Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 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; Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Device Description

The GE Vivid E9 Diagnostic Ultrasound is a full-featured echocardiography imaging and analysis system with additional capability in vascular and general ultrasound imaging. It consists of a mobile console with multiple electronic array transducers that provide digital acquisition, processing and display capability. The user interface includes a floating and variable height user control panel with specialized controls, high-resolution LCD display and separate LCD touch panel. This modification offers improved performance and productivity for users.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the GE Vivid E9 BT10 Ultrasound System. It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not detail specific acceptance criteria or performance studies in the way a clinical trial report for an AI device might. Instead, it relies on established safety and effectiveness for diagnostic ultrasound systems and the equivalence to predicate devices.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance studies, ground truth establishment for training and test sets, and effect sizes of AI assistance are generally not applicable or not provided in this type of regulatory document for an ultrasound system.

However, I can extract the relevant information regarding safety and equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of explicit performance-based acceptance criteria for a new AI feature or image analysis algorithm, nor does it present detailed quantitative performance metrics for the device. The "acceptance criteria" in this context are related to demonstrating substantial equivalence to a predicate device and adherence to general safety standards.

The reported device performance is primarily framed as improved performance and productivity compared to the predicate device, especially regarding new transducers and software features comparable to other cleared GE ultrasound systems.

Key statements on performance:

"This modification offers improved performance and productivity for users." (Section a): Device Description)
"The GE Vivid E9 BT10 is of a comparable type and substantially equivalent to the current GE Vivid E9 with enhanced performance and added transducers..." (Section a): Comparison with Predicate Device)

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

Not applicable / Not provided. This 510(k) submission does not describe a clinical test set or data provenance for evaluating a new algorithm's performance. The review focuses on the device as a whole and its equivalence to predicate devices.

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

Not applicable / Not provided. Ground truth establishment for a specific AI algorithm's performance is not part of this type of submission for a general diagnostic ultrasound system.

4. Adjudication Method for the Test Set:

Not applicable / Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable / Not provided. This document does not describe an MRMC study or AI assistance. The device is a diagnostic ultrasound system, not an AI-powered image analysis tool in the sense of comparing human readers with and without AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable / Not provided. This relates to an AI algorithm's performance, which is not the focus of this submission.

7. The Type of Ground Truth Used:

Not applicable / Not provided.

8. The Sample Size for the Training Set:

Not applicable / Not provided.

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

Not applicable / Not provided.

Summary of the Study that Proves the Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" demonstrating the device meets its "acceptance criteria" (which, in this context, means showing substantial equivalence for regulatory clearance) is summarized in Section b: Non-clinical Tests and Clinical Tests.

Non-clinical Tests:
- The device was evaluated for:
  - Acoustic output
  - Biocompatibility
  - Cleaning and disinfection effectiveness
  - Electromagnetic compatibility
  - Thermal, electrical, and mechanical safety
- It was found to conform with applicable and harmonized medical device safety standards.
Clinical Tests:
- "None required." This indicates that for this type of device modification and the established predicate, new clinical trials to demonstrate safety and effectiveness were not deemed necessary by the manufacturer or the FDA (as per the clearance letter). The long history of safe and effective performance of diagnostic ultrasound, combined with the substantial equivalence argument, negated the need for new clinical data.
Conclusion:
- The manufacturer stated that 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 conforms with 21 CFR 820, ISO 9001:2008, and ISO13485:2003 quality systems.
- Compliance with applicable medical device safety standards is verified through 3rd party product certifications and regular production monitoring.
- GE Healthcare's opinion is that the device is substantially equivalent in safety and effectiveness to devices already cleared for market.

The FDA's decision letter (starting on page 3 of the document) confirms that they reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, subject to general controls. This means the FDA agreed with GE Healthcare's assessment that the non-clinical tests and the comparison to predicate devices were sufficient to support clearance without a new clinical study.

Summary

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K101149 pg //2

Special 510(k) Premarket Notification GE Vivid E9 BT10 Ultrasound System April 21, 2010

OCT 1 3 2010

Attachment B

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

Section a):

Submitter:	GE Healthcare9900 W Innovation Dr., RP-2138Wauwatosa, WI 53226USA
Contact Person:	Bryan BehnRegulatory Affairs ManagerTelephone: 414-721-4214; Fax: 414-918-8275

Date Prepared:April 21, 2010

1. Device Name: GE Vivid E9 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
- 1. Marketed Devices: GE Vivid E9 Ultrasound System, K081921, and GE Logig E9 Ultrasound System. K092271. currently in commercial distribution.
- 1. Device Description: The GE Vivid E9 Diagnostic Ultrasound is a full-featured echocardiography imaging and analysis system with additional capability in vascular and general ultrasound imaging. It consists of a mobile console with multiple electronic array transducers that provide digital acquisition, processing and display capability. The user interface includes a floating and variable height user control panel with specialized controls, high-resolution LCD display and separate LCD touch panel. This modification offers improved performance and productivity for users.
- ട്. Indications for Use: The GE Vivid E9 ultrasound system is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis 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; Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
- Comparison with Predicate Device: The GE Vivid E9 BT10 is of a comparable type and 6. substantially equivalent to the current GE Vivid E9 with enhanced performance and added transducers; 4V-D, 12S-D, ML6-15-D and i13L, which are new to GE Vivid E9. It has the same overall characteristics, key safety and effectiveness features, physical design, general overall construction, materials, and has the same intended uses and operating modes as the predicate device. The additional software features are similar to other cleared GE Ultrasound systems like GE Logiq E9.

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Section b):

1. 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 and harmonized medical device safety standards.
1. Clinical Tests: None required.
1. 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 9001:2008 and ISO13485:2003 quality systems. The device conforms to applicable medical device safety standards. Compliance is verified through 30 party product certifications and regular production monitoring. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE Vivid E9 Diagnostic Ultrasound system is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

GE Vingmed Ultrasound AS % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W Innovation Dr., RP-2138 WAUWATOSA WI 53226

OCT 1 3 2010

Re: K101149

Trade/Device Name: GE Vivid E9 BT10 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 27, 2010 Received: August 30, 2010

Dear Mr. Behn:

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 E9 BT10 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

ML6-15-D 12S-D 4V-D i13L

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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 895. 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 1.000-1050.

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 1000 and 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 Jana Delfino at (301) 796-6503.

Sincerely yours,

Signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Diagnostic Ultrasound Indications for Use Form

GE Vivid E9 BT10 Ultrasound System

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

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	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
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
Transvaginal	P	P	P	P	P	P	P	P		P
Transuretheral
Intraoperative[5]	P	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);

System provides 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)

(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

K10114

Prescription User (Per 21 CFR 801.109)510K

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Diagnostic Ultrasound Indications for Use Form

GE Vivid E9 BT10 with ML6-15-D 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
Abdominal
Pediatric[2]	N	N	N		N	N	N	N	N	N
Small Organ [1][2]	N	N	N		N	N	N	N	N	N
Neonatal Cephalic	N	N	N		N	N	N	N	N	N	N
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular[2]	N	N	N		N	N	N	N	N	N
Musculo-skeletal Conventional[2]	N	N	N		N	N	N	N	N	N
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication, (Transducer previously cleared on GE LOGIQ E9 BT08 (K073408); P = previously cleared by FDA; E = added under Appendix E

Notes:

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

[2] Needle guidance imaging

[*] 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)

(Division Sign-Off)

Prescription User (Per 21 CFR 801.109)

Division of Radiological Devices OMSION of RadioIQgical Device Evaluation and Safety

619K ICIO1149

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Diagnostic Ultrasound Indications for Use Form

GE Vivid E9 BT10 with 12S-D 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
Abdominal
Pediatric	N	N	N	N	N	N	N	N	N	N	N
Small Organ
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N	N
Adult Cephalic
Cardiac [1]	N	N	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
Intravascular
Laparoscopic

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

Notes: [1] Cardiac is Adult and Pediatric.

[*] 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);

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

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

દ્વાદા

Prescription User (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

GE Vivid E9 BT10 with 4V-D Transducer

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	RT3DMode*
Ophthalmic
Fetal / Obstetrics	N	N	N	N	N	N	N	N	N	N	N
Abdominal [1]	N	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N	N
Small Organ
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N	N	N	N	N
Cardiac [2]	N	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [3]	N	N	N	N	N	N	N	N	N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Cardiac is Adult and Pediatric.

[3] Other use includes Urology/Prostate

[*] 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);

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

(Division Sign-Off)
ical Devices

Civision of Radiological Devices Division of Radiological Device Evaluation and Safety

510K K101149

Prescription User (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form GE Vivid E9 BT10 with i13L Transducer

Mode of Operation Clinical Application Power Combined Harmonic RT3D Color Color M Coded PW CW B M Doppler Doppler Doppler Modes lmaging Pulse Mode * Doppler Doppler Anatomy/ Region of Interest . . Ophthalmic Fetal / Obstetrics N N N N N N N N Abdominal(1) Pediatric Small Organ (specify) Neonatal Cephalic -Adult Cephalic N N N N N N N N Cardiac-21 Peripheral Vascular Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify) Exam Type, Means of Access Transesophageal Transrectal ; Transvaginal Transuretheral N N N N N N Intraoperative(3) N N Intraoperative Neurological Intravascular Laparoscopic

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

Lopatooople ================================================================================================================================================================== E = added under Appendix E

Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Cardiac is Adult and Pediatric via Intraoperative;

[3] 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. NEEDERAT

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitre Diagnostic Device Evaluation and Safety

510K R.101149

Prescription User (Per 21 CFR 801.109)

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.