The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculoskeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).

Device Description

The Voluson E6/E8/E8Expert/E10 system is a full-featured Track 3 ultrasound system, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability. It utilizes a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the GE Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria (e.g., minimum sensitivity, fidelity, or error rates) for the ultrasound system's performance. Instead, the "acceptance criteria" are implied by the process of demonstrating substantial equivalence to a predicate device (K112213 Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System).

The summary states: "GE Healthcare considers the Voluson E6/E8/E8 Expert/E10 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)."

Therefore, the "acceptance criteria" are implicitly that the new device performs within the same safety and effectiveness parameters as the predicate device across all its intended uses and modalities.

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Conformity with applicable medical device safety standards.	The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. The Voluson E6/E8/E8Expert/E10 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. Transducer materials and other patient contact materials are biocompatible.
Effectiveness/Performance: Substantial equivalence to the predicate device (K112213) across all clinical applications and modes of operation.	The Voluson E6/E8/E8Expert/E10 employs the same fundamental scientific technology as its predicate devices. The system and its transducers (C4-8-D, RAB6-D) support all previously cleared clinical applications (Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal, Transrectal, Transvaginal, Intraoperative), with the addition of CW mode for C4-8-D and RAB6-D transducers. This implies that its performance across these applications is equivalent to the predicate.
Quality Assurance: Adherence to development and testing protocols.	Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Final Acceptance Testing (Validation), Performance testing (Verification), Safety testing (Verification).

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

The summary explicitly states: "The subject of this premarket submission, Voluson E6/E8/E8/ Expert/E10, did not require clinical studies to support substantial equivalence."

Therefore, there is no specific test set or clinical data provenance mentioned in this submission for proving the device's performance in a clinical setting. The evaluation relies on non-clinical tests and comparison to the predicate device.

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

Since no clinical studies were performed or reported in this submission to establish a "ground truth" for a test set, this information is not applicable and therefore not provided.

4. Adjudication Method for the Test Set

As no clinical test set was used to assess new performance, an adjudication method for a test set is not applicable and therefore not provided.

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

No MRMC comparative effectiveness study was done, as clinical studies were not required for this submission. The submission is focused on demonstrating substantial equivalence to a previously cleared device through non-clinical testing and technological similarity.

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

Since this is an ultrasound imaging system and not a standalone AI algorithm designed for interpretation, the concept of "standalone performance" in the context of an algorithm's diagnostic output is not directly applicable in the way it might be for a CAD system. The device's performance is inherently tied to its imaging capabilities, which are assessed through non-clinical means (acoustic output, safety, electrical, mechanical, etc.) to ensure it performs comparably to the predicate. No separate "standalone" algorithm performance study is mentioned.

7. Type of Ground Truth Used

Given that clinical studies were not required, there is no explicit ground truth (e.g., pathology, outcomes data, expert consensus on clinical cases) used to establish the device's diagnostic accuracy in this submission. The "ground truth" for demonstrating substantial equivalence rests on:

Conformity to safety and performance standards.
The fact that it employs the same fundamental scientific technology as the predicate device, K112213. This implies that if the predicate was deemed safe and effective, and the new device uses the same technology and passes the non-clinical checks, it too is safe and effective.

8. Sample Size for the Training Set

This device is an ultrasound imaging system, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. Therefore, a training set sample size is not applicable to this submission.

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

As this is not an AI/ML algorithm requiring a training set, the establishment of ground truth for a training set is not applicable.

Summary

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K113758

JAN 1 0 2012

Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are in black, contrasting with the white background.

510(k) Premarket Notification Submission

510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	December 21, 2011
Submitter:	GE Healthcare [GE Healthcare Austria GmbH & Co OG]Tiefenbach 15Zipf, Austria 4871
Primary Contact Person:	Bryan BehnRegulatory Affairs ManagerGE HealthcareT:(414)721-4214F:(414)918-8275
Secondary Contact Person:	Roland KuntscherRegulatory Affairs SpecialistGE Healthcare Austria GmbH & Co OGT:(++43)7682-3800-660F:(++43)7682 3800-47
Device:	Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System
Trade Name:	Voluson E6/E8/E8Expert/E10
Common/Usual Name:	Voluson E6/E8/E8Expert/E10
Classification Names:	Class II
Product Code:	Class IIUltrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	K112213 Voluson E6/E8/E8Expert/E10 Diagnostic UltrasoundSystem
Device Description:	The Voluson E6/E8/E8Expert/E10 system is a full-featured Track 3 ultrasound system, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability. It utilizes a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes.
Intended Use:	The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are black, creating a high-contrast design.

Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Transrectal; and Vascular; Transvaginal; Peripheral Intraoperative (abdominal, PV and neurological).

The Voluson E6/E8/E8Expert/E10 employs the same Technology: fundamental scientific technology as its predicate devices.

Summary of Non-Clinical Tests: Determination of Substantial Equivalence:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. The Voluson E6/E8/E8Expert/E10 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

. Risk Analysis
Requirements Reviews .
Design Reviews
Testing on unit level (Module verification) ●
Integration testing (System verification) .
Final Acceptance Testing (Validation) .
Performance testing (Verification) .
Safety testing (Verification) ●

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Voluson E6/E8/E8/ Expert/E10, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Voluson E6/E8/E8 Expert/E10 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services, USA. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of an eagle or bird, with three curved lines forming its body and wings.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

JAN 1 0 2012

Mr. Bryan Behn GE Healthcare Regulatory Affairs Manager 9900 W Innovation Drive WAUWATOSA WI 53226

Re: K113758

Trade/Device Name: Voluson E6/E8/E8Expert/E10 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: December 21, 2011 Received: December 21, 2011

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 DUS 6000 Digital Ultrasonic Imaging System, as described in your premarket notification:

Transducer Model Number

C4-8-D RAB6-D

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

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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 (OS) 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/ReportalProblem/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 Michael O'Hara at (301) 796-0294.

Sincerely Yours.

Mary S Pastel

Mary S. Pastel, Sc.D. 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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510(k) Number (if known):

Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System Device Name:

.. "

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NA (Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Patel

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

510(k) Number K113758

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Image /page/5/Picture/0 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The letters are stylized and connected, creating a unique monogram. The logo is in black and white, with the letters and border appearing in black against a white background. The overall design is simple yet recognizable, representing the General Electric brand.

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Voluson E6/E8/E8Expert/E10 system and for all of its probe/mode combinations. There have been no changes to the system level indications for use or modes and no new transducers have been added to the unmodified device. The only change is CW mode has been added to C4-8-D and RAB6-D via Appendix E of the Ultrasound Guidance. This was mistakenly missed in the transducer tables in K112213 and is now being corrected.

(Division Sign-Off)

Division of Radiological De Office of In Vitro Diagnostic

510K K113758

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Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 Ultrasound System

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[5]
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P	[5]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Transvaginal	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Transuretheral
Intraoperative	P	P	P	P	P	P	P	P	P	P
Intraoperative Neurological	P	P	P	P	P	P	P	P	P	P
Intravascular
Laparoscopic

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

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, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

["] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[*] 4D color Doppler

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

y Pastel

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

510K.

and Safety

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are in black, contrasting with the white background.

Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with C4-8-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	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	E	P	P	P	P	P	P	[6]
Abdominal[1]	P	P	P	E	P	P	P	P	P	P	[6]
Pediatric	P	P	P	E	P	P	P	P	P	P	[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	E	P	P	P	P	P	P	[6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
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

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

[6] Includes imaging of guidance of biopsy (2D)

[7] Includes infertility monitoring of follicle development

[*] 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 In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Mary S. Patil
(Division Sign-Off)

દાપ્રદ

Division of Radiological Devices valuation and Safety Office of In Vitro D

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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white.

Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RAB6-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	Other[Notes)
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	E	P	P	P	P	P	P	[5,6]
Abdominal[1]	P	P	P	E	P	P	P	P	P	P	[5,6]
Pediatric	P	P	P	E	P	P	P	P	P	P	[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P	E	P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other
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

[ i ] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[ 1 ] frombined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Mary S Patil

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

יין יו

K113758

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.