ACUSON P50 ULTRASOUND SYSTEM

K083114 · Siemens Medical Solutions USA, Inc. · IYN · Mar 31, 2009 · Radiology

Device Facts

• Record ID: K083114
• Device Name: ACUSON P50 ULTRASOUND SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Mar 31, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Acuson P50 Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. The system includes the AcuNav 10F and 8F transducers which are intended for intra-cardiac and intra-luminal visualization of the cardiac and great vessel anatomy and physiology as well as the visualization of other devices in the heart of adult and pediatric patients. The system also includes the SieClear application. SieClear improves contrast resolution when using linear-type transducers by interrogating the target tissue from different imaging angles and adding these images together to create a composite image. This is performed in real-time.

Device Story

Acuson P50 is a diagnostic ultrasound system; utilizes AcuNav 10F and 8F transducers for intra-cardiac and intra-luminal imaging; inputs include acoustic signals from human tissue; system processes signals to produce real-time anatomical and physiological visualizations; includes SieClear application for contrast resolution enhancement via multi-angle spatial compounding; used in clinical settings by healthcare professionals; output assists in visualization of cardiac anatomy and device placement; benefits include improved diagnostic clarity and guidance for interventional procedures.

Clinical Evidence

No clinical data provided. Performance verified and validated via bench testing and design control processes.

Technological Characteristics

Diagnostic ultrasound system; supports B, M, PWD, CWD, Color Doppler, and combined modes; includes SieClear spatial compounding; 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 ultrasound imaging and fluid flow analysis in adult and pediatric patients. Clinical applications include cardiac, pediatric, and intra-cardiac/intra-luminal visualization of anatomy, physiology, and devices in the heart and great vessels.

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

• P50 ultrasound system (K072266)

Submission Summary (Full Text)

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K083114
Page 1 of 2

2009

#### 510(k) Summary Prepared October 13, 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. | | | |
| | Telephone: | [phone] | | |
| | Fax: | [phone] | | |
| Submission Date: | October 13, 2008 | | | |
| Device Name: | Siemens Acuson P50 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 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

The Acuson P50 Ultrasound system is substantially equivalent to the P50 ultrasound system (K072266).

#### B. Device Description:

The Siemens Acuson P50 system has been designed to meet the following product safety 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 ■
- 미 AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic ■ Ultrasound
- 트 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment 미
- 트 EN/IEC 60601-1
- EN/IEC 60601-1-1
- I EN/IEC 60601-1-2
- I IEC 1157 Declaration of Acoustic Power
- 마 ISO 10993-1 Biocompatibility

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KC83114
Page 2 of 2

The Acuson P50 Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. The system includes the AcuNav 10F and 8F transducers which are intended for intra-cardiac and intra-luminal visualization of the cardiac and great vessel anatomy and physiology as well as the visualization of other devices in the heart of adult and pediatric patients. The system also includes the SieClear application. SieClear improves contrast resolution when using linear-type transducers by interrogating the target tissue from different imaging angles and adding these images together to create a composite image. This is performed in real-time.

## D. 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 P50 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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sheila W. Pickering, Ph.D. Senior Director of Regulatory Affairs Siemens Medical Solutions USA, Inc. 1230 Shorebird Way, P.O. Box 7393 MOUNTAIN VIEW CA 94039

MAR 3 1 2009

Re: K083114

Trade/Device Name: ACUSON P50 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: March 4, 2009 Received: March 6, 2009

Dear Dr. Pickering:

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 P50 Diagnostic Ultrasound Systems, as described in your premarket notification:

#### Transducer Model Number

## AcuNav 10F Intracardiac AcuNav 8F Intracardiac

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.

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Page 2 - Dr. Pickering

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 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,

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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# Indications for Use

510(k) Number (if known): Device Name: ACH, SON P50 UHRAssund System

Indications For Use:

The Acuson P50 Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. The system includes the AcuNav 10F and 8F transducers which are intended for intra-cardiac and intra-luminal visualization of the cardiac and great vessel anatomy and physiology as well as the visualization of other devices in the heart of adult and pediatric patients. The system also includes the SieClear application. SieClear improves contrast resolution when using linear-type transducers by interrogating the target tissue from different imaging angles and adding these images together to create a composite image. This is performed in real-time.

Prescription Use (Part 21 CFR 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 Device Evaluation (ODE)

| (Division Sign Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K083114 |

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## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

| System: | ACUSON P50 Ultrasound System | | | | | | | |
|-----------------------------|--------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|-------------|--------------|--------|
| Transducer: | (see comments) | | | | | | | |
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General | Specific | B | M | PWD | CWD | Color Doppa | Comb. Modesb | Otherc |
| (Track I Only) | (Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | Pd | P | P | | Pd | P | Pd |
| | Abdominal | Pd | P | P | | Pd | P | Pd |
| | Intra-operative (Spec.)e | Pd | P | P | | Pd | P | Pd |
| | Intra-operative (Neuro) | P | P | P | | P | P | P |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | Pd | P | P | | Pd | P | Pd |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | Pd | P | P | | Pd | P | Pd |
| | Neonatal Cephalic | P | P | P | P | P | P | P |
| | Adult Cephalic | P | P | P | P | P | P | P |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | Pd | P | P | | Pd | P | Pd |
| | Musculo-skel. (Superfic) | Pd | P | P | | Pd | P | Pd |
| | Intra-luminall | P | P | P | P | Pd | P | P |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | P | P | Pt | P | Pg | P | P |
| Cardiac | Cardiac Pediatric | P | P | Pt | P | Pg | P | P |
| | Trans-esoph. (Cardiac) | P | P | P' | P | Pg | P | P |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | Pd | P | P | | P | P | Pd |
| | Other (Specify) | | | | | | | |

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

8 Includes Color Doppler (CD) and (non-directional) Power Doppler.

8 B+M; B+PWD; B+CWD; B+CD; B+PD.

° Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles & catheters,

് Abdominal organs and peripheral vessel.

' PW includes PW Doppler Tissue Imaging (DTI).

9 includes Doppler Tissue Imaging (DTI) .

Includes uses in military field settings in addition to hospital/clinic settings.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concerrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)

(Division Sign-O)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K083114

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K08 3//4

Diagnostic Ultrasound Indications for Use Form

083114

510(k) Number (if known):

Device Name:

Intended Use:

AcuNav 10F Intracardiac Transducer for use with : ACUSON P50 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 | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9, 10 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Intra-cardiac) | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |

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

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

- Note 2 Ensemble tissue harmonic imaging
- Note 3 3D imaging
- B&W SieScape panoramic imaging Note 4
- Power SieScape panoramic imaging Note 5
- Note 6 For example: abdominal, vascular
- Note 7 Contrast agent imaging
- Note 8 SieClear multi-view spatial compounding
- Tissue Equalization Technology Note 9
- Note 10 Intracardiac imaging

**Prescription Use**
(Per 21 CFR 801.109)

Stell (Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devic

0 A

510(k) Number

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K083//4

#### Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

083114

Device Name:

Intended Use:

AcuNav 8F Intracardiac Transducer for use with : ACUSON P50 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 | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Intra-cardiac) | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |

N = new indication; P = previously deared by Kxxxxxx; E = added under Appendix E

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

- Note 2 Ensemble tissue harmonic imaging
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
- Note 8 SieClear multi-view spatial compounding
- Note 9 Tissue Equalization Technology
- Note 10 Intracardiac imaging

**Prescription Use**
(Per 21 CFR 801.109)

(Division Sign Off) Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number

036