The LOGIQ E10s is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ E10s clinical applications include : Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transvaginal; Transesophageal and Intraoperative (Vascular).

Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M. B/Color. B/Color/PWD. B/Power/PWD. The LOG10 E10s is intended to be used in a hospital or medical clinic.

Device Description

The LOGIQ E10s is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, high resolution color touch screen, and color widescreen monitor. The system utilizes a variety of linear, curved, phased and matrix array transducers to support the broad imaging capabilities.

AI/ML Overview

The provided text states that the LOGIQ E10s did not require clinical studies to support substantial equivalence. Therefore, there is no information available in the document regarding acceptance criteria or a study proving the device meets acceptance criteria through clinical trials.

The document focuses on non-clinical tests and comparisons to predicate devices to establish substantial equivalence.

Here's a breakdown of the available information based on your requested points, highlighting the absence of clinical study data:

A table of acceptance criteria and the reported device performance
- Not available. The document does not provide a table of acceptance criteria or reported device performance from a clinical study. It discusses non-clinical compliance with safety standards and similarity to predicate devices.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set information is provided as clinical studies were not required.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical test set information is provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set information is provided.
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
- Not applicable. No MRMC comparative effectiveness study was done or reported. This device is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool as described in the question.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI algorithms. While the device connects to "Koios DS for Breast" (K190442), which is an AI-based system, the document refers to the LOGIQ E10s as a diagnostic ultrasound system, not an AI algorithm itself. No standalone performance of an algorithm is reported for the LOGIQ E10s.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No clinical test set information is provided.
The sample size for the training set
- Not applicable. No clinical test information or AI training set information is provided for the LOGIQ E10s itself.
How the ground truth for the training set was established
- Not applicable. No clinical test information or AI training set information is provided.

Instead of clinical studies, the submission relies on documentation of compliance with safety standards and a comparison to predicate devices, stating: "The subject of this premarket submission, LOGIQ E10s, did not require clinical studies to support substantial equivalence." The conclusion is that the LOGIQ E10s is considered "as safe, as effective, and performance is substantially equivalent to the predicate device(s)."

The non-clinical tests performed included:

Acoustic output
Biocompatibility
Cleaning and disinfection effectiveness
Thermal, electrical, electromagnetic, and mechanical safety

The device was found to conform with applicable medical device safety standards, including:

AAMI/ANSI ES60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1
ISO 14971
NEMA PS 3.1-3.20 (DICOM Set)
IEC 62359

Quality assurance measures applied during development included:

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

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226

Re: K200119

Trade/Device Name: LOGIO E10s Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX, IYO Dated: January 18, 2020 Received: January 21, 2020

Dear Tracey Ortiz:

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/cfpmp/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.

April 1, 2020

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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,

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) K200119

Device Name LOGIQ E10s

Indications for Use (Describe)

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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K200119	510(k) Summary
	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	January 18, 2020
Submitter:	GE Medical Systems Ultrasound and Primary care Diagnostics, LLC9900 Innovation DrWauwatosa, WI 53226
Manufacturer:	GE Ultrasound Korea, Ltd.9, Sunhwan-ro 214 beon-gil, Jungwon-gu,Seongnam-si, Gyeonggi-do, Republic of Korea
Primary Contact Person:	Tracey OrtizRegulatory Affairs DirectorGE HealthcareT:(262)676-6120
Alternate Contact Person:	Qingmeng ChenRegulatory Affairs Program ManagerGE HealthcareT: +86-18180590723
Device Trade Name:	LOGIQ E10s
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-IYN;Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Primary Predicate Device:	K173555 LOGIQ E10 Diagnostic Ultrasound System
Reference Device(s):	K170445 LOGIQ S8 Diagnostic Ultrasound SystemK192159 Voluson E10 Diagnostic Ultrasound SystemK161843 Aplio i900/i800/i700 Diagnostic Ultrasound System V2.0 (ATI)K190442 Koios DS for Breast
Device Description:	The LOGIQ E10s is a full featured, Track 3, general purpose diagnosticultrasound system which consists of a mobile console that provides digitalacquisition, processing and display capability. The user interface includesa computer keyboard, specialized controls, high resolution color touchscreen, and color widescreen monitor. The system utilizes a variety oflinear, curved, phased and matrix array transducers to support the broadimaging capabilities.

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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' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by decorative white swirls, giving the logo a classic and recognizable appearance.

The LOGIO E10s is a general-purpose diagnostic ultrasound system Intended Use: intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIO E10s clinical applications include : Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculoskeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIO E10s is intended to be used in a hospital or medical clinic. Technology: The LOGIO E10s employs the same fundamental scientific technology as its predicate device(s). Determination of Comparison to Predicates Substantial Equivalence: The proposed LOGIQ E10s is a new platform substantially equivalent to the predicate devices. The following is an overview of the differences between the proposed LOGIQ E10s and the predicate LOGIQ E10 (K173555). The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. The LOGIQ E10s and predicate LOGIQ E10 systems have the same ● clinical intended use. The LOGIQ E10s and predicate LOGIQ E10 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.
. The systems have acoustic power levels which are below the applicable FDA limits.
. The LOGIO E10s and predicate LOGIO E10 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
The LOGIQ E10s and predicate LOGIQ E10 systems have been designed in compliance with approved electrical and physical safety standards.
The probes supported in proposed LOGIQ E10s and predicate LOGIQ E10 are identical except: - the following probes have been migrated from LOGIQ S8 (K170445): L3-12-D, 6S-D, BE9CS-D, P6D -Add B-Flow (hybrid) as a new mode to: C2-9-D, C2-9VN-D,

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L2-9-D, L2-9VN-D, ML6-15-D, L8-18i-D -Add Shear Wave Elastography as a new mode to: IC5-9-D, ML6-15-D, L8-18i-D

-Add Elastography (strain) as a new mode to: L8-18i-D

The software features supported in proposed LOGIO E10s and o predicate LOGIQ E10 are identical except: - the following software features have been migrated from LOGIQ S8 (K170445): Scan on battery, HDLive, CTO.
the following software features have been migrated from Voluson E10 (K192159): SonoNT, SonoIT, SonoAVC for renal cyst, SonoRenderLive, Radiantflow.
UGAP is a new feature similar to ATI on Aplio i900/i800/i700 Diagnostic Ultrasound System V2.0 (K161843) that measures the attenuation value in the liver.
Connectivity to Koios DS SW (Koios DS for Breast, K190442) is a newly introduced capability. It allows data input to Koios and display of the output from Koios.

-Adding Tru 3D and V-nav Bracket as a new feature on M5Sc-D. - Other minor software feature modifications are: added Magnification Zoom and Pan Zoom capability, included a SWE Quality indicator, improved the Vnav image based registration, enabled Device Management, add a type 2 to SRI-HD.

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 LOGIQ E10s 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
o ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within A Risk Management Process, Fourth edition, 2009

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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular shape, and the entire logo is presented in a blue color.

ISO 14971, Application of risk management to medical devices, ● 2007
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) o

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, LOGIQ E10s, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the LOGIQ E10s 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.