ACUSON X300 ULTRASOUND SYSTEM

K072676 · Siemens Medical Solutions USA, Inc. · IYO · Dec 18, 2007 · Radiology

Device Facts

• Record ID: K072676
• Device Name: ACUSON X300 ULTRASOUND SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYO · Radiology
• Decision Date: Dec 18, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Device Story

ACUSON X300 is a multi-purpose diagnostic ultrasound system; utilizes ultrasound transducers to acquire anatomical and fluid flow data; processes signals to generate real-time B-mode, M-mode, pulsed wave Doppler, continuous wave Doppler, color Doppler, and amplitude Doppler images. System includes analysis packages for anatomical measurements; supports advanced imaging modes including ensemble tissue harmonic imaging, 3D imaging, panoramic imaging (SieScape), spatial compounding (SieClear), and tissue equalization. Operated by clinicians in clinical settings; output displayed on system monitor for diagnostic decision-making. Benefits include non-invasive visualization of internal structures and blood flow for clinical diagnosis.

Clinical Evidence

Bench testing only. The device modifications were verified and validated according to the manufacturer's design control process to ensure performance meets safety standards and intended use requirements.

Technological Characteristics

Diagnostic ultrasound system; supports phased array transducers (e.g., P5-1). Imaging modes: B, M, PWD, CWD, Color Doppler, Amplitude Doppler. Features: Ensemble tissue harmonic imaging, 3D imaging, SieScape panoramic imaging, SieClear spatial compounding, Tissue Equalization Technology. Complies with UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-2/UD-3, and ISO 10993-1 biocompatibility standards.

Indications for Use

Indicated for diagnostic imaging or fluid flow analysis of the human body in patients requiring ultrasound assessment across general radiology, fetal, abdominal, intraoperative, pediatric, small parts, neonatal/adult cephalic, cardiac, transesophageal, pelvic, transcranial, OB/GYN, urology, vascular, and musculoskeletal applications.

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

• Siemens Acuson X300 ultrasound system (K071036)
• Siemens Acuson X300 ultrasound system (K061946)

Submission Summary (Full Text)

{0}------------------------------------------------

K072676

Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON X300™ Ultrasound System Special 510(k) Submission

Product Code 74-DQO

## SECTION 11

#### 510(k) Summary

| Sponsor: | Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>1230 Shorebird Way<br>Mountain View, California 94043 | | | DEC 1 8 2007 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------|--|--------------|
| Contact Person: | Martina Vogt | | | |
| | Telephone: | [phone] | | |
| | Fax: | [phone] | | |
| Submission Date: | September 19, 2007 | | | |
| Device Name: | ACUSON X300™ Diagnostic Ultrasound System<br>SONOVISTA X300 Diagnostic Ultrasound System | | | |
| Common Name: | Diagnostic Ultrasound System with Accessories | | | |
| Classification: | | | | |
| Regulatory Class: | II | | | |
| 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 | | |

#### A. Legally Marketed Predicate Devices

Diagnostic Intravascular Catheter

The Siemens Acuson X300 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens Acuson X300 ultrasound system (K071036, K061946).

FR # 870.1200

## B. Device Description:

The Siemens Acuson X300 has been designed to meet the following product safety standards:

- 동 UL 60601-1, Safety Requirements for Medical Equipment
- E IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- I 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
- I 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment
- 트 EN/IEC 60601-1
- . EN/IEC 60601-1-1
- EN/IEC 60601-1-2
- 트 IEC 61157 Declaration of Acoustic Power
- 1 ISO 10993-1 Biocompatibility

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

## C. Intended Use

The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

## D. Substantial Equivalence

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

## E. Performance Data

The Acuson X300 modifications are verified and validated according to the company's design control process.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top half of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 8 2007

Ms. Martina Vogt Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 1230 Shorebird Way MOUNTAIN VIEW CA 94043

Re: K072676

Trade/Device Name: ACUSON X300 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and DQO Dated: November 14, 2007 Received: November 15, 2007

Dear Ms. Vogt:

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 X300 Diagnostic Ultrasound Systems, as described in your premarket notification:

## Transducer Model Number

## P5-1 Phased 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

{3}------------------------------------------------

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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html

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

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

## SECTION 7

# Intended Use of the Device

## Intended Use:

The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

forui Thihhay

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _ HO72 Co

{5}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

## ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

Diagnostic 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 | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Intraoperative<br>(Note 6) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Intraoperative<br>Neurological | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Small Organ<br>(Note 1) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transesophageal | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9 |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transurethral | | | | | | | | | | |
| Intravascular | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Other (specify) | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |

N = new indication; P = previously cleared by K071036; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

- Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

- SieClear multi-view spatial compounding Note 8
- Tissue Equalization Technology Note 9
- Note 10 Intracardiac imaging

etc.
(Division Sign-Off)

Division of Reproductive, Abdominal Radiological Devices 510(k) Number J KO + 26

(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)

{6}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

P5-1 Phased Array Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems Diagnostic 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 | N | | BMDC | Note 2,3,4,5,7,8,9 |
| Abdominal | | N | N | N | N | N | N | | BMDC | Note 2,3,5,6,7,8,9 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,9 |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,9 |
| Adult Cephalic | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,9 |
| Cardiac | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,9 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N = new indication; P = previously cleared by FDA; E = added under Appendix/E<br>Note 1 For example: breast, testes, thyroid, penis, prostate, etc.<br>Note 2 Ensemble tissue harmonic imaging<br>Note 3 3D imaging | | | | | | | | | | |

vote B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Note 8 SieClear multi-view spatial compounding

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices

Radiological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

(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)