The LOGIQ 700 with Harmonic Imaging 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; urological; and conventional and superficial musculo-skeletal.

Device Description

The LOGIQ 700 with Harmonic Imaging 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. Harmonic imaging enhances or highlights the imaging of nonlinear tissue characteristics.

AI/ML Overview

This submission is a Special 510(k) Premarket Notification for a modification to an existing device (GE LOGIQ 700 Diagnostic Ultrasound with Harmonic Imaging Modification). In such cases, clinical studies are often not required if the new device is found to be substantially equivalent to a predicate device.

Based on the provided document, here's an analysis of the acceptance criteria and study information:

1. A table of acceptance criteria and the reported device performance

Since no clinical studies were required, the acceptance criteria and performance are established through substantial equivalence to the predicate device, not empirical performance metrics from a study. Therefore, the table cannot be populated with specific performance metrics from a new study.

Acceptance Criterion	Reported Device Performance
Acoustic Output	Conforms with applicable medical device safety standards.
Biocompatibility	Conforms with applicable medical device safety standards.
Thermal Safety	Conforms with applicable medical device safety standards.
Electrical Safety	Conforms with applicable medical device safety standards.
Mechanical Safety	Conforms with applicable medical device safety standards.
Image Processing Technology	Harmonic imaging implemented with conventional digital image processing technology, deemed comparable to predicate.
Intended Uses	Consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Substantially equivalent to predicate device for all specified clinical applications and modes of operation including the new "Harmonic Imaging" mode, across all specified transducers.
Quality Systems	Design and development process conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No clinical test set was used for this 510(k) submission. "Clinical Tests: None required."

3. 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)

No clinical test set was used, therefore no experts were required to establish ground truth for a test set in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No clinical test set was used, therefore no adjudication method was applicable or employed.

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 conducted. This device is an ultrasound system with a new imaging mode, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was conducted. The device is a medical imaging system, not an independent algorithm. The harmonic imaging feature is integrated into the existing system.

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

No new ground truth was established as no clinical studies were performed. The "ground truth" for this submission relies on the established safety and effectiveness of the predicate device and the conventional nature of the new feature.

8. The sample size for the training set

No training set was explicitly mentioned or used for the purpose of a clinical study or algorithm development as part of this 510(k) submission. The "training" for the device's development refers to its adherence to established engineering and quality standards.

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

Not applicable, as no training set (in the context of machine learning/algorithm development) was used for this submission. The "ground truth" for the device's design and development comes from medical device safety standards, regulatory requirements, and established clinical practice as outlined in the "Conclusion" section.

Summary

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Image /page/0/Picture/1 description: The image contains a sequence of characters and numbers. The sequence starts with the letter 'K', followed by the number '9', then another '9', and then the numbers '3365'. The characters and numbers are written in a handwritten style, with a slightly irregular and imperfect appearance.

Special 510(k) Premarket Notification GE Medical Systems - LOGIQ 700 with Harmonic Imaging Modification October 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: This document appears to be a submission form from GE Medical Systems, dated October 5, 1999. It includes the submitter's information, which is GE Medical Systems located in Milwaukee, WI. The contact person is Allen Schuh, Manager of Safety and Regulatory Engineering, with contact numbers provided. The document also mentions the device name, GE LOGIQ 700 Diagnostic Ultrasound with Harmonic Imaging Modification.

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 LOGIQ 700 with Harmonic Imaging 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. Harmonic imaging enhances or highlights the imaging of nonlinear tissue characteristics.
Indications for Use: The LOGIQ 700 with Harmonic Imaging 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; urological; and conventional and superficial musculo-skeletal.
Comparison with Predicate Device: The GE LOGIQ 700 Diagnostic Ultrasound System with Harmonic Imaging iis 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 design, construction, and materials, and has the same intended uses, operating modes and probes 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, 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/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 1999

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

K993365 Re: GE Logiq 700 Diagnostic Ultrasound System (Harmonic Imaging) 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 21 CFR 892.1550/Procode: 90 IYN

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 leqally 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, 348c, LA 39, M12L, M3c, M7c

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 Druq 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 – 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,

Ovind G. Nyrom

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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Special 510(k) Premarket Notification GE Medical Systems - LOGIQ 700 with Harmonic Imaging Modification

October 5, 1999

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	N
Abdominal		P	P	P		P	P		P	N
Intraoperative (specify)		P	P	P		P	P		P	N
Intragperative Neurological		P	P	P		P	P		P	N
Pediatric		P	P	P		P	P		P	N
Small Organ (specify)		P	P	P		P	P		P	N
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	N
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P	P		P	N
Musculo-skeletal Superficial		P	P	P		P	P		P	N
Other (specify)		P	P	P		P	P		P	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, testes, thyroid. Other is urological. Combined includes B/M, B/Color, B/PWD, B/Color/PWD, Color includes Color M, Intraoperative includes abdominal organs, added via K964886. Musculo-skeletal added via K860527 3D Imaging added via K964617. B-mode includes B-flow imaging K990226. Initial 510(k): K930768 Other mode: Harmonic imaging is optional with B & M modes on selected probes,

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

Thind A. Siyam
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K993865

E-S

Prescription User (Per 21 CFR 801.109)

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GE Medical Systems - LOGIQ 700 with Harmonic Imaging Modification October 5, 1999

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	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal		P	P	P		P	P		P	N
Abdominal		P	P	P		P	P		P	N
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		P	N
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

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.

Other mode: Harmonic imaging is optional with B & M modes.

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

David A. Siegman

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

Prescription User (Per 21 CFR 801.109)

510(k) Number K943365

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Special 510(k) Premarket Notification

GE Medical Systems - LOGIQ 700 with Harmonic Imaging Modification October 5, 1999

Dlagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 348c 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	N
Abdominal		P	P	P		P	P		P	N
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		P	N
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

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.

Other mode: Harmonic imaging is optional with B & M modes.

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

Prescription User (Per 21 CFR 801,108)

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GE Medical Systems - LOGIQ 700 with Harmonic Imaging Modification October 5, 1999

Dlagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with LA39 Transducer

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

Clinical Application	A	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal		P	P	P	P	P	P	N
Abdominal
Intraoperative (specify)		P	P	P	P	P	P	N
Intraoperative Neurological	-	P	P	P	P	P	P	N
Pediatric		P	P	P	P	P	P	N
Small Organ (specify)		P	P	P	P	P	P	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular		P	P	P	P	P	P	N
Laparoscopic
Musculo-skeletal Conventional		P	P	P	P	P	P	N
Musculo-skeletal Superficial		P	P	P	P	P	P	N
Other (specify		P	P	P	P	P	P	N

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 K964617 Intraoperative includes abdominal organs. K964886, Musculo-skeletal added via K960527 Other mode: Harmonic imaging is optional with B & M modes.

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

Yavid a. Stegman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi

510(k) Number _

Prescription User (Per 21 CFR 801.109)

હેન્ડ

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GE Medical Systems - LOGIQ 700 with Harmonic Imaging Modification October 5, 1999

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with M12L Transducer

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P	N
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		P	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular		P	P	P		P	P		P	N
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P	P		P	N
Musculo-skeletal Superficial		P	P	P		P	P		P	N
Other (specify)		P	P	P		P	P		P	N
N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Small organ includes breast, testes, thyroid. Musculo-skeletal added via K860527 Other includes urological. Combined modes are B/M, B/Color, B/Color/PWD. Other mode: Harmonic imaging is optional with B & M modes.

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

Elmer A. Glynn

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

510(k) Number

Prescription User (Per 21 CFR 801.109)

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GE Medical Systems - LOGIQ 700 with Harmonic Imaging Modification October 5, 1999

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with M3c Transducer

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

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(specify)
Ophthalmic
Fetal	P	P	P	P	P	P	N
Abdominal	P	P	P	P	P	P	N
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)	P	P	P	P	P	P	N
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

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.

Other mode: Harmonic imaging is optional with B & M modes.

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

David A. Segari

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

510(k) Number K943365

Prescription User (Per 21 CFR 801.109)

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GE Medical Systems - LOGIQ 700 with Harmonic Imaging Modification October 5, 1999

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 tollows:

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

Other mode: Harmonic imaging is optional with B & M modes.

(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CORH, Office of Device Evaluation (OQE)

David A. Heymann

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

510(k) Number

Prescription User (Per 21 CFR 801.109)

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.