Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and measurement tools, with no mention of AI or ML capabilities.

Therapeutic

No
The device description states its function is to "transmit and receive ultrasound echo data and display it," indicating it is a diagnostic imaging system, not a therapeutic one. The intended use also focuses on providing images for diagnostic purposes and measurements for clinical diagnosis.

Diagnostic

Yes

The "Device Description" explicitly states, "The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system." Additionally, the "Intended Use / Indications for Use" section describes its use for obtaining images and signals for various clinical applications, and for providing measurements that "may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes."

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 as transmitting and receiving ultrasound echo data, which requires hardware components (transducers, processing units, etc.) in addition to software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body. The ACUSON Sequoia system is used to image structures inside the body using ultrasound technology.
The intended use and device description clearly state that the system provides images and signals from inside the body. It's a diagnostic imaging system, not a laboratory testing device.
The applications listed (Fetal, Abdominal, Cardiac, etc.) are all related to imaging internal anatomy.

Therefore, the ACUSON Sequoia ultrasound imaging system falls under the category of a diagnostic imaging device, 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

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

Not Found

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, Peripheral Vascular, hepatic, small organ.

Indicated Patient Age Range

Adult patients, Fetal, Pediatric, Neonatal.

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)

K201462

Reference Device(s)

K183575

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 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. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K211859

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: July 7, 2021 Received: July 8, 2021

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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

July 20, 2021

1

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

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) K211859

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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K2

K211859	510(k) Summary
Date:	May 21, 2021
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 (K201462) which is primary predicated device and the ACUSON S family (K183575).

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

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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 .

Combined Modes 2D-mode with color 2D-mode with Doppler 2D-mode with color and Doppler

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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 (K201462) and the ACUSON S family (K183575) 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:

The modified ACUSON Sequoia Ultrasound System updated the indications for use statement (Intended use) to add UDFF (Ultrasonically-Derived fat fraction) indication which was previously cleared on the predicate device, ACUSON S family (K183575).
. Also this Traditional 510(k) includes additional improved imaging features: UDFF (Ultrasonically-Derived fat fraction), Auto pSWE, Auto IMT, eSieDoppler, Virtual Workstation and Image Rotate which were cleared on the predicate device, ACUSON Sequoia (K201462) and ACUSON S family (K183575) 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(K201462) with features and transducers integrated with the ACUSON Sequoia(K201462) hardware and the ACUSON Sequoia (this submission) reuse software developed for Sequoia(K201462) mainly as well as UDFF, Auto IMT from ACUSON S family (K183575).

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# 201462
Predicate device | ACUSON S family
S2000/S3000
K# 183575
Reference device |
|----------------------------------------------|-----------------------------------|-------------------------------------------------|-----------------------------------------------------------------|
| Indications for Use: | | | |
| ■ Fetal | √ | √ | |
| ■ Abdominal | √ | √ | |
| ■ Pediatric | √ | √ | |
| ■ Small Organ | √ | √ | |
| ■ Cardiac | √ | √ | |
| ■ Transrectal | √ | √ | |
| ■ Transvaginal | √ | √ | |
| ■ Peripheral vessel | √ | √ | |
| ■ Musculo-skeletal
(conventional) | √ | √ | |
| Feature / Characteristic | ACUSON Sequoia
This Submission | ACUSON Sequoia
K# 201462
Predicate device | ACUSON S family
S2000/S3000
K# 183575
Reference device |
| Musculo-skeletal
(superficial) | √ | √ | |
| Neonatal cephalic | √ | √ | |
| Adult cephalic | √ | √ | √ |
| Frequencies Supported: | (1.0MHZ~~18MHz) | (1.0MHZ~~18MHz) | (2.0MHz~17MHz) |
| 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 | √ | √ | |
| 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 | √ | √ | |
| Feature / Characteristic | ACUSON Sequoia This Submission | ACUSON Sequoia K# 201462 Predicate device | ACUSON S family S2000/S3000 K# 183575 Reference device |
| 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) | √ | | √
(Quantitative Ultrasound (QUS)) |
| Auto pSWE | √ | √ | |
| Auto IMT | √ | | √
(Arterial health package) |
| eSieDoppler | √ | √ | |
| Virtual workstation | √ | | |
| 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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8

A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence

9

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety and have been found to conform to applicable medical device safety standards. The systems comply with the following voluntary standards:

트 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)
Safety and EMC Requirements for Medical Equipment
- O AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and 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, Medical electrical equipment Part 1: General requirements o 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: Electromaqnetic 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
ISO 10993-1 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)

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 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 system is substantially equivalent with respect to safety and effectiveness to the predicate device currently cleared for market.