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); Transesophageal; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic, and vascular), Intra-cardiac and Intra-luminal.

Device Description

The GE Vivid-i and Vivid-q is 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 36 cm wide, 31.5 cm deep and 6 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 GE Vivid-i and Vivid-q Diagnostic Ultrasound System is a compact and portable diagnostic ultrasound system.

Here's an analysis of the provided information, addressing your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for a premarket notification, seeking substantial equivalence to a predicate device. It primarily focuses on demonstrating that the modified device (GE Vivid-i and Vivid-q BT10) is as safe and effective as the previously cleared version (GE Vivid-i and Vivid-q BT09) and other cleared GE Ultrasound systems, and also to clear new transducers for specific indications. As such, it does not present a table of specific acceptance criteria (e.g., performance metrics like sensitivity, specificity, accuracy) that were met by the device itself in a typical clinical study, nor does it report numerical device performance against such criteria.

Instead, the acceptance criteria are implicitly related to:

Safety and Effectiveness: The device being "substantially equivalent" to predicate devices in terms of safety and effectiveness.
Conformance to Standards: Adherence to applicable medical device safety standards.
Intended Uses: The modified device performing its stated indications for use reliably.

The document asserts that these criteria have been met through non-clinical tests and a comparison with the predicate.

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

No specific test set or clinical data (sample size, data provenance) is mentioned for evaluating the performance of the GE Vivid-i and Vivid-q BT10 system itself beyond the non-clinical tests. The submission states "Clinical Tests: None required."

For the new transducers (8C-RS, 4C-RS, SoundStar 3D 10F, AcuNav™ 8F), the document lists new indications for use that are "N = new indication (previously cleared by FDA...)" on other existing and cleared devices (GE LOGIQ Book K032477, Vivid 7 K051449, stand-alone devices K070242 by Biosense Webster, Inc., and K071234 by Siemens Medical Solutions). This implies that the safety and effectiveness for these indications with these transducers have been established in previous clearance processes and are being leveraged for this new comprehensive system. However, specific test set sizes or data provenance for these previous clearances are not detailed in this document.

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

Not applicable, as no dedicated clinical test set with ground truth establishment is described for this submission. The "Clinical Tests: None required" statement implies that existing knowledge and previous clearances were sufficient.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated clinical test set with adjudication is described.

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

No MRMC comparative effectiveness study is mentioned. The submission relies on substantial equivalence and "Clinical Tests: None required."

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

The device is a diagnostic ultrasound system, not an algorithm-only device. Therefore, a standalone performance study in the context of an AI algorithm is not applicable. The device's performance is intrinsically linked to its use by a qualified physician.

7. Type of Ground Truth Used

Not explicitly stated for this particular submission, as "Clinical Tests: None required." For the previously cleared devices supporting the new indications for the transducers, ground truth would have been established through standard medical practices (e.g., expert clinical diagnosis, other imaging modalities, pathology, or surgical findings).

8. Sample Size for the Training Set

Not applicable. This document pertains to the clearance of a medical device (ultrasound system) and not the submission of an AI/ML algorithm that would typically involve a separate training set. The device's functionality is based on established ultrasound physics and signal processing, not a trained AI model in the modern sense.

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

Not applicable, as there is no mention of an AI/ML training set.

Summary

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AUG 21 2009

Kc92140
Page 1 of 2

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

GE Healthcare

General Electric Company 3000 N. Grandview Blvd., Waukesha, WI 53188

Section a):

Submitter:	GE Healthcare
	3000 N. Grandview Blvd., W450
	Waukesha, WI 53188
	USA
Contact Person:	James T. Turner, MS, RAC
	USA Premarket RA Leader
	Telephone: 262-544-3359; Fax: 414-908-9225
Date Prepared:	July 14, 2009
Device Name:	GE Vivid-i and Vivid q 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-ITX

GE Vivid i and Vivid q Diagnostic Ultrasound System K082374, currently in 3. Marketed Device: commercial distribution.

Device Description: The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with intearated kevboard, fold-up LCD type display and interchangeable electronic-arrav transducers. It has an overall size approximately 36 cm wide, 31.5 cm deep and 6 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; 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); Transesophageal; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic, and vascular), Intra-cardiac and Intra-luminal.

Comparison with Predicate Device: The modified GE Vivid-i and Vivid q BT10 is of a ତ. comparable type and substantially equivalent to the currently marketed GE Vivid-i and Vivid g It is a compact and readily portable unit having the same design, construction, and BT09. materials; is comparable in key safety and effectiveness features. It has the same intended uses as the predicate device and additional software features are identical to that of other cleared GE Ultrasound systems,

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.
Clinical Tests: None required.

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K09214c
Page 2 of 2

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 ISO13485 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 Vivid i and Vivid g BT10 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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

Image /page/2/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

AUG 21 2009

GE Medical Systems Israel, Ultrasound, Ltd. % Mr. James T. Turner, MS, RAC USA Premarket RA Leader GE Healthcare, QARA Regions-America 3000 N. Grandview Blvd. WAUKESHA WI 53188

Re: K092140

Trade/Device Name: GE Vivid i and Vivid q Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 5, 2009 Received: August 6, 2009

Mr. Turner:

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 Vivid i and Vivid q Diagnostic Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

8C-RS 4C-RS SoundStar 3D 10F AcuNavTM 8F

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

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.

Sincerely vours.

Vonguthr Whag

on Janine M. Morris Acting 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 Vivid i and Vivid q Diagnostic Ultrasound System

Intended Use: Ultrasound imaging, measurement and 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	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 (specify)[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
Transvaginal
Transuretheral
Intraoperative (specify)[5]	P	P	P	P	P	P	P	P	P	P
Intraoperative Neurological
Intracardiac and Intraluminal	P	P	P	P	P	P	P	P	P	P
Laparoscopic

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

Notes: [1] Abdominal includes Renal,

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

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

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

{"] Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CPI).

(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)

Argu Th Thang

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

510(k) Number

E-2

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

Kogaiyo

Diagnostic Ultrasound Indications for Use Form

GE Vivid i/q with 8C-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (specify)[1]	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac	N	N	N	N	N	N	N	N	N
Peripheral Vascular	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

N = new indication (previously cleared by FDA on GE LOGIQ Book Ultrasound K032477); P = previously cleared by FDA on Vivid i (K033139) and Vivid i/q (K082374); E = added under Appendix E

Notes: [1] Small organ includes breast, testes, thyroid.

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

["] Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CPI).

(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)

Hogn M. Whay

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

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with 4C-RS Transducer

Intended Use: Ultrasound imaging, measurement and 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	P	P	P		P	P	P	P	P	P
Abdominal[1]	P	P	P		P	P	P	P	P	P
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	N	N	N		N	N	N	N	N	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[2]	P	P	P		P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

N = new indication (previously cleared by FDA on Vivid 7 K051449); P = previously cleared by FDA on Vivid i (K061525) and Vivid i/q (K082374); E = added under Appendix E

Notes: [1] Abdominal includes Renal;

[2] Other use includes Urology.

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

["]Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CPI),

(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)

Tony K. Whang

(Division Sign-Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

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

KC92 140

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with SoundStar 3D 10F Transducer

Intended Use: Ultrasound imaging, measurement and 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
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [1]	N	N	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal	N	N	N	N	N	N		N	N
Laparoscopic

N = new indication (previously cleared as a stand alone medical device K070242 by Biosense Webster, Inc.); P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD,

(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)

Aquith Wh

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

E-5

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

K092 140

Diagnostic Ultrasound Indications for Use Form

GE Vivid i/q with AcuNav™ 8F Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	Combined Modes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac (1)	N	N	N	N	N	N		N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal	N	N	N	N	N	N		N	N
Laparoscopic

N = new indication (previously cleared as a stand alone medical device K071234 by Siemens Medical Solutions); P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Cardiac is Adult and Pediatric.

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

(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)

Argu In-Wh

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

510(k) Number K092176

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.