(47 days)
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 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).
I am sorry, but the provided text is a 510(k) premarket notification for the ACUSON SC2000 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.
Therefore, the document does not contain the information requested in your prompt regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or its data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
The document explicitly states in "Part 8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence" that: "Since the ACUSON SC2000 VC10A (v6.0) Diagnostic Ultrasound System uses the identical technology and principles of use as the existing predicate devices SC2000. VB21A (v5.1) K181098, clinical studies were not required to support substantial equivalence."
The non-clinical tests mentioned in Part 7 are related to device safety standards (acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical, electromagnetic, and mechanical safety), not performance against clinical acceptance criteria.
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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
Siemens Medical Solutions, USA, Inc. % Ms. Christine Dunbar Senior Regulatory Affairs Specialist 685 East Middlefield Road MOUNTAIN VIEW CA 94043
April 22, 2020
Re: K200585
Trade/Device Name: ACUSON SC2000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ, LLZ Dated: March 4, 2020 Received: March 6, 2020
Dear Ms. 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/cfpmp/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
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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
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Indications for Use
510(k) Number (if known) K200585
Device Name
ACUSON SC2000 Diagnostic Ultrasound System
Indications for Use (Describe)
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-sketal 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 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. 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 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
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 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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X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| SECTION 1. 2. | 510(K) SUMMARY |
|---|---|
| --------------- | ---------------- |
| Date: | March 04, 2020 | K200585 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 System892.155090-IYNUltrasonic Pulsed Echo Imaging System892.156090-IYODiagnostic Ultrasound Transducer892.157090-ITXDiagnostic Intravascular Catheter892.120090-OBJPicture archiving and Communications System (Optional PACS for SC2000)892.205090-LLZ | 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 | Picture archiving and Communications System (Optional PACS for SC2000) | 892.2050 | 90-LLZ | |
| 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 | ||||||||||||||
| Picture archiving and Communications System (Optional PACS for SC2000) | 892.2050 | 90-LLZ | ||||||||||||||
| 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, v5.1 (VB21) under K181098 on May 31, 2018, is the primary predicate device.
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Part 4. 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).
Part 5. Intended Use and Indications for Use Statements
SC2000 Diagnostic Ultrasound System, VC10A (v6.0)
(The Indications for Use remains unchanged as cleared under K181098 (VB21A)
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
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.
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
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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 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
6.1 The ACUSON SC2000 VC10A (v6.0) 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 VB21A (v5.1) (K181098) with regard to both 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 foundation of the ACUSON SC2000 VC10A (6.0) is the SC2000 VB21A (5.1) release with features and transducers integrated with the ACUSON SC2000 hardware and the software developed for SC2000 platform. The updated SC2000 system software VC10A includes the same currently cleared software applications and support for the optional SC2000 (WP) workplace.
It is Siemens' opinion that the ACUSON SC2000 VC10A (v6.0) is substantially equivalent to the predicate device, the ACUSON SC2000 VB21A (V5.1) with regard to both intended use, indications for use and technological characteristics.
| Feature / Characteristic | ACUSON SC2000 v6.0 IncludingTransducers & CathetersThis Submission | ACUSON SC2000 5.1K181098 Including Transducers&AcuNav Volume ICE Catheter & 3rd Party Catheters. | |
|---|---|---|---|
| Indications for Use: | |||
| Indications for Use - Device | Unchanged for VC10A (v6.0) | √ | |
| Feature / Characteristic | ACUSON SC2000 v6.0 Including Transducers & Catheters | ACUSON SC2000 5.1 K181098 Including Transducers &AcuNav Volume ICE Catheter & 3rd Party Catheters. | |
| This Submission | |||
| • Fetal | √ | √ | |
| • Abdominal | √ | √ | |
| • Pediatric | √ | √ | |
| • Small Organ | √ | √ | |
| • Cardiac | √ | √ | |
| • Peripheral vessel | √ | √ | |
| • Musculo-skeletal (conventional) | √ | √ | |
| • Musculo-skeletal (superficial) | √ | √ | |
| Frequencies Supported: | (1.7MHz~10MHz) | (1.7MHz~10MHz) | |
| Modes: | |||
| • B | √ | √ | |
| • M | √ | √ | |
| • PWD (Pulsed Wave Doppler) | √ | √ | |
| • CWD (Continuous Wave Doppler) | √ | √ | |
| • PW DTI (Doppler Tissue Image) | √ | √ | |
| • Color Doppler | √ | √ | |
| • Color Power Doppler (CPD) | √ | √ | |
| • Combined (BMDC) | √ | √ | |
| Transducers/ Catheters | |||
| Z6Ms - TEE Transducer | √ | √ | |
| 4Z1c - Phased Array Transducer | √ | √ | |
| 4Z1c - Phased Array Transducer – Imaging Preset update | optimized factory default preset for 4V1c | Preset available. | |
| 10V4 - Phased Array Transducer | √ | √ | |
| 9L4 - Linear Array Transducer | √ | √ | |
| 9L4 - Linear Array Transducer – update imaging presat | optimized factory default preset for 9L4 | Preset available. | |
| 4V1c - Phased Array Transducer | √ | √ | |
| V5Ms - TEE Transducer | √ | √ | |
| 8V3 - Phased Array Transducer | √ | √ | |
| V7M - TEE Transducer | √ | √ | |
| 6C1HD - Curved array transducer | √ | √ | |
| CW2 - Continuous Wave Transducer | √ | √ | |
| Feature / Characteristic | ACUSON SC2000 v6.0 IncludingTransducers & CathetersThis Submission | ACUSON SC2000 5.1K181098 Including Transducers&AcuNav Volume ICE Catheter &3rd Party Catheters. | |
| AcuNav 8F - Phased Array UltrasoundCatheter | √ | √ | |
| AcuNav 10F Intracardiac Transducer | √ | √ | |
| AcuNav™ V ICE Catheter | √ | √ | |
| AcuNav™ Volume ICECatheter (aka P6) | √ | √ | |
| AcuNav™ Volume ICECatheter Imaging Presetupdate | optimized factory default preset forAcuNav Volume | Preset available. | |
| Supports Third party USCatheters with Swift-Linkconnector: | √ | √ | |
| SoundStar™ eco 8 Frenchcatheter1 | √ | √ | |
| SoundStar™ eco 10 Frenchcatheter | √ | √ | |
| SoundStar™ 8 Frenchcatheter2 | √ | √ | |
| SoundStar™ 10 Frenchcatheter | √ | √ | |
| SwiftLink Connector | √ | √ | |
| Features on SC2000 System: | |||
| • Patient RegistrationFields | Improve Patient data entryworkflow | √ | |
| • Change/Edit PatientInformation Active exam | Improve Patient data entryworkflow | Edit non-active exam only | |
| • Native™ tissue harmonicimaging (2D Brightnessmode) | √ | √(Harmonic imaging) | |
| • TEQ™ ultrasoundtechnology | √ | √(Updated TEQ) | |
| • Volume ICE Package | √ | √ | |
| • Support for AcuNavVolume ICE Catheterconnected by SwiftLinkcable | √ | AcuNav Volume ICE Catheterconnected by SwiftLink Cathetersupported. | |
| Feature / Characteristic | ACUSON SC2000 v6.0 IncludingTransducers & Catheters | ACUSON SC2000 5.1K181098 Including Transducers&AcuNav Volume ICE Catheter &3rd Party Catheters. | |
| This Submission | |||
| ICE Catheter Auto-reduce Mechanical Index(MI) when imaging in airin order to protect thecatheter from thermaldamage and preserveimage quality. | New feature for V & Volume ICEand Sound Star ICE catheters. | - | |
| 2D ICE Package | √(Unchanged) | √ | |
| True Volume ImagingSupport, AcuNav Volume ICECatheter90° x 50° real-timevolume imaging | √(Unchanged) | √ | |
| ■ | Volume Color Doppler | √ | √ |
| ■ | Fetal Echo Calculations | √ | √ |
| ■ | Fetal Imaging Presets | √ | √ |
| ■ | Cardiac Imagingphysiological signaldisplay | √ | √ |
| ■ | eSie Measure on TEE | Update Trace | √ |
| ■ | Advanced SieClear™spatial compounding | √ | √ |
| ■ | Clarify™ vascularenhancement technology | √ | √ |
| ■ | syngo ® Velocity VectorImaging (eSie VVI) | Enhancement –Bullseye red/blue color map | √ |
| ■ | eSie Valves AdvancedMeasurement Package | √ | √ |
| ■ | eSie LVA | √ | √ |
| ■ | eSie LVA: 5 CardiacCycles | Update to number of cardiaccycles supported. | Currently 3 cardiac cycles |
| ■ | eSie PISA | √ | √ |
| ■ | eSie Left HeartMeasurement Package | √ | √ |
| ■ | Volume Right VentricularAnalysis (RVA) | √ | √ |
| ■ | Stress Echo Package | √ | √ |
| ■ | Rapid Stress VolumeStress Echo App. | √ | √ |
| ■ | Cardiac Measurementsand Calculations | √ | √ |
| Feature / Characteristic | ACUSON SC2000 v6.0 Including Transducers & CathetersThis Submission | ACUSON SC2000 5.1 K181098 Including Transducers & AcuNav Volume ICE Catheter & 3rd Party Catheters. | |
| syngo® TrueFusion v1.0 | √ | √ | |
| Septal Guide – Orthogonal Guidelines | √ | √ | |
| VR Measurement Tools (Volume) | The ability to measure anatomy and pathology directly on the Volume Rendered (VR) images in CINE and acquired in 4D. | – | |
| Reference LinesOne-click MPR alignment | New Display Feature | – | |
| Volume Reference Line ProjectionseSie Slice / eSie Lines | New Display Feature | – | |
| One-click MPR A/B Align on Volume Review (VR) | New Display Feature | – | |
| Trace erase, back up behavior with Trackball: B-Mode | Updated Display Feature | √ | |
| D'Art renamed Single V | Consolidated windows | √ | |
| Contrast Agent Imaging | √ | √ | |
| Edit patient data on active exam. | Edit patient data on active exam | Edit patient data on completed exam | |
| Zoom & Pan | √ | √ | |
| eSieScan (Protocols) | √ | √ | |
| InFocus Coherent Technology | √ | √ | |
| Circle Tool | √ | √ | |
| DICOM | √ | √ | |
| DICOM SR (Structure Reports) | √ | √ | |
| DICOM GSDF Monitor Support | DICOM GSDF (Gray scale Standard Display Function) review monitor to look comparable to those displayed on the SC2000 system monitor. | – | |
| Feature / Characteristic | ACUSON SC2000 v6.0 IncludingTransducers & Catheters | ACUSON SC2000 5.1K181098 Including Transducers&AcuNav Volume ICE Catheter &3rd Party Catheters. | |
| This Submission | |||
| DICOM Tags (Teamplay) | DICOM support the export ofDICOM tags for System DataCollection (SDC) / UtilizationManagement (UM) | - | |
| MS Windows 10 migration | Windows 10 | Windows 7 | |
| Wireless - enabled | √ | √ | |
| WiFi Update | WiFi EAP-TLS authenticationprotocol | - | |
| Cybersecurity Features | √ | √ | |
| Security - User Accounts | User Accounts \local userauthenticationcreate multiple local user accounts.And able to login/logout of thesystem | - | |
| Table Side Remote ControlJoy Stick Improvements | Updated skin layout to includeFreeze, Camera and Measure. | √ | |
| Service Save logs update | system to provide a mechanism totransfer the below list of log filesautomatically to the SRS server | Save Log feature not automatic. | |
| Security Hot-fix Installation | install a hotfix update via RUH(remote update handling) or USBdrive. | install a hotfix update via RUH(remote update handling) or USBdrive. | |
| Study Back-up and RestoreImprovements | Update: can restore settings fromprevious releases and not need tomake the changes manually andcan restore the same settings tomultiple systems | Back-up and RestoreFeature present | |
| Motherboard version | MBM250 | MBM201+MBM250 | |
| Mechanical column upgrade | Unchanged | Lighter | |
| Aluminum Card Cage | Unchanged | Weight reduction by 25 lbs | |
| Monitor: 21" FPD | √ | √ | |
| Output Display Standard(Track 3) | √ | √ | |
| Patient Contact Materials | Tested to ISO 10993-1 | Tested to ISO 10993-1 | |
| UL 60601-1 Certified | √ | √ |
6.2 - List of Technological Characteristics and SE Comparison Table
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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 company) holds the 510(k) clearances for these devices.
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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.
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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.
Part 8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the ACUSON SC2000 VC10A (v6.0) Diagnostic Ultrasound System uses the identical technology and principles of use as the existing predicate devices SC2000. VB21A (v5.1) K181098, 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 13485:2016 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.
Therefore, it is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON SC2000 VC10A (v6.0) system is substantially equivalent with respect to safety and effectiveness to the currently cleared predicate devices for the U.S. market.
§ 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.