Acuson SC2000 Diagnostic Ultrasound System

K211726 · Siemens Medical Solutions USA, Inc. · IYO · Nov 5, 2021 · Radiology

Device Facts

Record IDK211726
Device NameAcuson SC2000 Diagnostic Ultrasound System
ApplicantSiemens Medical Solutions USA, Inc.
Product CodeIYO · Radiology
Decision DateNov 5, 2021
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1560
Device ClassClass 2
AttributesAI/ML, Pediatric

Intended Use

The SC2000 ultrasound imaging system is intended for the following applications: 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.

Device Story

Multi-purpose mobile diagnostic ultrasound system; transmits/receives ultrasound echo data; displays B-Mode, M-Mode, PW/CW Doppler, Color Doppler, Color M Mode, Doppler Tissue Mode, Amplitude Doppler, and Harmonic Imaging. Used in clinical settings by physicians/technicians. Integrates with Siemens Axios Fluoroscopy system via syngo TrueFusion 2.0 software for real-time Live Image Overlay. Acquires ECG signals for image synchronization. Provides measurement/calculation packages for anatomical structures. Output viewed on display to assist clinicians in evaluating pathology and guiding interventional procedures. Benefits include enhanced visualization and diagnostic support.

Clinical Evidence

No clinical data; bench testing only. System validated on phantoms by clinical personnel. Verification testing included component, integration, and system-level testing per Siemens Product Lifecycle Procedure (PLP). Compliance with safety standards (IEC 60601 series, ISO 10993-1) confirmed.

Technological Characteristics

Multi-purpose ultrasound system; frequencies 1.7MHz–10MHz. Supports phased, linear, and curved array transducers and ICE catheters. Connectivity: DICOM, wireless, WiFi EAP-TLS. Software: Windows 10 OS. Patient contact materials tested to ISO 10993-1. Safety: UL 60601-1 certified, Track 3 acoustic output labeling (AIUM/NEMA UD-2/UD-3).

Indications for Use

Indicated for adult, pediatric, neonatal, and fetal cardiac patients; adult patients for vascular, superficial, intraoperative, and transcranial imaging. Used for visualization of anatomy, physiology, and pathology; guidance during interventional procedures. Contraindications not specified.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Siemens Medical Solutions USA, Inc. % Christine Dunbar Senior Regulatory Affairs Specialist 685 East Middlefield Road MOUNTAIN VIEW CA 94043 November 5, 2021 ## Re: K211726 Trade/Device Name: ACUSON SC2000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, IYN, ITX, OBJ, LLZ Dated: September 29, 2021 Received: October 4, 2021 Dear Christine Dunbar: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211726 #### Device Name ACUSON SC2000 Diagnostic Ultrasound System #### Indications for Use (Describe) The SC2000 ultrasound imaging system is intended for the following applications: 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 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 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. The catheter is 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 deep veins 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 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 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 conventional or superficial musculoskeletal structures and surrounding 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. 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 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 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. {3}------------------------------------------------ Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ #### SECTION 1. 2. 510(K) SUMMARY - K211726 | Date: | June 01, 2021 / September 28, 2021 | | | |----------------------|-----------------------------------------------------------------------------------------------------------------------------|----------|--------| | Part 1. Sponsor: | Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>685 East Middlefield Road<br>Mountain View, California 94043 | | | | Contact Person: | Christine Dunbar<br>Tel: (925) 374-2045 | | | | Part 2. Device Name: | ACUSON SC2000 Diagnostic Ultrasound System - 21 CFR 807.92(a)(1) | | | | Common Name: | Diagnostic Ultrasound System with Accessories - 21 CFR 807.92(a)(2) | | | | Classification: | Regulatory Class: II<br>Review Category: Tier II<br>Classification Panel: 90, Radiology | | | | | Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | | | Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | | | Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX | | | Diagnostic Intravascular Catheter | 892.1200 | 90-OBJ | | | Medical Image Management and<br>Processing System (Optional for SC2000<br>Diagnostic US System) | 892.2050 | 90-LLZ | | Manufacturing Site: | 22010 S. E. 51st Street, Issaquah, WA 98029, USA | | | | Legal Manufacturer: | Siemens Medical Solutions USA, Inc.<br>22010 S. E. 51st Street<br>Issaquah, WA 98029, USA | | | ## Part 3. Legally Marketed Predicate Devices - 21 CFR 807.92(a)(3) 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, v6.0 (VC10) under K202683 on October 15, 2021, is the primary predicate device. The feature under modification is the syngo® TrueFusion 1.0 originally cleared under K171766 on July 12, 2017. The syngo® TrueFusion 1.0 software feature has been subsequently cleared under successive SC2000 Diagnostic Ultrasound device clearances including the most recent under K202683 as an optional feature. Therefore, K171766 serves as a reference predicate since Siemens prefers to continue {5}------------------------------------------------ to clear the syngo® TrueFusion software application on the SC2000 Diagnostic Ultrasound system device. ## Part 4. Device Description - 21 CFR 807.92(a)(4) 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). ## Part 5. Intended Use and Indications for Use Statements - 21 CFR 807.92(a)(5) ## SC2000 Diagnostic Ultrasound System, VC10 (v6.0) ### (The Indications for Use remains unchanged as cleared under K202683 (VC10) The SC2000 ultrasound imaging system is intended for the following applications: Cardiac. Neo-natal and Fetal Cardiac. Pediatic. 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 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 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 or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic capture of ultrasound images. The system also supports catheters which are intended for 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. 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 deep veins and arteries in the arms and legs and abdomen; and surrounding 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 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 conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic capture of ultrasound images. ### Intraoperative Imaging Applications {6}------------------------------------------------ The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Dopler (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 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. ## Part 6. Summary of Technological Characteristics - 21 CFR 807.92(a)(6) 6.1 The ACUSON SC2000 VC11 (v6.1) 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 VC10 (v6.0) (K202683) with regard to both the intended use and technological characteristics. Both the subject ultrasound system and the predicate ultrasound system function in the same manner as similar diagnostic ultrasound systems and transducers including the cardiac catheters such as the ACUSON V and Volume ICE catheters and support for third party ICE catheters; the SoundStar™ 8F and 10F and the SoundStar™ eco 8F and eco 10F versions of the Diagnostic Ultrasound Catheters, which are developed, manufactured and distributed by Biosense Webster. Inc. under multiple clearances. The syngo® TrueFusion 1.0 software feature that is currently cleared as an optional software application on the SC2000 Diagnostic Ultrasound system has remained essentially unchanged except for the minor modification to serial communications to support Live Image Overlay which is the combined imaging of the SC2000 Ultrasound system and Siemens-Healthineers Axios™ Fluoroscopy system imaging in realtime. The syngo® TrueFusion software is comprised of the Siemens ACUSON SC2000 Diagnostic Ultrasound System used in conjunction with Siemens X-Ray Fluoroscopy systems called ArtisTM. This new Live Image Overlay feature will be described in design descriptions for the syngo® TrueFusion 2.0 software feature. The foundation of the ACUSON SC2000 VC11 (v6.1) with syngo® TrueFusion 2.0 software is the SC2000 VC10 (v6.0) release with syngo® TrueFusion 1.0 software. All other imaging features and transducers integrated with the ACUSON SC2000 Diagnostic Ultrasound system hardware and the software developed for SC2000 platform remain unchanged. The SC2000 (WP) workplace system software includes the same currently cleared software applications supports the viewing of the syngo® TrueFusion acquired images, however the WP does not acquire Ultrasound images and is not present in the surgical / interventional suite. It is Siemens' opinion that the ACUSON SC2000 VC11 (v6.1) is substantially equivalent to the predicate device, the ACUSON SC2000 VC10 (v6.0) with regards to both intended use, indications for use and technological characteristics. ## 6.2 - List of Technological Characteristics and SE Comparison Table {7}------------------------------------------------ | Feature / Characteristic | ACUSON SC2000 v6.1 Including<br>Transducers, Catheters &<br>syngo® TrueFusion 2.0<br>This Submission | ACUSON SC2000 6.0<br>K202683 Including Transducers<br>AcuNav Volume ICE Catheter &<br>3rd Party Catheters &<br>syngo® TrueFusion 1.0 option | |------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use: | | | | Indications for Use - Device | Unchanged for VC11 (v6.1) | | | Fetal | √ | √ | | Abdominal | √ | √ | | Pediatric | √ | √ | | Small Organ | √ | √ | | Cardiac | √ | √ | | Peripheral vessel | √ | √ | | Musculo-skeletal<br>(conventional) | √ | √ | | Musculo-skeletal<br>(superficial) | √ | √ | | Frequencies Supported: | (1.7MHz~10MHz) | (1.7MHz~10MHz) | | Modes: | Unchanged for VC11 (v6.1) | | | B | √ | √ | | M | √ | √ | | PWD (Pulsed Wave<br>Doppler) | √ | √ | | CWD (Continuous Wave<br>Doppler) | √ | √ | | PW DTI (Doppler Tissue<br>Image) | √ | √ | | Color Doppler | √ | √ | | Color Power Doppler<br>(CPD) | √ | √ | | Combined (BMDC) | √ | √ | | Transducers/ Catheters | Unchanged for VC11 (v6.1) | | | Z6Ms - TEE Transducer | √ | √ | | 4Z1c - Phased Array Transducer | √ | √ | | 4Z1c - Phased Array Transducer –<br>Imaging Preset update | √ | √ | | 10V4 - Phased Array Transducer | √ | √ | | 9L4 - Linear Array Transducer | √ | √ | | 9L4 - Linear Array Transducer –<br>update imaging presat | √ | √ | | 4V1c - Phased Array Transducer | √ | √ | | V5Ms - TEE Transducer | √ | √ | | 8V3 - Phased Array Transducer | √ | √ | | V7M - TEE Transducer | √ | √ | | 6C1HD - Curved array transducer | √ | √ | | CW2 - Continuous Wave Transducer | √ | √ | | AcuNav 8F - Phased Array Ultrasound<br>Catheter | √ | √ | | Feature / Characteristic | ACUSON SC2000 v6.1 Including<br>Transducers, Catheters &<br>syngo® TrueFusion 2.0<br>This Submission | ACUSON SC2000 6.0<br>K202683 Including Transducers<br>AcuNav Volume ICE Catheter &<br>3rd Party Catheters &<br>syngo® TrueFusion 1.0 option | | AcuNav 10F Intracardiac Transducer | √ | √ | | AcuNav™ V ICE Catheter | √ | √ | | AcuNav™ Volume ICE<br>Catheter (aka P6) | √ | √ | | AcuNav™ Volume ICE<br>Catheter Imaging Preset<br>update | √ | | | Supports Third party US<br>Catheters with Swift-Link<br>connector: | √ | √ | | SoundStar™ eco 8 French<br>catheter¹ | √ | √ | | SoundStar™ eco 10 French<br>catheter | √ | √ | | SoundStar™ 8 French<br>catheter² | √ | √ | | SoundStar™ 10 French<br>catheter | √ | √ | | SwiftLink Connector | √ | √ | | Features on SC2000 System: | Unchanged for VC11 (v6.1) | | | Patient Registration<br>Fields | √ | √ | | Change/Edit Patient<br>Information Active exam | √ | √ | | Native™ tissue harmonic<br>imaging (2D Brightness<br>mode) | √ | √ | | TEQ™ ultrasound<br>technology | √ | √ | | Volume ICE Package | √ | √ | | Support for AcuNav<br>Volume ICE Catheter<br>connected by SwiftLink<br>cable. | √ | √ | | ICE Catheter Auto-<br>reduce Mechanical Index<br>(MI) | √ | √ | | 2D ICE Package | √ | √ | | Feature / Characteristic | ACUSON SC2000 v6.1 Including Transducers, Catheters & syngo® TrueFusion 2.0<br>This Submission | ACUSON SC2000 6.0 K202683 Including Transducers AcuNav Volume ICE Catheter & 3rd Party Catheters & syngo® TrueFusion 1.0 option | | True Volume Imaging Support, AcuNav Volume ICE Catheter | √ | √ | | Volume Color Doppler | √ | √ | | Fetal Echo Calculations | √ | √ | | Fetal Imaging Presets | √ | √ | | Cardiac Imaging physiological signal display | √ | √ | | eSie Measure on TEE | √ | √ | | Advanced SieClear™ spatial compounding | √ | √ | | Clarify™ vascular enhancement technology | √ | √ | | syngo® Velocity Vector Imaging (eSie VVI) | √ | √ | | syngo® Velocity Vector Imaging (eSie VVI) | Changed to be consistent with v5.1 implementation. | √ | | eSie Valves Advanced Measurement Package | √ | √ | | eSie LVA: 5 Cardiac Cycles | √ | √ | | eSie PISA | √ | √ | | eSie Left Heart Measurement Package | √ | √ | | Volume Right Ventricular Analysis (RVA) | √ | √ | | Stress Echo Package | √ | √ | | Rapid Stress Volume Stress Echo App. | √ | √ | | Cardiac Measurements and Calculations | √ | √ | | syngo® TrueFusion v1.0 | √ | √ | | syngo® TrueFusion v2.0 | Updated to support Live Imaging Overlay | TrueFusion 1.0 | | syngo® TrueFusion v2.0 | Update communication protocol for True Fusion 2.0. | TrueFusion 1.0 | | Septal Guide – Orthogonal Guidelines | √ | √ | | VR Measurement Tools (Volume) | √ | √ | | Reference Lines<br>One-click MPR | √ | √ | | Feature / Characteristic | ACUSON SC2000 v6.1 Including<br>Transducers, Catheters &<br>syngo® TrueFusion 2.0 | ACUSON SC2000 6.0<br>K202683 Including Transducers<br>AcuNav Volume ICE Catheter &<br>3rd Party Catheters &<br>syngo® TrueFusion 1.0 option | | | This Submission | | | • Volume Reference Line<br>Projections<br>• eSie Slice / eSie Lines | √ | √ | | • One-click MPR A/B Align<br>on Volume Review (VR) | √ | √ | | • Trace erase, back up<br>behavior with Trackball:<br>B-Mode | √ | √ | | • Single V | √ | √ | | • Contrast Agent Imaging<br>LVO | √ | √ | | • Edit patient data on<br>active exam. | √ | √ | | • Zoom & Pan | √ | √ | | • eSieScan<br>(Protocols) | √ | √ | | • InFocus Coherent<br>Technology | √ | √ | | • Circle Tool | √ | √ | | • DICOM | √ | √ | | • DICOM SR<br>(Structure Reports) | √ | √ | | • DICOM GSDF (Gray<br>scale Standard Display<br>Function). | √ | √ | | • DICOM Tags (Teamplay)<br>• DICOM support the<br>export of DICOM tags for<br>System Data Collection | √ | √ | | MS Windows 10 OS | Windows 10 plus updates | Windows 10 | | Wireless - enabled | √ | √ | | WiFi EAP-TLS<br>authentication protocol | √ | √ | | Cybersecurity Features | √ | √ | | Security - User Accounts | | | | User Accounts \local user<br>authentication | √ | √ | | Table Side Remote Control<br>Joy-Stick | √ | √ | | Service Save logs | √ | √ | | Service Save logs | include save log location | Service Logs available | | Feature / Characteristic | ACUSON SC2000 v6.1 Including<br>Transducers, Catheters &<br>syngo® TrueFusion 2.0<br><br>This Submission | ACUSON SC2000 6.0<br>K202683 Including Transducers<br>AcuNav Volume ICE Catheter &<br>3rd Party Catheters &<br>syngo® TrueFusion 1.0 option | | Security Hot-fix Installation | install a hotfix update via RUH<br>(remote update handling) or USB<br>drive. | install a hotfix update via RUH<br>(remote update handling) or USB<br>drive. | | Study Back-up and Restore | √ | √ | | Monitor: 21" FPD | √ | √ | | Output Display Standard<br>(Track 3) | √ | √ | | Patient Contact Materials | Tested to ISO 10993-1 | Tested to ISO 10993-1 | | UL 60601-1 Certified | √ | √ | {8}------------------------------------------------ ¹ SoundStar and SoundStar eco catheters are products of Biosense Webster, Inc. (A Johnson company) holds the 510(k) clearances for these devices. ² SoundStar and SoundStar eco catheters are products of Biosense Webster, Inc. (A Johnson & Johnson company) holds the 510(k) clearances for these devices. {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ # Part 7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence. 21 CFR 807.92(b)(1) 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 SC2000 software update to VC11 (v6.1) does not involve any hardware modifications. The VC11A (v6.1) software update and the SC2000 System software has undergone component, integration and system level verification testing. The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria consistent with Siemens Product Lifecycle Procedure (PLP) and has passed. 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 equipment - IEC 60601-2-18:2009. Medical electrical equipment Part 2: Particular requirements . for the safety of endoscopic equipment - 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 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. {12}------------------------------------------------ ## Part 8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence. 21 CFR 807.92(b)(2) Since the ACUSON SC2000 VC11 (v6.1) Diagnostic Ultrasound System uses the identical technology and principles of use as the existing predicate devices SC2000, VC10 (v6.0) K202683, clinical studies were not required to support substantial equivalence. The SC2000 VC11A (v6.1) software was fully validated on phantoms by clinical personal with training in Ultrasound technology and has passed. ## Substantial Equivalence to Predicates (21 CFR §807.92(b)(1)) The verification testing to the Customer requirements (CRS) for the SC2000 Diagnostic Ultrasound System including component, integration and regression testing for TrueFusion 2.0 and validation of the intended use is intended to support the claim of substantial equivalence to the following predicates: > The ACUSON SC2000, v6.0 (VC10) under K202683 on October 15, 2021, is the primary predicate device. The VC10 software includes the syngo® TrueFusion 1.0 software feature as an option. > The feature under modification is the syngo® TrueFusion 1.0 which was originally cleared under K171766 on July 12, 2017, this clearance serves as a reference predicate. ## Part 9. Summary - 21 CFR 807.92(b)(3) The 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 13485:2016 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. In summary, based on the successful verification and validation testing to the software acceptance criteria, the update for the TrueFusion 2.0 feature does not introduce any new potential safety risks. It is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON SC2000 Diagnostic Ultrasound system with the VC11 (v6.1) software update is substantially equivalent with respect to safety and effectiveness and performs as well as the currently cleared predicate device.
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510(k) Summary
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