The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult & pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Transrectal (TR); and Transvaginal (TV) applications.

Device Description

The GE LOGIQ 100 PRO is a portable general purpose diagnostic ultrasound system. It consists of a small hand-carried console, weighing approximately 22 lbs., providing real-time B and M-mode images with a variety of linear and curved-linear array type transducers. The user interface includes a fold down keyboard, specialized controls and a B&W video CRT display.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	Compliance with applicable medical device safety standards (thermal, electrical, mechanical safety, acoustic output, biocompatibility, cleaning and disinfection effectiveness).	Device found to conform with applicable medical device safety standards through non-clinical tests and independent evaluation.
Effectiveness/Performance	Comparable type, technological characteristics, key safety and effectiveness features, design, construction, materials, intended uses, and basic operating modes to the predicate device (GE LOGIQ x100).	The GE LOGIQ 100 PRO is stated to be of a "comparable type" and "substantially equivalent" to the current GE LOGIQ x100, having "the same technological characteristics" and being "comparable in key safety and effectiveness features," and utilizing "similar design, construction, and materials," with "the same intended uses and basic operating modes."
Clinical Tests	None required for this device, based on established safety and effectiveness history of diagnostic ultrasound and substantial equivalence to predicate.	"None required."

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

No explicit test set or clinical data is mentioned for the GE LOGIQ 100 PRO Diagnostic Ultrasound System. The submission states "Clinical Tests: None required." The device's safety and effectiveness were primarily evaluated through non-clinical tests and a comparison of its features and intended uses to an existing predicate device.

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

Not applicable, as no clinical test set requiring expert-established ground truth was performed or reported in this document.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was performed or reported in this document.

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:

Not applicable. This document pertains to a diagnostic ultrasound system, not an AI-assisted diagnostic tool, and no MRMC study was conducted or reported.

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

Not applicable. This device is a diagnostic ultrasound system (hardware), not a standalone algorithm.

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

Not applicable, as no clinical test required specific ground truth data for the GE LOGIQ 100 PRO. The evaluation was based on non-clinical testing and substantial equivalence to a predicate device.

8. The Sample Size for the Training Set:

Not applicable. This device is a hardware system, not an artificial intelligence or machine learning algorithm that requires a training set.

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

Not applicable, as no training set was used for this device.

Summary

{0}------------------------------------------------

AUG 2 3 2001

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 a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines and flourishes, giving the logo a classic and recognizable 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: August 7, 2001
2.	Device Name: GE LOGIQ 100 PRO Diagnostic Ultrasound SystemUltrasonic Pulsed Echo Imaging System. 21 CFR 892.1560. 90-IYC

Marketed Device: GE LOGIQ x100 diagnostic ultrasound system: K953752, currently in commercial distribution.
Device Description: The GE LOGIQ 100 PRO is a portable general purpose diagnostic ultrasound system. It consists of a small hand-carried console, weighing approximately 22 lbs., providing real-time B and M-mode images with a variety of linear and curved-linear array type transducers. The user interface includes a fold down keyboard, specialized controls and a B&W video CRT display.
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult & pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Transrectal (TR); and Transvaginal (TV) applications.

Comparison with Predicate Device: The GE LOGIQ 100 PRO is of a comparable type and ે. substantially equivalent to the current GE LOGIQ x100. It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar design, construction, and materials, and has the same intended uses and basic operating modes as the predicate device.

Section b):

Non-dinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.

2. 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 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 100 PRO Diagnostic Ultrasound 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person, or perhaps a stylized representation of a bird in flight. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2001

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

Re: K012560

Trade Name: GE LOGIQ 100 PRO Diagnostic Ultrasound System Regulatory Class: II/21 CFR 892.1560 Product Code: 90 IYO Dated: August 7, 2001 Received: August 8, 2001

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 GE LOGIQ 100 PRO Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number
C36
C55
E72
L76
C31
VE5
CZB
LB

{2}------------------------------------------------

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.

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 International and Consumer 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".

{3}------------------------------------------------

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Nancyc Brogdon

Nancy C. Brogdon

Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{4}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 100 PRO 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
Ophthalmic
Fetal / Obstetrics	P	P						P
Abdominal[1]	P	P						P
Pediatric	P	P						P
Small Organ[2]	P	P						P
Neonatal Cephalic	P	P						P
Adult Cephalic
Cardiac[3]	P	P						P
Peripheral Vascular	P	P						P
Musculo-skeletal Conventional	P	P						P
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P						P
Transvaginal	P	P						P
Transuretheral
Intraoperative[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic and Urology/Prostate

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[*] Combined mode is B/M.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

{5}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 100 PRO with C36 Transducer

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
Ophthalmic
Fetal / Obstetrics	P	P						P
Abdominal[1]	P	P						P
Pediatric	P	P						P
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P						P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN;

[3] Cardiac is adult and pediatric;

[*] Combined mode is B/M.

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

Nancy Brogdon

{6}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 100 PRO with C55 Transducer

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
Ophthalmic
Fetal / Obstetrics	P	P						P
Abdominal[1]	P	P						P
Pediatric	P	P						P
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes Urology;

[*] Combined mode is B/M.

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

Nancy C. Hodgson

(Division Sign/On)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012560

{7}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 100 PRO with E72 Transducer

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

Clinical ApplicationAnatomy/ Region of Interest	B	M	CombinedModes
Ophthalmic
Fetal / Obstetrics	P	E	E
Abdominal[1]	P	E	E
Pediatric	P	E	E
Small Organ (specify)
Neonatal Cephalic	P
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P
Transvaginal	P	P	P
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic and Urology/Prostate;

[*] Combined mode is B/M.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. brazdon

Division
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number

{8}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 100 PRO with L76 Transducer

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
Ophthalmic
Fetal / Obstetrics	E	E						E
Abdominal[1]	P	P						P
Pediatric	P	P						P
Small Organ[2]	P	P						P
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P						P
Musculo-skeletal Conventional	P	P						P
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes Urology;

[2] Small organ includes breast, testes, thyroid.

[*] Combined mode is B/M.

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

Nancy Brogdon

{9}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 100 PRO with C31 Transducer

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	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse
Ophthalmic
Fetal / Obstetrics	E	E						E
Abdominal	E	E						E
Pediatric	E	E						E
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	E	E						E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: {*] Combined mode is B/M;

[3] Cardiac is Adult and Pediatric

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Hodgson

510(k) Nun

{10}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 100 PRO with VE5 Transducer

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
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	E	E						E
Pediatric	E	E						E
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN;

[*] Combined mode is B/M.

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

Nancy C broydon

(Divisio Division of Renma and Radiological Devic 510(k) Number

{11}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 100 PRO with CZB Transducer

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

Clinical ApplicationAnatomy/Region of Interest	B	M	CombinedModes
Ophthalmic
Fetal / Obstetrics			E
Abdominal	E	E	E
Pediatric	E	E	E
Small Organ[2]	E	E	E
Neonatal Cephalic	E	E	E
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5] (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [2] Small organ includes breast, testes, thyroid.

[*] Combined mode is B/M ..

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C hogdon
(Division Sign-Off)

ive. At ninal and Ra diological Devic 510(k) Number

{12}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 100 PRO with LB Transducer

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	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse
Ophthalmic
Fetal / Obstetrics	E	E						E
Abdominal[1]	E	E						E
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	E	E						E
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN;

[*] Combined mode is B/M,.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Hogdon
(Division Sign-Off)

510(k)

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.