Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description of the SieClear application details a deterministic image processing technique (combining images from different angles) and does not mention any AI/ML components. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".

Therapeutic

No.
The device is clearly stated as "intended for diagnostic ultrasound imaging" and "visualization", which indicate diagnostic rather than therapeutic use.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "The Acuson P50 Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "Ultrasound System" and includes "transducers," which are hardware components essential for ultrasound imaging. The description also lists compliance with hardware safety standards (UL 60601-1, IEC 60601-2-37, etc.). While it mentions a software application ("SieClear"), the overall device is a hardware-based ultrasound system with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Acuson P50 Ultrasound System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states "diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes a device that performs imaging on the body, not on samples taken from the body.
Device Description: The description focuses on the system's components and compliance with safety standards for medical equipment used for imaging.
Input Imaging Modality: The input is "Diagnostic ultrasound imaging," which is a non-invasive imaging technique applied externally or internally to the body.
Anatomical Site: The anatomical sites listed are all locations within the human body.

IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The Acuson P50 system operates by sending and receiving ultrasound waves to create images of internal structures, which is a different type of diagnostic process.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

90-IYN, 90-IYO, 90-ITX

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

Mentions image processing

Yes, "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." and "SieClear multi-view spatial compounding".

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Diagnostic ultrasound imaging; fluid flow analysis

Anatomical Site

Human body; cardiac and great vessel anatomy; heart; Ophthalmic; Fetal; Abdominal; Intra-operative (Spec.); Intra-operative (Neuro); Laparoscopic; Pediatric; Small Organ (Thyroid, Breast, Testes, etc.); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Trans-urethral; Trans-esoph. (non-Card.); Musculo-skel. (Convent.); Musculo-skel. (Superfic); Intra-luminal; Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Peripheral vessel; Intravascular

Indicated Patient Age Range

Adult and pediatric patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The P50 modifications are verified and validated according to the company's design control process.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072266

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

K083114
Page 1 of 2

2009

510(k) Summary Prepared October 13, 2008

| Sponsor: | Siemens Medical Solutions USA, Inc.,
Ultrasound Division
1230 Shorebird Way
P.O. Box 7393
Mountain 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

1

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.

2

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.

3

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)

4

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

5

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
Imaging
& 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)
Peripheral
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

6

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
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
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

7

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
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
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