(74 days)
NotFound
No
The document describes a receive-only coil for an MRI system, focusing on hardware improvements (signal-to-noise, resolution, acquisition time) and does not mention any software or processing capabilities that would involve AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as an NMR device that produces images for diagnostic purposes, not for treating a disease or condition.
Yes
The "Intended Use" section states that the 1.5T Infinion system (which this coil is part of) produces images that, "When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis." This explicitly links the output of the system to diagnostic utility.
No
The device description clearly states the SENSE Body Coil is a physical component enclosed in a flexible housing with Velcro straps, indicating it is hardware.
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 SENSE Body Coil is a component of an MRI system. It is a receive-only coil used to improve the quality of images produced by the MRI machine.
- Intended Use: The intended use clearly states that the system produces images of the soft tissue structure of the head and whole body. These images are then interpreted by a trained physician to aid in diagnosis. This is an in vivo (within the living body) diagnostic process, not an in vitro process.
- No Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the patient's body to acquire imaging data.
Therefore, the SENSE Body Coil, as described, is a medical device used for in vivo diagnostic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SENSE Body Coil does not change the intended use of the Philips 1.5T Infinion system.
The 1.5T Infinion system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The SENSE Body Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Anatomic Regions: Abdominal, pelvic and thoracic.
Nuclei Excited: Hydrogen.
Product codes
MOS
Device Description
The SENSE Body Coil is enclosed in a flexible, water-resistant fabric housing and is secured to the patient with Velcro straps. This receive-only coil is designed to give improved signal-to-noise, image resolution and image acquisition time over that of the standard body coil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
NMR (Nuclear Magnetic Resonance)
Anatomical Site
Abdominal, pelvic and thoracic regions.
Indicated Patient Age Range
Not Found
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.
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K031095
JUN 2 0 2003
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
General Information 1.
| Classification: | Class II
Magnetic Resonance Imaging (MRI) Accessory |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) Coil |
| Proprietary Name: | SENSE Body Coil |
| Establishment Registration: | Philips Medical Systems
MR PMG Cleveland
595 Miner Road
Highland Heights, Ohio 44143
Contact: Duane C. Praschan
Phone Number: (440) 483-3000
FDA Owner Number: #1217116
FDA Registration Number: #1525965 |
| Performance Standards: | Not Applicable. |
2. Intended Uses
The SENSE Body Coil does not change the intended use of the Philips 1.5T Infinion system.
The 1.5T Infinion system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The SENSE Body Coil is indicated for use in the following anatomic regions and with the designated nuclei:
| Anatomic Regions: | Abdominal, pelvic and thoracic. |
|---|---|
| Nuclei Excited: | Hydrogen. |
| PHILIPS MEDICAL SYSTEMS | (SBC) | 4/2/03 | I - 1 |
|---|---|---|---|
| ------------------------- | ------- | -------- | ------- |
1
3. Device Description
The SENSE Body Coil is enclosed in a flexible, water-resistant fabric housing and is secured to the patient with Velcro straps. This receive-only coil is designed to give improved signal-to-noise, image resolution and image acquisition time over that of the standard body coil.
Safety and Effectiveness 4.
The Philips SENSE Body Coil is substantially equivalent to the Philips Phased Array Flexible Cardiac Coil (K984588) in safety and effectiveness. The following chart has been compiled to demonstrate this equivalence.
| Parameter | SENSE Body Coil | Predicate Device: Phased Array
Flexible Cardiac Coil (K984588) |
|-------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible MRI
Systems | Same. | Philips 1.5T Infinion Systems |
| Mode of Operation | Same. | Receive-Only |
| Antenna Configuration | Two anterior loops and
two posterior loops. | Co-rotating saddle coils and loops |
| Tuning/Impedance
Matching | Same. | Fixed tuning and matching. Factory
set. |
| Method of Decoupling | Same. | Active PIN diode decoupling |
| Coil Enclosure | Same. | Flame rated foam and fabric |
| Number of Receive
Channels | Same. | Four |
| Intended Use | Same. | The 1.5T Infinion system is intended
for use as a NMR device that
produces images that: (1) correspond
to the distribution of protons
exhibiting NMR, (2) depend upon
NMR parameters (proton density,
flow velocity, spin-lattice relaxation
time T1, spin-spin relaxation time
T2) and (3) display the soft tissue
structure of the head and whole body.
When interpreted by a trained
physician, these images yield
information that can be useful in the
determination of a diagnosis. |
2
| Parameter | SENSE Body Coil | Predicate Device: Phased Array
Flexible Cardiac Coil (K984588) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Flexible Cardiac Coil
is indicated for use in the
following anatomic
regions and with the
designated nuclei: | The Flexible Cardiac Coil is
indicated for use in the following
anatomic regions and with the
designated nuclei: |
| | Anatomic Regions:
Abdominal, pelvic and
thoracic regions.
Nuclei Excited: Hydrogen | Anatomic Regions: Heart and
associated structures in the thoracic
region.
Nuclei Excited: Hydrogen. |
.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, symbolizing strength and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" encircles the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2003
Mr. Duane C. Praschan Manager, Regulatory Affairs Philips Medical Systems (Cleveland) Inc. 595 Miner Road Cleveland OH 44143
Re: K031095 Trade/Device Name: SENSE Body Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic imaging Regulatory Class: II Product Code: 90 MOS Dated: April 4, 2003 Received: April 30, 2003
Dear Mr. Praschan:
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.
4
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 the 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" (21CFR Part 807.97) you may obtain. 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. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
SENSE Body Coil Device Name:
Indications for Use:
Intended Use
The SENSE Body Coil does not change the intended use of the Philips 1.5T Infinion system.
The 1.5T Infinion system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time TI, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Indications for Use
The SENSE Body Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Anatomic Regions: Abdominal, pelvic and thoracic regions
Hydrogen. Nuclei Excited:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Szyman
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)