Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10 Expert are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10 Expert clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV).

Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10 Expert are intended to be used in a hospital or medical clinic.

Device Description

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes. All probes on the subject device have been previously cleared on the predicate K180374 with the exception of the IC9b-RS which was previously cleared on predicate K201828. All probes available as accessories for the subject systems Voluson are used unchanged from the cleared predicates. They are made of the same materials and their shape is unchanged The primary differences between the difference models are the Voluson S10 Expert/S10 and S8t have a touch panel in the user interface and the S8 and S6 do not. Additionally, the Voluson S10 Expert is the highest configuration offering all the features and probes available on the S Series and the other models offer a subset of them.

AI/ML Overview

The provided document is a 510(k) premarket notification for the GE Healthcare Voluson S series diagnostic ultrasound system. It details the device's characteristics, intended use, and comparison to predicate devices to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or quantify device performance in terms of metrics like sensitivity, specificity, or AUC for any specific diagnostic task. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, K180374 Voluson S series Diagnostic Ultrasound System, and reference device K201828 Voluson SWIFT, Voluson SWIFT+ Diagnostic Ultrasound System.

The "reported device performance" is implicitly that the device is as safe and effective as its predicate, adhering to the same performance standards of diagnostic ultrasound systems. The summary states:

Acceptance Criteria (Implicit - Substantial Equivalence Basis):

Acoustic power levels below applicable FDA limits.
Similar capability in performing measurements, capturing digital images, reviewing, and reporting studies as predicate devices.
Designed in compliance with approved electrical and physical safety standards.
Same clinical intended use and imaging modes as predicate devices.
Manufactured with materials found to be safe for intended use.
Transducer materials and patient contact materials are biocompatible.
Compliance with voluntary standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA PS 3.1 3.20, IEC 62359).

Reported Device Performance (Implicit - Demonstrated Equivalence):
The document asserts that the Voluson S Series meets these implicit criteria by being substantially equivalent to the predicate devices. It explicitly mentions:

"The systems have acoustic power levels which are below the applicable FDA limits."
"The proposed Voluson S Series and predicate Voluson S series systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies."
"The proposed Voluson S Series and predicate Voluson S series systems have been designed in compliance with approved electrical and physical safety standards."
"Transducer materials and other patient contact materials are biocompatible."
The system complies with a list of voluntary standards related to safety, electromagnetic compatibility, and medical diagnostic ultrasonic fields.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The subject of this premarket submission, Voluson S Series did not require clinical studies to support substantial equivalence."

Therefore, there is no test set in the context of clinical performance evaluation mentioned in this document, as no clinical studies were performed for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

As no clinical studies were conducted for this submission, there was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies were conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done, as explicitly stated that "The subject of this premarket submission, Voluson S Series did not require clinical studies to support substantial equivalence."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not mentioned or performed, as the submission relies on substantial equivalence to predicate devices, not on proving new diagnostic performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable, as no clinical studies were conducted. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices, which the new device is claimed to be substantially equivalent to, based on technical and performance similarity.

8. The Sample Size for the Training Set

Not applicable. This submission is for a diagnostic ultrasound system (hardware and associated software for image acquisition and display), not an AI/Machine Learning algorithm that requires a training set in the conventional sense for a diagnostic task. The document lists "Risk Analysis," "Requirements Reviews," "Design Reviews," "Testing on unit level," "Integration testing," "Performance testing," and "Safety testing" as quality assurance measures for the development of the system. These refer to engineering and system validation, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an AI/Machine Learning algorithm described in this submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.

GE Healthcare % Mr. Bryan Behn RA Director 9900 Innovation Drive WAUATOSA WI 53226

January 13, 2022

Re: K213642

Trade/Device Name: Voluson S6, Voluson S8, Voluson S10, Voluson S10, Voluson S10 Expert Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 17, 2021 Received: November 18, 2021

Dear Mr. Behn:

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 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)

K213642

Device Name

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert

Indications for Use (Describe)

Voluson S6 / Voluson S8 / Voluson S10 / Voluson S10 Expert are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson S6 / Voluson S8 / Voluson S10 / Voluson S10 Expert clinical applications include: Fetal/Obstetrics: Abdominal (including renal and GYN/Pelvic): Small Organ (Breast. Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV).

Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson S6 / Voluson S8 / Voluson S10 / Voluson S10 Expert are intended to be used in a hospital or medical clinic.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by three stylized water droplets, also in blue, which give the impression of movement or flow around the central letters.

510(k) Summary K213642

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	November 17, 2021
Submitter:	GE Medical Systems Ultrasound and Primary care Diagnostics, LLC9900 Innovation DrWauwatosa, WI 53226
Manufacturer:	GE Ultrasound Korea, Ltd.9, Sunhwan-ro 214beon-gil, Jungwon-gu,Seongnam-si, Gyeonggi-do, Republic of Korea
Primary Contact Person:	Bryan BehnRegulatory Affairs DirectorGE HealthcareT:(262) 247-5502
Alternate Contact Person:	Jiyeon ParkSenior Regulatory Affairs LeaderGE HealthcareT: +82 317406307
Device Trade Name:	Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
Common/Usual Name:	Diagnostic Ultrasound System
Classification Names:	Class II
Product Code:	IYN (primary), IYO, ITX (secondary)Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Primary Predicate Device:	K180374 Voluson S series Diagnostic Ultrasound System
Classification Names:	Class II
Product Code:	IYN (primary), IYO, ITX (secondary)Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Reference Device(s):	K201828 Voluson SWIFT, Voluson SWIFT+ Diagnostic Ultrasound System
Classification Names:	Class II
Product Code:	IYN (primary), IYO, ITX (secondary)
	Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN;
	Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;
	Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Device Description:	The systems are full-featured Track 3 ultrasound systems, primarily forgeneral radiology use and specialized for OB/GYN with particularfeatures for real-time 3D/4D acquisition. They consist of a mobileconsole with keyboard control panel; color LCD/TFT touch panel, colorvideo display and optional image storage and printing devices. Theyprovide high performance ultrasound imaging and analysis and havecomprehensive networking and DICOM capability. They utilize a varietyof linear, curved linear, matrix phased array transducers includingmechanical and electronic scanning transducers, which provide accuratereal-time three-dimensional imaging supporting all standard acquisitionmodes. All probes on the subject device have been previously cleared onthe predicate K180374 with the exception of the IC9b-RS which waspreviously cleared on predicate K201828. All probes available asaccessories for the subject systems Voluson are used unchanged from thecleared predicates. They are made of the same materials and their shapeis unchangedThe primary differences between the difference models are the VolusonS10 Expert/S10 and S8t have a touch panel in the user interface and theS8 and S6 do not. Additionally, the Voluson S10 Expert is the highestconfiguration offering all the features and probes available on the SSeries and the other models offer a subset of them.
Intended Use:	Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10Expert are a general-purpose diagnostic ultrasound system intended foruse by a qualified and trained healthcare professional that are legallyauthorized or licensed by law in the country, state or other localmunicipality in which he or she practices for ultrasound imaging,measurement, display and analysis of the human body and fluid. Theusers may or may not be working under supervision or authority of aphysician. Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 /Voluson S10 Expert clinical applications include: Fetal/Obstetrics;Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ(Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic;Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (includingUrology/Prostate) (TR); Transvaginal (TV).
	Mode of operation include: B, M, AMM, PW Doppler, CW Doppler,Color Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode,Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color,B/PWD, B/Power/PWD. The Voluson S6 / Voluson S8 / Voluson S8t/Voluson S10 / Voluson S10 Expert are intended to be used in a hospitalor medical clinic.
Technology:	The Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / VolusonS10 Expert employs the same fundamental scientific technology as itspredicate device(s).
Determination ofSubstantial Equivalence:	Comparison to PredicatesThe proposed Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 /Voluson S10 Expert is substantially equivalent to the predicate devices.The following is an overview of the differences between the proposedVoluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10Expert and the predicate Voluson S Series (K180374).The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. The proposed Voluson S Series and predicate Voluson S series systems have the same clinical intended use. The proposed Voluson S Series and predicate Voluson S series systems have the same imaging modes. The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are decorative swirls or flourishes around the outer edge of the circle, giving it a dynamic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The frame has decorative flourishes resembling water droplets or stylized leaves. The logo is rendered in a blue color.

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Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are three white water droplets around the circle. The logo is simple and recognizable.

The systems have acoustic power levels which are below the ● applicable FDA limits.
The proposed Voluson S Series and predicate Voluson S series systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
The proposed Voluson S Series and predicate Voluson S series systems have been designed in compliance with approved electrical and physical safety standards.
The probes supported in proposed Voluson S Series and predicate ● Voluson S series systems are identical - The following probe has been migrated from Voluson SWIFT, Voluson SWIFT+ (K201828): IC9B-RS - The C2-9-RS probe has been expanded to Voluson S10, Voluson S8t, Voluson S8 and Voluson S6.
The following software features have been migrated from . Voluson SWIFT, Voluson SWIFT+(K201828): SonoCNS, Uterine Trace, Sonobiometry Brain.
The following minor improvements have been made IDEA ● Assessment, IOTA ADNEX, IETA Tool, Sono FHR, SonoAVCantral20, OS update, Security update, Measurement package updates, Refresh of connectivity.

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The Voluson S Series complies with voluntary standards:

AAMI/ANSI ES60601-1, Medical Electrical Equipment Part 1: ● General Requirements for Safety, 2005/(R)2012 And A1:2012
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General . Requirements for Basic Safety and Essential Performance -Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, Edition 4.0, 2014
. IEC 60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1, 2015

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo, which is a circular emblem with a stylized "GE" monogram in the center. The monogram is surrounded by a circular border, and there are three stylized water droplets or flourishes evenly spaced around the outer edge of the circle. The logo is rendered in a blue color.

ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: . Evaluation and Testing Within A Risk Management Process, Fourth edition, 2009
ISO 14971, Application of risk management to medical devices, 2019
NEMA PS 3.1 3.20, Digital Imaging and Communications in ● Medicine (DICOM) Set. (Radiology), 2016
IEC 62359, Ultrasonics Field characterization Test methods ● for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, Edition 2.1, 2017

The following quality assurance measures are applied to the development of the system:

Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification) ●
Integration testing (System verification)
Performance testing (Verification) ●
Safety testing (Verification) .

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Voluson S Series did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Voluson S Series to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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.