The device is intended for use by a qualified physician for use with GE Diagnostic Ultrasound Systems for ultrasound evaluation of Fetal; Abdominal; Pediatric; Peripheral Vascular; Urology (including prostate).

Device Description

The C1-6-D is an ultrasound-imaging device that is attached to a GE ultrasound imaging system and used for diagnostic imaging. This device does not directly control energy delivered to the patient nor contain any software. The CI-6-D is primarily an abdominal transducer and its primary applications are pediatrics and obstetrics, however it may also be used for other applications as described in the indications for use.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for the GE Healthcare C1-6-D Ultrasound Transducer. It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical tests and technology.

Therefore, the following information cannot be extracted from the document:

A table of acceptance criteria and the reported device performance: The document states that "The subject of this premarket submission, C1-6-D Transducer, did not require clinical studies to support substantial equivalence." This means there are no clinical acceptance criteria or reported device performance metrics related to a clinical study provided.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No clinical test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No clinical test set required ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical test set was used.
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-powered diagnostic tool, and no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware transducer, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical ground truth was established for this submission.
The sample size for the training set: Not applicable as there is no training set mentioned for this device.
How the ground truth for the training set was established: Not applicable as there is no training set.

Conclusion from document:

The GE Healthcare C1-6-D Ultrasound Transducer did not require clinical studies to support substantial equivalence. The submission focused on demonstrating substantial equivalence through non-clinical tests, including acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety. The device's technology is stated to be the same as its predicate device.

Summary

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OCT 5 2012

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summarv

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

September 21, 2012 Date:

Submitter: GE Healthcare 9900 Innovation Dr. Wauwatosa, WI 53226

Brvan 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 C1-6-D Ultrasound Transducer

Trade Name: Device: Common/Usual Name:

C1-6-D Ultrasound Transducer Classification Names: Diagnostic Ultrasound Transducer, 21 CFR 892.1570

Product Code: 90-ITX

Predicate Device(s):

K110943 GE LOGIQ E9 Diagnostic Ultrasound System including C1-5-D transducer

The C1-6-D is an ultrasound-imaging device that is attached to a Device Description: GE ultrasound imaging system and used for diagnostic imaging. This device does not directly control energy delivered to the patient nor contain any software. The CI-6-D is primarily an abdominal transducer and its primary applications are pediatrics and obstetrics, however it may also be used for other applications as described in the indications for use.

The device is intended for use by a qualified physician for use Intended Use: with GE Diagnostic Ultrasound Systems for ultrasound evaluation of Fetal; Abdominal; Pediatric; Peripheral Vascular; Urology (including prostate).

The C1-6-D Transducer employs the same fundamental scientific Technology: technology as its predicate device(s).

Determination of Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, Substantial Equivalence: 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 C1-6-D Transducer and its applications comply

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The design is intricate and stylized, with the letters having a flowing, cursive appearance. The logo is presented in black and white, giving it a classic and recognizable look.

GE Healthcare

510(k) Premarket Notification Submission

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- 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 system:

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

Summary of Clinical Tests:

The subject of this premarket submission, C1-6-D Transducer, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the C1-6-D Transducer 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 shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

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

OCT 5 2012

Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Dr. RP-2138 WAUWATOSA WI 53226

Re: K122921

Trade/Device Name: C1-6-D Diagnostic Ultrasound Transducer Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: September 21, 2012 Received: September, 24, 2012

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 C1-6-D Diagnostic Ultrasound Transducer, as described in your premarket notification:

Transducer Model Number

C1-6-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 may publish further announcements concerning your device in the Federal Register.

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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 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/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 Jeffrey Ballyns at (301) 796-6105.

Sincerely Yours,

Michael O'Hearn for

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

Enclosure(s)

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GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known): KI22921

Device Name:

C1-6-D Diagnostic Ultrasound Transducer

Indications for Use:

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

Over-The-Counter Use N/A (Part 21 CFR 801 Subpart C)

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Page 1 of 1

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

Arad D. Khan
Division Sign Off

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

510(k) Number

iological Reater.
office of In Vitro
Diagnostics and Radiology
Health

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GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE C1-6-D Transducer

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

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse*	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]	N	N	N	N	N	N	N	N	N	N	[5,6,9]
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	[3,5,6,9]
Pediatric	N	N	N	N	N	N	N	N	N	N	[3,5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N	N	N	N	N	N	N	N	[3,5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

[1] Abdominal includes Renal, GYN/Pelvic. Notes:

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance im aging

[7] Includes infertility monitoring of follicle development

[9] Volume navigation

(Division Sign-Off) Division at Asulological Devices Office of In Vitro Diagnostic Davice Evaluation and Safety

510K K122921

[*] Combined modes are BIM, 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 CER 801.109)

Murhal DD
Division of Radiologic Heal

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.