(25 days)
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).
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.
The provided 510(k) Premarket Notification Submission for the GE Healthcare C2-9-D Ultrasound Transducer does not contain a study that proves the device meets acceptance criteria related to clinical performance or diagnostic accuracy.
This submission is for a transducer, which is a component of an ultrasound system, not a standalone diagnostic device with algorithms or AI. The substantial equivalence is based on technical, safety, and performance characteristics compared to a predicate device, rather than a clinical efficacy study typically seen for AI/diagnostic software.
Therefore, many of the requested details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or ground truth types, are not applicable or not available in this document.
However, I can extract information related to the non-clinical acceptance criteria and the evaluation conducted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance/Compliance |
|---|---|---|
| Acoustic Output | NEMA UD 3: Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment | "The device has been evaluated for acoustic output... and has been found to conform with applicable medical device safety standards." "The C2-9-D Transducer and its applications comply with voluntary standards: NEMA UD 3... NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment when connected to a GE Ultrasound System" (implies compliance with the standards' criteria). |
| NEMA UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment | (See above) | |
| Biocompatibility | ISO 10993-1: Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing | "The device has been evaluated for... biocompatibility... and has been found to conform with applicable medical device safety standards." "The C2-9-D Transducer and its applications comply with voluntary standards: ISO10993-1" (implies compliance with the standard's criteria for biological safety). |
| Cleaning & Disinfection | (No specific standard referenced for this but is a general requirement for reusable medical devices) | "The device has been evaluated for... cleaning and disinfection effectiveness... and has been found to conform with applicable medical device safety standards." (This implies that effective cleaning and disinfection protocols were verified). |
| Thermal Safety | IEC 60601-2-37: Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment | "The device has been evaluated for... thermal... safety, and has been found to conform with applicable medical device safety standards." "The C2-9-D Transducer and its applications comply with voluntary standards: IEC60601-2-37" (implies compliance regarding thermal safety aspects for diagnostic ultrasound). |
| Electrical Safety | IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety | "The device has been evaluated for... electrical... safety, and has been found to conform with applicable medical device safety standards." "The C2-9-D Transducer and its applications comply with voluntary standards: IEC60601-1" (implies compliance with general electrical safety requirements). |
| Electromagnetic Safety | IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests | "The device has been evaluated for... electromagnetic... safety, and has been found to conform with applicable medical device safety standards." "The C2-9-D Transducer and its applications comply with voluntary standards: IEC60601-1-2" (implies compliance with EMC requirements to prevent interference). |
| Mechanical Safety | (No specific standard referenced, but often covered by general safety standards like IEC 60601-1) | "The device has been evaluated for... mechanical safety, and has been found to conform with applicable medical device safety standards." (This implies structural integrity and safe operation from a mechanical standpoint were verified). |
| Risk Management | ISO 14971: 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)." "The C2-9-D Transducer and its applications comply with voluntary standards: ISO14971." (Indicates a formal risk management process was followed). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission did not require clinical studies or a diagnostic test set for substantial equivalence. The "test sets" referred to were likely for engineering verification and validation against technical standards, not patient data.
3. 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)
- Not applicable. No clinical ground truth was established as no clinical studies were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication of diagnostic outcomes.
5. 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 is a hardware component (ultrasound transducer), not an AI/software device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was established for the device. The "truth" for this device's acceptance relied on meeting predefined physical, electrical, and safety standards.
8. The sample size for the training set
- Not applicable. This is a hardware component; there is no "training set" in the context of machine learning or algorithms.
9. How the ground truth for the training set was established
- Not applicable. Same as above.
Study Proving Device Meets Acceptance Criteria:
The document states: "The subject of this premarket submission, C2-9-D Transducer, did not require clinical studies to support substantial equivalence."
Instead of a clinical study, the evidence for meeting acceptance criteria comes from non-clinical tests and conformance to recognized consensus standards:
- 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."
- Compliance with Voluntary Standards: The document explicitly lists voluntary standards that the C2-9-D Transducer and its applications comply with:
- IEC 60601-1 (General Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- IEC 60601-2-37 (Safety of Ultrasonic Medical Diagnostic Equipment)
- NEMA UD 3 (Acoustic Output Display)
- NEMA UD 2 (Acoustic Output Measurement)
- ISO 10993-1 (Biocompatibility)
- ISO 14971 (Risk Management)
- Quality Assurance Measures: The development process included risk analysis, requirements reviews, design reviews, unit-level testing (module verification), integration testing (system verification), performance testing (verification), safety testing (verification), and final acceptance testing (validation). These are the "studies" or processes by which the device's technical and safety acceptance criteria were met.
In summary, the "study" proving the device meets acceptance criteria is a series of non-clinical engineering verification and validation activities demonstrating compliance with established safety, performance, and international harmonized standards, rather than a clinical trial or AI performance study.
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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 Healthcare9900 Innovation Dr.Wauwatosa, WI 53226 |
| Contact Person: | Bryan BehnRegulatory Affairs ManagerGE Healthcare, GE Medical Systems Ultrasound and PrimaryCare Diagnostics, LLC.Phone: 414-721-4214Fax: 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 Systemincluding C1-5-D transducer |
| Device Description: | The C2-9-D is an ultrasound-imaging device that is attached to aGE ultrasound imaging system and used for diagnostic imaging.This device does not directly control energy delivered to thepatient nor contain any software. The C2-9-D is primarily anabdominal transducer and its primary applications are pediatricsand obstetrics, however it may also be used for other applicationsas described in the indications for use. |
| Intended Use: | The device is intended for use by a qualified physician for usewith GE Diagnostic Ultrasound Systems for ultrasoundevaluation of Fetal; Abdominal; Pediatric; Peripheral Vascular;Urology (including prostate). |
| Technology: | The C2-9-D Transducer employs the same fundamental scientifictechnology as its predicate device(s). |
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests:The device has been evaluated for acoustic output,biocompatibility, cleaning and disinfection effectiveness as wellas thermal, electrical, electromagnetic and mechanical safety, andhas been found to conform with applicable medical device safetystandards. 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.
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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 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<br>Anatomy/Region of Interest | Mode of Operation | | | | | | | | | | |
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes' | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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)**
19
§ 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.