(9 days)
No
The summary describes a passive MRI coil and does not mention any AI/ML components or image processing capabilities beyond basic signal reception.
No
The device is described as an accessory for MRI scanners to produce diagnostic images, not to provide therapy.
Yes
Explanation: The device is described as being used for "obtaining diagnostic images" and the images, "when interpreted by a trained physician, yields information that may assist in diagnosis." This explicitly states its role in the diagnostic process.
No
The device description explicitly states it is a "4-channel phased array, receive-only coil" with "elements and associated circuitry... enclosed in a rigid fire rated housing," indicating it is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The description clearly states that this device is a coil used in conjunction with an MRI scanner to produce images of the wrist, hand, and elbow. This is an imaging device that works on the patient's body to create visual representations of internal structures.
- Intended Use: The intended use is to produce images that, when interpreted by a physician, may assist in diagnosis. This is a diagnostic imaging function, not an in vitro test.
The device is an accessory for a medical imaging system (MRI) and is used for diagnostic imaging, which is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
The coil is intended to be used in conjunction with a PHILIPS 1.5T MRI scanner as an accessory to produce images of the wrist, hand and elbow.
Product codes
90MOS, MOS
Device Description
The Wrist Hand Coil 1.5T 4ch is a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of wrist, hand and elbow in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yields information that may assist in diagnosis. The elements and associated circuitry of the coil are enclosed in a rigid fire rated housing. The sensitive region of the coil offers an approximate 220x117x83 mm3 field of view. With two opening in the coil, patients can bend their wrists at different angles in scanning process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
wrist, hand and elbow
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
The SNR is slightly higher for the predicate Model HRW-63-INT Wrist Array coil, as this predicate coil is somewhat smaller. The Field of View of the submitted Wrist Hand Coil 1.5T 4ch is a considerable amount larger than this predicate coil. The uniformity of the coil is good, same as this predicate coil, but over a larger Field of View.
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.
0
Image /page/0/Picture/0 description: The image shows the text "K071882" in a handwritten style on the top line. Below that, the text "JUL 1 8 2007" is printed in a simple font. The text appears to be part of a document or label, possibly indicating a date or identification number. The overall impression is that of a record or document with both handwritten and printed elements.
- 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: +86-21-54902488 Fax: +86-21-54263330 E-mail: stzhang@shanghaicg.net Company Contact: Songtao Zhang Date Summary Prepared: 9th of June, 2007
Device Name: Model CG-WHC18-H150-AP Wrist Hand Coil 1.5T 4ch 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-WHC18-H150-AP Wrist Hand Coil 1.5T 4ch Establishment Registration Number: 3006239787 Regulatory Class: II
Predicate Devices (Legally Marketed Devices)
The predicate devices for the Wrist Hand Coil 1.5T 4ch are the Model HRW-63-NT Wrist Array coil, submitted as K022588 and Model EXS-63 Small Extremity Array Coil, submitted as K020036. Both the predicate coils are from MRI Devices Corporation.
Device Description
The Wrist Hand Coil 1.5T 4ch is a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of wrist, hand and elbow in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yields information that may assist in diagnosis. The elements and associated circuitry of the coil are
1
enclosed in a rigid fire rated housing. The sensitive region of the coil offers an approximate 220x117x83 mm3 field of view. With two opening in the coil, patients can bend their wrists at different angles in scanning process.
Intended Use
The coil is intended to be used in conjunction with a PHILIPS 1.5T MRI scanner as an accessory to produce images of the wrist, hand and elbow.
Summary of Technical Characteristics of the Device Compared to the Predicate Devices (Legally Marketed Devices)
The submitted Wrist Hand Coil 1.5T 4ch and the two predicate devices have the similar intended use, work in the similar principle, are compliant with the similar standards and are of the similar safety and effectiveness.
Summary of Performance Testing
The SNR is slightly higher for the predicate Model HRW-63-INT Wrist Array coil, as this predicate coil is somewhat smaller. The Field of View of the submitted Wrist Hand Coil 1.5T 4ch is a considerable amount larger than this predicate coil. The uniformity of the coil is good, same as this predicate coil, but over a larger Field of View.
Conclusions
As stated above, the Wrist Hand Coil 1.5T 4ch , Model CG-WHC18-H150-AP are
safe and effective and comply with the appropriate medical device standards and are substantially equivalent to the predicate devices.
- End of Section -
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 1 8 2007
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: K071882
Trade/Device Name: Model CG-WHC18-H150-AP Wrist Hand Coil 1.5T 4ch Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 7, 2007 Received: July 9, 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 Tood. 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/2/Picture/10 description: The image shows a circular logo with the letters "FDA" in the center. The logo also includes the words "Centennial" and "1906-2006". The logo is surrounded by text that reads "Protecting and Promoting Public Health". The image is a black and white image.
3
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 21 CFR 884.xxxx 21 CFR 892.xxxxx Other
(Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0115 (Radiology); 240-276-0120 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
4
Indications for Use
510(k) Number (if known): ریب 1882
Device Name: Model CG-WHC18-H150-AP Wrist Hand Coil 1.5T 4ch
Indications for Use:
The coil is intended to be used in conjunction with a PHILIPS 1.5T MRI scanner as an accessory to produce images of the wrist, hand and elbow.
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
- End of Section -
Helin Resum
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 13 of 28