The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional: Urology (including prostate), Transesophageal; Transrectal (TR); and Intraoperative (abdominal, thoracic, & vascular).

Device Description

The GE Vivid 7 Diagnostic Ultrasound is a full featured echocardiography imaging and analysis system. It consists of a mobile console approximately 65 cm wide, 96 cm deep and 139 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT or LCD display. This modification offers improved performance and productivity for users.

AI/ML Overview

The GE Vivid 7 Diagnostic Ultrasound System with EchoPAC BT06 is a medical device for diagnostic ultrasound imaging and fluid flow analysis. The device is an update to the already marketed GE Vivid 7 Diagnostic Ultrasound System. No clinical tests were required for this 510(k) submission, as the manufacturer states that "intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination." The submission relies on non-clinical testing and the established safety and effectiveness of Diagnostic Ultrasound.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance (Reference)
Acoustic Output	Conforms with applicable medical device safety standards (Section b.1)
Biocompatibility	Conforms with applicable medical device safety standards (Section b.1)
Cleaning and Disinfection Effectiveness	Conforms with applicable medical device safety standards (Section b.1)
Electromagnetic Compatibility	Conforms with applicable medical device safety standards (Section b.1)
Thermal Safety	Conforms with applicable medical device safety standards (Section b.1)
Electrical Safety	Conforms with applicable medical device safety standards (Section b.1)
Mechanical Safety	Conforms with applicable medical device safety standards (Section b.1)
Quality Systems	Conforms with 21 CFR 820, ISO 9001:2000, and ISO 13485 (Section b.3)
Overall Safety and Effectiveness	Substantially equivalent to predicate device (GE Vivid 7) (Section b.3, Section a.6)

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

No specific test set data (e.g., patient cases) was provided or mandated for this submission. The "test set" for this device's acceptance relied on adherence to established medical device safety standards and the substantial equivalence to a predicate device. Therefore, there is no sample size or data provenance in the traditional sense of a clinical study with patient data.

3. 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 required, there was no "ground truth" derived from expert consensus on patient data for this submission. The ground truth for safety and performance was based on conformance to engineering and quality standards, and the history of safe and effective performance of diagnostic ultrasound.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set requiring adjudication was used for this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Tests: None required" (Section b.2).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable, as this device is a diagnostic ultrasound system intended for use by a qualified physician. Its performance is inherently linked to human operation and interpretation. The submission does not detail any standalone algorithmic performance studies.

7. The Type of Ground Truth Used:

The ground truth used for this submission primarily revolved around:

Conformance to internationally recognized medical device safety standards (e.g., acoustic output limits, electrical safety, biocompatibility).
Compliance with quality system regulations (21 CFR 820, ISO 9001:2000, ISO 13485).
Substantial equivalence to a legally marketed predicate device (GE Vivid 7), meaning its indications for use, fundamental technology, and safety/effectiveness profile are comparable.
The established history of safe and effective performance of diagnostic ultrasound technology in general.

8. The Sample Size for the Training Set:

Not applicable. This submission does not describe a machine learning algorithm that would typically require a training set of data. The "training" in this context refers to the development and manufacturing processes adhering to quality systems and engineering standards.

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

Not applicable. Since there was no machine learning algorithm or training set in the typical sense, there was no ground truth for a training set to be established. The "ground truth" for the device's development was established through adherence to engineering principles, regulatory standards, and manufacturing quality controls.

Summary

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K060542

MAR 3 1 2006 Special 510(k) Premarket Notification Opeolal 010(1) PIGE Vivid 7 and EchoPAC BT06 February 28, 2006

Attachment B:

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

1200- 10000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000001		GE Medical Systems
	General Electric Company

P.O. Box 414, Mihwaukee, WI 53201

Section a):

1.	Submitter: GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLCPO Box 414, Milwaukee, WI 53201Contact Person: Allen Schuh,Manager, Safety and Regulatory EngineeringTelephone: 414-647-4385; Fax: 414-647-4090Date Prepared: February 28, 2006
2.	Device Name: GE Vivid 7 Diagnostic Ultrasound System with EchoPAC BT06Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYOUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYNDiagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX
3.	Marketed Device: GE Vivid 7 Diagnostic Ultrasound System K003931/K031663/K041552/K05144(90-IYO/IYN/ITX) A device currently in commercial distribution.

Device Description: The GE Vivid 7 Diagnostic Ultrasound is a full featured echocardiography imaging and analysis system. It consists of a mobile console approximately 65 cm wide, 96 cm deep and 139 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT or LCD display. This modification offers improved performance and productivity for users.
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional: Urology (including prostate), Transesophageal; Transrectal (TR); and Intraoperative (abdominal, thoracic, & vascular).
Comparison with Predicate Device: The GE Vivid 7 BT06 is of a comparable type and substantially equivalent to the current GE Vivid 7 with enhanced cardiac analysis and display capability and alternate image display options. It has the same overall characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and operating modes as the predicate device.

Section b):

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, as well as thermal, 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 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 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 Healthcare that the GE Vivid 7 BT06 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 and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three streams or lines flowing downwards. The logo is encircled by the words "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement.

MAR 3 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060542

Trade Name: GE Vivid 7 Ultrasound System 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: II Product Code: IYN, IYO, and ITX Dated: February 28, 2006 Received: March 1, 2006

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, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the GE Vrvid 7 Ultrasound System, as described in your premarket notification:

Image /page/1/Picture/11 description: The image is a circular logo with the letters "FDA" in bold, stylized font in the center. Above the letters, there are the numbers "17XX - 18XX". Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by a circular border with text that is difficult to read due to the image quality.

noting Public .

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Transducer Model Number

9L 3V

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 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 Seeking 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 (240) 276-0120. Also, please note the regulation entitled,

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Page 3 – Mr. Schuh

"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 (301) 443-6597 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 Andrew Kang, M.D. at (301) 594-1212.

Sincerely yours,

David A. Bergmann

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

Enclosure(s)

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Special 510(k) Premarket Notification GE Healthcare - GE Vivid 7 and EchoPAC BT06 February 28, 2006

Diagnostic Ultrasound Indications for Use Form

GE Vivid 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	RT3DMode*
Ophthalmic
Fetal / Obstetrics	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
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
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial
Other[4]	P	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
Transvaginal	P	P	P	P	P	P	P	P		P
Transuretheral
Intraoperative[5]	P	P	P	P	P	P	P	P		P
Intraoperative Neurological
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.

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Limbh Segum

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K060542
510(k) Number

Prescription User (Per 21 CFR 801.109)

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Special 510(k) Premarket Notification GE Healthcare - GE Vivid 7 and EchoPAC BT06 February 28, 2006

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 9L 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	N	N	N		N	N	N	N	N	N
Small Organ[2]	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
Musculo-skeletal Conventional	N	N	N		N	N	N	N	N	N
Musculo-skeletal Superficial
Other [4]
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: [2] Small organ includes breast, testes, thyroid.

[*] 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. Loym

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

Prescription User (Per 21 CFR 801.109)

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page 3/3

Special 510(k) Premarket Notification GE Healthcare - GE Vivid 7 and EchoPAC BT06 February 28, 2006

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 3V 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	RT3DMode*
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	P
Abdominal	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 (specify)
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	P
Cardiac	P	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)[4]	P	P	P	P	P	P	P	P	P	P	P
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: [*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

[3] Cardiac is Adult and Pediatric

[4] Other use includes Urology;

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Hodgson

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

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.