Predicate Devices

Reference Devices

K032477, K033139, K061525, K051449, K070242, K071234

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound technology and image processing.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" intended for "ultrasound evaluation" of various anatomical sites, and its function is "digital acquisition, processing and display capability." It does not mention any therapeutic use or function.

Diagnostic

Yes
The "Device Description" explicitly states, "The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers," indicating it is a hardware device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes the device as being used for ultrasound evaluation of various anatomical sites and patient populations. This involves imaging the internal structures of the body.
Device Description: The description confirms it's a diagnostic ultrasound system that acquires, processes, and displays images.
Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device operates in vivo (within the body) using ultrasound waves.

Therefore, the GE Vivid-i and Vivid-q is a diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

90-IYN, 90-IYO, 90-ITX

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal; Abdominal (includes Renal); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Intraoperative (abdominal, thoracic, and vascular); Intra-cardiac; Intra-luminal; Transesophageal; Transrectal; Transvaginal.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Qualified physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K082374

Reference Device(s)

K032477, K033139, K061525, K051449, K070242, K071234

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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.

1

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)

4

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 Application
Anatomy/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 Application
Anatomy/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 | | | | | | | | | | | |
| 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 Application
Anatomy/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
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 Application
Anatomy/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
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 Application
Anatomy/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
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