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.

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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria through a rigorous clinical or standalone study. Instead, it is a 510(k) summary for a medical device (ACUSON Sequoia Diagnostic Ultrasound System) seeking substantial equivalence to previously cleared predicate devices.

The document primarily focuses on demonstrating that the new device shares the same intended use and technological characteristics as the predicate devices, with minor modifications (like new transducers and software features that were already cleared for other transducers/devices).

Therefore, I cannot extract the requested information (like a table of acceptance criteria, sample size for test/training sets, number of experts for ground truth, adjudication method, MRMC study results, or detailed standalone performance) because the document explicitly states:

"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." (Section 8)

This means the submission relies on the established safety and effectiveness of the predicate devices and general compliance with performance and safety standards, rather than new performance studies with specific acceptance criteria.

The information closest to what you requested, but not a direct answer, is the list of features where the submission device and its predicate are compared (Table in Section 6). This table shows that features are present (marked with '√') but does not specify quantitative acceptance criteria or performance metrics for those features.

If this were a submission for an AI/ML-driven device requiring performance validation, the content would be significantly different and would include the types of studies and criteria you've listed. As it stands, this is a traditional 510(k) for an ultrasound system primarily focused on demonstrating substantial equivalence to prior versions.

Summary

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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

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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 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.

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 Division22010 South East 51st StreetIssaquah, Washington 98029
Contact Person:	Sulgue ChoiTel: (425) 281-9898
2. Device Name:	ACUSON Sequoia Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class: IIReview Category: Tier IIClassification 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

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 SequoiaThis Submission	ACUSON SequoiaK# 211859Predicate 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 WaveDoppler)	√	√
■	CWD (Continuous WaveDoppler)	√	√
■	PW DTI (Doppler TissueImage)	√	√
■	Color Doppler	√	√
■	Power Doppler	√	√
■	Combined (BMDC)	√	√
Features:
■	Harmonic imaging	√	√
Feature / Characteristic	ACUSON SequoiaThis Submission	ACUSON SequoiaK# 211859Predicate device
■	Panoramic imaging	√	√
■	Color Panoramicimaging	√	√
■	Auto TEQ	√	√
■	Cardiac Imagingphysiological signaldisplay	√	√
■	eSie OB	√	√
■	Compounding	√	√
■	Contrast imaging	√	√
■	Clarify	√	√
■	Virtual Touch - Strain	√	√
■	syngo ® Velocity VectorImaging	√	√
■	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 DopplerState	√	√
■	Dynamic MultiHertz	√	√
■	3D/4D Volume ImagingMode	√	√
■	UDFF (Ultrasonically-Derived Fat Fraction)	√	√
■	Auto pSWE	√	√
Feature / Characteristic	ACUSON SequoiaThis Submission	ACUSON SequoiaK# 211859Predicate device
• Auto IMT	√	√
• eSieDoppler	√	√
• Virtual workstation	√	√
• Velocity VarianceMapping	√	√(Color doppler map)
Wireless	√	√
Monitor: 21" FPD (OLED)	√	√
Touch Screen: 15"adjustable Touch Screen	√	√
Output Display Standard(Track 3)	√	√
Patient Contact Materials	Tested to ISO10993-1	Tested to ISO10993-1
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.

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.