The LOGIQ 500 with Harmonic Imaging is a general purpose utrasound imaging system intended for use in the evaluation of soft tissue and vascular disease in the head, neck, chest, abdomen, pelvis, male and female reproductive organs, limbs and pregnant uterus. Specific indications are: fetal, abdominal, pediatric, small organ, cephalic, cardiac, transesophageal, transvaginal, peripheral vascular, intra-operative, neurological, and musculo-skeletal.

Device Description

The LOGIQ 500 with Harmonic Imaging is a mobile console approximately 53 cm wide, 94 cm deep and 130 cm high equipped with a keyboard control panel, small A/N display panel, color video display monitor, assorted transducers and optional image storage or hard-copy devices. Harmonic imaging enhances or highlights the imaging of nonlinear tissue characteristics and contrast media.

AI/ML Overview

Here’s an analysis of the acceptance criteria and study information based on the provided text, using the specified format.

GE LOGIQ 500 with Harmonic Imaging Modification

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Safety:	The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. A postclearance special report containing complete information, including acoustic output measurements based on production line devices, is required to be submitted to the FDA.
Effectiveness:	Harmonic imaging is implemented with conventional digital image processing technology. Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The device is considered substantially equivalent to the currently marketed GE LOGIQ 500 (predicate device) in terms of technological characteristics, key safety and effectiveness features, design, construction, materials, intended uses, operating modes, and transducers. The indications for use for the LOGIQ 500 with Harmonic Imaging are consistent with those previously cleared for the LOGIQ 500, with specific additions for certain transducers (S222, S317, and C358) across various clinical applications and modes of operation (e.g., Abdominal, Adult Cephalic, Cardiac, Other for S222; Abdominal, Cardiac for S317).
Quality System:	The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 9001 & EN 46001 quality system standards.
Substantial	The GE LOGIQ 500 with Harmonic Imaging is of a comparable type and substantially equivalent to the currently marketed GE LOGIQ 500. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same design, construction, and materials, and has the same intended uses, operating modes and transducers as the predicate device. Diagnostic ultrasound has accumulated a long history of safe and effective performance. The FDA reviewed the 510(k) and determined the device is substantially equivalent for the indications for use stated to legally marketed predicate devices. Key transducers (C358, S317, S222) were also determined to be substantially equivalent for their described uses.
Equivalence:

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. The submission states "Clinical Tests: None required." The assessment for this device was based on non-clinical tests (acoustic output, biocompatibility, thermal, electrical, and mechanical safety) and a comparison to a predicate device.
Data Provenance: Not applicable, as no clinical test set was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication method for the test set:

Not applicable, as no clinical test set was used.

5. 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 comparative effectiveness study was done. This device is an ultrasound system with a "Harmonic Imaging" modification, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is an ultrasound imaging system, not an algorithm, and its performance inherently involves a human operator for image acquisition and interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable, as no clinical ground truth was established or used for performance evaluation in this 510(k) submission. The primary ground for acceptance was substantial equivalence to a predicate device and compliance with safety standards.

8. The sample size for the training set:

Not applicable, as this is an ultrasound system and not an AI/machine learning device that would require a training set.

9. How the ground truth for the training set was established:

Not applicable, as no training set was used.

Summary

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9 1999 JUN

K991611

Special 510(k) Premarket Notification GE Medical Systems - LOGIQ 500 with Harmonic Imaging Modification Mav 7, 1999

Attachment B:

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The logo is black and white.

GE Medical Svstems

General Electric Company P.O. Box 414, Milwaukee, WI 53201

Section a):

1.	Submitter:	GE Medical SystemsPO Box 414Milwaukee, WI 53201
	Contact Person:	Allen Schuh,Manager, Safety and Regulatory EngineeringTelephone: 414-647-4385; Fax: 414-647-4090
	Date Prepared:	May 7, 1999

Device Name: GE LOGIQ 500 Diagnostic Ultrasound with Harmonic Imaging Modification. Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Marketed Device: GE Medical Systems LOGIQ 500 diagnostic ultrasound system, 510(k) Numbers K933202 and K970901, currently in commercial distribution.
Device Description: The LOGIQ 500 with Harmonic Imaging is a mobile console approximately 53 cm wide, 94 cm deep and 130 cm high equipped with a keyboard control panel, small A/N display panel, color video display monitor, assorted transducers and optional image storage or hard-copy devices. Harmonic imaging enhances or highlights the imaging of nonlinear tissue characteristics and contrast media.
Indications for Use: The LOGIQ 500 with Harmonic Imaging is a general purpose utrasound imaging system intended for use in the evaluation of soft tissue and vascular disease in the head, neck, chest, abdomen, pelvis, male and female reproductive organs, limbs and pregnant uterus. Specific indications are: fetal, abdominal, pediatric, small organ, cephalic, cardiac, transesophageal, transvaginal, peripheral vascular, intra-operative, neurological, and musculo-skeletal.
Comparison with Predicate Device: The GE LOGIQ 500 Diagnostic Ultrasound System with Harmonic Imaging iis of a comparable type and substantially equivalent to the currently marketed GE LOGIQ 500. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same design, construction, and materials, and has the same intended uses, operating modes and transducers as the predicate device.

Section b):

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. Harmonic imaging is implemented with conventional digital image processing technology.
Clinical Tests: None required.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 9001 & EN 46001 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE LOGIQ 500 with harmonic imaging is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 9 1999

Allen Schuh Manager GE Ultrasound Safety & Regulatory Engineering General Electric Co. GE Medical Systems, Inc. P.O. Box 414 Milwaukee, Wisconsin 53201

K991611 Re: GE LOGIQ 500 (Harmonic Imaging) Dated: May 7, 1999 Received: May 10, 1999

Dear Mr. Schuh:

We have reviewed your Section 510(k) 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 LOGIQ 500 System as described in your premarket notification:

Transducer Model Number(s):

C358, S317 and S222

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic OS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page -2 - Mr. Allen Schuh

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling. nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification' (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

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Page –3 – Mr, Allen Schuh

If you have any questions regarding the content of this letter, please contact Robert Phillips, Ph.D at (301) 594-1212.

Sincerely yours,

CAPT Daniel Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Special 510(k) Premarket Notification GE Medical Systems - LOGIQ 500 with Harmonic Imaging Modification May 7, 1999

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 500 System

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P			P	P	P
Abdominal		P	P	P	P	P	P	P	P
Intraoperative (specify)		P	P	P			P	P	P
Intraoperative Neurological		P	P	P			P	P	P
Pediatric		P	P	P	P	P	P	P	P
Small Organ (specify)		P	P	P			P	P	P
Neonatal Cephalic		P	P	P	P	P	P	P	P
Adult Cephalic		P	P	P	P	P	P	P	P
Cardiac		P	P	P	P	P	P	P	P
Transesophageal		P	P	P	P	P	P	P	P
Transrectal		P	P	P			P	P	P
Transvaginal		P	P	P			P	P	P
Transuretheral
Intravascular
Peripheral Vascular		P	P	P	P	P	P	P	P
Laparoscopic
Musculo-skeletal Conventional		P	P	P			P	P	P
Musculo-skeletal Superficial		P	P	P			P	P	P
Other (specify)		P	P	P	P	P	P	P	P

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

Additional Comments: Cardiac is Adult and Pediatric. Small organ includes breast, testes, thyroid. Other includes urological. Combined modes are B/M, B/Color/PWD, Color/M K970901

Harmonic Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Ra-C. Pally
(Division Sign-Off)

eproductive, Abdominal, ENT and Radiological

510(k) Number K991611

Prescription User (Per 21 CFR 801.109)

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Special 510(k) Premarket Notification GE Medical Systems - LOGIQ 500 with Harmonic Imaging Modification May 7, 1999

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 500 with S222 Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		E	E	E	E	E	E		E
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic		E	E	E	E	E	E		E
Cardiac		E	E	E	E	E	E		E
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)		E	E	E	E	E	E		E

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

Additional Comments: Other includes urology. Cardiac includes adult and pediatric.

Combined modes are B/M, B/Color, B/PWD, B/Color/PWD, Color/M K970901

Harmonic Imaging

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R-P

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological De

510(k) Number K991611

Prescription User (Per 21 CFR 801.109)

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Special 510(k) Premarket Notification GE Medical Systems - LOGIQ 500 with Harmonic Imaging Modification May 7, 1999

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 500 with S317 Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric. Small organ includes breast, testes, thyroid.

Combined modes are B/M, B/Color, B/PWD, B/Color/PWD, Color/M K970901

Harmonic Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-Off) Division of Reproductive, Abdominal, ENT. Prescription User (Per 21 CFR 801.109) and Radiological De 510(k) Number E-19

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.