(56 days)
No
The summary describes a hardware component (a body coil for an MRI system) and does not mention any software or algorithms that would utilize AI or ML for image processing, analysis, or diagnosis.
No
The device is described as a diagnostic device that produces images to assist in diagnosis, not for therapeutic purposes.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images..." and that these images "yield information that may assist in diagnosis."
No
The device description clearly states it is a "bird-cage type transmit/receive coil," which is a hardware component used in MRI systems.
No, 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 outside of the body (in vitro).
- Device Function: The Transmit/Receive Quadrature Body Coil 3.0T is a component of a Magnetic Resonance (MR) imaging system. It is used to generate and receive radiofrequency signals within the body to create images of internal structures. This is an in vivo (within the body) diagnostic method.
- Intended Use: The intended use clearly states that the device produces images of the internal structure of the whole body based on 'H metabolites. These images are then interpreted by a physician to assist in diagnosis. This is consistent with the function of an MR imaging system, not an IVD.
Therefore, based on the provided information, the Transmit/Receive Quadrature Body Coil 3.0T is a component of an in vivo diagnostic imaging system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The indication for use for the Transmit/Receive Quadrature Body Coil 3.0T expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis
Product codes
MOS, 90 MOS
Device Description
The Transmit Receive Quadrature Body Coil 3.0T is a bird-cage type transmit/receive coil designed for use in the Intera 3.0T system. In transmit mode the coil is used in almost every kind of scan. In receive mode the coil is mainly used for imaging with a large field of view. The QBC has a fixed position inside the gradient coil. The Transmit/Receive Quadrature Body Coil 3.0T permits the INTERA 3.0T system to be used as a whole body scanner. It was distributed as a head scanner only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
whole body
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 (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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KO1 3894
Philips Medical Systems PMG Magnetic Resonance XJR-148-4750/bf 2001-11-16
JAN 1 8 2002
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is being submitted in accordance with the requirements of 21 CFR 807.92.
General information
| Company Name | : Philips Medical Systems North America Company. |
|---|---|
| Address | : 22100 Bothell Everett Highway |
| P.O. Box 3003 | |
| Registration No. | : Bothell, WA 98041-3003 |
| Contact person | : Lynn Harmer |
| Device (Trade) Name | : Transmit/Receive Quadrature Body Coil 3.0T. |
| Classification Name | : Magnetic Resonance Diagnostic Device (MRDD). |
| Classification | : Class II. |
| Product code | : MOS |
| Performance standards | : NEMA voluntary standards, FDA MRDD guidance's, UL |
| and IEC 601 appropriate safety standards and/or draft | |
| standards are used. | |
| Common/Usual Name | : Transmit/Receive Quadrature Body Coil 3.0T |
Predicate Device(s):
The Transmit/Receive Quadrature Body Coll 3.0T is an extension to the MRDD Philips INTERA 3.0T System (re K003516). The Transmit/Receive Quadrature Body Coil 3.0T is equivalent to Quadrature Body Coil used with the INTERA 1.5T system.
Indications for use:
The indication for use for the Transmit/Receive Quadrature Body Coil 3.0T expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis
Device description:
The Transmit Receive Quadrature Body Coil 3.0T is a bird-cage type transmit/receive coil designed for use in the Intera 3.0T system. In transmit mode the coil is used in almost every kind of scan. In receive mode the coil is mainly used for imaging with a large field of view. The QBC has a fixed position inside the gradient coil .
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Page 2 of 2
General Safety and Effectiveness.
The safety of the INTERA 3.0T system with the Transmit/Receive Quadrature Body Coil 3.0T remain the same as with the FDA cleared INTERA 1.5T (re. K001796).The Transmit/Receive Quadrature Body Coil 3.0T permits the INTERA 3.0T system to be used as a whole body scanner. It was distributed as a head scanner only. The QBC 3.0T does not result in any new potential hazard.
Substantial Equivalence.
It is the opinion of Philips Medical Systems that the Transmit/Receive Quadrature Body Coil 3.0T is substantially equivalent to its predicate device quadrature body coil used in the INTERA 1.5T (re.K001796)
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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 is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JAN 1 8 2002
Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems 22100 Bothell Everett Highway BOTHELL WA 98021-8431
Re: K013894
Trade/Device Name: Transmit/Receive Quadrature Body Coil 3.0T System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 21, 2001 Received: November 23, 2001
Dear Ms. Harmer:
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 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.
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.
3
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
Page 1 of 1.
510(k) Number (if known):
Kol 3894
Device Name :
Transmit/Receive Quadrature Body Coil 3.0T
Indication For Use :
The indication for use for the Transmit/Receive Quadrature Body Coil 3.0T expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, vield information that may assist in diagnosis
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Nancy C. Burgdon
and Rac 510(k) Num