The GE Diasonics Gateway & Gateway FX with Harmonic Imaging are general purpose ultrasound imaging systems 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: Ophthalmic, Fetal, Abdominal, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, TR, TV, PV, and Musculo-skeletal Conventional & Superficial.

Device Description

The GE Diasonics Gateway FX with Harmonic Imaging are mobile consoles approximately 69 cm wide, 107 cm deep and 132 cm high equipped with a keyboard control panel, black and white video display monitor, 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

The provided document (K993069) describes a special 510(k) premarket notification for a modification to the GE Diasonics Gateway and Gateway FX Diagnostic Ultrasound System to include Harmonic Imaging.

Based on the document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the Harmonic Imaging modification is substantially equivalent to the currently marketed Gateway FX. The "acceptance criteria" here are based on the device conforming to safety standards and demonstrating equivalence to a predicate device, rather than specific performance metrics like sensitivity or specificity.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	Conformance with applicable medical device safety standards for: - Acoustic output - Biocompatibility - Thermal safety - Electrical safety - Mechanical safety Conformance with 21 CFR 820 (GMP) and ISO 9001/EN 46001 quality system standards	"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 design and development process of the manufacturer conforms with 21 CFR 820 and ISO 9001/EN 46001 quality system standards." "Compliance is verified through independent evaluation with ongoing factory surveillance."
Effectiveness/ Equivalence	Same technological characteristics, design, construction, materials as predicate device. Comparable in key safety and effectiveness features as predicate device. Same intended uses, operating modes, and transducers as predicate device. Consistency with traditional clinical practice, FDA guidelines, and established methods of patient examination.	"The GE Diasonics Gateway FX with Harmonic Imaging are of a comparable type and substantially equivalent to the currently marketed Gateway FX. They have the same technological characteristics, use the same design, construction and materials, are comparable in key safety and effectiveness features, and have the same intended uses, operating modes and transducers as the predicate device." "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination."
Intended Use	The GE Diasonics Gateway & Gateway FX with Harmonic Imaging are general purpose ultrasound imaging systems 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: Ophthalmic, Fetal, Abdominal, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, TR, TV, PV, and Musculo-skeletal Conventional & Superficial.	The Harmonic Imaging modification is specifically applied to B mode for the CLA/3.5MI/50-2D probes for the Gateway FX system and to B mode for the CLA/3.5MI/40 probe for the Gateway system, supporting the stated general purpose ultrasound imaging indications.

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

No clinical test set was required or performed for this specific 510(k) modification. The submission states: "Clinical Tests: None required."
The data provenance would therefore be internal engineering evaluations and comparisons to the predicate device, rather than patient data.

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

Not applicable. No clinical test set with a ground truth established by experts was used for this modification. The assessment focused on technical equivalence and compliance with engineering and safety standards.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set requiring adjudication was performed.

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 study was done. This device predates widespread "AI" in medical imaging as we understand it today (1999). Harmonic imaging is a signal processing technique, not an AI-driven interpretive tool. The submission refers to it as "conventional digital image processing technology."

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

Not applicable in the context of an "algorithm only" performance study. The device itself is an ultrasound system that produces images for human interpretation. The "Harmonic Imaging" feature is an image enhancement, not a diagnostic algorithm that provides a standalone output. Its performance is intrinsically tied to the system's overall image quality and safety, which was assessed through non-clinical tests.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was established by medical device safety standards and the performance characteristics of the predicate device. For example, acoustic output limits would be a "ground truth" for safety, and the image quality and functionality of the established predicate device served as the benchmark for equivalence.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of a machine learning or AI algorithm for this device. Harmonic imaging is a physics- and signal-processing-based technique.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there was no training set, there was no ground truth for a training set to be established.

Summary

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K993069

Special 510(k) Premarket Notification GE Diasonics Gateway with Harmonic Imaging Modification September 10, 1999

SEP 2 2 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 within a circle. The letters and the circle are black, while the background is white.

GE Medical Systems

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

Section a):

GE Medical Systems 1. Submitter: PO Box 414 Milwaukee, WI 53201
- Allen Schuh, Contact Person: Manager, Safety and Regulatory Engineering Telephone: 414-647-4385; Fax: 414-647-4090

September 10, 1999 Date Prepared:

GE Diasonics Gateway & Gateway FX Diagnostic Ultrasound with Harmonic Imaging 2. Device Names: Modification. Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN

Marketed Device: Diasonics Gateway & Gateway FX diagnostic ultrasound system, 510(k) Numbers K951998 and K961002, currently in commercial distribution.
Device Description: The GE Diasonics Gateway FX with Harmonic Imaging are mobile consoles approximately 69 cm wide, 107 cm deep and 132 cm high equipped with a keyboard control panel, black and white video display monitor, 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 GE Diasonics Gateway & Gateway FX with Harmonic Imaging are general purpose ultrasound imaging systems 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: Ophthalmic, Fetal, Abdominal, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, TR, TV, PV, and Musculo-skeletal Conventional & Superficial.
Comparison with Predicate Device: The GE Diasonics Gateway FX with Harmonic Imaging are of a comparable type and substantially equivalent to the currently marketed Gateway FX. They have the same technological characteristics, use the same design, construction and materials, are comparable in key safety and effectiveness features, and have 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 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 Diasonics Gateway & Gateway FX 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" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1999

Mr. Allen Schuh Manager, GE Ultrasound Safety and Regulatory Engineering GE Medical Systems General Electric Company P.O. Box 414 Milwaukee, WI 53201

Re: K993069

GE Diagnostics Gateway and Gateway FX Diagnostic Ultrasound System Regulatory Class: II (TWO) Product Code: 90-IYO and 90-ITX 21 CFR 892.1560 21 CFR 892.1570 Dated: September 10, 1999 Received: September 13, 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 misbranion.

This determination of substantial equivalence applies to the following transducers intended for use with the GE Diagnostics Gateway and Gateway FX Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Numbers: CLA/3.5MI/40 CLA/3.5MI/50-2D

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 (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS 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

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".

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

Sincerely yours,

Kinnel C. Sgmm
CAPT Daniel C. Schultz, M.J.

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

Enclosure(s)

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Diagnostic Ultrasound Indications for Use Form

GE Diasonics Gateway and Gateway FX Systems

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	P	P	P	P		P	P		P
Fetal	P	P	P	P		P	P		P
Abdominal	P	P	P	P		P	P		P
Intraoperative (specify)	P	P	P	P		P	P		P
Intraoperative Neurological
Pediatric
Small Organ (specify)	P	P	P	P		P	P		P
Neonatal Cephalic	P	P	P	P		P	P		P
Adult Cephalic	P	P	P	P		P	P		P
Cardiac	P	P	P	P	P	P	P		P
Transesophageal
Transrectal	P	P	P	P		P	P		P
Transvaginal	P	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		P
Musculo-skeletal Superficial	P	P	P	P		P	P		P
Other (specify)	N

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

Additional Comments: Cardiac is Adult and Pediatric. Small Organ includes: breast, thyroid, testes and penis. Combined modes include B or M and Pulsed, Color or Power Doppler. Clearance via K951998.

Intraoperative (K961002) includes abdominal organs.

Harmonic Imaging (other feature) applies to CLA 3.5/MI-50-2D probes in B mode only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Timmills Flynn
Division Sign-Off

Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number

Prescription User (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

GE Diasonics Gateway and Gateway FX with CLA/3.5MI/40 Probe

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
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)		N

N= new indication; P= previously cleared by FDA via K951998; E= added under Appendix E

Additional Comments: Combined modes include B or M and Pulsed, Color or Power Doppler.

Harmonic Imaging (other feature) applies to B mode only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Hegemann

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological D 510(k) Number

Prescription User (Per 21 CFR 801.109)

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Special 510(k) Premarket Notification GE Diasonics Gateway with Harmonic Imaging Modification September 10, 1999

Diagnostic Ultrasound Indications for Use Form

GE Diasonics Gateway FX with CLA/3.5Ml/50-2D Probe

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		E	E	E		E	E		E
Abdominal		E	E	E		E	E		E
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)		N

N= new indication; P= previously cleared by FDA; E= added under Appendix E (24 OCT 1996)

Additional Comments: Combined modes include B or M and Pulsed, Color or Power Doppler.

Harmonic Imaging (other feature) applies to B mode only.

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

Arind C. Ingram
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number

Prescription User (Per 21 CFR 801.109)

E-4

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.