(36 days)
No
The summary describes a receive-only coil for MRI and does not mention any software or processing capabilities that would utilize AI or ML.
No
The device is described as a receive-only coil used for obtaining diagnostic images to assist in diagnosis, not for therapeutic purposes.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the images obtained "may assist in diagnosis." The "Device Description" also reiterates that the images "yield information that may assist in diagnosis."
No
The device description explicitly states it is a "receive-only coil" consisting of physical parts (bottom part with a cable and a base plate), which are hardware components.
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 a receive-only coil used in a Magnetic Resonance Imaging (MRI) system. Its purpose is to obtain diagnostic images of a pediatric patient's cardiac and body areas.
- Mechanism of Action: MRI is an imaging modality that uses magnetic fields and radio waves to create images of the inside of the body. It does not involve testing samples taken from the body.
- Intended Use: The intended use is to obtain images that, when interpreted by a physician, assist in diagnosis. This is a characteristic of medical imaging devices, not IVDs.
In summary, this device is a component of a medical imaging system used for non-invasive imaging of the body, which is distinct from the in vitro testing performed by IVDs.
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 1.5T magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
Product codes
MOS
Device Description
The Model 010040201-AP Body Cardiac ArrayCoil1.5T 8ch consists of two parts, bottom part with a cable and a base plate. Bottom part forms an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of body and cardiac of a pediatric body in magnetic resonance imaging systems. Bottom part forms an 8channel phased array, receive-only coil, used for obtaining diagnostic images of the cardiac -body area of a pediatric patient in magnetic resonance imaging systems. These images when interpreted by a trained physician, yield 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
Body and Cardiac regions of a pediatric body/patient
Indicated Patient Age Range
Pediatric
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
KOSI3YO
JUN 1 8 2008
- 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: International Regulatory Consultants
For: 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: April 5, 2008
Device Name
Trade Name: Body Cardiac ArrayCoil1.5T 8ch Common Name: Body Cardiac Coil Classification Name: 892.1000 Magnetic Resonance Diagnostic Devices Classification: Class II
Predicate Devices (Legally Marketed Devices)
A predicate device for the 0100040201-AP Pediatric Cardiac Body coil 1.5T is the Echelon MR-RCC-150 Coil, manufactured by Hitachi and cleared under K063513 and also the Model PHS-63 Pediatric Head Spine Array Coil, manufactured by MRI Devices.
Device Description
The Model 0100040201-AP Body Cardiac ArrayCoil1.5T 8ch consists of two parts, bottom part with a cable and a base plate. Bottom part forms an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of body and cardiac of a pediatric body in magnetic resonance imaging systems. Bottom part forms an 8channel phased array, receive-only coil, used for obtaining diagnostic images of the Page 17 of 132
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cardiac -body area of a pediatric patient in magnetic resonance imaging systems. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Intended 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.
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" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 2008
Shanghai Chenguang Medical Technologies % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K081340
Trade/Device Name: Magnetic Resonance Diagnostic Device, Model 010040201, Pediatric Body-Cardic Coil
Regulation Number: 21 CFR 892,1000
Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II
Product Code: MOS
Dated: June 2, 2008
Received: June 3, 2008
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 (PMA), 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.
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) prematket 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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy 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): ____________________________________________________________________________________________________________________________________________________
Device Name: Magnetic Resonance Diagnostic Device, Model 0100040201 , Pediatric Body-Cardiac Coil
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 1.5T magnetic resonance imaging systems. 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
- End of Section -
Aogn MWhay
(Division Sidn-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __