(51 days)
Not Found
No
The summary describes a physical RF coil for MRI, focusing on its hardware components and performance characteristics related to signal acquisition and safety. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
No.
The device is an RF surface coil for Magnetic Resonance Imaging, used for diagnostic imaging rather than therapy.
Yes
The device is an MRI coil, which is a component of a Magnetic Resonance Imaging system. MRI systems are used to produce images that aid in the diagnosis of various medical conditions, thus classifying them as diagnostic devices.
No
The device description explicitly states it is a physical RF surface coil comprised of hardware components like coil elements, preamplifiers, and a base plate. The performance studies also include hardware-specific testing like biocompatibility, electrical safety (IEC standards), and RF performance tests.
Based on the provided information, the GE 8CH Foot Ankle Coil is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The GE 8CH Foot Ankle Coil is a component of an MRI system. It's a receive-only RF surface coil used to acquire signals from the hydrogen nuclei within the patient's foot and ankle during an MRI scan. This is an in vivo (within the living body) process, not an in vitro process.
- Intended Use: The intended use is for "foot and ankle imaging" using MRI, which is a medical imaging technique performed directly on the patient.
Therefore, the GE 8CH Foot Ankle Coil is a medical device used for in vivo imaging, not an IVD.
N/A
Intended Use / Indications for Use
The GE 8CH Foot Ankle Coil is a receive-only RF surface coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The 8ch Foot Ankle Coil for GE 1.5T MRI systems is indicated for use for foot and ankle imaging. The nucleus excited is hydrogen.
Product codes
90MOS
Device Description
The GE 8CH Foot Ankle Coil is a surface coil used for Magnetic Resonance Imaging. It's tuned to image Protor nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques.
The GE 8CH Foot Ankle Coil comprises the coil and the base plate. The coil conforms to patients' anatomy, accommodating various foot contours while minimizing patient discomfort. The base plate separated from the coil part is used to place the patients' anatomy on the table.
The GE 8CH Foot Ankle Coil is a receive-only RF surface coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The 8ch Foot Ankle Coil for GE 1.5T MRI systems is indicated for use for foot and ankle imaging. The nucleus excited is hydrogen.
The GE 8CH Foot Ankle Coil is 8-element phased array RF receive only coils with integrated preamplifiers. The coil designs consist of RF chokes with switching diodes to provide decoupling which isolates the coil elements from RF fields during RF transmission. This coil is designed based on the same technology as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
foot 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
Sample clinical images included in Section20 Performance Testing-clinical were performed within GE Healthcare facilities under the control of GE Global Research Study Work Instruction.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
Verification testing has been performed and is documented in the sections noted below of this submission. The following verification tests have been performed:
- Biocompatibility Testing (section 15) 1.
- IEC 60601-1-2 testing (section 17) 2.
- IEC 60601-1 testing and NRTL certification to UL 3. 60601-1 (section 17)
-
- IEC60601-2-33 testing (section17)
- 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. (section 18)
-
- Signal to Noise ratio and uniformity test according to NEMA standard (section 18)
- Blocking Network analysis This test determines the 7. effectiveness of the blocking networks(s) for transmit decoupling to ensure safety and to minimize B1 distortion. (section 18)
- Surface temperature test normal condition (section 8. 18)
- Surface temperature test unplugged condition 9. (section 18)
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.
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长1226 ക്കുന്നു.
അവലംബം കേരള കേരള കാലാക്കും അത്തരം അതിനു അവലംബം കേരള
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
OCT 2 5 2012
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | August 15, 2012 |
|---|---|
| Submitter: | GE Hangwei Medical Systems Co.,Ltd. |
| No.2, Yong Chang North Road | |
| Econ. & Tech. Development Zone | |
| Beijing, 100176, P.R.China | |
| Primary Contact Person: | Ms. Zhirong Huang |
| Regulatory Affairs Leader | |
| GE Hangwei Medical Systems Co., Ltd. | |
| Phone: +86 10 58068888 70236 | |
| Fax: +86 10 67803267 | |
| Email: Zhirong.Huang@ge.com | |
| Secondary Contact Person: | Mr. Glen Sabin |
| Regulatory Affairs Director | |
| GE Healthcare (GE Medical Systems, LLC) | |
| 3200N Grandview Blvd., Mail Coil-W-827 | |
| Waukesha, WI 53188, USA | |
| Phone: +1 262 521 6848 | |
| Fax: +1 262 521 6439 | |
| Email: Glen.sabin@ge.com | |
| Device: Trade Name: | GE 8CH Foot Ankle Coil |
| Common/Usual Name: | Coil, magnetic resonance, specialty |
| Classification Names: | 21CFR 892.1000, Magnetic resonance diagnostic device |
| Product Code: | 90MOS |
| Predicate Device(s): | K050514, Foot Ankle coil (MRI Devices Corporation, |
| which known as Invivo Corporation ) | |
| Device Description: | The GE 8CH Foot Ankle Coil is a surface coil used for |
| Magnetic Resonance Imaging. It's tuned to image Protor |
Image /page/0/Picture/6 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circle. The letters and the circle are in black, contrasting with the white background.
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized and have a vintage look.
GE Healthcare
510(k) Premarket Notification Submission
nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques.
The GE 8CH Foot Ankle Coil comprises the coil and the base plate. The coil conforms to patients' anatomy, accommodating various foot contours while minimizing patient discomfort. The base plate separated from the coil part is used to place the patients' anatomy on the table.
The GE 8CH Foot Ankle Coil is a receive-only RF surface coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The 8ch Foot Ankle Coil for GE 1.5T MRI systems is indicated for use for foot and ankle imaging. The nucleus excited is hydrogen.
The GE 8CH Foot Ankle Coil is 8-element phased array RF receive only coils with integrated preamplifiers. The coil designs consist of RF chokes with switching diodes to provide decoupling which isolates the coil elements from RF fields during RF transmission. This coil is designed based on the same technology as the predicate device.
Summary of Non-Clinical Tests:
Verification testing has been performed and is documented in the sections noted below of this submission. The following
verification tests have been performed:
- Biocompatibility Testing (section 15) 1.
- IEC 60601-1-2 testing (section 17) 2.
- IEC 60601-1 testing and NRTL certification to UL 3. 60601-1 (section 17)
-
- IEC60601-2-33 testing (section17)
- ડા 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. (section 18)
-
- Signal to Noise ratio and uniformity test according to
Intended Use:
Technology:
Determination of Substantial Equivalence:
2
Image /page/2/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 letters and the border are in black, creating a strong contrast against the white background.
GE Healthcare
510(k) Premarket Notification Submission
NEMA standard (section 18)
- Blocking Network analysis This test determines the 7. effectiveness of the blocking networks(s) for transmit decoupling to ensure safety and to minimize B1 distortion. (section 18)
- Surface temperature test normal condition (section 8. 18)
- Surface temperature test unplugged condition 9. (section 18)
Summary of Clinical Tests:
Sample clinical images included in Section20 Performance Testing-clinical were performed within GE Healthcare facilities under the control of GE Global Research Study Work Instruction.
Conclusion:
GE Healthcare considers the GE 8CH Foot Ankle Coil for 1.5T MRI systems to be as safe, as effective, and performance is substantially equivalent to the predicate device.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The overall design is simple and conveys a sense of authority and professionalism.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
GE HANGWEI Medical Systems Co., Ltd. % Mr. Glen Sabin Regulatory Affairs Director GE Medical Systems, LLC 3200 N. Grandview Blvd. Mail Code-W-827 WAUKESHA WI 53188
Re: K122694
Trade/Device Name: GE 8CH Foot Ankle Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 15, 2012 Received: September 6, 2012
OCT 25 2012
Dear Mr. Sabin:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours,
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):_ K122694
GE 8CH Foot Ankle Coil Device Name:
Indications For Use:
The GE 8CH Foot Ankle Coil is a receive-only RF surface coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The 8ch Foot Ankle Coil for GE 1.5T MRI systems is indicated for use for foot and ankle imaging. The nucleus excited is hydrogen.
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)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D'Amico
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
51004 JK122694
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