The GE LOGIQ 700 with CE is a general purpose ultrasound 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; intraoperative abdominal and neurological; pediatric; small organ including breast, testes, thyroid: neonatal cephalic: cardiac adult and pediatric: TR: TV: PV; urological; and conventional and superficial musculo-skeletal.

Device Description

The GE LOGIQ 700 with CE is a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability and assorted probes. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design. Coded Excitation is useful for enhancing B or M mode performance characteristics providing improved high frequency depth penetration without loss of spatial resolution.

AI/ML Overview

The GE LOGIQ 700 Diagnostic Ultrasound with coded excitation (CE) modification is an ultrasonic pulsed echo imaging system. The submission documents indicate that this device is substantially equivalent to the currently marketed GE LOGIQ 700. The primary claim here is on substantial equivalence to an existing device, rather than new performance criteria being proven.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for substantial equivalence with a modification (coded excitation) to an already cleared device, the "acceptance criteria" are not framed as specific performance metrics to be met by a new algorithm or diagnostic capability. Instead, the acceptance criteria are met by demonstrating that the modified device has comparable technological characteristics, safety, and effectiveness to the predicate device.

The reported device performance, in this context, is that the Coded Excitation is useful for enhancing B or M mode performance characteristics, providing improved high frequency depth penetration without loss of spatial resolution, and it utilizes conventional digital image processing technology.

Acceptance Criterion (Implied by Substantial Equivalence)	Reported Device Performance
Comparable technological characteristics to predicate device	Utilizes conventional digital image processing technology for Coded Excitation.
Comparable in key safety features to predicate device	Evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety. Found to conform with applicable medical device safety standards.
Comparable in effectiveness features to predicate device	Coded Excitation is useful for enhancing B or M mode performance characteristics, providing improved high frequency depth penetration without loss of spatial resolution.
Same intended uses, operating modes, and probes as predicate device	Yes, the device has the same intended uses, operating modes, and probes as the predicate (GE LOGIQ 700). Specific transducers (548c, M7c, 618e, 618c, 739L) are cleared for various clinical applications.
Conformance to applicable medical device safety standards and quality systems	Conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems. Compliance verified through independent evaluation with factory surveillance.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No clinical test set was required for this submission.
Data Provenance: Not applicable. No clinical studies were conducted to prove clinical efficacy. The assessment was based on non-clinical tests and a comparison of technological characteristics to a predicate device.

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

Not applicable. No clinical test set with medical expert ground truth was required or performed.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was utilized.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of the query.

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

Not applicable. The Coded Excitation is a hardware/software modification to enhance image quality in the ultrasound system, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission primarily relies on non-clinical testing results demonstrating compliance with safety standards (acoustic output, biocompatibility, thermal, electrical, mechanical safety) and the established safe and effective performance history of diagnostic ultrasound technology in general and the predicate GE LOGIQ 700 system. The "ground truth" for the effectiveness of the Coded Excitation is described as enhancing B or M mode performance, providing improved high frequency depth penetration without loss of spatial resolution, which is a technical characteristic rather than a clinical diagnostic outcome.

8. The Sample Size for the Training Set

Not applicable. The "Coded Excitation" technology is described as implemented with conventional digital image processing, and there is no mention of a machine learning model requiring a training set in the context of this 1999 submission.

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

Not applicable, as no training set for a machine learning model was used.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The study proving the device meets its acceptance criteria is primarily a non-clinical assessment and a comparison to a predicate device, rather than a clinical trial.

Non-clinical Tests: The device underwent evaluation for:
- Acoustic output
- Biocompatibility
- Thermal safety
- Electrical safety
- Mechanical safety
  The device was found to conform with applicable medical device safety standards in these non-clinical tests.
Technological Comparison and Feature Description: The submission argues for substantial equivalence by stating that the modified GE LOGIQ 700 with CE has:
- The same technological characteristics (with CE being a digital image processing enhancement).
- Comparable key safety and effectiveness features to the predicate GE LOGIQ 700.
- The same basic design, construction, and materials.
- The same intended uses, operating modes, and probes.
Rationale for No Clinical Tests: "Clinical Tests: None required." This statement is based on the argument of substantial equivalence to an already cleared device, leveraging the long history of safe and effective performance of diagnostic ultrasound, and the fact that the coded excitation is an enhancement to an existing technology rather than a fundamentally new diagnostic modality. The claim is that the modification via Coded Excitation (providing improved high frequency depth penetration without loss of spatial resolution) is an inherent performance characteristic of the system rather than a new diagnostic capability that would require clinical validation.

In essence, the "study" for this 510(k) submission is the comprehensive documentation and testing showing that the modified device remains safe, performs as intended, and does not raise new questions of safety or effectiveness when compared to its existing, legally marketed predicate device.

Summary

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K993364

NOV - 5 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 "G" and "E" intertwined within a circle. There are small, stylized protrusions or embellishments around the circle's perimeter, giving it a slightly decorative appearance.

GE Medical Systems

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: October 5, 1999

Device Name: GE LOGIQ 700 Diagnostic Ultrasound with coded excitation (CE) modification. Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Marketed Device: GE Medical Systems LOGIQ 700 diagnostic ultrasound system, 510(k) Numbers K930768, K960527, K964617, K964886 and K990226, currently in commercial distribution.
Device Description: The GE LOGIQ 700 with CE is a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability and assorted probes. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design. Coded Excitation is useful for enhancing B or M mode performance characteristics providing improved high frequency depth penetration without loss of spatial resolution.
Indications for Use: The GE LOGIQ 700 with CE is a general purpose ultrasound 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; intraoperative abdominal and neurological; pediatric; small organ including breast, testes, thyroid: neonatal cephalic: cardiac adult and pediatric: TR: TV: PV; urological; and conventional and superficial musculo-skeletal.
Comparison with Predicate Device: The GE LOGIQ 700 Diagnostic Ultrasound System with CE is of a comparable type and substantially equivalent to the currently marketed GE LOGIQ 700. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended uses, operating modes and probes as the predicate device.

Section b):

Nor-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. Coded Excitation 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, ISO 9001 and EN 46001 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with 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 700 with CE 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The bird is facing to the left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Nov - 5 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K993364

GE Logiq 700 Diagnostic Ultrasound System with Coded Excitation Dated: October 5, 1999 Received: October 6, 1999 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX

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 Ultrasound Imaging and Doppler Fluid Flow Measurements of the Human Body, as described in your premarket notification:

Transducer Model Number

548c, M7c, 618e, 618c, 739L

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.

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 investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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Page 2 - Allen Schuh

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,

for

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

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 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
Intraoperative (specify)		P	P	P		P	P		P
Intraoperative Neurological		P	P	P		P	P		P
Pediatric		P	P	P		P	P		P
Small Organ (specify)		P	P	P		P	P		P
Neonatal Cephalic		P	P	P		P	P		P
Adult Cephalic
Cardiac		P	P	P		P	P		P
Transesophageal
Transrectal		P	P	P		P	P		P
Transvaginal		P	P	P		P	P		P
Transuretheral
Intravascular
Peripheral Vascular		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

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 is urological. Combined includes BM, B/Color, B/PWD, B/Color/PWD. Color includes Color M. Intraoperative includes abdominal organs, added via K964886. Musculo-skeletal added via K960527 3D Imaging added via K964617. B-mode includes B-flow imaging K990226. Initial 510(k): K930768 B and M modes include coded excitation for limited probes and scan conditions.

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

Daniel A. Bessesen

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

Prescription User (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 548c 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		P	P	P		P	P		P
Abdominal		P	P	P		P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)		P	P	P		P	P		P

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

Additional Comments: Small organ includes breast, testes, thyroid. Other includes urological.

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

B and M modes include coded excitation (CE) capability.

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

Concurrence of CDRH, Office of Device Evaluation (ODI

Jamil A. Seymm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

Prescription User (Per 21 CFR 801.109)

510(k) Number K493364

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 618e 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		P	P	P		P	P		P
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		P
Transvaginal		P	P	P		P	P		P
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)		P	P	P		P	P		P

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

Additional Comments: Combined modes are B/M, B/Color, B/PWD, B/Color/PWD

Other includes urological. B and M modes include coded excitation (CE) capability.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Bergson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices KG97364

510(k) Number.

Prescription User (Per 21 CFR 801.109)

E-4

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 618c 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
Intraoperative (specify)		P	P	P		P	P		P
Intraoperative Neurological		P	P	P		P	P		P
Pediatric		P	P	P		P	P		P
Small Organ (specify)
Neonatal Cephalic		P	P	P		P	P		P
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular		P	P	P		P	P		P
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Combined modes are B/M, B/Color, B/PWD, B/Color/PWD

Intraoperative includes abdominal organs. K964886

B and M modes include coded excitation (CE) capability.

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

Evaluation (ODE)

Daniel A. Seymann

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device

K993364 510(k) Number .

Prescription User (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 739L 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		P	P	P		P	P		P
Abdominal
Intraoperative (specify)		P	P	P		P	P		P
Intraoperative Neurological		P	P	P		P	P		P
Pediatric		P	P	P		P	P		P
Small Organ (specify)		P	P	P		P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular		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

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

Additional Comments: Small organ includes breast, testes, thyroid. Other includes urological.

Combined modes are B/M, B/Color, B/Color/PWD, Musculo-skeletal added via K960527

Intraoperative includes abdominal organs. K964886,

B and M modes include B-flow (K990226) with or without CE type coding.

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

Ohrid le. Seymm

vision Sign-Off) ision of Reproductive, Abdominal, ENT, Radiological Devices i islumber

Prescription User (Per 21 CFR 801.109)

E-6

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with M7c 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		E	E	E		E	E		E
Abdominal		E	E	E		E	E		E
Intraoperative (specify)
Intraoperative Neurological
Pediatric		E	E	E		E	E		E
Small Organ (specify)		E	E	E		E	E		E
Neonatal Cephalic
Adult Cephalic
Cardiac
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: Combined modes are B/M, B/Color, B/PWD, B/Color/PWD

Small organ my include breast and testes.

B and M modes include coded excitation (CE) capability.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device

Prescription User (Per 21 CFR 801.109)

510(k) Number K993364

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.