Predicate Devices

Reference Devices

ACUSON Redwood(K210743)

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on traditional ultrasound imaging modes and measurement tools.

Therapeutic

No.
The device is described as a diagnostic ultrasound system intended to generate images and measurements for clinical diagnosis, not to provide therapy.

Diagnostic

Yes

The "Device Description" explicitly states, "The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system." The "Intended Use / Indications for Use" section also describes its use for obtaining images and signals from inside the body to provide information for clinical diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-purpose mobile, software controlled, diagnostic ultrasound system" and describes its function in transmitting and receiving ultrasound echo data, which requires hardware components (transducers, processing units, etc.) beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the ACUSON Sequoia ultrasound imaging system is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The ACUSON Sequoia system uses ultrasound technology to create images of structures inside the body. It transmits and receives ultrasound waves and displays the resulting echoes as images. This is an in vivo (within the living body) process, not an in vitro process.
Intended Use: The intended use describes imaging various anatomical sites within the body and providing measurements and information to aid in clinical diagnosis. This is consistent with an imaging device used for diagnostic purposes on the patient, not a test performed on a sample from the patient.
Device Description: The description details the ultrasound modes and imaging capabilities, all of which are related to generating images from within the body.

Therefore, the ACUSON Sequoia is a diagnostic imaging system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal. Abdominal. Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal 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.

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

IYN, IYO, ITX, OIJ

Device Description

The ACUSON Sequoia 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, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular, transrectal, transvaginal.

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Appropriately trained healthcare professional in a clinical setting

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

Not Found

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

Not Found

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

Since the ACUSON Sequoia Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence.

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

Not Found

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

ACUSON Sequoia (K211859)

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

ACUSON Redwood(K210743)

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

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 & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The seal features a stylized depiction of a human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 14, 2022

Siemens Medical Solutions USA, Inc % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K221500

Trade/Device Name: ACUSON Sequoia 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, OIJ Dated: May 21, 2022 Received: May 23, 2022

Dear Prithul Bom:

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

1

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 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 mediation-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

Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy OHT8: Office of 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) K221500

Device Name

ACUSON Sequoia Diagnostic Ultrasound System

Indications for Use (Describe)

The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal. Abdominal. Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal 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.

Operating Modes

2D-mode

. 2D-mode
. 2D-mode with Harmonics Imaging
. 2D-mode with Harmonics Imaging for Contrast Agent Imaging
3D/4D Volume Imaging

Color flow Doppler

Color (velocity)
Power (energy)

Doppler

Pulsed Wave Doppler .
. Pulsed Wave Doppler Tissue Imaging
. High Pulsed Repetition Frequency Pulsed Wave Doppler
. Steerable Continuous Wave Doppler for imaging transducers
Continuous Wave Doppler for non-imaging transducers

M-mode

M-mode with Harmonics Imaging .
Anatomical M-Mode
Elastography
Strain Imaging
. Shear Wave Elastography

Combined Modes

2D-mode with color 2D-mode with Doppler 2D-mode with color and Doppler 2D-mode with M-mode 2D-mode with M-mode and Color

2D-mode with Elastography

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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)

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K221500	510(k) Summary
Date:	April 25, 2022
1. Sponsor:	Siemens Medical Solutions USA, Inc.
Ultrasound Division
22010 South East 51st Street
Issaquah, Washington 98029
Contact Person:	Sulgue Choi
Tel: (425) 281-9898
2. Device Name:	ACUSON Sequoia Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class: II
Review Category: Tier II
Classification Panel: Radiology

Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX
Biopsy Needle Guide Kit	892.1560	90-OIJ

| Manufacturing Site: | Siemens Medical Solutions USA, Inc.
22010 South East 51st Street,
Issaquah, Washington 98029, UNITED STATES |

---------------------	-------------------------------------------------------------------------------------------------------------------

3. Legally Marketed Predicate Devices

The ACUSON Sequoia 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 Sequoia (K211859) which is primary predicated device and the ACUSON Redwood(K210743).

-Primary Predicate Device: ACUSON Sequoia (K211859)
-Reference Device: ACUSON Redwood(K210743)

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4. Device Description

The ACUSON Sequoia 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, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.

5. Intended Use/Indications for Use

The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal. Abdominal. Pediatric. Neonatal Cephalic. Small Parts. OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures). Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal 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.

Operating Modes

2D-mode

2D-mode .
. 2D-mode with Harmonics Imaging
. 2D-mode with Harmonics Imaging for Contrast Agent Imaging 3D/4D Volume Imaging

Color flow Doppler

Color (velocity) .
. Power (energy)

Doppler

Pulsed Wave Doppler .
Pulsed Wave Doppler Tissue Imaging .
High Pulsed Repetition Frequency Pulsed Wave Doppler
Steerable Continuous Wave Doppler for imaging transducers
. Continuous Wave Doppler for non-imaging transducers

M-mode

M-mode with Harmonics Imaging .
. Anatomical M-Mode
Elastography
Strain Imaging .
. Shear Wave Elastography

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Combined Modes 2D-mode with color 2D-mode with Doppler 2D-mode with color and Doppler 2D-mode with M-mode 2D-mode with M-mode and Color 2D-mode with Elastography

6. Summary of Technological Characteristics

The modified ACUSON Sequoia Ultrasound System is the same as the company's own previously cleared ACUSON Sequoia (K211859) and the ACUSON Redwood(K210743) with reqard to both intended use and technological characteristics. Both the modified ultrasound system under this review and the predicate ultrasound systems function in the same manner as all diagnostic ultrasound systems and transducers.

The submission device differs from the predicated devices as following:

. The modified ACUSON Sequoia Ultrasound System includes the addition of the 15L4 transducer which is substantially equivalent to the 14L5 transducer previously cleared on the ACUSON Sequoia (K211859)
. The modified ACUSON Sequoia Ultrasound System includes the addition of the 9C2 transducer which is substantially equivalent to the 9C3 transducer previously cleared on the ACUSON Sequoia (K211859)
. The modified ACUSON Sequoia Ultrasound System includes the addition of the 10EV3 transducer which is substantially equivalent to the 9EC4 transducer previously cleared on the ACUSON Sequoia (K211859)
. The modified ACUSON Sequoia Ultrasound System includes the addition of the 7VC2 transducer. This identical transducer has been previously cleared on the ACUSON Redwood (K210743)
. The addition of needle guide kit, 15L4, which is substantially equivalent to the needle guide Kit, 18L6 previously cleared on the ACUSON Sequoia (K211859)
. The addition of needle guide kit, 9C2, which is substantially equivalent to the needle guide Kit, 9C3 previously cleared on the ACUSON Sequoia (K211859)
. The addition of needle quide kit. 10EV3. which is substantially equivalent to the needle quide Kit, 9EC4 previously cleared on the ACUSON Sequoia (K211859)
. The addition of the needle kit for 9VE4 transducer, which is substantially equivalent to the needle guide for 9EC4 transducer previously cleared on the ACUSON (K211859)
. The addition of new physio module which is substantially equivalent to the physio module previously cleared on the ACUSON Sequoia (K211859)
The modified ACUSON Sequoia Ultrasound System includes the expansion of the UDFF (Ultrasonically-Derived fat fraction) and Auto pSWE software features for 9C2 transducer which were already cleared on the ACUSON Sequoia (K211859)
Also this Traditional 510(k) includes additional improved imaging features an image . quality improvement: Velocity Variance Mapping, image quality improvements for 501,

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5V1 which were cleared on the predicate device, ACUSON Sequoia (K211859) to enable an improved customer experience.

All other hardware and software features of the ACUSON Sequoia Diagnostic Ultrasound device remain unchanged. The foundation of the ACUSON Sequoia (this submission) is the ACUSON Sequoia(K211859) with features and transducers integrated with the ACUSON Sequoia(K211859) hardware and the ACUSON Sequoia (this submission) reuse software developed for Sequoia(K211859) mainly as well as 7VC2 transducer from ACUSON Redwood (K210743).

The submission device is substantially equivalent to the predicate with regards to both intended use and technological characteristics.

| Feature / Characteristic | | ACUSON Sequoia
This Submission | ACUSON Sequoia
K# 211859
Predicate device |
|----------------------------------------------|----------------------------------------------------|-------------------------------------------------|-------------------------------------------------|
| | Indications for Use: | | |
| ■ | Fetal | √ | √ |
| ■ | Abdominal | √ | √ |
| ■ | Pediatric | √ | √ |
| ■ | Small Organ | √ | √ |
| ■ | Cardiac | √ | √ |
| ■ | Transrectal | √ | √ |
| ■ | Transvaginal | √ | √ |
| ■ | Peripheral vessel | √ | √ |
| ■ | Musculo-skeletal
(conventional) | √ | √ |
| ■ | Musculo-skeletal
(superficial) | √ | √ |
| ■ | Neonatal cephalic | √ | √ |
| ■ | Adult cephalic | √ | √ |
| Modes: | | | |
| ■ | B | √ | √ |
| ■ | M | √ | √ |
| ■ | PWD (Pulsed Wave
Doppler) | √ | √ |
| ■ | CWD (Continuous Wave
Doppler) | √ | √ |
| ■ | PW DTI (Doppler Tissue
Image) | √ | √ |
| ■ | Color Doppler | √ | √ |
| ■ | Power Doppler | √ | √ |
| ■ | Combined (BMDC) | √ | √ |
| Features: | | | |
| ■ | Harmonic imaging | √ | √ |
| Feature / Characteristic | ACUSON Sequoia
This Submission | ACUSON Sequoia
K# 211859
Predicate device | |
| ■ | Panoramic imaging | √ | √ |
| ■ | Color Panoramic
imaging | √ | √ |
| ■ | Auto TEQ | √ | √ |
| ■ | Cardiac Imaging
physiological signal
display | √ | √ |
| ■ | eSie OB | √ | √ |
| ■ | Compounding | √ | √ |
| ■ | Contrast imaging | √ | √ |
| ■ | Clarify | √ | √ |
| ■ | Virtual Touch - Strain | √ | √ |
| ■ | syngo ® Velocity Vector
Imaging | √ | √ |
| ■ | eSie Calc | √ | √ |
| ■ | Speed of Sound | √ | √ |
| ■ | Fusion | √ | √ |
| ■ | Virtual Touch – pSWE | √ | √ |
| ■ | Virtual Touch – SWE | √ | √ |
| ■ | UltraArt | √ | √ |
| ■ | Modality Compare | √ | √ |
| ■ | HD Zoom | √ | √ |
| ■ | Protocols | √ | √ |
| ■ | InFocus | √ | √ |
| ■ | Flash sequencing | √ | √ |
| ■ | Gesture control | √ | √ |
| ■ | TeamViewer | √ | √ |
| ■ | Motion Stabilized | √ | √ |
| ■ | Persistence | √ | √ |
| ■ | DICOM | √ | √ |
| ■ | DICOM SR | √ | √ |
| ■ | Slow Flow Color Doppler
State | √ | √ |
| ■ | Dynamic MultiHertz | √ | √ |
| ■ | 3D/4D Volume Imaging
Mode | √ | √ |
| ■ | UDFF (Ultrasonically-
Derived Fat Fraction) | √ | √ |
| ■ | Auto pSWE | √ | √ |
| Feature / Characteristic | ACUSON Sequoia
This Submission | ACUSON Sequoia
K# 211859
Predicate device | |
| • Auto IMT | √ | √ | |
| • eSieDoppler | √ | √ | |
| • Virtual workstation | √ | √ | |
| • Velocity Variance
Mapping | √ | √
(Color doppler map) | |
| Wireless | √ | √ | |
| Monitor: 21" FPD (OLED) | √ | √ | |
| Touch Screen: 15"
adjustable Touch Screen | √ | √ | |
| Output Display Standard
(Track 3) | √ | √ | |
| Patient Contact Materials | Tested to ISO
10993-1 | Tested to ISO
10993-1 | |
| UL 60601-1 Certified | √ | √ | |
| Indications for Use | √ | √ | |

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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 systems comply with the following voluntary standards:

IEC 62359: Edition 2.1 2017-09, Ultrasonics Field characterization Test methods for I the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields / Combines IEC 62359 (2010-10) and AMD 1 (2017-09)
I Safety and EMC Requirements for Medical Equipment
- AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and O A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
- IEC 60601-1:2005/A1(2012), Medical electric equipment Part 1: General о requirements for basic safety and essential performance / This document and its separate amendments continue to be valid together with the consolidated version
- IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment Part 1-2: O General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-18: Edition 3.0 2009-08, Medical electrical equipment Part 2-18: റ Particular requirements for the basic safety and essential performance of endoscopic equipment

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IEC 60601-2-37 Edition 2.1 2015, Medical electrical equipment Part 2-37: o Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
I ISO 10993-1 Fifth edition 2018-08, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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

Since the ACUSON Sequoia Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence.

9. Summary

Intended uses and other kev features are consistent with traditional clinical practice and FDA quidelines. 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. Diagnostic ultrasound system has accumulated a long history of safe and effective performance. Therefore, it is the opinion of Siemens Medical Solutions USA. Inc. that the ACUSON Sequoia system is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.