The ACUSON Sequoia and Sequoia Select 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, Musculosketal 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 and Sequoia Select Diagnostic Ultrasound Systems are 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, 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 is a 510(k) summary for the Siemens ACUSON Sequoia and Sequoia Select Diagnostic Ultrasound Systems. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria, especially for new or AI-driven features.

The most relevant section about specific performance is regarding the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool, which is described as reporting "an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis" (Page 3, Page 6). The document states that the modified ACUSON Sequoia Ultrasound System includes "the expansion of the UDFF (Ultrasonically-Derived fat fraction) software features for 5C1 transducer which were already cleared on the ACUSON Sequoia (K221500)" (Page 7). This implies that the UDFF feature itself was previously cleared.

However, the 510(k) submission does not provide details about acceptance criteria or a study proving the device meets these criteria for the UDFF feature or any other feature in the format requested. In fact, it explicitly states:

"Since the ACUSON Sequoia and Sequoia Select Diagnostic Ultrasound Systems use the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence." (Page 10)

This statement indicates that their substantial equivalence argument relies on the technological similarity to existing cleared devices, and thus a detailed clinical performance study (including acceptance criteria, sample sizes, expert ground truth, etc.) was not performed for this specific 510(k) submission.

Therefore, I cannot extract the requested information from the provided text. The document is a regulatory submission for a diagnostic ultrasound system based on substantial equivalence, not a clinical study report for a novel AI/software feature with detailed performance metrics.

To directly answer your request based on the provided text, many fields will be "Not Applicable" or "Not Provided."

Here's how the information would map to your request if it were available in the document:

Acceptance Criteria and Device Performance Study for Siemens ACUSON Sequoia and Sequoia Select Diagnostic Ultrasound Systems (as per provided document)

Given the nature of the provided 510(k) summary, which relies on substantial equivalence and states that clinical studies were not required, many of the requested details are not present.

A table of acceptance criteria and the reported device performance

Feature/Criterion	Acceptance Criteria (if stated)	Reported Device Performance (if stated)
Ultrasonically-Derived Fat Fraction (UDFF) measurement tool	Not provided in this document	"an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis" (indicative only, no quantitative performance reported)
General Device Performance	Not provided in this document	Relies on substantial equivalence to predicate device (K221500)
Overall Conclusion	Not provided for specific features in a quantitative manner, as clinical studies were not required for this submission.	Not provided for specific features in a quantitative manner, as clinical studies were not required for this submission.

Sample sizes used for the test set and the data provenance
- Test Set Sample Size: Not applicable / Not provided, as clinical studies were not required for this 510(k) based on substantial equivalence.
- Data Provenance: Not applicable / Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided, as clinical studies were not required for this 510(k) based on substantial equivalence.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided, as clinical studies were not required for this 510(k) based on substantial equivalence.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was performed or reported in this document. The submission states, "clinical studies were not required to support substantial equivalence."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone performance study reported in this document. The submission states, "clinical studies were not required to support substantial equivalence."
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided, as clinical studies were not required for this 510(k) based on substantial equivalence.
The sample size for the training set
- Not applicable / Not provided. This document does not describe the development or training of an AI algorithm; rather, it describes a diagnostic ultrasound system relying on existing technology and a predicate device. The UDFF is a "software feature" that was "already cleared" on a previous device.
How the ground truth for the training set was established
- Not applicable / Not provided, for the same reasons as above. The document does not detail the training of any new AI/software feature unique to this submission.

Summary

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February 6, 2023

Image /page/0/Picture/1 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 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. % Sulgue Choi Regulatory Affairs Manager 22010 South East 51st Street ISSAQUAH WA 98029

Re: K223735

Trade/Device Name: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select 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: December 13, 2022 Received: January 12, 2023

Dear Sulgue Choi:

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

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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 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.

Yanna S. Kang -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices 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) K223735

Device Name

ACUSON Sequoia Diagnostic Ultrasound System ACUSON Sequoia Select 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 .
o 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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3D/4D Volume Imaging with color
---------------------------------

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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510(k) Summary

K223735

Date:	January 11, 2023
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 SystemACUSON Sequoia Select Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class: IIReview Category: Tier IIClassification Panel: Radiology
	Ultrasonic Pulsed Doppler Imaging System892.155090-IYNUltrasonic Pulsed Echo Imaging System892.156090-IYODiagnostic Ultrasound Transducer892.157090-ITXBiopsy Needle Guide Kit892.156090-OIJ	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
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 and Sequoia Select Diagnostic Ultrasound Systems are a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the company's own products, the ACUSON Sequoia (K221500) which is primary predicated device.

-Primary Predicate Device: ACUSON Sequoia (K221500)

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4. Device Description

5. Intended Use/Indications for Use

The ACUSON Sequoia and Sequoia Select 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 manaqing adult patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaqinal, 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

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. 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 3D/4D Volume Imaging with color

6. Summary of Technological Characteristics

The modified ACUSON Sequoia and Sequoia Select Ultrasound Systems are the same as the company's own previously cleared ACUSON Sequoia (K221500) with regard 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:

-Software feature
- . The modified ACUSON Sequoia Ultrasound System includes the expansion of the UDFF (Ultrasonically-Derived fat fraction) software features for 5C1 transducer which were already cleared on the ACUSON Sequoia (K221500)
Transducer & Accessories -
- The addition of needle quide kit, 10EV3, which is substantially equivalent to the ● needle quide Kit, 9EC4 previously cleared on the ACUSON Sequoia (K221500)
Hardware change and improvement -
- . New monitor and monitor arm
- . Common Control Panel and Control Panel cradle
- . Update rear storage basket

The foundation of the ACUSON Sequoia and Sequoia Select (this submission) are the ACUSON Sequoia(K221500) with features and transducers integrated with the ACUSON Sequoia(K221500) hardware and the ACUSON Sequoia Select(this submission) reuse software developed for Sequoia(K221500) mainly. All other hardware and software features of the ACUSON Sequoia and Sequoia Select Diagnostic Ultrasound devices remain unchanged.

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

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ACUSON Sequoia & Sequoia Select Diagnostic Ultrasound System Special 510(k) Submission

Feature / Characteristic	ACUSON SequoiaThis Submission	ACUSON SequoiaSelectThis Submission	ACUSON SequoiaK# 221500Predicate device
	Indications for Use:
■	Fetal	√	√	√
■	Abdominal	√	√	√
■	Pediatric	√	√	√
■	Small Organ	√	√	√
■	Cardiac	√	√	√
■	Transrectal	√	√	√
■	Transvaginal	√	√	√
■	Peripheral vessel	√	√	√
■	Musculo-skeletal(conventional)	√	√	√
■	Musculo-skeletal(superficial)	√	√	√
■	Neonatal cephalic	√	√	√
■	Adult cephalic	√	√	√
	Frequencies Supported:	(1.0MHZ~18MHz)	(1.0MHZ~18MHz)	(1.0MHZ~18MHz)
	Modes:
■	B	√	√	√
■	M	√	√	√
■	PWD (Pulsed WaveDoppler)	√	√	√
■	CWD (Continuous WaveDoppler)	√	√	√
■	PW DTI (Doppler TissueImage)	√	√	√
■	Color Doppler	√	√	√
■	Power Doppler	√	√	√
■	Combined (BMDC)	√	√	√
	Features:
■	Harmonic imaging	√	√	√
■	Panoramic imaging	√	√	√
■	Color Panoramicimaging	√	√	√
■	Auto TEQ	√	√	√
■	Cardiac Imagingphysiological signaldisplay	√	√	√
■	eSie OB	√	√	√
■	Compounding	√	√	√
■	Contrast imaging	√	√	√
Feature / Characteristic	ACUSON SequoiaThis Submission	ACUSON SequoiaSelectThis Submission	ACUSON SequoiaK# 221500Predicate device
Clarify	√	√	√
Virtual Touch - Strainsyngo ® 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 StabilizedPersistence	√	√	√
DICOM	√	√	√
DICOM SR	√	√	√
Slow Flow Color DopplerState	√	√	√
Dynamic MultiHertz	√	√	√
3D/4D Volume ImagingMode	√	√	√
UDFF (Ultrasonically-Derived Fat Fraction)	√	√	√
Auto pSWE	√	√	√
Auto IMT	√	√	√
eSieDoppler	√	√	√
Virtual workstation	√	√	√
Velocity VarianceMapping	√	√	√
Feature / Characteristic	ACUSON SequoiaThis Submission	ACUSON SequoiaSelectThis Submission	ACUSON SequoiaK# 221500Predicate device
Monitor: 21" FPD(OLED)	√(23.8" Dual LayerHigh Dynamic RangeFPD)	√(23.8" Dual LayerHigh Dynamic RangeFPD)	√
Touch Screen: 15"adjustable TouchScreen	√(13.3" adjustabletouch screen)	√(13.3" adjustabletouch screen)	√
Output DisplayStandard (Track 3)	√	√	√
Patient Contact Materials	Tested to ISO10993-1	Tested to ISO10993-1	Tested to ISO10993-1
UL 60601-1 Certified	√	√	√
Indications for Use	√	√	√

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ACUSON Sequoia & Sequoia Select Diagnostic Ultrasound System Special 510(k) Submission

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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 devices have 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:

I IEC 62359: Edition 2.1 2017-09, Ultrasonics - Field characterization - Test methods for 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 O 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: O Particular requirements for the basic safety and essential performance of endoscopic equipment
- 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

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

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

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. 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 and Sequoia Select systems are 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.