(11 days)
Not Found
No
The device description explicitly states that the device "does not directly control energy delivered to the patient nor contain any software." Additionally, there are no mentions of AI, DNN, or ML, nor descriptions of training or test sets, which are typical for AI/ML-based devices. The device is described as a transducer, which is a hardware component for ultrasound imaging.
No
The device is described as being for "diagnostic imaging" and "ultrasound evaluation," which indicates diagnostic rather than therapeutic use. It does not directly control energy delivered to the patient or perform any treatment.
Yes
The device description states that the C1-6-D is "used for diagnostic imaging," and the intended use specifies "ultrasound evaluation" for various anatomical sites, which are all diagnostic activities.
No
The device description explicitly states that the device "does not directly control energy delivered to the patient nor contain any software." It is described as an ultrasound-imaging device (transducer) that is attached to a GE ultrasound imaging system, indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "ultrasound evaluation" of various anatomical sites. This is a diagnostic imaging procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description confirms it's an "ultrasound-imaging device" that is "attached to a GE ultrasound imaging system and used for diagnostic imaging." This reinforces its role in generating images of internal structures.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not handle or analyze such specimens.
Therefore, the C1-6-D Transducer is a medical device used for diagnostic imaging in vivo (within the body), not an IVD.
N/A
Intended Use / Indications for Use
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).
Product codes
90-ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal; Abdominal; Pediatric; Peripheral Vascular; Urology (including prostate).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, C1-6-D Transducer, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110943 GE LOGIQ E9 Diagnostic Ultrasound System including C1-5-D transducer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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:
-
- IEC60601-1. Medical Electrical Equipment Part 1: General Requirements for Safety
-
- IEC60601-1-2,Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
-
- IEC60601-2-37, Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
-
- 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
-
- ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing
-
- NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment when connected to a GE Ultrasound System
-
- 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.
3
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:
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).
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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Image /page/5/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 logo is black and white and has a vintage look.
F
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 | PW | |||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse* | 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
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