SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER

K081148 · Siemens Medical Solutions USA, Inc., Ultrasound DI · IYO · Dec 22, 2008 · Radiology

Device Facts

• Record ID: K081148
• Device Name: SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER
• Applicant: Siemens Medical Solutions USA, Inc., Ultrasound DI
• Product Code: IYO · Radiology
• Decision Date: Dec 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Modified S2000, the S2000 ABVS Ultrasound System, is intended for the following applications: General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system supports the 14LSBV for Bmode imaging of a patient's breast using an optional automatic scanning function. The device is not intended to be used as a replacement for screening mammography. The system also provides for the measurement of anatomical structures and analysis as provided in the original S2000 Ultrasound System, which provides information that is used by medical health care professionals for clinical diagnosis purposes.

Device Story

Acuson S2000 ABVS is a diagnostic ultrasound system for clinical imaging and anatomical measurement. It processes acoustic signals from various transducers (e.g., 14LSBV for automated breast scanning) to produce B-mode, M-mode, Doppler, and 3D/4D images. Operated by clinicians in radiology, cardiology, and other specialties, the system provides real-time visualization and quantitative data to assist in clinical diagnosis. Features include tissue harmonic imaging, spatial compounding, tissue equalization, and elasticity imaging. Output is displayed on the system monitor for physician interpretation to guide clinical decision-making. The device is intended for professional use in clinical settings.

Clinical Evidence

Bench testing only. The device modifications were verified and validated according to the manufacturer's design control process to ensure compliance with safety and performance standards, including IEC 60601-1, IEC 60601-2-37, and AIUM/NEMA acoustic output standards.

Technological Characteristics

Diagnostic ultrasound system utilizing pulsed echo and Doppler imaging. Supports multiple transducer types (curved, linear, phased array, mechanical 3D). Complies with UL 60601-1, IEC 60601-2-37, and ISO 10993-1 (biocompatibility). Features include SieClear spatial compounding, 3-Scape real-time 3D, and eSie Touch elasticity imaging. Connectivity via standard ultrasound interfaces.

Indications for Use

Indicated for ultrasound imaging or fluid flow analysis in patients requiring diagnostic evaluation of abdominal, fetal, small parts (breast, testes, thyroid, etc.), transcranial, OB/GYN, pediatric, urological, vascular, and musculoskeletal structures. Includes automatic breast scanning via 14LSBV transducer. Not for screening mammography. Prescription use only.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Acuson S2000 ultrasound system (K072786)
• U-Systems ultrasound system

Submission Summary (Full Text)

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# DEC 22 2011

### 510(k) Summary Prepared August 27, 2008 Revised December 18, 2008

| Sponsor: | Siemens Medical Solutions USA, Inc..<br>Ultrasound Division<br>1230 Shorebird Way<br>P.O. Box 7393<br>Mountain View, California 94039-7393 | |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Contact Person: | Sheila W. Pickering Ph.D.<br>Telephone:<br>Fax: | [phone]<br>[phone] |
| Submission Date: | April 18, 2008 | |
| Device Name: | Acuson S2000 ABVS Ultrasound System | |
| Common Name: | Diagnostic Ultrasound System with Accessories | |
| Classification:<br>Regulatory Class:<br>Review Category:<br>Classification Panel: | II<br>Tier II<br>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 |

## A. Legally Marketed Predicate Devices

The Acuson S2000 ABVS Ultrasound system is substantially equivalent to the Acuson S2000 ultrassund system (K072786)and the U-Systems ultrasound system.

#### B. Device Description:

The Acuson S2000 ABVS Ultrasound System has been designed to meet the following product safety standards:

- UL 60601-1, Safety Requirements for Medical Equipment .
- I IFC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment D
- AJUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and 이 Mcchanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, 1998 Acoustic Output Measurcment Standard for Diagnostic 1 Ultrasound
- l 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment L
- . EN/IEC 60601-1
- 8 EN/IEC 60601-1-1
- B EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power .
- . ISO 10993-1 Biocompatibility

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#### C. Intended Use

The Modified S2000, the S2000 ABVS Ultrasound System, is intended for the following The Modified Beeral Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, apprications: Contral News Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Supericial Musculoskeletal, and Peripheral Vascular applications. The system supports the Superilean Massantanteretalters for Use tables, including the 14LSBV for Bmode imaging of a patient's breast using an optional automatic scanning function. The device is not intended to be used as a replacement for screening mammography.

The system also provides for the measurement of anatomical structures and analysis as provided in the original S2000 Ultrasound System, which provides information that is used by medical heulth care professionals for clinical diagnosis purposes.

#### I). Substantial Equivalence

The submission device is substantially equivalent to the predicate devices with regard to both intended use and technological characteristics.

### E. Performance Data

The S2000 modifications are verified and validated according to the company's design control process.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 an abstract symbol resembling a stylized caduceus or a representation of the human form.

Public Health Service

# DEC 16 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Shelly Pearce Regulatory Affairs Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way MOUNTAIN VIEW WAY CA 94043-1344

Re: K081148

Trade/Device Name: Acuson S2000 ABVS Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 21, 2008 Received: November 26, 2008

Dear Ms. Pearce:

This letter corrects our substantially equivalent letter of December 22, 2008.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

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

Transducer Model Number

CW2 Probe CW5 Probe EC9-4 Curved Array 9L4 Linear Array 14L5 Multi-D Array 4P1 Phased Array 6C2 Curved Array 4C1 Curved Arrav 4V1 Phased Array

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10V4 Phased Array 14L5 SP Linear Array 7CF2 Curved Array Mechanical 3D 9EVF4 Curved Array V5Ms Multiplane TEE 18L6HD Linear Array 8V3 Phased Array 14L5BV Multi-D Array

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at [phone].

Sincerely yours,

Jope Mr Why

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Special 510(k) Notification
Siemens Ultrasound Division
CONFIDENTIAL

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

K081148

Device Name:

ACUSON S2000 ABVS Ultrasound System

Intended Use:

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

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|--------------------------|------------------------------|---------------------------|-----------------------------------|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitud<br>e<br>Doppler | Color<br>Velocity<br>Imaging | Combin<br>ed<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | P | P | P | P | P | P | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,10, 11,<br>13 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,10, 11,<br>13 |
| Intraoperative<br>(Note 9) | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,10, 11,<br>14 |
| Intraoperative<br>Neurological | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,10, 11,<br>14 |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,10, 11 |
| Small Organ<br>(Note 1) | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,10,<br>11,14 |
| Neonatal<br>Cephalic | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,10 |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note<br>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 |
| Trans-<br>esophageal | | P | P | P | P | P | P | | BMDC | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,10,<br>11,14 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,10, 11 |
| Transurethral<br>Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note2,3,4,5,6,7,8,<br>10, 11,14 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,10,<br>11,14 |

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#### Special 510(k) Notification Siemens Ultrasound Division CONFIDENTIAL

| Musculo-skeletal<br>Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
|-------------------------------------|---|---|---|---|---|------|-------------------------------|
| Other (specify)<br>Neonatal Cardiac | P | P | P | P | P | BMDC | Note 3,4,6 |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 9 For example: vascular, abdominal

Note 10Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear multi-view spatial compounding

Note 13 STIC

Note 14 eSie™ Touch elasticity imaging/FTI

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Aogui m Why

Prescription Use (Per 21 CFR 801.109) 1

(Division/Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K081148

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Special 510(k) Notification Siemens Ultrasound Division CONFIDENTIAL

#### Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

# 14LSBV Multi-D Array Transducer for use with ACUSON S2000 ABVS

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

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|---------------------------|-----------------------|-----------------------------------|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Note 1) | | N | | | | | | | | Note<br>2,3,4,5,7,8,10,<br>11, 14 |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K# 063085; E = added under Appendix E

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

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Special S10(k) Notification Siemens Ultrasound Division CONFIDENTIAL

Note 8 Power SieScape panoramic imaging Note 10Clarify VE vascular enhancement technology Note 11 Advanced Sieclear multi-view spatial compounding Note 14 eSie™ Touch elasticily imaging/FTI

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Hozan M. Wly
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices, 510(k) Number _