ACUSON S1000 / S2000 / S3000

K132804 · Siemens Medical Solutions USA, Inc. Ultrasound Gro · IYN · Oct 24, 2013 · Radiology

Device Facts

• Record ID: K132804
• Device Name: ACUSON S1000 / S2000 / S3000
• Applicant: Siemens Medical Solutions USA, Inc. Ultrasound Gro
• Product Code: IYN · Radiology
• Decision Date: Oct 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The 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, pediatric, small organ, neonatal cephalic, cardiac, cardiac, trans-esophageal, 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 normalive 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 Carolid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardionraphy: 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.

Device Story

Multi-purpose mobile diagnostic ultrasound systems; acquire harmonic/non-harmonic echo data; display in B-Mode, M-Mode, PW/CW Doppler, Color Doppler, Amplitude Doppler, Harmonic Imaging, and 3D/4D. Operated by clinicians in clinical settings. Systems provide anatomical measurements and calculation packages (e.g., Arterial Health Package for Intima Media Thickness) to assist physician diagnosis. Output displayed on flat panel monitor; includes thermal/mechanical indices. Benefits include non-invasive visualization of anatomy/physiology and adjunctive data for clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data required as the systems use the same technology and principles as existing, legally marketed predicate devices. Compliance with safety standards (UL 60601-1, IEC 60601-2-37, AIUM/NEMA UD-2/UD-3) and biocompatibility (ISO 10993-1) was verified.

Technological Characteristics

Mobile, software-controlled ultrasound systems. Supports B, M, PW/CW Doppler, Color/Amplitude Doppler, 3D/4D imaging. Patient contact materials tested to ISO 10993-1. Connectivity includes wireless. Safety standards: UL 60601-1, IEC 60601-2-37, AIUM/NEMA UD-2/UD-3. Software-controlled.

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

• S1000 (K130619, K123622, K123001)
• S2000 (K130739, K112596, K123622, K123001)
• S3000 (K130739, K121138, K123622, K123001)

Reference Devices

• Acuson SC2000 (K123622)

Submission Summary (Full Text)

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K132804
page 1 of 5

S-Family Ultrasound Systems 510(k) Submission

## 510(k) Summary Prepared July 18, 2013

| 1. Sponsor: | Siemens Medical Solutions, Inc.,<br>Ultrasound Division<br>685 East Middlefield Road<br>Mountain View, California 94043 | | OCT 2 4 2013 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------|
| Contact Person: | Christine Dunn<br>Telephone:<br>Fax: | [phone]<br>[phone] | |
| 2. Device Name: | Acuson S1000, S2000, 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-IYC |
| 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 modified Acuson S1000, S2000, S3000 Ultrasound Systems are substantially equivalent to the company's own systems:

| System | 510(k) |
|--------|------------------------------------|
| S1000 | K130619; K123622; K123001 |
| S2000 | K130739; K112596; K123622; K123001 |
| S3000 | K130739; K121138; K123622; K123001 |

## 4. Device Description:

The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and onscreen display for thermal and mechanical indices related to potential bio-effect mechanisms. The function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-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.

## 5. Intended Use

The 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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| Siemens Medical Solutions, Inc. | S-Family Ultrasound Systems |
|---------------------------------|-----------------------------|
| Ultrasound Division | 510(k) Submission |

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, cardiac, cardiac, trans-esophageal, 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 normalive 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 Carolid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardionraphy: 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.

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| | Feature / Characteristic | Acuson<br>S1000/S2000<br>/S3000<br>This<br>Submission | Acuson<br>SC2000<br>K123622 | Acuson<br>S1000<br>K130619 | Acuson<br>S2000<br>K112596 | Acuson<br>S2000<br>K130739 | Acuson<br>S3000<br>K121138 | Acuson<br>S3000<br>K130739 |
|---------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|-----------------------------|----------------------------|----------------------------|----------------------------|----------------------------|----------------------------|
| | Indications for Use: | | | | | | | |
| | Fetal | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | Abdominal | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | Intraoperative | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | 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 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | 3.0 MHz | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | 3.2 MHz | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | 3.3 MHz | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | 4.2 MHz | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | 4.4 MHz | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Feature / Characteristic | Acuson<br>S1000/S2000<br>/S3000<br>This<br>Submission | Acuson<br>SC2000<br>K123622 | Acuson<br>S1000<br>K130619 | Acuson<br>S2000<br>K112596 | Acuson<br>S2000<br>K130739 | Acuson<br>S3000<br>K121138 | Acuson<br>S3000<br>K130739 | |
| 4.8 MHz | √ | √ | √ | √ | √ | √ | √ | |
| •<br>5.0 MHz | √ | √ | √ | √ | √ | √ | √ | |
| 5.2 MHz | √ | √ | √ | √ | √ | √ | √ | |
| •<br>6.0 MHz | √ | √ | √ | √ | √ | √ | √ | |
| •<br>6.5 MHz | √ | √ | √ | √ | √ | √ | √ | |
| •<br>6.9 MHz | √ | √ | √ | √ | √ | √ | √ | |
| •<br>9.5 MHz | √ | √ | √ | √ | √ | √ | √ | |
| 10.0 MHz | √ | √ | √ | √ | √ | √ | √ | |
| Modes: | | | | | | | | |
| •<br>B | √ | √ | √ | √ | √ | √ | √ | |
| •<br>Parallel processing in B mode | √ | √ | √ | √ | √ | √ | √ | |
| •<br>M | √ | √ | √ | √ | √ | √ | √ | |
| •<br>PWD (Pulsed Wave Doppler) | √ | √ | √ | √ | √ | √ | √ | |
| •<br>CWD (Continuous Wave Doppler) | √ | √ | √ | √ | √ | √ | √ | |
| •<br>D (Color Doppler) | √ | √ | √ | √ | √ | √ | √ | |
| •<br>Amplitude Doppler | √ | √ | √ | √ | √ | √ | √ | |
| •<br>Combined (BMDC)<br>Features: | √ | √ | √ | √ | √ | √ | √ | |
| Quad processing in color | √ | √ | √ | √ | √ | √ | √ | |
| •<br>Native™ tissue harmonic imaging | √ | √ | √ | √ | √ | √ | √ | |
| •<br>SieScape™ panoramic imaging | √ | √ | √ | √ | √ | √ | √ | |
| •<br>Color SieScape™ panoramic<br>imaging | √ | √ | √ | √ | √ | √ | √ | |
| • 3-Scape™ real-time 3D imaging | √ | √ | √ | √ | √ | √ | √ | |
| • fourSight™ 4D transducer<br>technology | √ | √ | √ | √ | √ | √ | √ | |
| • TEQ™ ultrasound technology | √ | √ | √ | √ | √ | √ | √ | |
| Cardiac Imaging<br>physiological signal display | √ | √ | √ | √ | √ | √ | √ | |
| syngo ® Auto OB measurements | √ | √ | √ | √ | √ | √ | √ | |
| •<br>Advanced SieClear™ spatial<br>compounding | √ | √ | √ | √ | √ | √ | √ | |
| STIC (Fetal Heart Imaging) | √ | √ | √ | √ | √ | √ | √ | |
| •<br>Amnioscopic rendering | √ | √ | √ | √ | √ | √ | √ | |
| •<br>Cadence contrast agent imaging | √ | √ | √ | √ | √ | √ | √ | |
| •<br>Clarify ™ vascular enhancement<br>technology | √ | √ | √ | √ | √ | √ | √ | |
| •<br>eSie™ Touch elasticity imaging | √ | √ | √ | √ | √ | √ | √ | |
| •<br>syngo ® Auto Left heart | √ | √ | √ | √ | √ | √ | √ | |
| •<br>syngo ® Velocity Vector Imaging | √ | √ | √ | √ | √ | √ | √ | |
| Semi Auto-segmentation (eSie<br>Calc) | √ | √ | √ | √ | √ | √ | √ | |
| Custom Tissue Imaging / Speed of<br>Sound | √ | √ | √ | √ | √ | √ | √ | |
| •<br>AHP | √ | √ | √ | √ | √ | √ | √ | |
| Feature / Characteristic | Acuson<br>S1000/S2000<br>/S3000<br>This<br>Submission | Acuson<br>SC2000<br>K123622 | Acuson<br>S1000<br>K130619 | Acuson<br>S2000<br>K112596 | Acuson<br>S2000<br>K130739 | Acuson<br>S3000<br>K121138 | Acuson<br>S3000<br>K130739 | |
| • VTI (S2000 & S3000 only) | √ | | | | √ | | √ | |
| Wireless | √ | √ | √ | | | | | |
| Monitor: 21' FPD | √ | √ | √ | √ | √ | √ | √ | |
| Output Display Standard (Track 3) | √ | √ | √ | √ | √ | √ | √ | |
| Patient Contact Materials | Tested to ISO<br>10993-1 | Tested to<br>ISO 10993-1 | Tested to<br>ISO 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 | √ | √ | √ | √ | √ | √ | √ | |
| Indications for Use | √ | √ | √ | √ | √ | √ | √ | |

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

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## S-Family Ultrasound Systems 510(k) Submission

S-Family 510(k) Submission

Page 10 of 64

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## S-Family Ultrasound Systems 510(k) Submission

## 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, electrical, electromagnetic 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 이
- 트 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 l
- Safety and EMC Requirements for Medical Equipment I
- 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.

Additional testing was performed to verify the software release as well as transducer and wireless performance.

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

Since the S1000, S2000, S3000 systems use the same technology and principles as existing devices, clinical data is not required.

## 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 to 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

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K132804
Page 5 of 5

S-Family Ultrasound Systems 510(k) Submission

of Siemens Medical that the S1000, S2000 and S3000 systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market. .

S-Family 510(k) Submission

.

·

Page 12 of 64

-

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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 features the department's seal, which includes an emblem of an eagle with three bars on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

Public Health Service

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

October 24, 2013

Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K132804

Trade/Device Name: Acuson S1000/ S2000/ 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 and OBJ Dated: October 9, 2013 Received: October 10, 2013

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,

This determination of substantial equivalence applies to the following transducers intended for use with the Acuson S1000/S3000 Diagnostic Ultrasound System, as described in your premarket notification:

| | Transducer Model Number | |
|-----------|-------------------------|---------|
| CW2 | CWS | EC9-4 |
| MC9-4 | 91_4 | 141.5 |
| 4 | 6C2 | 4CI |
| RCIFID | 8C3HD | 4V |
| 10V4 | 141.5 SP | 7CF2 |
| 7CF1 | 9EVF4 | V SMs |
| 18L6 | 8V3 | 4V lc |
| 613 | EV8C4 | V7M TEE |
| AcuNav 8F | AcuNav 10F | |

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Page 2-Mr. Job

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 clectronic 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.lda.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.lda.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 vours.

Smhif)

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

#### K132804 A. 510(k) Number (if known):

Device Name: S1000, S2000, S3000 Diagnostic Ultrasound Systems

## Indications for Use:

The 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, pediatric, small organ, neonatal cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) 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 gublished in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with palients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carolid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardionraphy: 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.

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

AND/OR

(min. 77)

.

Division Sign-Off Division of Radiological Health; Office of In Vitro Diagnostics and Radiological Health

K132804 510(k)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

S-Family 510(k) Submission

Page 16 of 64

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#### 1.3 Indications for Use Forms

#### Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

#### ACUSON S1000, S2000, S3000 Ultrasound System 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 | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13 | |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13, 16, 18 | |
| 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 | | | 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 | |
| Small Organ<br>(Note 1) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11.14. 16, 18 | |
| 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 2,3,4,5,7,8,10 | |
| Cardiac | | 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 | | BMDC | Note 4 | |
| Transrectal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11.14 | |
| Transvaginal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6,7,8,10,<br>11,14,15 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11.14, 18 | |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14, 18 | |
| Other (specify) | | P | P | P | P | P | P | | BMDC | Note 3,4,6, 10 | |

N = new natalian, P = previously classed by FDA K032142, K03034, K09302, K111674, K112556, K12113, K123001, K120615, K12136 K12302, K12053

Nole 1 e breast, testes thyroid penis, prostate etc

Nole 7

Clarity VE vascular ennancoment technology
eSæ ™ Touch elasticity imaging / FTI Nole 10

Nole 14

Note 17 e Sie Fusion

Note 18 VTI

A

Note 2 Ensamble tissue harmonic imaging Note 5 3-Scape real-time 3D imaging Note 8 Power SieScape panoramic imaging Note 11 Advanced Sieclear spatial compounding Note 15 AHP

Note 3 SieClear mulli-view spatial compounding Note 6 Cadence contrast agent imaging Note 9 For example vascular, abdominal Note 13 STIC

Note 16 Custom Tissue Imaging

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S-Family 510(k) Submission

Page 17 of 64

Tissue Equa ization Technology
B&W SieScape panoramic imaging Note 4

{9}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

510 (k) Number (il known):

Device Name: Intended Use:

CW2 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System 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# 063803, K072786, K090334, , K093812, K111674, K121138

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Additional Comments:

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

Note 9 For example: vascular, abdominal

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S-Family 510(k) Submission

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

## S-Family Ultrasound Systems 510(k) Submission

## Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

#### CW5 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation Color Color Amplitude Combined Other PWD CWD Clinical Application A B M Velocity Doppler Doppler (Specify) (Specify) Imaging Oph:halmic P Fetal P Abdomina! Intraoperative P (Note 9) Intraoperative P Neurological P Pediatric Small Organ P (Note 1) P Neonatal Cephalic Adult Cephalic P P Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular P Peripheral vessel Laparoscopic Musculo-skeletal P Conventional Musculo-skeletal P Superficial Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K090334 , K093812, K111674, K121138

Additional Comments:

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

Note 9 For example vascular, abdominat

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{11}------------------------------------------------

510 (k) Number (if known):

Device Name:

EC9-4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systom

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 | | | | | | | | | | | |
| 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 Cepnalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,11 | |
| 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# 063803, K072786, K090334, K093812, K111674, K121138

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2

Nole 3 SieClear multi-view spatial compounding

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

Note B Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Advanced Sieclear spatial compounding Note 11

Note 14 eSie™ Touch elasticity imaging / FTI

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510(k)_

Page 5 of ____________________________________________________________________________________________________________________________________________________________________

## S-Family 510(k) Submission

Page 20 of 64

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

#### Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

#### Device Name:

#### MC9-4 Curved Array Transducer For Uso On ACUSON S1000, S2000, S3000 Ultrasound Systems

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 | | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Abdominal | | N | N | N | | N | N | | BMDC | Note 2,3,4,5,6,7,8,10, 11 |
| Intraoperative<br>Note 9 | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Note 1) | | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,10, 11,14 |
| Neonatal Cephalic | | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | | BMDC | Note 2,3,4,5, 6, 7,8,10,<br>11,14 |
| Transvaginal | | N | N | N | | N | N | | 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# 063803, K072786, K09034, K093812, K111674, K121138, K123001

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

Note 4 Tissue Equalization Technology

Note 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note B

Note 9 Abdomen and Vascular

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie 14 Touch elasticity imaging / FT1

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) =======================================================================================================================================================================

S-Family 510(k) Submission

Page 21 of 64

Page 6 of

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

#### Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

# For Use On ACUSON S1000, S2000, S3000

Device Name:

| | 9L4 Linear Array Transducer For Use On ACUSON S1000, S2000, S30 | | | |
|--------------------|-----------------------------------------------------------------|--|--|--|
| Ultrasound Systems | | | | |

| 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 | | | | | | | | | | | | | |
| Intraoperative<br>Note 9 | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | | 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 | | BMDC | Note 2,3,4,5,6,7,8,10, 11,14,<br>16, 18 | | | |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 | | | |
| Adult Cephalic | | P | P | P | | P | P | | | | | | |
| Cardiac | | P | P | P | | P | P | | BMDC | Note 15 | | | |
| Trans-esophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6, 7,8,10, 11,<br>14.15 | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11, 14 | | | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11, 14 | | | |
| Other (specify) | | | | | | | | | | | | | |

N = new indication: P = previously cleared by FDA K# 053085, K072786, K081148, K093812, K111674, K121138, K130739

Additional Comments:

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 Nole 9 Abdomen and Vascular
- Note 11 Advanced Sieclear spatial compounding
- Note 15 AHP

Note 18 VTI (Virtual Touch Imaging)

- Nole 2 Ensemble tissue harmonic imaging Tissue Equalization Technology Note 4
-
- Note 6 Cadence contrast agent imaging Power SieScape panoramic imaging Note B
- Note 10
- Clarify VE vascular enhancement technology Note 14 eSie™ Touch elasticity imaging / FTI
- Note 16 Custom Tissue Imaging
-

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510(k)_

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S-Family 510(k) Submission

Page 22 of 64

e In Vitro Diagnostics and Radiological

{14}------------------------------------------------

#### Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

14L5 Multi-D Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

| 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 | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Note 9 | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14, 16 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular |…