6VT-D is intended for use by a qualified physician for use with GE Diagnostic Ultrasound Systems for ultrasound evaluation of Cardiac anatomy of adults through Transesophageal means of access, having imaging capabilities in 2D as well as in real-time 3D / 4D mode.

Device Description

The 6VT-D is an ultrasound-imaging device that is attached to a GE ultrasound imaging system and used for diagnostic imaging. 6VT-D does not directly control energy delivered to the patient nor does it contain any software. The 6VT-D is a transducer for imaging cardiac anatomy in adults with transesophageal means of access.

AI/ML Overview

The provided document is a 510(k) summary for the GE Healthcare 6VT-D Diagnostic Ultrasound Transducer. It describes a modification to an existing transducer, specifically the replacement of a patient contact material.

The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of advanced AI/ML performance metrics (such as sensitivity, specificity, or AUC) as it is a submission for a hardware modification of an ultrasound transducer.

Here's a breakdown of why this information is missing and what is available:

Type of Device: The 6VT-D is an ultrasound transducer, a hardware component that attaches to an ultrasound imaging system. It "does not directly control energy delivered to the patient nor does it contain any software" (Page 1). This explicitly states it's not a software device with AI/ML capabilities, which would typically undergo performance studies with acceptance criteria based on diagnostic accuracy.
Nature of the Submission: This 510(k) submission is for an "incremental improvement where one patient contact material of the endoscope is replaced by another" (Page 1). The focus of the submission is on demonstrating "substantial equivalence" to a predicate device, particularly regarding the safety and biocompatibility of the new material.

What the document does provide in relation to "acceptance criteria" and "study" are engineering and safety standards:

Acceptance Criteria (Safety and Performance Standards): The device's "acceptance criteria" are compliance with various international standards for medical electrical equipment, acoustic output, biocompatibility, and risk management. These are the "general requirements for safety" and "particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment."
- IEC60601-1 (General Safety)
- IEC60601-1-2 (EMC)
- IEC60601-2-37 (Ultrasonic Medical Equipment Safety)
- NEMA UD 3 (Acoustic Output Display)
- ISO10993-1 (Biocompatibility Evaluation)
- NEMA UD 2 (Acoustic Output Measurement)
- ISO14971 (Risk Management)
Study/Evaluation (Non-Clinical Tests): The "study" mentioned for these acceptance criteria are "Non-Clinical Tests," which include:
- Acoustic output evaluation
- Biocompatibility evaluation
- Cleaning and disinfection effectiveness
- Thermal, electrical, electromagnetic, and mechanical safety testing
- Quality assurance measures: Risk Analysis, Requirements Reviews, Design Reviews, Unit-level testing, Integration testing, Performance testing, Safety testing, Final Acceptance testing (Validation).
Clinical Studies: The document explicitly states: "The subject of this premarket submission, 6VT-D Transducer, did not require clinical studies to support substantial equivalence." (Page 2). This further confirms that no performance study involving human subjects or diagnostic accuracy metrics was conducted or deemed necessary for this specific submission.

Therefore, the requested information elements related to AI/ML performance (sample size for test/training set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types) are not applicable to and cannot be extracted from this document.

Summary of available information as per your request, framed by the context of this device:

Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Compliance with Standards)	Reported Device Performance (as per Non-Clinical Tests)
IEC60601-1: General Requirements for Safety	Found to conform
IEC60601-1-2: Electromagnetic Compatibility Requirements	Found to conform
IEC60601-2-37: Safety of Ultrasonic Medical Diagnostic Equipment	Found to conform
NEMA UD 3: Real Time Display of Thermal and Mechanical Acoustic Output Indices	Complies
ISO10993-1: Biological Evaluation of Medical Devices	New patient contact material (and existing) evaluated and found acceptable for transducer's intended use and relevant patient contact.
NEMA UD 2: Acoustic Output Measurement Standard	Complies
ISO14971: Application of risk management to medical devices	Applied as part of quality assurance measures.
Biocompatibility of new material	Evaluated according to international standards and found acceptable; identical to material used in predicate Karl Storz Video Gastroscope System (K060907).
Acoustic output, cleaning/disinfection effectiveness, thermal, electrical, electromagnetic, mechanical safety	Evaluated and found to conform

Sample size used for the test set and the data provenance: Not applicable. No clinical or performance accuracy test set was used for this hardware modification submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for diagnostic performance was established for this hardware modification.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is an ultrasound transducer, not an AI-enabled software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware component.
The type of ground truth used: Not applicable. Ground truth for diagnostic performance was not relevant for this hardware modification. For biocompatibility, the ground truth was conformance to ISO10993-1 using laboratory testing.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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

MAY 1 5 2014

K141093
Page 1 of 3

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

April 25, 2014 Date:

Submitter: GE Healthcare, GE Vingmed Ultrasound AS Strandpromenaden 45 N-3191. Horten. Norway

6VT-D Ultrasound Transducer

Bryan Behn Contact Person:

Regulatory Affairs Manager GE Healthcare. GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC. Phone: 414-721-4214 Fax: 414-918-8275

Trade Name: Device: Common/Usual Name:

Diagnostic Ultrasound Transducer, 21 CFR 892.1570 Classification Names:

Product Code: 90-ITX

Predicate Device(s):

K131514 GE Vivid E9 Diagnostic Ultrasound System including 6VT-D transducer.

K060907 Karl Storz Video Gastroscope System

Device Description:

The objective of this 510(k) submission is to present the proposed modifications to the 6VT-D Transducer (K131514), and to demonstrate substantial equivalence. The 6VT-D transducer modification is an incremental improvement where one patient contact material of the endoscope is replaced by another. Both the current endoscope material, and the proposed new material, were evaluated for biocompatibility according to the same international standards, and both were found to be acceptable for the transducer's intended use and relevant patient contact. No design inputs are affected by the change of material.

Image /page/0/Picture/18 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular shape. The logo is black and white and appears to be a vector graphic.

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

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, while the background is white.

GE Healthcare

510(k) Premarket Notification Submission

Intended Use:

Determination of

Substantial Equivalence:

The device is intended for use by a qualified physician for use with GE Diagnostic Ultrasound Systems for ultrasound evaluation of Cardiac anatomy of adults in 2D modes as well as in real-time 3D / 4D mode.

The 6VT-D Transducer employs the same fundamental scientific Technology: technology as its predicate device(s).

Comparison to Predicate Devices

The 6VT-D Diagnostic Ultrasound Transducer is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

The 6VT-D is identical to the predicate 6VT-D transducer . with respect to imaging and applications.
. The transducers are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
The endoscope of 6VT-D uses identical patient contact . material as the Karl Storz Video Gastroscope System (K060907)

Summary of Non-Clinical Tests:

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 6VT--D Transducer and its applications comply with voluntary standards:

1. IEC60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety
1. IEC60601-1-2,Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
1. IEC60601-2-37, Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
1. NEMA UD 3. Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment when connected to a GE Ultrasound System
1. ISO10993-1. Biological Evaluation of Medical Devices-

ﺗﺮ ﺗ

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

K141093
Page 3 of 3

GE Healthcare

510(k) Premarket Notification Submission Part 1: Evaluation and Testing

1. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment when connected to a GE Ultrasound System
1. ISO14971, Application of risk management to medical devices

The following quality assurance measures were applied to the development of the complete medical system:

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

Summary of Clinical Tests:

The subject of this premarket submission, 6VT-D Transducer, did not require clinical studies to support substantial equivalence. 100

GE Healthcare considers the 6VT-D Transducer to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).

Image /page/2/Picture/17 description: The image contains the number 22. The number is written in a simple, sans-serif font. The number is black and is set against a white background.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 15, 2014

GE VINGMED ULTRASOUND AS % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W. Innovation Drive, RP-2138 WAUWATOSA WI 53226

Re: K141093

Trade/Device Name: 6VT-D Diagnostic Ultrasound Transducer Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: April 25, 2014 Received: April 28, 2014

Dear Mr. Behn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

Image /page/3/Picture/11 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be an eagle or similar bird with outstretched wings, stylized with thick, curved lines.

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

Page 2-Mr. Behn

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misoranding 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141093

Device Name

6VT-D Diagnostic Ultrasound Transducer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017 See PRA Statement below.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Smh.7)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/6/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 in black, contrasting with the white background. The logo is a classic and recognizable symbol of the General Electric company.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form

6VT-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
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
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 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 In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.