The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.

The AcuNav 8F and 10F Ultrasound Catheter, ACUSON AcuNav™ V 10F Ultrasound Catheter, ACUSON AcuNav™ Volume 12F Ultrasound Catheter, SoundStar™ 8F Ultrasound Catheter, SoundStar™ 10F Ultrasound Catheter, SoundStar™ eco 8F Ultrasound Catheter, and SoundStar™ eco 10F Ultrasound Catheter are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. Catheters are intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

Device Description

The ACUSON SC2000 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode. M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display. The transducer and catheter based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a).

Additional features for the ACUSON SC2000 v5.1 update includes the Joystick remote control accessory that is intended to be used for interventional procedures with the ACUSON AcuNav Volume ICE catheter where remote control of the cursor is desired. The joystick plugs into the system and allows selected control panel and cursor events to be triggered via joystick movement and button-press.

AI/ML Overview

This is a premarket notification (510k) for the ACUSON SC2000 Diagnostic Ultrasound System. The information provided heavily references previous clearances for substantial equivalence rather than presenting new studies with acceptance criteria explicitly defined for the current submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics for this specific 510(k) submission (K181098). Instead, it relies on the substantial equivalence to previously cleared devices. The "Features on SC2000 System" table in Section 6.1 (pages 25-26) implicitly acts as a comparison to the predicate device, showing that the current device either has the same feature (√) or improved features (e.g., "Updated TEQ", "Added Manual Trace", "New" features). The "Frequencies Supported" are identical across the three compared devices for most applications.

The acceptance criteria here are implicit and based on the predicate device's established performance, meaning the new device must perform at least as well as, or be substantially equivalent to, the predicate in all relevant aspects.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "clinical studies were not required to support substantial equivalence" (Part 8, page 29). Therefore, there is no test set sample size mentioned, nor any data provenance (country of origin, retrospective/prospective). The submission relies on non-clinical tests (acoustic output, biocompatibility, safety standards compliance) and comparison to predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since no clinical studies were performed for this submission, there is no mention of experts or their qualifications for establishing ground truth. The substantial equivalence is based on technical specifications and adherence to recognized standards.

4. Adjudication Method for the Test Set:

As no clinical studies were conducted, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MrMC comparative effectiveness study was done or reported as clinical studies were deemed unnecessary due to substantial equivalence to predicate devices. Therefore, no effect size of human reader improvement with AI vs. without AI assistance is mentioned.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study:

No standalone performance study of an algorithm is described or reported. The device is an ultrasound system with accessories, not an AI/algorithm-only product.

7. Type of Ground Truth Used:

For this 510(k) submission, the "ground truth" is established through adherence to recognized medical device safety standards (e.g., AAMI / ANSI ES60601-1, IEC series, ISO 10993-1) and comparison of technological characteristics to already cleared predicate devices. Clinical outcomes data or expert consensus for new evaluations were not used for this submission's substantial equivalence determination.

8. Sample Size for the Training Set:

The document does not mention any training set or its sample size, as it does not involve a de novo AI/ML model development requiring such data for this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established:

Since no training set is discussed, the method for establishing its ground truth is not provided.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 31, 2018

Siemens Medical Solutions USA, Inc % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

Re: K181098

Trade/Device Name: ACUSON SC2000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: May 24, 2018 Received: May 25, 2018

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Barlupo

for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181098

Device Name

ACUSON SC2000 Diagnostic Ultrasound System

Indications for Use (Describe)

The typical examinations performed using the SC2000 Ultrasound System are:

Cardiac Imaging Applications and Analysis

The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, MMode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heail, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system also supports catheters which are intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. Catheters are intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Vascular Imaging Applications and Analysis

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchromizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Superficial Imaging Applications

Intraoperative Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.

Transcranial Imaging Applications

The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Dopler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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Prescription Use (Part 21 CFR 801 Subpart D)

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Diagnostic Ultrasound Indications for Use Form (Per Appendix G, FDA Ultrasound Guidance)

510(k) Number (if known): K181098

Device Name: SC2000 Diagnostic Ultrasound System

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:HarmonicImaging	Other:3D	Other:RealTime3D
Ophthalmic
Fetal	P	P	P	P	P	P	P		P*	P		P
Abdominal	P	P	P	P	P	P	P		P*	P	P
IntraoperativeAbdominal	P	P	P	P	P	P	P		P*	P
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P		P*	P	P	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic	P	P	P	P	P	P	P		P*	P
Cardiac	P	P	P	P	P	P	P		P*	P	P	P
Trans-esophageal	P	P	P	P	P	P	P		P*		P
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P	P		P*				P
Peripheral Vessel	P	P	P	P	P	P	P	P	P*	P
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	P	P		P*	P
Musculo-skeletalSuperficial	P	P	P	P	P	P	P		P*	P
Other (NeonatalCardiac)	P	P	P	P	P	P	P		P*	P
Other (Intra-Cardiac)	P	P	P	P	P	P	P		P*				P
Other(AbdominalVascular)	P	P	P	P	P	P	P		P*	P

N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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510(k) Number (if known): K181098

CW2 Device Name:

Intended Use:

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric					P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel					P
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=new indication. Previously Cleared in 510(k) K162221, K170315, K171766

Additional Comments:

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4Z1c

510(k) Number (if known): K181098

Device Name:

Intended Use:

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other:HarmonicImaging	Other:RealTime3D
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P	P
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P*	P	P
Small Organ(specify) **
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P*	P	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766

Additional Comments:

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510(k) Number (if known): K181098

Device Name: 4V1c

Intended Use:

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P	P *	P
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	P *	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic	P	P	P	P	P	P	P	P *	P
Cardiac	P	P	P	P	P	P	P	P *	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (NeonatalCardiac)	P	P	P	P	P	P	P	P *	P

N=new indication. Previously Cleared in 510(k) K162221, K170315, K171766

Additional Comments:

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510(k) Number (if known): K181098

Device Name: VSMs

Intended Use:

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

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other:3D
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P*	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P*	P
Trans-esophageal	P	P	P	P	P	P*	P
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766

Additional Comments:

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6C1HD

510(k) Number (if known): K181098

Device Name:

Intended Use:

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal	P	P	P	P	P	P	P	P*	P
Intraoperative
Pediatric	P	P	P	P	P	P	P	P*	P
Small Organ(specify)	P	P	P	P	P	P	P	P*	P
NeonatalCephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel	P	P	P	P	P	P	P	P*	P
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other(AbdominalVascular)	P	P	P	P	P	P	P	P*	P

N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766

Additional Comments:

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Z6Ms

510(k) Number (if known): K181098

Device Name:

Intended Use:

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other:HarmonicImaging	Other:RealTime3D
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P*	P	P
Trans-esophageal	P	P	P	P	P	P	P*	P	P
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766

Additional Comments:

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V7M

510(k) Number (if known): K181098

Device Name:

Intended Use:

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:HarmonicImaging	Other:3D
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P*	P	P
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	P*		P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P*		P
Trans-esophageal	P	P	P	P	P	P	P	P*		P
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766

Additional Comments:

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8V3

510(k) Number (if known): K181098

Device Name:

Intended Use:

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

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P*	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P*	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (NeonatalCardiac)	P	P	P	P	P	P	P*	P

N=new indication. Previously Cleared in 510(k) K162221, K170315, K171766

Additional Comments:

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9L4

510(k) Number (if known): K181098

Device Name:

Indications for Use:

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

ClinicalApplication	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel	P	P	P	P	P	P	P*	P
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	P	P*	P
Musculo-skeletalSuperficial	P	P	P	P	P	P	P*	P
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766

Additional Comments:

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10V4

510(k) Number (if known): K181098

Device Name:

Intended Use:

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal	P	P	P	P	P	P	P	P*	P
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	P*	P
Small Organ(specify)
Neonatal
CephalicAdult Cephalic
Cardiac	P	P	P	P	P	P	P	P*	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (NeonatalCardiac)	P	P	P	P	P	P	P	P*	P

N=new indication. Previously Cleared in 510(k) K162221, K170315, K171766

Additional Comments:

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510(k) Number (if known): K181098

Device Name:

AcuNav 8F and 10F Ultrasound Catheter

Intended Use:

Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients as follows:

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Other:HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	P*
Small Organ(specify) **
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P*
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P	P	P*
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)	P	P	P	P	P	P	P	P*

N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler

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510(k) Number (if known): K181098

Device Name:

ACUSON AcuNav™ V 10F Ultrasound Catheter

Intended Use:

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:RealTime3D
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P*	P
Small Organ(specify) **
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P*	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P	P*	P
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)	P	P	P	P	P	P	P*	P

N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766

Additional Comments:

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510(k) Number (if known): K181098

Device Name:

ACUSON AcuNav™ Volume 12F Ultrasound Catheter

Intended Use:

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:RealTime3D
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	P*	P
Small Organ(specify) **
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P*	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P	P	P*	P
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)	P	P	P	P	P	P	P	P*	P

N=new indication. P = Previously Cleared in 510(k) K173618

Additional Comments:

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510(k) Number (if known): K181098

Device Name:

SoundStar™ 8F Ultrasound Catheter

Intended Use:

Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(specify) **
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P*
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P	P	P*
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)	P	P	P	P	P	P	P	P*

N=new indication. P = Previously Cleared in 510(k) K140318**

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, ** Biosense Webster Inc. 510(k) Clearance.

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510(k) Number (if known): K181098

Device Name:

SoundStar™ 10F Ultrasound Catheter

Intended Use:

Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)

Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(specify) **
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P*
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal		P	P	P	P	P	P	P*
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)		P	P	P	P	P	P	P*

N=new indication. P = Previously Cleared in 510(k) K112050**, K162221, K170315, K171766

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, **Biosense Webster Inc. 510(k) Clearance.

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510(k) Number (if known): K181098

Device Name:

SoundStar™ eco 8F Ultrasound Catheter

Intended Use:

Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(specify) **
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P*
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P	P	P*
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)	P	P	P	P	P	P	P	P*

N=new indication. P = Previously Cleared in 510(k) K163396, K140318**

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, **Biosense Webster Inc. 510(k) Clearance.

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510(k) Number (if known): K181098

Device Name:

SoundStar™ eco 10F Ultrasound Catheter

Intended Use:

Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(specify) **
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P*
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P	P	P*
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)	P	P	P	P	P	P	P	P*

N=new indication. P = Previously Cleared in 510(k) K163396, K140318**

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, **Biosense Webster Inc. 510(k) Clearance.

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1.1.2 510(k) Summary

Date:	March 12, 2018
Updated:	May 23, 2018
Part 1. Sponsor:	Siemens Medical Solutions USA, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043
Contact Person:	Christine DunbarTel: (925) 374-2045
Part 2. Device Name:	ACUSON SC2000 Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class: IIReview Category: Tier IIClassification Panel: 90, Radiology
	Ultrasonic Pulsed Doppler Imaging System 892.1550 90-IYN
	Ultrasonic Pulsed Echo Imaging System 892.1560 90-IYO
	Diagnostic Ultrasound Transducer 892.1570 90-ITX
	Diagnostic Intravascular Catheter 892.1200 90-OBJ
Manufacturing Site:	2500 Millbrook Drive, Suite B Buffalo Grove, Illinois USA
Legal Manufacturer:	Siemens Medical Solutions USA, Inc.685 East Middlefield RoadMountain View, CA 94043

Part 3. Legally Marketed Predicate Devices

The ACUSON SC2000 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the company's own products, the ACUSON SC2000, v5.0 under K171766, is the primary predicate device. Additionally, the currently cleared ACUSON AcuNav™+ Volume Intracardiac Echocardiography (or ICE) Catheter (K173618) and support for the catheter updates to the currently cleared Biosense Webster SoundStar™ catheters (eco versions) are intended to be included in the transducers and catheter accessories provided with the ACUSON SC2000 Diagnostic Ultrasound System.

1 ACUNAV™ is a trademark of Siemens Medical Solutions USA, Inc.

ACUSON SC2000 Diagnostic Ultrasound System 510(k) Submission

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Part 4. Device Description

During intracardiac imaging with ultrasound catheters, the ultrasound system is not within the sterile environment. You can use the joystick remote control within the sterile environment as an alternative to using the control panel on the ultrasound system. The joystick does not control the ultrasound catheter.

Part 5. Intended Use and Indications for Use Statements

5.1 SC2000 Diagnostic Ultrasound System, VB21A (v5.1)

The typical examinations performed using the SC2000 Ultrasound System are:

Cardiac Imaging Applications and Analysis

The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, MMode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. Catheters are intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Vascular Imaging Applications and Analysis

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anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Superficial Imaging Applications

Intraoperative Imaging Applications

Transcranial Imaging Applications

The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology.

The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

5.2 Intended Use - ACUSON AcuNav Volume Intracardiac Echocardiography Catheter (K173618) as cleared and is as follows:

The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

The catheter is intended for imaging quidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

5.3 Intended Use - Biosense Webster Inc. SoundStar eco Diagnostic Ultrasound Catheter 8F & 10F, (Part Number M-5723-17 / Catalogue Number 10439011, compatible with Siemens Ultrasound Systems (K140318) as cleared and is as follows:

The Biosense Webster SOUNDSTAR® eco Diagnostic Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO®D 3 EP Navigation Systems, the SOUNDSTAR® eco Catheter provides location information.

Part 6. Summary of Technological Characteristics

6.1 The ACUSON SC2000 VB21A (v5.1) Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the company's own products, the ACUSON SC2000 VB20A (v5.0) (K171766) and the ACUSON AcuNav™ Volume ICE Catheter (K173618) with regard to both intended use and technological characteristics. Both the subject ultrasound system and the predicate ultrasound

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system function in the same manner as all diagnostic ultrasound systems and transducers including cardiac catheters.

The foundation of the ACUSON SC2000 VB21A (5.1) is the SC2000 VB20A (5.0) release with features and transducers integrated with the ACUSON SC2000 hardware and the updated v5.1 software developed for SC2000 platform. The updated SC2000 system VB21A includes the same currently cleared transducers and catheters in addition to the currently cleared ACUSON AcuNav Volume ICE Catheter and also supporting the SoundStar™ eco 8F and eco 10F Diagnostic Ultrasound Catheters which are developed, manufactured and distributed by Biosense Webster, Inc. under multiple clearances. In addition, the v5.1 update includes a new optional Joystick remote control accessory that plugs into the system and allows selected control panel and cursor events to be triggered via joystick movement and button-press. The joystick is extension of the keyboard. It works everywhere where these functions are available and with all transducers.

It is Siemens' opinion that the ACUSON SC2000 VB21A (v5.1) is substantially equivalent to the predicate devices with regard to both intended use, indications for use and technological characteristics.

Feature / Characteristic	ACUSON SC2000 v5.1IncludingTransducersThis Submission	ACUSON SC2000 5.0K171766 IncludingTransducers &AcuNav V ICECatheter & 3rd PartyCatheters.	ACUSON AcuNavVolume ICE CatheterK173618
Indications for Use:
Fetal	√	√	--
Abdominal	√	√	--
Pediatric	√	√	--
Small Organ	√	√	--
Cardiac	√	√	√
Peripheral vessel	√	√	--
Musculo-skeletal(conventional)	√	√	--
Musculo-skeletal(superficial)	√	√	--
Frequencies Supported:	√(1.7MHz~10MHz)	√(1.7MHz~10MHz)	√(4.0MHz~10MHz)
Modes:
B	√	√	√
M	√	√	--
PWD (Pulsed WaveDoppler)	√	√	√
CWD (Continuous WaveDoppler)	√	√	√
Feature / Characteristic	ACUSON SC2000 v5.1IncludingTransducersThis Submission	ACUSON SC2000 5.0K171766 IncludingTransducers &AcuNav V ICECatheter & 3rd PartyCatheters.	ACUSON AcuNavVolume ICE CatheterK173618
PW DTI (Doppler TissueImage)	√	√	√
Color Doppler	√	√	√
Color Power Doppler (CPD)	√	√	√
Combined (BMDC)	√	√	--
Features on SC2000 System:
Native™ tissue harmonicimaging (2D Brightnessmode)	√(Harmonic imaging)	√	--
TEQ™ ultrasoundtechnology	√(Updated TEQ)	√	--
Volume ICE Package	√	√	√
Support for AcuNavVolume ICE Catheterconnected by SwiftLinkcable.	√	AcuNav V ICECatheter connectedby SwiftLinkCatheter supported.	√
2D ICE Package	√	√	√
True Volume ImagingSupport	√	AcuNav V ICE Catheter90° x 24° real-timevolume imaging.	AcuNav Volume ICECatheter90° x 50° real-timevolume imaging.
Volume Color Doppler	√	√	--
Fetal Echo Calculations	√	√	--
Fetal Imaging Presets	√	√	--
Cardiac Imagingphysiological signaldisplay	√	√	--
eSie Measure	√	√	--
Advanced SieClear™spatial compounding	√	√	--
Clarify™ vascularenhancement technology	√	√	--
syngo ® Velocity VectorImaging (eSie VVI)	√	√	--
eSie Flow Quantification	Z6Ms & 4Z1c & P6	Z6Ms & 4Z1c	--
eSie Valves AdvancedMeasurement Package	√	√	--
eSie LVA	√	√	--
eSie PISA	√	√	--
Feature / Characteristic	ACUSON SC2000 v5.1IncludingTransducersThis Submission	ACUSON SC2000 5.0K171766 IncludingTransducers &AcuNav V ICECatheter & 3rd PartyCatheters.	ACUSON AcuNavVolume ICE CatheterK173618
eSie Left HeartMeasurement Package	Added Manual Trace	√	--
Volume Right VentricularAnalysis (RVA)	√	√	--
Stress Echo Package	√	√	--
Rapid Stress VolumeStress Echo App.	√	√	--
Cardiac Measurementsand Calculations	√	√	--
syngo ® TrueFusion	√	√	--
Contrast Agent Imaging	√	√	--
Zoom & Pan	√	√	--
eSieScan(Protocols)	√	√	--
InFocus CoherentTechnology	√	--	--
DICOM	√	√	--
DICOM SR	√	√	--
Wireless	√	√	--
Table Side Remote ControlJoy Stick	New	--	--
Circle Tool	New	--	--
Motherboard Upgrade	NewMBM250	√MBM201+	--
Mechanical column upgrade	Lighter	--	--
Aluminum Card Cage	Weight reduction by 25lbs	--	--
Monitor: 21" FPD	√	√	--
Output Display Standard(Track 3)	√	√	--
Patient Contact Materials	Tested to ISO 10993-1	Tested to ISO 10993-1	Tested to ISO 10993-1
UL 60601-1 Certified	√	√	√
Indications for Use	√	√	√
AcuNav™ V ICE Catheter	Supported	√	Currently clearedK170992
AcuNav™ Volume ICECatheter (aka P6)	√	No	Currently cleared,K173618 on 12/19/2017
Feature / Characteristic	ACUSON SC2000 v5.1IncludingTransducersThis Submission	ACUSON SC2000 5.0K171766 IncludingTransducers &AcuNav V ICECatheter & 3rd PartyCatheters.	ACUSON AcuNavVolume ICE CatheterK173618
Supports Third party USCatheters with Swift-Linkconnector:	√	√	N/A
SoundStarTM eco 8 Frenchcatheter2	√	No	N/A
SoundStarTM eco 10 Frenchcatheter	√	No	N/A
SoundStarTM 8 Frenchcatheter3	√	√	N/A
SoundStarTM 10 Frenchcatheter	√	√	N/A
SwiftLink Connector	√	√	√
CARTOSOUND4 SW Module&CARTO 3 System	√	SoundStar 2D ICEOnly.	-

6.2 - List of Technological Characteristics and SE Comparison Table

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Part 7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and have been found to conform to applicable medical device safety standards. The ACUSON SC2000 Ultrasound system complies with the following standards:

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and . A2:2010/(R) 2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements For Basic Safety ● And Essential Performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2: 2007(Third Edition), Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-2-37:2007+A1:2015, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasound medical diagnostic and monitoring equipmen.t
IEC 60601-2-18:2009, Medical electrical equipment Part 2: Particular requirements ● for the safety of endoscopic equipment.

4 SoundStar and SoundStar eco catheters are products of Biosense Webster, Inc. (A Johnson company) holds the 510(k) clearances for these devices.

3 SoundStar and SoundStar eco catheters are products of Biosense Webster. Inc. (A Johnson company) holds the 510(k) clearances for these devices.

4 CARTOSOUND Module and CARTO 3 System are products of Biosense Webster, Inc. (A Johnson & Johnson company) holds the 510(k) clearances for these devices.

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IEC 62304:2006 Medical Device Software - Software Life Cycle Processes
AIUM/NEMA UD-3:2004, Standard for Real Time Display of Thermal and Mechanical ● Acoustic Output Indices on Diagnostic Ultrasound Equipment.
AIUM/NEMA UD-2:2004, Acoustic Output Measurement Standard for Diagnostic ● Ultrasound Equipment.
ISO 10993-1:2009, Biological evaluation of Medical Devices ●
IEC 62366:2014, Medical Devices - Application of Usability
IEC 62359:2010, Ultrasonics - Field characterization - Test Methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields.

Part 8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.

Since the ACUSON SC2000 VB21A (v5.1) Diagnostic Ultrasound System with the AcuNav Volume ICE Catheter use the same technology and principles as the existing predicate devices SC2000, VB20A (v5.0) K171766, and AcuNav Volume ICE Catheter (K173618) respectively, clinical studies were not required to support substantial equivalence.

Part 9. Summary

Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms to 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. The SC2000 Diagnostic ultrasound systems have accumulated a long history of safe and effective performance.

Therefore, it is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON SC2000 VB21A (v5.1) system including the ACUSON AcuNav Volume ICE Catheter accessory, is substantially equivalent with respect to safety and effectiveness to the currently cleared predicate devices for the U.S. market.

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.