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 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; 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; 93/42/EEC Medical Devices Directive; Safety and EMC Requirements for Medical Equipment; EN/IEC 60601-1; EN/IEC 60601-1-1; EN/IEC 60601-1-2; IEC 1157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.

AI/ML Overview

The provided text describes the Siemens Acuson P50 Ultrasound System. However, it does not include specific acceptance criteria or an explicit study proving the device meets performance criteria as typically found in a clinical performance study. Instead, it details regulatory compliance, predicate device information, and a summary of the system's intended use and technical features.

The "Performance Data" section ([1]E. Performance Data) simply states: "The P50 modifications are verified and validated according to the company's design control process." This is a general statement about internal quality processes, not a report of a specific study with defined acceptance criteria and results.

Therefore, many of the requested details cannot be extracted from the provided document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document states "The P50 modifications are verified and validated according to the company's design control process," but does not list specific performance metrics or thresholds.	Not specified in the document. No quantitative performance data (e.g., sensitivity, specificity, accuracy, image quality scores) is provided that could be compared against acceptance criteria.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: Not mentioned or indicated. The document focuses on the ultrasound system and its transducers, not on AI-assisted interpretation.
Effect size: Not applicable as no such study is presented.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Performance Study: Not mentioned or indicated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: Not specified.

8. The sample size for the training set:

Sample Size: Not specified.

9. How the ground truth for the training set was established:

Ground Truth Establishment: Not specified.

In summary, the provided submission focuses on regulatory compliance, outlining the device's technical specifications, intended uses, and substantial equivalence to a predicate device, rather than providing detailed clinical performance study results with acceptance criteria. The "Performance Data" section is a general statement about internal validation processes, not a report of specific study findings.

Summary

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K083114
Page 1 of 2

2009

510(k) Summary Prepared October 13, 2008

Sponsor:	Siemens Medical Solutions USA, Inc.,Ultrasound Division1230 Shorebird WayP.O. Box 7393Mountain View, California 94039-7393
Contact Person:	Sheila W. Pickering Ph.D.
	Telephone:	(650) 943 7187
	Fax:	(650) 943 7053
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

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 (240) 276-3666.

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:

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
FetalImaging& Other	Pediatric	Pd	P	P		Pd	P	Pd
	Small Organ (Thyroid,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)
PeripheralVessel	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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10
Small Organ(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-skeletalConventional
Musculo-skeletalSuperficial
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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10
Small Organ(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-skeletalConventional
Musculo-skeletalSuperficial
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

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.