(16 days)
Not Found
No
The summary describes a hardware component (a receive-only coil) for an MRI system and does not mention any software or algorithms that would utilize AI or ML for image processing or analysis.
No.
The device is used for obtaining diagnostic images and assists in diagnosis, but it does not directly treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" section states that the images obtained by the coil "when interpreted by a trained physician, yield information that may assist in diagnosis." This indicates its role in the diagnostic process.
No
The device description explicitly details physical components (phased-array receive-only coil, eight elements, upper and bottom parts, PC enclosure) and mentions hardware-related tests (performance and safety tests, bio-compatibility tests, IEC60601-1 compliance tests), indicating it is a hardware device.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pediatric Body-Cardiac Coil is a receive-only coil for Magnetic Resonance Imaging (MRI). It is used to acquire images of the body, not to analyze samples from the body.
- Intended Use: The intended use is to obtain diagnostic images of pediatric cardiac and body areas. These images are then interpreted by a physician. This is a function of an imaging device, not an IVD.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pediatric Cardiac Body Coil is a receive-only coil, used for obtaining diagnostic images of pediatric body and cardiac regions in magnetic resonance imaging systems. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Anatomic regions: Cardiac Body areas of a pediatric body.
The Pediatric Body-Cardiac Coil is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in Philips Achieva 3.0T magnetic resonance imaging systems. 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)
MOS
Device Description
The Pediatric Body-Cardiac Coil is a phased-array receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. It includes two parts (upper part and the bottom). The upper part can be easily taken down from the bottom. So the Pediatric Body-Cardiac Coil could be operated expediently. The enclosure is 3.5mm thick PC, which is UL 94V 0 rated and can withstand highest peak RF voltage up to 4200V and drop and impact.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic resonance imaging systems
Anatomical Site
Cardiac Body areas of a pediatric body.
Indicated Patient Age Range
pediatric
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 Pediatric Body-Cardiac Coil has been proved to be safe and effective by performance and safety tests, bio-compatibility tests and IEC60601-1 compliance tests.
As stated above, Pediatric Body-Cardiac Coil complies with the appropriate medical device standards and is substantially equivalent to the predicate device in safety and effectiveness.
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
JUL 28 2010
K10194/9
- 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
Address: Building 8, Lane 1199, Jidi Road, Shanghai, P.R.C. 201107
Company Contact: Jie Huang Telephone: +86-21-52961075-837 Fax: +86-21-52961075-826 E-mail: huangjie@shanghaicg.net Date Summary Prepared: Feb 2, 2010
2 : 1 :
1 1 1 1 1
Device Name: Pediatric Body-Cardiac Coil (Model: 5000012601) Applicability: Compatible with PHILIPS ACHIEVA 3.0T system 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: Pediatric Body-Cardiac Coil (Model: 5000012601) Establishment Registration Number: 3006239787 Regulatory Class: II
Predicate Device (Legally Marketed Device)
Pediatric Body-Cardiac Coil, manufactured by Shanghai Chenguang Medical Technologies Co., Ltd.
510k number is K081340.
Device Description
The Pediatric Body-Cardiac Coil is a phased-array receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. It includes two parts (upper part and the bottom). The upper part can be easily taken down from the bottom. So the Pediatric Body-Cardiac Coil could be operated expediently. The enclosure is 3.5mm thick PC, which is UL 94V 0 rated and can withstand highest peak RF voltage up to 4200V and drop and impact.
1
Intended Use
3 . . .
The Pediatric Cardiac Body Coil is a receive-only coil, used for obtaining diagnostic images of pediatric body and cardiac regions in magnetic resonance imaging systems. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Anatomic regions: Cardiac Body areas of a pediatric body.
Indications for Use
The Pediatric Body-Cardiac Coil is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in Philips Achieva 3.0T magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
Comparison with Predicate Device:
Pediatric Body-Cardiac Coil is identical to the predicate device. They have the similar intended use, work in the similar principle, are compliant with the similar standards and are of the similar safety. The difference is the applicable system. The predicate device is compatible with 1.5T system, while the submitted device is compatible with 3.0T system. The different applicable system will not result in big difference in their effectiveness. So the submitted Pediatric Body-Cardiac Coil does not result in any new potential hazards.
Conclusions
The submitted Pediatric Body-Cardiac Coil has been proved to be safe and effective by performance and safety tests, bio-compatibility tests and IEC60601-1 compliance tests.
As stated above, Pediatric Body-Cardiac Coil complies with the appropriate medical device standards and is substantially equivalent to the predicate device in safety and effectiveness.
- End of Section -
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle, represented by three curved lines that suggest the bird's wings and body.
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
Shanghai Chenguang Medical Technologies CO., Ltd. % Mr. Marc M. Mouser Manager & FDA Office Coordinator, Program Reviewer Underwriters Laboratories. Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542
IJUL 2 8 2010
Re: K101949
Trade/Device Name: Magnetic Resonance Diagnostic Device, Pediatric Body-Cardiac Coil (Model: 5000012601)
Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 24, 2010 Received: July 12, 2010
Dear Mr. Mouser:
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
3
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,
Arnold J. Roth
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
!JUL 2 8 2010
Section 3
Indications for Use
510(k) Number (if known):
12101949
Device Name: Magnetic Resonance Diagnostic Device, Pediatric Body-Cardiac Coil (Model: 5000012601)
Indications for Use: The Pediatric Body-Cardiac Coil is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in Philips Achieva 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Prescription Use V (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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 -
David W
fon Sion-Orn Division of Radiological De Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K