(25 days)
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, ML, or related terms, nor are there descriptions of training or test sets typically associated with AI/ML development. The performance studies focus on safety and standards compliance, not AI/ML performance metrics.
No.
The device is described as an "ultrasound-imaging device" used for "diagnostic imaging" and "ultrasound evaluation," indicating its purpose is to diagnose conditions rather than treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for ultrasound evaluation," and the "Device Description" section clarifies it is "used for diagnostic imaging."
No
The device description explicitly states "This device does not directly control energy delivered to the patient nor contain any software." It is described as an ultrasound-imaging device (transducer) that attaches to a system, indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is an "ultrasound-imaging device" that is "attached to a GE ultrasound imaging system and used for diagnostic imaging." It works by transmitting and receiving ultrasound waves to create images of internal structures.
- Intended Use: The intended use is for "ultrasound evaluation of Fetal; Abdominal; Pediatric; Peripheral Vascular; Urology (including prostate)." This involves imaging the body directly, not analyzing samples taken from the body.
The device is a diagnostic imaging transducer, which is a different category of medical device than 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 (comma separated list FDA assigned to the subject device)
90-ITX
Device Description
The C2-9-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 C2-9-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)
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 C2-9-D Transducer and its applications comply.
Summary of Clinical Tests: The subject of this premarket submission, C2-9-D Transducer, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K110943 GE LOGIQ E9 Diagnostic Ultrasound System including C1-5-D transducer
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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K|22515
SEP 1 1 2012
GE Healthcare 510(k) Premarket Notification Submission 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | August 17, 2012 |
|---|---|
| Submitter: | GE Healthcare |
| 9900 Innovation Dr. | |
| Wauwatosa, WI 53226 | |
| Contact Person: | Bryan Behn |
| Regulatory Affairs Manager | |
| GE Healthcare, GE Medical Systems Ultrasound and Primary | |
| Care Diagnostics, LLC. | |
| Phone: 414-721-4214 | |
| Fax: 414-918-8275 | |
| Device: | |
| Trade Name: | C2-9-D Ultrasound Transducer |
| Common/Usual Name: | C2-9-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 | |
| Device Description: | The C2-9-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 C2-9-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. | |
| Intended 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). | |
| Technology: | The C2-9-D Transducer employs the same fundamental scientific |
| technology as its predicate device(s). | |
| Determination of | |
| Substantial Equivalence: | 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 C2-9-D Transducer and its applications comply |
Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The logo is black and white.
... ... ......................................................................................................................................................................
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' in a stylized, cursive font. The letters are enclosed within a circular border. The logo is black and white, with the letters and border appearing in black against a white background.
GE Healthcare
510(k) Premarket Notification Submission with voluntary standards:
- l. 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) .
- . Integration testing (System verification)
- Performance testing (Verification) .
- . Safety testing (Verification)
- Final Acceptance testing (Validation) .
Summary of Clinical Tests:
The subject of this premarket submission, C2-9-D Transducer, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the C2-9-D Transducer to be as safe, as Conclusion: 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 logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of several curved lines.
10903 New Hampshire Avenue Silver Spring, MD 20993
SEP 11 2012
Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive WAUWATOSA WI 53226
Re: K122515
Trade/Device Name: C2-9-D Diagnostic Ultrasound Transducer Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: August 17, 2012 Received: August 17, 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 C2-9-D Diagnostic Ultrasound Transducer, as described in your premarket notification:
Transducer Model Number
GE C2-9-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 Joshua C. Nipper at (301) 796-6524.
Sincerely Yours,
Michael D'Aun for
Janine M. Morris 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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GE Healthcare 510(k) Premarket Notification Submission
510(k) Number (if known):
Device Name: C2-9-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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Alh D'h
(Division Sign-Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
199515 510(k) Number
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance. The logo is black and white.
# GE Healthcare 510(k) Premarket Notification Submission
| Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical Application
Anatomy/Region of Interest | Mode of Operation | | | | | | | | | | |
| | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes' | Harmonic
Imaging | Coded
Pulse | Other
[Notes] |
| 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 | | | | | | | | | | | |
### Diagnostic Ultrasound Indications for Use Form GE C2-9-D Transducer
N = new indication; P = previously cleared by FDA
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[9] Volume navigation
[*] 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)
_
**(Division Sign-Off)**
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