The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Device Description

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.

AI/ML Overview

The GE LOGIQ E9 Diagnostic Ultrasound System is a full-featured, general-purpose diagnostic ultrasound system. It consists of a mobile console and provides digital acquisition, processing, and display capabilities. The user interface includes a computer keyboard, specialized controls, a 10-inch LCD touch screen, and a 19-inch LCD image display.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or numerical performance metrics for the LOGIQ E9 system's image quality or diagnostic accuracy. Instead, the "acceptance criteria" are implied through the statement of substantial equivalence to its predicate device(s).

The reported device performance is that it is considered "as safe, as effective, and performance is substantially equivalent to the predicate device(s)."

Acceptance Criteria (Implied)	Reported Device Performance
Safety (electrical, thermal, mechanical, biocompatibility etc.)	Conforms with applicable medical device safety standards.
Effectiveness (general ultrasound imaging capabilities)	Substantially equivalent to predicate device(s).
Performance (image quality, functionality across indications)	Substantially equivalent to predicate device(s).
Conformance to voluntary standards	Complies with voluntary standards detailed in sections 9, 11, and 17.

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

The document explicitly states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set of clinical data from human subjects mentioned in this 510(k) summary. The evaluation focused on non-clinical tests.

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

Since no clinical studies were performed on a test set, no experts were used to establish ground truth for a test set in the context of clinical performance evaluation. The evaluation was primarily engineering and performance testing against standards and the predicate device.

4. Adjudication Method for the Test Set

As no clinical test set was utilized, there was no adjudication method described for clinical data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states no clinical studies were required.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Since the LOGIQ E9 is a diagnostic ultrasound system and not an AI-powered algorithm for image interpretation, the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI/ML devices is not directly applicable.

The "performance" evaluation for this device was based on engineering verification and validation, demonstrating that the system's technical specifications and imaging capabilities were comparable to its predicate devices, rather than a standalone AI performance study.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be established by:

Engineering specifications and test standards: For acoustic output, thermal, electrical, electromagnetic, and mechanical safety.
Biocompatibility testing results: Conformance to established biocompatibility protocols.
Cleaning and disinfection effectiveness testing results: Verification against established protocols.
Comparison to predicate device's established performance: The predicate device serves as a benchmark for "substantial equivalence."

No pathology, expert consensus on images, or outcomes data were used as ground truth for clinical performance, as clinical studies were not performed.

8. Sample Size for the Training Set

The LOGIQ E9 is a traditional diagnostic ultrasound system, not an AI/ML device that requires a "training set" of data in the same way. Therefore, there is no mention of a training set sample size.

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

As there is no mention of an AI/ML training set, this question is not applicable to this 510(k) submission.

Summary of Device Evaluation Approach:

The GE LOGIQ E9 Diagnostic Ultrasound System received 510(k) clearance based on its substantial equivalence to previously cleared predicate devices (K092271 GE LOGIQ E9 Diagnostic Ultrasound System and K052441 GE LOGIQ 7 Diagnostic Ultrasound System). This determination was made primarily through non-clinical tests and verification activities, rather than clinical studies. The non-clinical tests included evaluations for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and various safety aspects (thermal, electrical, electromagnetic, mechanical). The device also underwent a series of internal quality assurance measures such as risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, and final acceptance). The core argument for substantial equivalence rested on the device employing the "same fundamental scientific technology as its predicate device(s)" and conforming to applicable safety standards and voluntary standards.

Summary

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K110943

・

JUL 2 2 2 2011

510(k) Summary

・

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	April 1, 2011
Submitter:	GE Healthcare, GE Medical Systems Ultrasound and PrimaryCare Diagnostics, LLC.9900 Innovation Dr.Wauwatosa, WI 53226
Contact Person:	Bryan BehnRegulatory Affairs ManagerGE Healthcare, GE Medical Systems Ultrasound and PrimaryCare Diagnostics, LLC.Phone: 414-721-4214Fax: 414-918-8275
Device: Trade Name:	GE LOGIQ E9 Diagnostic Ultrasound System
Common/Usual Name:	LOGIQ E9
Classification Names:	Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-ΙΥΝUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Product Code:	Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	K092271 GE LOGIQ E9 Diagnostic Ultrasound SystemK052441 GE LOGIQ 7 Diagnostic Ultrasound System
Device Description:	The LOGIQ E9 is a full featured, general purpose diagnosticultrasound system which consists of a mobile consoleapproximately 58 cm wide, 86cm deep and 141 cm high thatprovides digital acquisition, processing and display capability.The user interface includes a computer keyboard, specializedcontrols, 10-inch LCD touch screen and color 19-inch LCDimage display.
Intended Use:	The device is intended for use by a qualified physician forultrasound evaluation of Fetal; Abdominal; Pediatric; SmallOrgan (breast, testes, thyroid); Neonatal Cephalic; AdultCephalic; Cardiac (adult and pediatric); Peripheral Vascular;Musculo-skeletal Conventional and Superficial; Urology(including prostate); Transrectal; Transvaginal; Transesophagealand Intraoperative (abdominal, thoracic, vascular andneurosurgical).
Technology:	The LOGIQ E9 employs the same fundamental scientifictechnology as its predicate device(s).
Determination of Substantial Equivalence:	Summary of Non-Clinical Tests:The device has been evaluated for acoustic output,biocompatibility, cleaning and disinfection effectiveness as well

: :

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as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The LOGIQ E9 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were 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)
. Final Acceptance testing (Validation)

Summary of Clinical Tests:

The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the LOGIQ E9 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human face in profile, with flowing lines representing hair or other features.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Dr. WAUWATOSA WI 53226

JUL 222 2011

Re: K110943

Trade/Device Name: LOGIC E9 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 18, 2011 Received: July 19, 2001

Dear Mr. Behn:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

This determination of substantial equivalence applies to the following transducers intended for use with the LOGIC E9 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

C1-5-D

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Behn

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy, Ph.D. at (301) 796-6242.

Sincerely Yours,

Mary S. Patil

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a circular border. The logo is black and white and has a vintage look.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known):

Device Name: LOGIQ E9 Diagnostic Ultrasound System

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use N/A (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Patil

(Division Sign-Of Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K110943
Page 1 of 1

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Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 Ultrasound System

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes'	HarmonicImaging	CodedPulse"	Other[Notes]
Ophthalmic	P	P	P	P	P	P	P	P	P	P
Fetal/Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[3,5,6,9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[3,5,6,9]
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	[3,5,6,9]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Cardiac Adult	P	P	P	P	P	P	P	P	P	P
Cardiac Pediatric	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[3,5,6,9]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[3,5,6,9]
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	[3,5,6,9]
Other[4]	P	P	P	P	P	P	P	P	P	P	[3,5,6,9]
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P
Transrectal	P	P	P	P	P	P	P	P	P	P	[3,5,6,9]
Transvaginal	P	P	P	P	P	P	P	P	P	P	[3,5,6,9]
Transurethral
Intraoperative[8]	P	P	P	P	P	P	P	P	P	P	[3,5,6,9]
Intraoperative Neurological	P	P	P	P	P	P	P	P	P	P
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes Renal, GYN/Pelvic.

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance im aging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, t horacic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

System provides real-time 3D and 4D acquisition when used with special 4D probes

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Postle

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K

110943

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Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with C1-5-D Transducer

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes'	HarmonicImaging	CodedPulse'	Other[Notes]

Ophthalmic

[5,6,9]

[3,5,6,9]

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes Renal, GYN/Pelvic.

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle quidance im aging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD,

System provides real-time 3D and 4D acquisition when used with special 4D probes

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S/Postif
(Division Sign-Off)

Fetal/Obstetrics™

Abdominal[1]

Small Organ (21 Neonatal Cephalic Adult Cephalic Cardiac Adult Cardiac Pediatric Peripheral Vascular

Musculo-skeletal Conventional Musculo-skeletal Superficial

Exam Type, Means of Access

Intraoperative Neurological

Transesophageal Transrectal Transvaginal Transurethral

Intraoperative[в]

Intravascular Laparoscopic

Pediatric

Other 141

Division of tadiological Devices Office of in Vitro Diagnostic Device Evaluation and Safety

510K K110943

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.