(84 days)
No
The description focuses on the hardware components and basic signal processing (phased array technique) of an MR coil, with no mention of AI or ML for image processing or analysis.
No.
The device is designed to produce diagnostic images and is described as a general-purpose coil for Magnetic Resonance (MR) systems, indicating a diagnostic rather than a therapeutic function.
Yes
The device is described as "designed to produce diagnostic images of human anatomies," indicating its role in the diagnostic process.
No
The device description explicitly details physical hardware components (flexible coils, elements, integrated preamplifiers) designed to interact with an MR system to produce images. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Flex Coils are described as "receive-only coils designed to produce diagnostic images of human anatomies" using Magnetic Resonance (MR). They are used externally on the body to capture signals for imaging.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The device interacts directly with the patient's body to generate images.
Therefore, the Flex Coils fall under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Flex Coils are designed to produce diagnostic images of human anatomies and are used as general purpose coils. The Flex Coils are receive-only coils designed to be used with 1.5T MRI systems manufactured by GE Healthcare to provide images of various parts of human body including shoulder, elbow, wrist, knee, hip and ankle. Large flex coil can be used for scanning large anatomy and small flex coil can be used for scanning smaller anatomy. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.
Product codes
MOS
Device Description
The 1.5T 4CH Flex Coils are receive-only coils designed to provide images of various parts of human body. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.
The 1.5T 4CH Flex coils are available in two models – 1.5T 4CH Large Flex coil and 1.5T 4CH Small Flex Coil, and are designed for use with GE 1.5T MR systems.
1.5T 4CH Flex coils are General Purpose receive only coils with 4 elements and integrated preamplifiers.
1.5T 4CH Flex coils are based on phased array technique for combining the images from 4 different channels. Coils are tuned to the proton frequency of 63.86MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
human anatomies including shoulder, elbow, wrist, knee, hip and ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Internal scans within GE Healthcare facility were performed to obtain sample clinical images. The subject of this premarket submission, 1.5T 4CH Flex Coil did not require external clinical studies to support substantial equivalence
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/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.
K123681 Page 1 of 3
GE Healthcare 510(k) Premarket Notification Submission
FEB 2 2 2013
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | 26-Nov-2012 |
| Submitter: | GE Healthcare, (Wipro GE Healthcare Pvt Ltd) |
| 122 (Part 1), John F. Welch Technology Centre, | |
| Export Promotional Industrial Park, Whitefield, | |
| Bangalore, INDIA 560066 | |
| Primary Contact Person: | Shashidhar C S |
| Regulatory Affairs Leader | |
| GE Healthcare, (Wipro GE Healthcare Pvt Ltd) | |
| 122 (Part 1), John F. Welch Technology Centre, | |
| Export Promotional Industrial Park, Whitefield, | |
| Bangalore, INDIA 560066 | |
| Telephone: +91 80 40883613 | |
| Fax: +91 80 28411645 | |
| Secondary Contact Person: | Glen Sabin |
| Regulatory Affairs Director - MR | |
| GE Healthcare,(GE Medical Systems LLC) | |
| 3200N Grandview Blvd., Mail Coil-W-827 | |
| Waukesha, WI 53188, USA | |
| Phone: (262) 521-6848 | |
| Fax: (262) 364-2785 | |
| Device: | |
| Trade Name: | 1.5T 4CH FLEX COIL |
| Common/Usual Name: | Coil, magnetic resonance, specialty |
| Classification Names: | 21CFR 892.1000, Magnetic resonance diagnostic device |
| Product Code: | MOS |
| Predicate Device(s): | K030953, GE 3.0T General Purpose Flex Coil |
| Device Description: | The 1.5T 4CH Flex Coils are receive-only coils designed |
| to provide images of various parts of human body. The | |
| flexible coil is wrapped around the anatomy of interest, | |
| such as an elbow or knee or can be used for planar | |
| imaging. |
The 1.5T 4CH Flex coils are available in two models –
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The letters are connected and have a flowing, elegant appearance. The logo is in black and white.
K123681 Page 2 of 3
GE Healthcare 510(k) Premarket Notification Submission
1.5T 4CH Large Flex coil and 1.5T 4CH Small Flex Coil, and are designed for use with GE 1.5T MR systems.
Intended Use: The Flex Coils are designed to produce diagnostic images of human anatomies and are used as general purpose coils. The Flex Coils are receive-only coils designed to be used with 1.5T MRI systems manufactured by GE Healthcare to provide images of various parts of human body including shoulder, elbow, wrist, knee, hip and ankle. Large flex coil can be used for scanning large anatomy and small flex coil can be used for scanning smaller anatomy. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.
Technology: 1.5T 4CH Flex Coils are flexible and can be wrapped around the anatomy of interest, which is similar to its predicate device.
1.5T 4CH Flex coils are General Purpose receive only coils with 4 elements and integrated preamplifiers.
1.5T 4CH Flex coils are based on phased array technique for combining the images from 4 different channels. Coils are tuned to the proton frequency of 63.86MHz.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
Substantial Equivalence:
The 1.5T 4CH Flex Coil complies with voluntary standards IEC60601-1, IEC60601-2-33, IEC60601-1-2, ISO14971, and ISO10993-1.
The following quality assurance measures were applied to the development of the system:
- . Risk Analysis
- Requirements Reviews ●
- Design Reviews �
- . Performance testing
- Integration testing .
- Safety testing .
2
K123681 Page 3 of 3
GE Healthcare 510(k) Premarket Notification Submission
- Maximum B1 Peak test -- This test is to verify the . coil's ability to withstand maximum B1 peak fields and high B1 field energy concentrations without posing a risk to safety through arcing or voltage breakdown
- Blocking Network analysis This test determines . the effectiveness of the blocking networks(s) for transmit decoupling to ensure safety and to minimize B1 distortion
- Surface temperature test under normal condition .
- Surface temperature test under unplugged condition .
Summary of Clinical Tests:
Internal scans within GE Healthcare facility were performed to obtain sample clinical images. The subject of this premarket submission, 1.5T 4CH Flex Coil did not require external clinical studies to support substantial equivalence
Conclusion: GE Healthcare considers the 1.5T 4CH Flex Coil to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
Section 05
Image /page/2/Picture/11 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 letters are white against a black background, and the circle is outlined in white.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2013
Shashidhar C S Regulatory Affairs Leader WIPRO GE HEALTHCARE PRIVATE, LTD. 122 (Part 1) John F Welch Trading Centre, EPIP, Whitefield Rd BANGALORE, INDIA 560066
Re: K123681
Trade/Device Name: 1.5T 4CH FLEX COIL Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 26, 2012 Received: November 30, 2012
Dear Mr. Shashidhar C S:
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.
4
Page 2-Mr. Shashidhar C S
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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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.
Michael Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
1.5T 4CH FLEX COIL
Indications For Use:
The Flex Coils are designed to produce diagnostic images of human anatomies and are used as general purpose coils. The Flex Coils are receive-only coils designed to be used with 1.5T MR1 systems manufactured by GE Healthcare to provide images of various parts of human body including shoulder, elbow, wrist, knee, hip and ankle. Large flex coil can be used for scanning large anatomy and small flex coil can be used for scanning smaller anatomy. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Michael FDA Hara
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)
Page 1 of