Diagnostic ultrasound imaging or motion analysis of the human body as follows: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vasculo-skeletal (conventional & superficial); Intraoperative including neurological, Transrectal; and Transvaginal.

Device Description

The GE LOGIQ A3 is a small, general purpose diagnostic ultrasound system. It consists of a mobile console approximately 42 cm wide, 59 cm deep and 125 cm high that provides digital acquisition, processing and display capability. The user interface consists of a computer keyboard, specialized controls and color video LCD display. The modification provides for a more compact, lighter weight and easily maneuverable system with updated and efficient electronic hardware.

AI/ML Overview

The provided document is a 510(k) premarket notification for the GE LOGIQ A3 Diagnostic Ultrasound System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

1. Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or a dedicated performance study with numerical results for the GE LOGIQ A3. Instead, it relies on the concept of substantial equivalence to predicate devices (GE LOGIQ 3 and LOGIQ 200MD) and compliance with general safety and medical device standards.

The acceptance criteria are implicitly met by demonstrating that the GE LOGIQ A3:

Has the same intended uses as the predicate devices.
Shares comparable technological characteristics.
Is comparable in key safety and effectiveness features.
Utilizes similar design, construction, and materials.
Conforms with applicable medical device safety standards through non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, and mechanical safety).
Conforms to 21 CFR 820, ISO 9001, and 13485 quality systems.

No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the device as part of newly established acceptance criteria. The "performance" is considered equivalent to that of the predicate devices due to the lack of significant technological changes that would raise new questions of safety or effectiveness.

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

No clinical test set was used for the GE LOGIQ A3 in this submission. The document explicitly states: "Clinical Tests: None required." This is typical for submissions asserting substantial equivalence to predicate devices where there are no new indications or significant technological changes that would necessitate new clinical data.

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

Since no clinical test set was used, there were no experts establishing ground truth for such a set within the scope of this submission. The determination of device safety and effectiveness relies on the established safety and effectiveness of the predicate ultrasound systems and compliance with recognized standards.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

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

No MRMC comparative effectiveness study was done. The submission for the GE LOGIQ A3 is based on substantial equivalence, not a comparative clinical trial to demonstrate improved human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The GE LOGIQ A3 is a diagnostic ultrasound system intended for direct use by a qualified physician, not an AI algorithm operating in a standalone capacity. No standalone algorithm performance was assessed or reported.

7. Type of Ground Truth Used:

No new ground truth from pathology, outcomes data, or expert consensus was generated specifically for the GE LOGIQ A3 as part of this submission. The ground truth for the device's acceptable safety and effectiveness is implicitly derived from:

The known safe and effective performance of previously cleared diagnostic ultrasound devices (predicates).
Compliance with recognized industry standards for acoustic output, biocompatibility, electrical safety, etc.
General acceptance of diagnostic ultrasound as a safe and effective imaging modality.

8. Sample Size for the Training Set:

Not applicable, as this submission pertains to a diagnostic ultrasound system and not an AI/ML algorithm that requires a training set.

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

Not applicable, as no training set was used.

Summary

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K012015

Attachment B:

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

AUG 2 9 2007

GE Healthcare

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, Ultrasound Regulatory AffairsTelephone: 414-721-3992; Fax: 414-721-3899
	Date Prepared: July 26, 2007
2.	Device Name: GE LOGIQ A3 Diagnostic Ultrasound SystemUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYNUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYODiagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX

Marketed Device: GE LOGIQ 3 Diagnostic Ultrasound System, 510(k) No: K020263.
Device Description: The GE LOGIQ A3 is a small, general purpose diagnostic ultrasound system. It consists of a mobile console approximately 42 cm wide, 59 cm deep and 125 cm high that provides digital acquisition, processing and display capability. The user interface consists of a computer keyboard, specialized controls and color video LCD display. The modification provides for a more compact, lighter weight and easily maneuverable system with updated and efficient electronic hardware.
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 & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vasculo-skeletal (conventional & superficial); Intraoperative including neurological, Transrectal; and Transvaginal.
Comparison with Predicate Device: The LOGIQ A3 Diagnostic Ultrasound System is of a comparable type and substantially equivalent to the GE LOGIQ 3 and LOGIQ 200MD. 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. Basic acquisition and operating modes are identical to that of the LOGIQ 200MD.

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 and 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation by a Nationally Recognized Testing Lab. (NRTL) with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ A3 is substantially equivalent with respect to safety and effectiveness to diagnostic ultrasound devices currently cleared for market.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Allen Schuh Manager Regulatory Affairs General Electric Company GE Healthcare 9900 Innovation Drive WAUWATOSA WI 53226

AUG 2 9 2007

Re: K072075

Trade/Device Name: GE LOGIQ A3 Ultrasound System Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: July 26, 2007 Received: July 30, 2007

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 Covisions 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 A3 Ultrasound System, as described in your premarket notification:

Transducer Model Number

GE LOGIQ A3 with 8L GE LOGIQ A3 with E8C GE LOGIO A3 with 4C GE LOGIQ A3 with 3S

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.

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Page 2 - Mr. Allen Schuh

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 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Ms. Lauren Hefner at (240) 276-3666.

Sincerely vours,

logui Thhang GNCB

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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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ A3 Ultrasound System

Intended Use: Diagnostic ultrasound imaging or motion 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	P
Abdominal[1]	P	P						P	P
Pediatric	P	P						P	P
Small Organ(2)	P	P						P	P
Neonatal Cephalic	P	P						P	P
Adult Cephalic	P	P						P	P
Cardiac[3]	P	P						P	N
Peripheral Vascular	P	P						P	N
Musculo-skeletal Conventional	P	P						P	P
Musculo-skeletal Superficial	P	P						P	P
Other[4]	P	P						P	P
Exam Type, Means of Access
Transesophageal
Transrectal	P	P						P	P
Transvaginal	P	P						P	P
Transuretheral
Intraoperative	P	P						P	N
Intraoperative Neurological	P	P						P	N
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

[*] Combined modes are B/M.

(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 801.109)

J.Whang

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

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ A3 with 4C Transducer

Intended Use: Diagnostic ultrasound imaging or motion 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						P	P
Abdominal(1)	P	P						P	P
Pediatric	P	P						P	P
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other(4)	P	P						P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Transperineal

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

Notes: [1] Abdominal includes GYN;

[4] Other use includes Urology;

[*] Combined modes are B/M.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

JWhang

510(k) Number.

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

Prescription User (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ A3 with E8C Transducer

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

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

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.

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

JWhang

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

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ A3 with 8L Transducer

Intended Use: Diagnostic ultrasound imaging or motion 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	N	N						N	N
Pediatric	N	N						N	N
Small Organ [2]	N	N						N	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	N	N						N	N
Musculo-skeletal Conventional	N	N						N	N
Musculo-skeletal Superficial	N	N						N	N
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	N	N						N	N
Intraoperative Neurological	N	N						N	N
Intravascular

N = new indication/mode for this probe; P = previously cleared by FDA; E = added under Appendix E

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

[*] Combined modes are B/M.

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

Jzhan

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

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ A3 with 3S Transducer

Intended Use: Diagnostic ultrasound imaging or motion 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	P	P						P	P
Abdominal[1]	P	P						P	P
Pediatric	P	P						P	P
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic	P	P						P	P
Cardiac[3]	P	P						P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P						P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Intraluminal

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.

(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 801.109)

TWhan

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

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.