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 Cephalio; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Transrectal; and Transvaginal.

Device Description

The GE LOGIQbook is a compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 33 cm wide, 27 cm deep and 7 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

AI/ML Overview

The provided document is a 510(k) premarket notification for the GE LOGIQbook Diagnostic Ultrasound System, dated December 20, 2001. It describes the device and claims substantial equivalence to a predicate device, the GE LOGIQ 100.

Within this document, it explicitly states:

"2. Clinical Tests: None required."

Therefore, based on the provided information:

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

No specific acceptance criteria for clinical performance are reported, as no clinical tests were required or performed for this premarket notification. The company's conclusion states that "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination," and that "Diagnostic ultrasound has accumulated a long history of safe and effective performance."

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

Not applicable. No clinical test set was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No clinical test set was used, and therefore no experts were required to establish ground truth for such a set.

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

Not applicable. No clinical test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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, not an AI algorithm.

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

Not applicable. No specific ground truth related to clinical performance was established because no clinical studies were required. The submission relies on the established safe and effective performance of diagnostic ultrasound in general and the substantial equivalence to a predicate device.

8. The sample size for the training set:

Not applicable. This submission does not describe an AI or machine learning model that would require a training set.

9. How the ground truth for the training set was established:
Not applicable. No training set was used.

In summary, the FDA clearance for the GE LOGIQbook Diagnostic Ultrasound System was based on demonstrating substantial equivalence to a predicate device (GE LOGIQ 100) and adherence to non-clinical safety and performance standards for medical devices, rather than on new clinical performance data or studies.

Summary

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K014206

JAN 1 6 2002

Attachment B:

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

GE Medical Systems

General Electric Company P.O. Box 414. Milwaukee. W1 53201

Section a):

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:	December 20, 2001

Device Name: GE LOGIQbook Diagnostic Ultrasound System
Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN
Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITXGE LOGIQ 100 Diagnostic Ultrasound System, 510(k) Nos: K953752 and K012560 3. Marketed Device: currently in commercial distribution.
Device Description: The GE LOGIQbook is a compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 33 cm wide, 27 cm deep and 7 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.
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 Cephalio; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Transrectal; and Transvaginal.
Comparison with Predicate Device: The GE LOGIQbook is of a comparable type and substantially equivalent to the currently marketed GE LOGIQ 100. It is a compact and readily portable unit having the same technological characteristics of design, construction, and materials; is comparable in key safety and effectiveness features; and has the same intended uses as the predicate device.

Section b):

Non-clinical 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 LOGIQbook 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three horizontal lines that curve upwards, resembling a stylized caduceus without the snake.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2002

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

Re: K014206

Trade Name: GE LOGIQbook Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: 90 IYN Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: 90 IYO Regulatory Class: II Dated: December 20, 2001 Received: December 21, 2001

Dear Mr. Schuh:

We have reviewed your Section 510(k) premarket 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 LOGIQbook Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

Image /page/1/Picture/12 description: The image shows three lines of text stacked on top of each other. The first line reads "3C-RS", the second line reads "3MC-RS", and the third line reads "CZB-RS". The text is in a simple, sans-serif font and is black against a white background. The lines are centered and evenly spaced.

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Page 2 - Mr. Schuh

E8C-RS 10LB-RS

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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, 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 Part 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".

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

Sincerely yours,

Nancy C. Brogdon

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 LOGIQbook with 3MC-RS 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	N		N		N	N	N
Abdominal[1]	P	P	N		N		N	N	N
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	P	P	N		N		N	N	N
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/Pelvic, Renal and Aorta-iliac artery;

[3] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Hoadon

Division Sin Division of Reproduc and Radiological Devices 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQbook with CZB-RS Transducer

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

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal [1]	P	P	N		N		N	N	N
Pediatric	P	P	N		N		N	N	N
Small Organ (specify)	P	P	N		N		N	N	N
Neonatal Cephalic	P	P	N		N		N	N	N
Adult Cephalic
Cardiac [3]	P	P	N		N		N	N	N
Peripheral Vascular	P	P	N		N		N	N	N
Musculo-skeletal Conventional	P	P	N		N		N	N	N
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
l anarosconic

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

Notes: [1] Abdominal includes GYN/Pelvic, Renal and Aorta-iliac artery;

[3] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.

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

Nancy C. Brogdon

(Division Sian-Of Division of Reproduct and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQbook with 3C-RS 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	Other
Ophthalmic
Fetal / Obstetrics	P	P	N	N	N	N	N	N	N
Abdominal[1]	P	P	N	N	N	N	N	N	N
Pediatric	P	P	N	N	N	N	N	N	N
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	N	N	N	N	N	N	N
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.

[4] Other use includes Urology;

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.

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

Nancy Swadon

and Ra 510(k) Number

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQbook 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	N		N		N	N	N
Abdominal[1]	P	P	N		N		N	N	N
Pediatric	P	P	N		N		N	N	N
Small Organ[2]	P	P	N		N		N	N	N
Neonatal Cephalic	P	P	N		N		N	N	N
Adult Cephalic
Cardiac[3]	P	P	N		N		N	N	N
Peripheral Vascular	P	P	N		N		N	N	N
Musculo-skeletal Conventional	P	P	N		N		N	N	N
Musculo-skeletal Superficial
Other[4]	P	P	N		N		N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	N		N		N	N
Transvaginal	P	P	N		N		N	N
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular

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

Notes: [1] Abdominal includes renal, GYN/Pelvic

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. hrodon

Divisio and Radioloo 510(k) Numb

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQbook with E8C-RS 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	N		N		N	N
Abdominal[1]	P	P	N		N		N	N
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	N		N		N	N
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	N		N		N	N
Transvaginal	P	P	N		N		N	N
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;

[4] Other use includes Urology/Prostate;

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brocton

(Division Sign-Off ve, Abdo Division of Reproduct and Radiological Devices 510(k) Number _

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQbook with 10LB-RS 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	P	P	N		N		N	N
Pediatric	P	P	N		N		N	N
Small Organ[2]	P	P	N		N		N	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	N		N		N	N
Musculo-skeletal Conventional	P	P	N		N		N	N
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
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 modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Si Divisio n of Renron and Radiological Devices 510(k) Number

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.