(46 days)
Not Found
No
The summary describes a hardware component (a cardiac coil) for an existing MRI system and focuses on its physical characteristics and improved signal acquisition. There is no mention of software algorithms, image processing, or any terms related to AI/ML.
No
The device is used to produce images for diagnostic purposes, not for treating a condition or disease.
Yes
The "Intended Use" states that the device produces images that, when interpreted by a trained physician, "yield information that can be useful in the determination of a diagnosis." This indicates its role in the diagnostic process.
No
The device description explicitly states it is a "Phased Array Flexible Cardiac Coil" enclosed in a "flexible, water-resistant fabric housing" and secured with "Velcro straps." This describes a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- Device Function: The Phased Array Flexible Cardiac Coil is a component of an MRI system. It is a receive-only coil used to improve the quality of images generated by the MRI system. It does not interact with or analyze biological specimens.
- Intended Use: The intended use is to produce images of the human body (specifically the heart and associated structures) using NMR principles. These images are then interpreted by a trained physician for diagnostic purposes. This is a function of an imaging device, not an IVD.
Therefore, the device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Intended Use: The Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T Edge Eclipse system. The 1.5T Edge Eclipse 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.
Indications for Use: The Phased Array Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Heart and associated structures in the thoracic region. Nuclei Excited: Hydrogen.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Picker Phased Array Flexible Cardiac 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
Magnetic Resonance Imaging (MRI)
Anatomical Site
Heart and associated structures in the thoracic region.
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): 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
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
K98 4588
General Information 1.
| Classification: | Class II
Magnetic Resonance Imaging (MRI) Accessory |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) Coil |
| Proprietary Name: | Phased Array Flexible Cardiac Coil |
| Establishment Registration: | Picker International, Inc.
World Headquarters
595 Miner Road
Highland Heights, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965 |
| Performance Standards: | Not Applicable. |
2. Intended Uses
The Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T Edge Eclipse system.
The 1.5T Edge Eclipse 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 Phased Array Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Heart and associated structures in the thoracic region. Anatomic Regions:
Nuclei Excited: Hydrogen.
【 - 【 12/23/98 PICKER INTERNATIONAL, INC. (CARDIAC)
1
Device Description 3.
The Picker Phased Array Flexible Cardiac 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 Picker Phased Array Cardiac Coil is substantially equivalent to the Picker Phased Array Flexible Body Coil (K962117) in safety and effectiveness. The following chart has been compiled to demonstrate this equivalence.
| Parameter | Phased Array Flexible
Cardiac Coil | Predicate Device: Phased Array
Flexible Body Coil (K962117) |
|-------------------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible MRI
Systems | Same. | Picker International 1.5T 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 EDGE 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. |
PICKER INTERNATIONAL, INC.
(CARDIAC)
2
| Parameter | Phased Array Flexible
Cardiac Coil | Predicate Device: Phased Array
Flexible Body Coil (K962117) |
|---------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei: | The Flexible Body Coil is indicated for use in the following anatomic regions and with the designated nuclei: |
| | Anatomic Regions: Heart and associated structures in the thoracic region. | Anatomic Regions: Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures. |
| | Nuclei Excited: Hydrogen | Nuclei Excited: Hydrogen. |
・
.
(CARDIAC)
I - 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 FEB
Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, OH 44143 Re:
K984588 Phased Array Flexible Cardiac Coil Dated: December 23, 1998 Received: December 24, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Dr. Keeler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
R. I. R. U.S.I. M.P.
Capt. Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known):
Phased Array Flexible Cardiac Coil Device Name:
Indications for Use:
Intended Use
The Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T EDGE ECLIPSE system.
The 1.5T EDGE ECLIPSE 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.
Indications for Use
The Phased Array Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Anatomic Regions: Heart and associated structures in the thoracic region.
Nuclei Excited: Hydrogen.
(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)