Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics, Abdominal[1], Pediatric, Small Organ[2], Neonatal Cephalic, Adult Cephalic, Cardiac[3], Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Other[4], Transesophageal, Transrectal, Transvaginal, Intraoperative[5], Intraoperative Neurological.

Device Description

The GE LOGIQ 7 is a full featured general purpose diagnostic uitrasond bystem. The user interface includes a Computer Reyboard, Specialized official and a color video CRT or LCD image display & LCD touch panel. It provides digital acquisition, processing and display capability.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the GE LOGIQ 7 Ultrasound System, specifically mentioning the BT05 model and a submission date of September 2, 2005.

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE LOGIQ 7 Diagnostic Ultrasound System K010329, K032182, K04181) rather than establishing novel safety and effectiveness criteria or proving performance against specific acceptance metrics derived from a study.

The core "acceptance criteria" here is that the GE LOGIQ 7 BT05 system and its associated transducers are substantially equivalent to legally marketed predicate devices with respect to safety and effectiveness. This implies that the new device performs at least as well as the predicate in its intended uses and does not raise new questions of safety or effectiveness.

The reported device performance is its conformity to safety standards and its intended uses being consistent with traditional clinical practice and FDA guidelines.

Here's a table summarizing conceptual "acceptance criteria" as implicitly stated by the 510(k) process in this context, and the reported device performance. It's crucial to understand that for a 510(k), explicit quantitative acceptance criteria for clinical performance are often not required if substantial equivalence can be demonstrated through other means (e.g., comparison of technological characteristics and safety data).

Acceptance Criteria (Implied by 510(k) for Substantial Equivalence)	Reported Device Performance (from document)
Technological Characteristics: Comparable to predicate device.	The GE LOGIQ 7 BT05 "has the same technological characteristics" as the predicate device. It is a "full featured general purpose diagnostic ultrasound system" with digital acquisition, processing, display capability, and a user interface including a computer keyboard, specialized official (presumably "control panel" or "interface"), and a color video CRT or LCD image display & LCD touch panel.
Safety and Effectiveness: Key safety and effectiveness features comparable to predicate device. Does not raise new questions of safety/effectiveness.	The GE LOGIQ 7 BT05 has "the same key safety and effectiveness features" as the predicate device. It has been evaluated for: - Acoustic output - Biocompatibility - Cleaning and disinfection - Electrical and mechanical safety It "has been found to conform with applicable medical device safety standards." The conclusion states, "Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ 7 BT05 is safe and effective and substantially equivalent with respect to safety and effectiveness to devices currently cleared for market." The FDA's letter concurs with the substantial equivalence finding.
Intended Uses: Same as predicate device.	The GE LOGIQ 7 BT05 "has the same intended uses as the predicate device." The "Indications for Use" list a broad range of clinical applications (e.g., Fetal, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, etc.) for the main system. For the new transducers (4C, 4D3C-L, 4D10L, i739/t739), the document details "new indications" (marked with 'N') or "added under Appendix E" (marked with 'E') for specific anatomical regions and modes of operation. These are additions/expansions to previously cleared uses.
Basic Operating Modes: Same as predicate device.	The GE LOGIQ 7 BT05 "has the same basic operating modes as the predicate device." Various modes are listed in the "Indications for Use" tables, including B-mode, M-mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Doppler, Color M-Doppler, Power Doppler, Combined Modes, Harmonic Imaging, and Coded Pulse.
Design, Construction, and Materials: Comparable to predicate device.	The GE LOGIQ 7 BT05 "is of a comparable type and substantially equivalent to the predicate device... It has the same ... design, construction, and materials" as the predicate.
Conformity to Standards: Device conforms to applicable medical device safety standards.	The device "has been found to conform with applicable medical device safety standards." Compliance is "verified through independent evaluation with ongoing factory surveillance." The device's development process follows FDA guidelines and ISO 13485 quality systems.
No Clinical Tests Required (for 510(k) comparison):	The document explicitly states: "Clinical Tests: None required." This is a key finding for a 510(k) submission, indicating that the device's technological characteristics and intended uses are sufficiently similar to a predicate such that new clinical data are not deemed necessary to establish substantial equivalence.

Study Proving Acceptance Criteria:

The document explicitly states: "Clinical Tests: None required."

Therefore, no clinical study was conducted as part of this 510(k) submission to prove the device meets specific performance criteria. The basis for safety and effectiveness is substantial equivalence to a predicate device, supported by non-clinical tests.

Given the above, the following information cannot be extracted from the provided document:

Sample size used for the test set and the data provenance: Not applicable, as no clinical tests were performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical tests were performed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical tests were performed.
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 is not an AI device, and no clinical studies were performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is an ultrasound imaging system, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical tests were performed.
The sample size for the training set: Not applicable, as no clinical tests were performed and this is not an AI device that would typically have a "training set."
How the ground truth for the training set was established: Not applicable.

In summary, the GE LOGIQ 7 Ultrasound System BT05 gained clearance through the 510(k) pathway by demonstrating substantial equivalence to a previously cleared predicate device, relying on non-clinical engineering and safety testing. No clinical performance studies were required for this specific submission.

Summary

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K052441

SEP 2 1 2005

Special 510(k) Premarket Notification GE LOGIQ 7 Ultrasound BT05 September 2, 2005

Attachment B:

Summary of Safety and Effectiveness

Prepared in accordance with 21 CFR Part 807.92(c).

Image /page/0/Picture/6 description: The image shows the General Electric (GE) logo. The logo is a circular emblem with the letters 'GE' intertwined in a stylized, cursive font. The logo is black and white.

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, Safety and Regulatory EngineeringTelephone: 414-647-4385; Fax: 414-647-4090
	Date Prepared:	September 2, 2005
2.	Device Name:	GE LOGIQ 7 Diagnostic Ultrasound System, BT05Ultrasonic 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 7 Diagnostic Ultrasound System K010329, K032182, K04181

3 3. Marketed Device: A device currently in commercial distribution.

Device Description: The GE LOGIQ 7 is a full featured general purpose diagnostic uitrasond bystem. 4. Device Describitori. The OC EOON Ploade, 100 cm deep and 140-160 cm (adjustable) high The user interface includes a that provides digital acquisition, processing and display capability. that provides "digital" acquisition, "processing" and a color video CRT or LCD image display & LCD touch panel. Computer Reyboard, Specialized official and a color rease acquisition, additional measurements and productivity enhancement.
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation ാ. Indications for USC. The deville Io Incent (breast, thyroid); Neonatal Cephalic; Adult Cephalic; OF Fetal, Addonimal, Fediatio, Onliar Organ (Irondo, Releatal Conventional and Superficial, Gardias (addit and poditation), Polipiter researchageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Comparison with Predicate Device: The GE LOGIQ 7 BT05 is of a comparable type and substantially o. Our partson with Fredicall Boths. It has the same technological characteristics, key safety and equivalent to the banon. De Lesign, 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, creaning and 1. Norrainidal rosts. The down has been , electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
Clinical Tests: None required.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA 5. Goricusion: michod doos and other key to see in and development process of the guldelines, and octorned model and ISO 13485 quality systems. The device manforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrassund has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ 7 BT04 Sale and onlootive performantially 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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or stripes, which are often interpreted as an abstract representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2005

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

Re: K052441

Trade Name: GE LOGIQ 7 Ultrasound System Trade Name: CE ES STORE FR 892.1550, 892.1560, and 892.1570 Regulation Name: Ultrasonic pulsed doppler imaging system Ultrasonic pulsed echo imaging system Diagnostic ultrasonic transducer Regulatory Class: II

Product Code: IYN, IYO, and ITX

Dated: September 2, 2005

Received: September 6, 2005

Dear Mr. Schuh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 310(x) promative is substantially equivalent (for the referenced above and we nave determined the arrily marketed predicate devices marketed in indications for use stated in the encreations of the enactment date of the Medical Device interslate commerce proc to May 20, 1970, the entired in accordance with the provisions of the Amendments, or to devices mat liave been receive, market the device, subject to Federal Food, Drug, and Cosmette Act. The general controls provisions of the Act include the general controls provisions of the Act. "The general of the super of the manufacturing practice, labeling, requirements against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for I his determination of substantar equivalenee uppressions in your premarket notification:

Transducer Model Number

4C 4D3C-L 4D10L i739 or t739

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Page 2 -- Mr. Schuh

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into entires major regulations affecting your device (roddition, FDA It may be subject to such additional controls: "Zhoting 21, Parts 800 to 898. In addition, FDA Can be found in the Code of I eachar roganized in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised that FDA s issuance of a sucsainnial equirements of the Act
that FDA has made a determination that your device complies with other water that FDA has made a decidimation that Jour secred by other Federal agencies. You must or any Federal Statutes and regulations administers by of not limited to: registration and listing (21 comply with an the Act 3 requirements, news and acturing practice requirements as set CFK Fart 807), ademig (21 OFR Part 820); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping I his determination of Substance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested Information, meruding acoused of the Center's September 30, 1997 "Information for Manufacturers" in Appendix CT, (enclosed) of the Center 3 Beptems and Transducers'. If the special Seeking Marketing Clearance of Diagnosto Of Diagram - Structic output greater than approved report is mobiliplete of commis unaceptation 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 The special report of & 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 I fills letter will anow you to oegin nameling your device to a legally marketed noutication. The I Driving of basian 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 II you ucsile specific advice for your acon 2011 276-0120. Also, please note the regulation entitled, Contact the Office of Compilance at (21 notification" (21CFR Part 807.97). You may obtain Misolanding by reference to premainter nobilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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Page 3 – Mr. Schuh . . . .

: :

. . . . . . . .

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

Sincerely yours,

David A. Ingram

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

Enclosure(s)

Comments of the comments of

. . . . . . . . . .

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 7 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	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ[2]	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P
Other[4]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P
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
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] Intracperative 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.

[ ] Sombinou modes real-time 3D and 4D acquisition when used with special 4D probes.

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

David R. Syverson

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

Prescription Use (Per 21 CFR 801.109)

E-2

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 7 with 4C Transducer

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

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

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, B/Color 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)

David A. Leyson
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number K052441

Prescription Use (Per 21 CFR 801.109)

E-3

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 7 with 4D3C-L Transducer

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

	Mode of Operation
ClinicalApplication	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics	N	N	N		N		N	N	N	N
Abdominal[1]	N	N	N		N		N	N	N	N
Pediatric	N	N	N		N		N	N	N	N
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
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
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular

Eaparooople
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, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.

I I Combined model are bring in the elevational plane providing real-time 3D acquisition.

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

Daniel R. Larson

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

Prescription Use (Per 21 CFR 801.109)

E-4

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 7 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
Ophthalmic
Fetal / Obstetrics	N	N	N	N	N	N	N	N	N	N
Abdominal	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ[2]	N	N	N	N	N	N	N	N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular

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, B/Color/PWD, B/Power/PWD.

[ ] Ochained than anay motion in the elevational plane providing real-time 3D acquisition.

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

Davidh. Lymann

(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

દ-૨

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 7 with i739 or t739 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	E	E	E		E	E	E	E	E	E
Small Organ[2]	E	E	E		E	E	E	E	E	E
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	E	E	E		E	E	E	E	E	E
Musculo-skeletal Conventional	E	E	E		E	E	E	E	E	E
Musculo-skeletal Superficial	E	E	E		E	E	E	E	E	E
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative [5] (specify)	E	E	E		E	E	E	E	E	E
Intraoperative Neurological	E	E	E		E	E	E	E	E	E
Intravascular
Laparoscopic

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

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

[5] Intraoperative includes abdominal, thoracic, and vascular.

["] Combined modes are B/M, B/Color 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)

David A. Leggrom
(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

E-6

)

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.