Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional and Superficial, Urology (including prostate), Transvaginal, and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Device Description

The GE LOGIQ 9 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 64 cm wide, 90 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT and LCD display. This modification will provide users with additional probe options, improved user interface and productivity.

AI/ML Overview

GE LOGIQ 9 Ultrasound System with BT04 Modification

1. Table of Acceptance Criteria and Reported Device Performance

This document primarily focuses on the substantial equivalence of the GE LOGIQ 9 BT04 to existing predicate devices and the expansion of its indicated uses with new transducers. The "acceptance criteria" here are implicitly defined by the FDA's criteria for substantial equivalence, which primarily revolve around demonstrating that the modified device is as safe and as effective as legally marketed predicate devices. The "reported device performance" is essentially the claim of substantial equivalence and the expansion of indications.

Acceptance Criteria Category	Specific Criteria/Requirement	Reported Device Performance	Evidence/Justification
Technological Characteristics	"Same technological characteristics" as predicate device.	The GE LOGIQ 9 BT04 has "the same technological characteristics" as the current GE LOGIQ 9 and GE Voluson.	Stated in Section b) 6. Comparison with Predicate Device.
Safety and Effectiveness	"Key safety and effectiveness features" are same as predicate.	The GE LOGIQ 9 BT04 has "key safety and effectiveness features" as the current GE LOGIQ 9 and GE Voluson.	Stated in Section b) 6. Comparison with Predicate Device.
Physical Design, Construction, Materials	"Same physical design, construction, and materials" as predicate device.	The GE LOGIQ 9 BT04 has "the same physical design, construction, and materials" as the current GE LOGIQ 9 and GE Voluson.	Stated in Section b) 6. Comparison with Predicate Device.
Intended Uses/Basic Operating Modes	"Same intended uses and basic operating modes" as predicate device.	The GE LOGIQ 9 BT04 has "the same intended uses and basic operating modes" as the current GE LOGIQ 9 and GE Voluson, with new indications for specific transducers.	Stated in Section b) 6. Comparison with Predicate Device, and detailed in the Intended Use tables for each transducer.
Non-clinical Safety Conformity	Conforms to applicable medical device safety standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, and mechanical safety.	The device has been evaluated and found to conform with applicable medical device safety standards in these areas.	Stated in Section b) 1. Non-clinical Tests.
Quality Systems	Manufacturer conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems.	The manufacturer's design and development process conforms to these quality systems.	Stated in Section b) 3. Conclusion.
Clinical Practice Consistency	Intended uses and key features are consistent with traditional clinical practice and FDA guidelines.	Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination.	Stated in Section b) 3. Conclusion.
Post-market Requirements (for new transducers)	Submission of a post-clearance special report containing complete information, including acoustic output measurements based on production line devices.	Condition for market clearance for new transducers (4D3C, 4D10L, 4DE7C, P8D).	Stated in the FDA 510(k) clearance letter.

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

Sample Size for Test Set: Not applicable. No clinical test set data is provided in this submission, as the device was deemed to not require clinical tests for its 510(k) clearance.
Data Provenance: Not applicable, as no clinical test data was submitted.

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

Not applicable. No clinical test data was submitted.

4. Adjudication Method for the Test Set

Not applicable. No clinical test data was submitted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states, "Clinical Tests: None required." The clearance is based on substantial equivalence to predicate devices and non-clinical testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. This document describes an ultrasound imaging system, not an AI or algorithm-only device requiring standalone performance evaluation. The "device" is the ultrasound machine itself, intended for use by a qualified physician.

7. Type of Ground Truth Used

Not applicable. No clinical data with ground truth was used for this 510(k) submission, as clinical tests were not required. The "ground truth" for demonstrating safety and effectiveness relied on comparison to established predicate devices and non-clinical engineering evaluations against safety standards.

8. Sample Size for the Training Set

Not applicable. This submission does not pertain to an AI/ML algorithm or device that would require a training set.

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

Not applicable. This submission does not pertain to an AI/ML algorithm or device that would require a training set.

Summary

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Koyo251

FEB 2 0 2004

Special 510(k) Premarket Notification GE Medical Systems - LOGIQ 9 Ultrasound BT04 January 30, 2004

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 logo for General Electric (GE). The logo is a circular emblem with the letters "GE" intertwined in a stylized script. The letters are white against a black background, and the circle is outlined with a thin white border.

GE Medical Systems

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

Section a):

1. Submitter:	GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLCPO Box 414Milwaukee, WI 53201
Contact Person:	Allen Schuh,Manager, Safety and Regulatory EngineeringTelephone: 414-647-4385; Fax: 414-647-4090
Date Prepared:	January 30, 2004
2. Device Name:	GE LOGIQ 9 Diagnostic Ultrasound BT04,Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYOUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN
3. Marketed Device:	GE LOGIQ 9 Diagnostic Ultrasound System K011188/K030934/K032656

A device currently in commercial distribution.

Device Description: The GE LOGIQ 9 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 64 cm wide, 90 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT and LCD display. This modification will provide users with additional probe options, improved user interface and productivity.
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal: Abdominal: Pediatric: Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Comparison with Predicate Device: The GE LOGIQ 9 BT04 is of a comparable type and substantially equivalent to the current GE LOGIQ 9 and GE Voluson. It has the same technological characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and basic operating modes 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.

1. 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 9001:2000 and ISO 13485 guality 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 9 BT04 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, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

Mr. Allen Schuh Manager, GE Ultrasound Safety and Regulatory Engineering GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue MILWAUKEE W1 53219

Re: K040251

Trade Name: GE LOGIQ 9 Ultrasound System with BT04 Modification Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: 90 IYN, IYO, and ITX Dated: January 30, 2004 Received: February 3, 2004

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. Iabeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the GE LOGIQ 9 Ultrasound System, as described in your premarket notification:

Transducer Model Number

4D3C

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4D10L 4DE7C P8D

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 (OS) 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 Secking 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

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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".

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

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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GE LOGIQ 9 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[1]	P	P	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P	P
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	P
Other[4]	P	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P	P
Transuretheral
Intraoperative[5]	P	P	P	P	P	P	P	P	P	P	P
Intraoperative Neurological	P	P	P	P	P	P	P	P	P	P
Intravascular
Laparoscopic

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

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

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

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

Nancy Broglon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K040251

Prescription User (Per 21 CFR 801.109)

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GE LOGIQ 9 with 4D3C 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	N	N	N		N		N	N	N	N
Abdominal[1]	N	N	N		N		N	N	N	N
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
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: [1] Abdominal includes renal, GYN/Pelvic

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

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

	(Division Sign-Off)
	Division of Reproductive, Abdominal,
	and Radiological Devices
Prescription User (Per 21 CFR 801.109)
510(k) Number	K040251

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GE LOGIQ 9 with 4D10L 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
Abdominal[1]	N	N	N		N		N	N	N	N
Pediatric	N	N	N		N		N	N	N	N
Small Organ [2]	N	N	N		N		N	N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N		N		N	N	N	N
Musculo-skeletal Conventional	N	N	N		N		N	N	N	N
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	N	N	N		N		N	N	N	N
Intraoperative Neurological	N	N	N		N		N	N	N	N
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/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

	(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
Prescription User (Per 21 CFR 801.109)	510(k) Number: K040251

E-4

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GE LOGIQ 9 with 4DE7C 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	N	N	N		N		N	N	N	N
Abdominal[1]
Pediatric[6]	N	N	N		N		N	N	N	N
Small Organ[2]
Neonatal Cephalic[6]	N	N	N		N		N	N	N	N
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N		N		N	N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal	N	N	N		N		N	N	N	N
Transvaginal	N	N	N		N		N	N	N	N
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [4] Other use includes Urology/Prostate

[6] Probe used in surface scanning only

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, 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 Brandon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

Prescription User (Per 21 CFR 801.109)

510(k) Number

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GE LOGIQ 9 with P8D 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
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular				N
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:

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

Nancy C Boydon
Division Sign-Off

(Division Division of Reproductive, Abdominal, and Radiological Device

510(k) Number K040251

Prescription User (Per 21 CFR 801.109)

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.