(37 days)
This document does not contain any Reference Devices (K/DEN numbers).
No
The summary describes a passive receive-only coil for MRI, with no mention of image processing, AI, or ML.
No
The device is described as a "receive-only coil, used for obtaining diagnostic images" in MRI systems, and its output "may assist in diagnosis," indicating a diagnostic rather than therapeutic purpose.
No
Explanation: The device is a receive-only coil used for obtaining diagnostic images. It does not interpret the images or provide a diagnosis itself. The images, once produced, are then interpreted by a trained physician to assist in diagnosis. Therefore, the device itself is not a diagnostic device, but rather a tool used in the diagnostic imaging process.
No
The device description explicitly details a physical coil with multiple channels and components designed for use with an MRI system, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Pediatric Head-Spine Coil is a component of an MRI system. Its function is to receive radiofrequency signals from the patient's body during an MRI scan to create diagnostic images. This process happens within the body (in vivo).
- Intended Use: The intended use is to obtain diagnostic images of the head and spine. These images are then interpreted by a physician. This is a form of medical imaging, not an in vitro test.
Therefore, the device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Pediatric Head-Spine Coil is a receive-only coil, used for obtaining diagnostic images of pediatric head and spine in magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
Anatomic regions: Head-Spine of a pediatric body.
Indications for Use:
The Pediatric Head-Spine Coil is a receive-only coil, used for obtaining diagnostic images of pediatric head and spine in magnetic resonance imaging systems. This coil is designed to be used in a Philips Achieva MRI 1.5T system. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Product codes
MOS
Device Description
The Model 0100140201 Pediatric Head and Spine Array Coil1.5T 8ch consists is a single unit with eight coils. Four coils are in the head area and four coils reside in the back portion of the device. This forms a 8-channel phased array, receive-only coil, used for obtaining diagnostic images of head and spine of a pediatric body in magnetic resonance imaging systems. Combination of back part and head part forms an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of the head and spine in magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding 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
Head-Spine 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)
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.
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JUN 18 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: Pediatric Head and Spine Array Coil1.5T 8ch Common Name: Pediatric Head and Spine Array Coil Classification Name: 892.1000 Magnetic Resonance Diagnostic Device Classification: Class II
Predicate Devices (Legally Marketed Devices)
A predicate device for the 0100140201 Pediatric Head Spine coil 1.5T is the PHS-63 Pediatric Head Spine Coil, manufactured by MRI Devices Corporation and cleared under K003655.
Device Description
The Model 0100140201 Pediatric Head and Spine Array Coil1.5T 8ch consists is a single unit with eight coils. Four coils are in the head area and four coils reside in the back portion of the device. This forms a 8-channel phased array, receive-only coil, used for obtaining diagnostic images of head and spine of a pediatric body in magnetic resonance imaging systems. Combination of back part and head part forms an 8-channel phased array, receive-only coil, used for Page 19 of 153
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obtaining diagnostic images of the head and spine in magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
Intended Use
The Pediatric Head-Spine Coil is a receive-only coil, used for obtaining diagnostic images of pediatric head and spine in magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
Anatomic regions: Head-Spine of a pediatric body.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 graphic of three overlapping human figures.
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: K081322
Trade Device Name: Magnetic Resonance Diagnostic Device, Model 0100140201. Pediatric Head-Spine 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.
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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 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" (21 CFR 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/cdrb/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
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INDICATIONS FOR USE
Indications for Use
510(k) Number (if known): ______________________________
Device Name:
Magnetic Resonance Diagnostic Device, Model 0100140201, Pediatric Head-Spine Coil
Indications for Use:
The Pediatric Head-Spine Coil is a receive-only coil, used for obtaining diagnostic images of pediatric head and spine in magnetic resonance imaging systems. This coil is designed to be used in a Philips Achieva MRI 1.5T system. These images, when interpreted by a trained physician, yield 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 ·
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
- End of Section -
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