(119 days)
Not Found
No
The description focuses on the hardware components and physical design of an MRI coil, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an RF surface coil for Magnetic Resonance Imaging (MRI) specifically designed for foot and ankle imaging. Its function is to receive signals for image creation, not to provide therapy.
No
Explanation: The device is a receive-only RF surface coil used to acquire images for Magnetic Resonance Imaging (MRI). It does not perform any interpretation or analysis of the images; its function is solely data acquisition. Therefore, it is a medical imaging device, not a diagnostic device.
No
The device is a physical coil with integrated preamplifiers, cables, and accessories, clearly indicating it is a hardware device used in conjunction with an MRI system.
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 description clearly states that this device is an RF surface coil used for Magnetic Resonance Imaging (MRI). It receives signals from the patient's foot or ankle directly during the imaging process. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "foot and ankle imaging," which is a diagnostic imaging procedure performed on the patient's body, not on a sample.
Therefore, this device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with GE 3.0T MRI systems. 8ch Foot Ankle Coil is indicated to use for foot and ankle imaging. The nucleus excited is hydrogen.
Product codes
MOS
Device Description
The 8ch Foot Ankle Coil is a surface coil used for Magnetic Resonance Imaging. It's tuned to image Proton nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements which receive the signal from patient's foot or ankle. Preamplifiers are integrated in the coil. The geometry is optimized for use with parallel imaging techniques.
The 8ch Foot Ankle Coil receives foot or ankle signal through 8-element phased array under 3T static magnetic field and presents the foot or ankle images based on the above mentioned theory.
The 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 associated accessories include:
- 1 cable
- 1 baseplate,
- 1 ankle pad,
- 1 foot pad,
- 1 ramp pad,
- 1 knee pad support,
- 1 strap.
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
Not Found
Summary of Performance Studies
The following performance data: SNR test report, Surface temperature test report and Uniformity test report for each GE 3.0T MRI system were provided in support of the substantial equivalence determination.
Key Metrics
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles incorporated into the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SHENZHEN RF TECH CO., LTD. August 1, 2016 C/O ELENA LU CONSULTANT ROOM 1122, INTERNATIONAL MAYORS COMMUNICATION CENTRE SHENZHEN, 518000 CHINA
Re: K160932
Trade/Device Name: 8ch Foot Ankle Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: May 25, 2016 Received: July 5, 2016
Dear Ms. Lu:
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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
Robert Ochs
Robert Ochs, PhD Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160932
Device Name 8ch Foot Ankle Coil
Indications for Use (Describe)
8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with GE 3.0T MRI systems. 8ch Foot Ankle Coil is indicated to use for foot and ankle imaging. The nucleus excited is hydrogen.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 05 510(k) Summary
This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.
5.1 Administrative Information
| Date of Summary prepared | Mar., 25, 2015 |
|---|---|
| Manufacturer information | Company title: |
| Shenzhen RF Tech Co., Ltd. |
Company address:
2-F, Bld4, Juhui Industrial Park, Tianliao,
Guangming, Shenzhen, P.R.China 518132
Phone: +86-755-2664 1989
Fax: +86-755-2664 2989
Contact Person: Mr. Ke Xi
E-mail: xike@rft.cn |
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd.
Room 1122, International Mayors
Communication Centre, NO. 55 Shizhou middle
road, Nanshan District, Shenzhen
Contact person: Ms. Elena. Lu; Mr. Field. Fu
E-Mail: elena@cefda.com;
cefda13485@163.com
Image: [logo] |
| Establishment registration number | |
5.2 Device Information
| Type of 510(k)
| submission: | Special |
|---|---|
| Trade Name: | 8ch Foot Ankle Coil |
| Model: | 10-F21457 |
| Classification name: | Magnetic resonance diagnostic device |
| Review Panel: | Radiology |
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Proposed product: 8ch Foot Ankle Coil
MOS Product Code: Device Class: =
Regulation Number: | 892.1000
5.3 Predicate Device Information
Shenzhen RF Tech Co., Ltd. Sponsor: Device: 8ch Foot Ankle Coil 510(K) Number: | K151653
5.4 Device Description
The 8ch Foot Ankle Coil is a surface coil used for Magnetic Resonance Imaging. It's tuned to image Proton nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements which receive the signal from patient's foot or ankle. Preamplifiers are integrated in the coil. The geometry is optimized for use with parallel imaging techniques.
The 8ch Foot Ankle Coil receives foot or ankle signal through 8-element phased array under 3T static magnetic field and presents the foot or ankle images based on the above mentioned theory.
The 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 associated accessories include:
- 1 cable
- 1 baseplate,
- 1 ankle pad,
- 1 foot pad,
- 1 ramp pad,
5
- 1 knee pad support,
- 1 strap.
5.5 Intended Use/Indications for Use
8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with GE 3.0T MRI systems. 8ch Foot Ankle Coil is indicated to use for foot and ankle imaging. The nucleus excited is hydrogen.
The Indications for Use statement for the 8ch Foot Ankle Coil is not identical to the predicate device; however, the differences do not alter the intended diagnostic use of the device nor do they affect the safety and effectiveness of the device relative to the predicates. Both Indications for Use statements indicate that the device is intended to be used in conjunction with a GE 3.0T MRI system to produce images of the knee and foot, and that the images can be interpreted by a trained physician.
5.6 Compatibility
The connector of 8ch Foot Ankle Coil is p-port. The 3.0T 8ch Foot Ankle Coil is compatible with GE 3.0T MRI systems where coil ID allows. Such as: GE Discovery 750W 3.0T system GE Discovery MR750 3.0T system GE SIGNA PET/MR 3.0T system
For GE SIGNA PET/MR system, 8ch Foot Ankle Coil is only compatible with the MR scanner of PET/MR, is not optimized for PET scanner, and may compromise PET image quality.
5.7 Technological characteristics of the proposed device compared to the predicate device
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| Shenzhen RF Tech Co.,Ltd | 005_510K Summary |
|---|---|
| Proposed product: 8ch Foot Ankle Coil | Version:A/0 |
The proposed device and the predicate device have similar intended use, same technological characteristics, and similar material composition. The only difference in the design is the baseplate, which is modified to make the coil easy to be compatible with different GE 3.0T MRI systems. However, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the proposed device is substantially equivalent to the predicate devices.
5.8 Brief discussion of the nonclinical tests
The following performance data: SNR test report, Surface temperature test report and Uniformity test report for each GE 3.0T MRI system were provided in support of the substantial equivalence determination.
5.9 Brief discussion of clinical tests
Not applicable.
5.10 Other information (such as required by FDA guidance)
No other information.
5.11 Conclusions
The non-clinical data support the safety and effectiveness of the device. The device should perform as intended in the specified use conditions. Shenzhen RF Tech Co., Ltd. considers the 8ch Foot Ankle Coil does not raise any new issues of safety or effectiveness, and performs as well as the legally marketed predicate device.