound Systems<br>Intended Use:<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 | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13 |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13, 17 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 |
| Intraoperative<br>(Note 9) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14, 16, 17 |
| Small Organ<br>(Note 1) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,6,7,8,10,15 |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 4 |
| Trans-esophageal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6,7,8,10,<br>11,14,15 |
| Peripheral vessel | | | | | | | | | | |
| -Laparoscopic- | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14, 17 |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14, 17 |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | BMDC | Note 3,4,6, 10 |
| Other (specify)<br>Neonatal Cardiac | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K111674, 121138
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 3 SieClear multi-view spatial compounding
3-Scape real-time 3D imaging Note 5
B&W SieScape panoramic imaging Note 7
Note 9 For example: vascular, abdominal
Note 11 Advanced Siectear spatial compounding Note 14 eSie™ Touch elasticity imaging / FTI
Note 16
Custom Tissue Imaging
Note 2 Ensemble tissue harmonic imaging
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 Note 15 AHP
Note 17 VTI
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Division Sign-Off
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
510(k)_
Page 2 of
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## Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
| Device Name:<br>Intended Use: | CW2 Probe for use with ACUSON S2000/S3000<br>Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------|-----------------------|--------------------|
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | <table><tr><th>A</th><th>B</th><th>M</th><th>PWD</th><th>CWD</th><th>Color<br/>Doppler</th><th>Amplitude<br/>Doppler</th><th>Color<br/>Velocity<br/>Imaging</th><th>Combined<br/>(Specify)</th><th>Other<br/>(Specify)</th></tr></table> | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | |
| Ophthalmic | <table><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | | | | | | |
| | | | | | | | | | | | |
| Fetal | <table><tr><td></td><td></td><td></td><td></td><td>P</td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | P | | | | | |
| | | | | P | | | | | | | |
| Abdominal | <table><tr><td></td><td></td><td></td><td></td><td>P</td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | P | | | | | |
| | | | | P | | | | | | | |
| Intraoperative<br>(Note 9) | <table><tr><td></td><td></td><td></td><td></td><td>P</td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | P | | | | | |
| | | | | P | | | | | | | |
| Intraoperative<br>Neurological | <table><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | | | | | | |
| | | | | | | | | | | | |
| Pediatric | <table><tr><td></td><td></td><td></td><td></td><td>P</td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | P | | | | | |
| | | | | P | | | | | | | |
| Small Organ<br>(Note 1) | <table><tr><td></td><td></td><td></td><td></td><td>P</td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | P | | | | | |
| | | | | P | | | | | | | |
| Neonatal Cephalic | <table><tr><td></td><td></td><td></td><td></td><td>P</td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | P | | | | | |
| | | | | P | | | | | | | |
| Adult Cephalic | <table><tr><td></td><td></td><td></td><td></td><td>P</td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | P | | | | | |
| | | | | P | | | | | | | |
| Cardiac | <table><tr><td></td><td></td><td></td><td></td><td>P</td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | P | | | | | |
| | | | | P | | | | | | | |
| Trans-esophageal | <table><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | | | | | | |
| | | | | | | | | | | | |
| Transrectal | <table><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | | | | | | |
| | | | | | | | | | | | |
| Transvaginal | <table><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | | | | | | |
| | | | | | | | | | | | |
| Transurethral | <table><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | | | | | | |
| | | | | | | | | | | | |
| Intravascular | <table><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | | | | | | |
| | | | | | | | | | | | |
| Peripheral vessel | <table><tr><td></td><td></td><td></td><td></td><td>P</td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | P | | | | | |
| | | | | P | | | | | | | |
| Laparoscopic | <table><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | | | | | | |
| | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | <table><tr><td></td><td></td><td></td><td></td><td>P</td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | P | | | | | |
| | | | | P | | | | | | | |
| Musculo-skeletal<br>Superficial | <table><tr><td></td><td></td><td></td><td></td><td>P</td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | P | | | | | |
| | | | | P | | | | | | | |
| Other (specify) | <table><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr></table> | | | | | | | | | | |
| | | | | | | | | | | | |
-N .= . new .indication ; _ R = . previously. cleared. by . F.DA. K # 1.1.1674 ... 12 1.138 _
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 9 For example: vascular, abdominal
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510(k)_
Page 3 of
{10}------------------------------------------------
## S2000 and S3000 Virtual Touch Imaging 510(k) Submission
## Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
| Device Name:<br>Intended Use: | CW5 Probe for use with ACUSON S2000/3000<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 | | | | | | | | | | | |
| 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 | | | | | | |
| 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.
Note 9 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Division Sign-Off
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
510(k)__
Page 4 of
{11}------------------------------------------------
## S2000 and S3000 Virtual Touch Imaging 510(k) Submission
#### Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
| Device Name: | | EC9-4 Curved Array Transducer for use with ACUSON S2000/3000 | | | | | | | | | | |
|-----------------------------------|---|-------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|----------------------------------|--|--|
| 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 | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 | | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,.7,8,10, 11, | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11,14 | | |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6, 7,8,10,<br>11,14 | | |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>-Superficial- | | | | | | | | | | | | |
| -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. Note 10 Clarify VE vascular enhanceme…
