Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics, Abdominal (including Renal and GYN/Pelvic), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Other (including Urology/Prostate), Transesophageal, Transrectal, Transvaginal, 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 cart or a large console with Service, 96 cm deep and 139 cm deep and 139 cm and analysis system. The user interface includes and high that provides digital acquisition, processing and display. This modification will provide users with for improved performance and productivity.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the GE Vivid 7 Diagnostic Ultrasound System with EchoPAC BT05. This submission focuses on comparing the new device to a predicate device and demonstrating substantial equivalence, rather than establishing new performance criteria or efficacy beyond what is already accepted for diagnostic ultrasound systems.

Thus, the document explicitly states: "Clinical Tests: None required." This means no specific acceptance criteria or dedicated study proving the device meets those criteria were conducted beyond non-clinical tests. The submission relies on the existing substantial equivalence to predicate devices and established safety standards for diagnostic ultrasound.

Therefore, many of the requested details about acceptance criteria and clinical study design cannot be extracted from this document, as such a study was not deemed necessary for this type of submission.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and where information is not available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	The device's "key safety and effectiveness information" is comparable and substantially equivalent to the currently marketed GE Vivid 7, which is already in commercial distribution and deemed safe and effective.
Predicate Device Equivalence	The GE Vivid 7 BT05 is described as "of a comparable type and substantially equivalent to the current GE Vivid 7." It has the "same basic intended use and overali characteristics, key safety and effectiveness information and operating modes as the predicate device." This includes enhanced measurement capability, upgraded beamformer, and improved patient exam reporting.
Compliance with Non-Clinical Standards	"The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, as well as thermal, electrical and mechanical safety standards." The manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems.
Intended Uses consistency with traditional clinical practice	The "Intended uses and other key features are consistent with traditional clinical practice, FDA guidance documents and development process of the development process of the device manufacturer..."
Specific Performance Metrics	Not applicable/Not provided. This is a 510(k) for an incremental update (BT05) to an existing device (GE Vivid 7), demonstrating equivalence, not establishing new performance benchmarks.

2. Sample sized used for the test set and the data provenance

Sample Size: Not applicable. No clinical test set was used, as clinical tests were "None required."
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set was used.

4. Adjudication method for the test set

Not applicable. No clinical test set was used.

5. 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

No MRMC comparative effectiveness study was done. The document states "Clinical Tests: None required."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a diagnostic ultrasound system, not an AI-only algorithm. No standalone performance study was conducted or required.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No specific ground truth was established for "clinical tests" as they were not required. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate GE Vivid 7 device.

8. The sample size for the training set

Not applicable. This is not a submission for an AI/ML algorithm that would undergo a training phase.

9. How the ground truth for the training set was established

Not applicable.

Summary

{0}------------------------------------------------

KOSIA49

Special 510(k) Premarket Notification i Special 010(10) - GE Vivid 7 and EchoPAC BT05 June 1, 2005

JUN 16 2005

Attachment B:

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

Image /page/0/Picture/5 description: The image shows the logo for GE Medical Systems. The logo includes the GE monogram on the left. The text "GE Medical Systems" is on the right side of the image.

General Electric Company P.O. Box 414, Milwaukee, WI 53201

Section a):

1. Submitter:	GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLCPO Box 414, Milwaukee, WI 53201
Contact Person:	Allen Schuh,Manager, Safety and Regulatory EngineeringTelephone: 414-647-4385; Fax: 414-647-4090
Date Prepared:	June 1, 2005
2. Device Name:	GE Vivid 7 Diagnostic Ultrasound System with EchoPAC BT05Ultrasonic 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/K041552 (90-IYO/IYN/ITX)A device currently in commercial distribution.

Device Description: The GE Vivid 7 Diagnostic Ultrasound is a full featured echocardiography imaging 4. Device Describiti. The GL Viva 7 Diagnostic or a large with Service, 96 cm deep and 139 cm deep and 139 cm and analysis system. It consists or a mobile capability. The user interface includes and high that provides algital acquisition, processing and alsplay. This modification will provide users with for improved performance and productivity.
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation 5. Indications for USB. The device is miended by a qualifical phybash, testes, thyroid); Neonatal of Fetal, Addominal (including Tenal and OTTA), Podiatric), Peripheral Vasculo-skeletal
Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculosio Cephanic, Audit Cephalic, Cardian and podiation, Policino, Postprosisted (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Comparison with Predicate Device: The GE Vivid 7 BT05 is of a comparable type and substantially 6. Companson will Fredicate Detros: "The enhanced measurement capability, upgraded beamfformer and equivalent to the current OE viva I than overali characteristics, key safety and effectiveness Inforoved patient exam reporting. It has the band overal than been and operating modes as the predicate device.

Section b):

Non-Jinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, as well as thermal, electrical and mechanical ulsimection 'enectiveness, 'clootionogricatio' sempally, 'sempalle safety standards.
Clinical Tests: None required.
Conclusion: Intended uses and other key features are consistent with traditional dinical practice, FDA 3. Obligusion: Therided uses and other Rey foataro and development process of the development process of the dowio manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 qualify systems. The device manulaculer conforms with 21 OF N 820, 100 coo new and compliance is verified through independent contomis to applicable infealcal device surveillance. Diagnostic ultrasound has accumulation CC Vivid 7 DTC Vivid 7 DTC Vivid 7 DTC evaluation with Ungoling Tactory Survellanos: "Bitlynotion of GE Healthcare that the GE Vivid 7 Broo sale and enective performatice. Therefore, it is the opinion of Survey and effectiveness to devices currently cleared for market.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle, with three stylized lines forming the body and wings.

JUN 16 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051449

Trade Name: GE Vivid 7 and EchoPAC BT05 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: June 1, 2005 Received: June 2, 2005

Dear Mr. Schuh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion of resir proxing 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 interstate commerce pror to that have been reclassified in accordance with the provisions of the Amendinents, of to devices that in t t (Act). You may, therefore, market the device, subject to I coordi i ood, Drug, and Oostions of the Act. The general controls provisions of the Act include the general controls pro risting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for I mis determination of busiantal equit in the start of the sour premarket notification:

Transducer Model Number

4C M4S

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 11 your device is classified (see above) inrols. Existing major regulations affecting your device EDA it may be subject to such additional confront. "Entrailig and to 898. In addition, FDA can be Nound in the Oode of I vecture concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issualite or a basevice complies with other requirements of the Act that FDA has made a decemination that your accessed by other Federal agencies. You must of ally rederal statutes and regulations and intelling, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, 11); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 800); and if applicable, the electronic a form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted or the condition that prior to shipping I ins device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested Information, meruding acoustic occepter's September 30, 1997 "Information for Manufacturers in Appendix U, (cherosco) or the Center Fooplessic Ultrasound Systems and Transducers." If the special Secking Manketing Orcarantes or macceptable values (e.g., acoustic output greater than approved report is incomplete or comans anasvipat 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 rne special reported "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 predication. The I Drivenians ssification 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 If you desire speetits arragliance at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Cours to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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

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

Page 3 – Mr. Schuh

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

Sincerely yours,

David A. Sygnam
Nancy C. Brogdon

Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{4}------------------------------------------------

Special 510(k) Premarket Notification Special 010(tre - GE Vivid 7 and EchoPAC BT05 June 1, 2005

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:

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
Transvaginal	P	P	P		P	P	P	P		P
Transuretheral
Intraoperative[5]	P	P	P		P	P	P	P		P
Intraoperative Neurological
Intravascular
Laparoscopic

Exparedople
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

[4] Othor doo metaooninal, thoracic (cardiac), and vascular (PV).

[c] Intraoperative Indiados abooming B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition;

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Dygert

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

V Prescription User (Per 21 CFR 801.109)

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

Special 510(k) Premarket Notification GE Healthcare - GE Vivid 7 and EchoPAC BT05 June 1, 2005

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 4C 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	Other
Ophthalmic
Fetal / Obstetrics	N	N	N		N	N	N	N	N	N
Abdominal[1]	N	N	N		N	N	N	N	N	N
Pediatric	N	N	N		N	N	N	N	N	N
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[4]	N	N	N		N	N	N	N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
anarosconic

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)

Danith hysom
(Division Sign-Off)

Division of Reproductive. A and Radiological Devic 510(k) Number

Prescription User (Per 21 CFR 801.109)

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

Special 510(k) Premarket Notification Special 910(K) Promisit 7 and EchoPAC BT05 June 1, 2005

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with M4S 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[1]	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N	N	N	N
Cardiac[3]	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify) [4]	N	N	N	N	N	N	N	N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular

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

Notes: [1] Abdominal includes Renal and GYN;

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology;

[4] Other use included Grology!
[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, 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. Ingram

Division Sign-O Division of Reproductive, and Radiological De 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.