(128 days)
Not Found
No
The summary describes a hardware component (a receive-only coil) for MRI systems and does not mention any software or algorithms that would incorporate AI or ML for image processing or interpretation.
No
The device is described as a "receive-only coil" used for "obtaining diagnostic images" in MRI systems, indicating its purpose is for diagnosis, not therapy.
Yes
The text explicitly states, "The Carotid Coil is used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis." This indicates its role in the diagnostic process.
No
The device is described as a "Carotid Coil," which is a physical hardware component used in MRI systems. The description details its physical characteristics, materials, and performance tests related to hardware. There is no mention of software as the primary or sole 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "receive-only coil" used for "high resolution imaging of the bifurcation of the carotid artery" using Magnetic Resonance Imaging (MRI). It is a component of an imaging system.
- No Specimen Analysis: The device does not analyze any specimens taken from the patient's body. It interacts with the patient's body externally to receive signals generated by the MRI system.
- Imaging Modality: MRI is an imaging modality, not a method of analyzing biological specimens.
The device is a component of an MRI system used for diagnostic imaging, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The carotid coil is a receive-only coil, used for high resolution imaging of the bifurcation of the carotid artery in 1.5T and 3T General Electric, Siemens and Philips Magnetic Resonance Imaging (MRI) systems. Nucleus Excited: Proton 1H
Anatomic regions: Carotid.
The Carotid Coil is used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
Carotid Coil is a phased array, receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. Semi-flexible design makes the coil reliable and comforts the patient.
The enclosure of all the carotid coils above is the same. The enclosure, which may contact the patient, is made up of biocompatible material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Carotid, bifurcation of the carotid artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained 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)
The submitted Carotid Coil has been proved to be safe and effective by performance tests, bio-compatibility tests and IEC60601-1 compliance tests.
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.
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
§ 892.1000 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
K1120.0.2
NOV 1 8 2011
- This document can be copied and submitted to interested parties as required by 21 CFR 807.92.
510(k) Summary of Safety and Effectiveness
Submitter: Shanghai Chenguang Medical Technologies Co., Ltd Building 8, Lane 1199, Jidi Road, Shanghai, P.R.C. 201107
Company Contact: Name: Meijuan Chen Telephone: +86-21-52961075-833 Fax: +86-21-52961075-826 E-mail: chenmeijuan@shanghaicg.net Date Summary Prepared: May 26, 2011
Reason for 510(K): New Device Classification Name: Magnetic Resonance Diagnostic Device Classification Panel: Radiology Classification Number: 892.1000 Product Code: MOS Common Name: Magnetic Resonance Imaging Coil Proprietary Name: Carotid Coil Establishment Registration Number: 3006239787 Regulatory Class: II
Predicate Devices (Legally Marketed Devices)
Carotid Coil, manufactured by Shanghai Chenguang Medical Technologies Co., Ltd.
510k number is K092962.
Device Description
Carotid Coil is a phased array, receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. Semi-flexible design makes the coil reliable and comforts the patient. The devices are as follows:
| Coil type | Part number | Compatible system | Field strength |
|---|---|---|---|
| Carotid Coil | 5000011501 or | ||
| 0200130101 | GE | 3T | |
| 5000011401 or | |||
| 0300190101 | Siemens | 3T | |
| 5000021901 or | |||
| 0100450201 | Philips | 1.5T | |
| 5000002201 or | |||
| 0200120201 | GE | 1.5T | |
| 5000022001 or | Siemens | 1.5T |
1
| of Children Concession Concession Concession Corporation of Children Company of | STATE AND THE FOR FREE FOR COLLECTION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION
0300190201 | ートーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Canada Canada Caracterial Concession | AND THE LEAST | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
The enclosure of all the carotid coils above is the same. The enclosure, which may contact the patient, is made up of biocompatible material.
Intended Use
The carotid coil is a receive-only coil, used for high resolution imaging of the bifurcation of the carotid artery in 1.5T and 3T General Electric, Siemens and Philips Magnetic Resonance Imaging (MRI) systems. Nucleus Excited: Proton 1H
Anatomic regions: Carotid.
Indications for Use:
The Carotid Coil is used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Comparison with Predicate Device:
Carotid Coil is similar to the Shanghai Chenguang Medical Technologies Co., Ltd. made predicate device in all aspects as follow:
Intended use- The carotid coil is a receive-only coil, used for high resolution imaging of the bifurcation of the carotid artery in 1.5T and 3T General Electric, Siemens and Philips Magnetic Resonance Imaging (MRI) systems. Anatomic regions: Carotid.
Indication for use- The Carotid Coil is used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Technical Characteristics-The MR system is an imaging device. The fundamental scientific technology of a radio frequency (RF) coil is that the coil receives radio frequency signals from the tissue of interest. It is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.
The fundamental scientific technology of the subject device is the same as the predicate device.
Suitable standards - UL 60601-1, ISO 10993-5 and ISO 10993-10.
2
Conclusions
The submitted Carotid Coil has been proved to be safe and effective by performance tests, bio-compatibility tests and IEC60601-1 compliance tests.
As stated above, Carotid Coil complies with the appropriate medical device standards and is substantially equivalent to the predicate device in safety and effectiveness based on similarities in design features, overall indications for use, and technological characteristics.
It is the opinion of Shanghai Chenguang Medical Technologies Co. LTD. that the Carotid Coils are substantially equivalent to Shanghai Chenguang Medical Technologies Co. LTD. made Carotid Coil (K092962). Testing and usage of the Carotid Coils do not result in any new potential hazards.
- End of Section -
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the left side of the emblem.
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
Mr. Meijuan Chen Regulatory Engineer Shanghai Chenguang Medical Technologies Co., LTD Building 8, Lane 1199, Jidi Road 201107 SHANGHAI CHINA
NOV 1 8 2011
Re: K112002
Trade/Device Name: Magnetic Resonance Diagnostic Device, Carotid Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 14, 2011 Received: November 14, 2011
Dear Mr. Chen:
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 (OS) 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,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Section 3
Indications for Use
510(k) Number (if known): _ K 11 200 2
Device Name: Magnetic Resonance Diagnostic Device, Carotid Coil
Indications for Use: The Carotid Coil is used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)
- End of Section -
| (Division Sign-Off) |
|---|
| Division of Radiological Devices |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
510K K1262