(18 days)
Not Found
No
The summary describes a passive receive-only coil for MRI, with no mention of image processing, AI, ML, or any software functionality beyond image acquisition.
No
The device is described as a receive-only coil used for obtaining diagnostic images, which are then interpreted by a trained physician to assist in diagnosis. It does not provide therapy.
Yes
The device is described as assisting in obtaining "diagnostic images" and yielding "information that may assist in diagnosis" when interpreted by a trained physician. This indicates its role in the diagnostic process.
No
The device description explicitly states it consists of three physical parts (bottom part, knee part, foot part) and is a "receive-only coil," which are hardware components used in conjunction with an MRI scanner.
No, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states this device is a "receive-only coil" used in conjunction with an MRI scanner to obtain "diagnostic images" of anatomical sites (knee, foot, ankle, lower leg).
- Mechanism of Action: It works by receiving signals generated within the body during an MRI scan, not by analyzing samples taken from the body.
- Intended Use: The intended use is to provide images that, when interpreted by a physician, assist in diagnosis. This is a function of an imaging device, not an IVD.
The device is an accessory for an MRI system, which is an imaging modality used for diagnosis, but the coil itself is not an IVD.
N/A
Intended Use / Indications for Use
The Knee/Foot/Ankle Coil is a receive-only coil, used for obtaining diagnostic images of knee, foot, ankle and lower leg in conjunction with a PHILIPS 1.5T MRI scanner. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
90MOS
Device Description
The Knee/Foot/Ankle Coil consists of three parts, bottom part with a cable and a base plate, a knee part and a foot part. The combination of the bottom part and knee part forms a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of knee, foot, ankle and lower leg in magnetic resonance imaging systems. Combination of bottom part and foot part forms a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of foot and ankle. These images, when interpreted by a trained physician, vields information that may assist in diagnosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
knee, foot, ankle, lower leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / 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)
The primary performance of MRI coil including signal to noise ratio and uniformity of images are tested and compared with the predicate 473PH-64Quadrature lower extremity coil. The signal to noise ratio is same as or better than this predicate device and the uniformity is similar to this predicate device.
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
510(k) Summary
JUL 2 3 2007
Model: CG-KFC18-H150-AP
Section 4
510(k) Summary of Safety and Effectiveness
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1
* 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
Telephone: +86-21-54500777-801 Fax: +86-21-54500777-824 E-mail: stzhang@shanghaicg.net Company Contact: Songtao Zhang Date Summary Prepared: June. 7th, 2007
Device Name: Knee/Foot/Ankle Coil Applicability: Compatible with PHILIPS Intera+Achieva 1.5T System Reason for 510(K): New Device Classification Name: Magnetic Resonance Diagnostic Device Classification Panel: Radiology Classification Number: 892,1000 Product Code: 90MOS Common Name: Magnetic Resonance Imaging Coil Proprietary Name: Model CG-KFC18-H150-AP Knee/Foot/Ankle Coil Establishment Registration Number: 3006239787 Regulatory Class: II
Predicate Devices (Legally Marketed Devices)
The predicate devices for the Knee-Foot-Ankle coil 4ch 1.5T are the 473PH-64Quadrature lower extremity coil,with 510(k) number of K991724, Model 1300GE-64 - Pediatric Positioner with 510(k) number of K030317 and Model PHS-63 Pediatric Head and Spine Array Coil with 510(k) number of K003655.
Device Description
The Knee/Foot/Ankle Coil consists of three parts, bottom part with a cable and a base plate, a knee part and a foot part. The combination of the bottom part and knee part forms a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of knee, foot, ankle and lower leg in magnetic resonance imaging systems.
2
Combination of bottom part and foot part forms a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of foot and ankle. These images, when interpreted by a trained physician, vields information that may assist in diagnosis.
Intended Use
Diagnostic Uses: 2D,3D imaging, proton density, T1 and T2 weighted imaging. 2D,
3D time of flight, phase contrast imaging in conjunction with a PHILIPS 1.5T MRI scanner.
Anatomic regions: knee, foot ankle and lower leg
Comparison with Predicate Device:
The Knee/Foot/Ankle Coil has similar intended use with the predicate 473PH-64Quadrature lower extremity coil, Model 1300GE-64 - Pediatric Positioner and Model PHS-63 Pediatric Head and Spine Array Coil. They work in the similar principle, are compliant with the similar standards and are of the similar safety and effectiveness.
Summary of Performance Testing
The primary performance of MRI coil including signal to noise ratio and uniformity of images are tested and compared with the predicate 473PH-64Quadrature lower extremity coil. The signal to noise ratio is same as or better than this predicate device and the uniformity is similar to this predicate device.
Conclusions
As stated above, the Knee/Foot/Ankle Coil [Model CG-KFC18-H150-AP are safe and effective and comply with the appropriate medical device standards and are substantially equivalent to the predicate devices.
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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 three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter of the circle.
JUL 2 3 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Shanghai Chenguang Medical Technologies Co., Ltd. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K071847
Trade/Device Name: Magnetic Resonance Diagnostic Device, CG-KFC18-H150-AP. Knee/Foot/Ankle Coil Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 3, 2007
Received: July 5, 2007
Dear Mr. Job:
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 either class II (Special Controls) or class III (Premarket Approval), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/11 description: The image is a circular logo or seal. The central element is the acronym "FDA" in a bold, sans-serif font. Above the acronym, the years "1906-2006" are printed, indicating a centennial celebration. Below the acronym, the word "Centennial" is written in a cursive font, further emphasizing the anniversary. Three stars are aligned beneath the word "Centennial". The entire design is encircled by text, which appears to be part of the organization's name or a related slogan.
Protecting and Promoting Public Health
4
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 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | () | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _ 大 0 7 1 8 4 7
Device Name: Magnetic Resonance Diagnostic Device, CG-KFC18-H150-APD Knee/Foot/Ankle Coil
Indications for Use:
The Knee/Foot/Ankle Coil is a receive-only coil, used for obtaining diagnostic images of knee, foot, ankle and lower leg in conjunction with a PHILIPS 1.5T MRI scanner. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
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 Device Evaluation (ODE)
Page 1 of 1
Herbert Lewis
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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