(57 days)
No
The summary describes a receive-only coil for an NMR system and does not mention any AI/ML capabilities or image processing beyond standard NMR image generation.
No
The device is described as an imaging system used to produce images that aid in diagnosis, not to treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device 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 indicates a diagnostic purpose.
No
The device description explicitly states it is a "Large Phased Array Neck Coil," which is a hardware component used in NMR imaging. The summary focuses on the physical characteristics and function of this coil, not on software.
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 Picker Outlook system and the Large Phased Array Neck Coil are described as an NMR (Nuclear Magnetic Resonance) device that produces images of the body's internal structures. This is an in vivo imaging technique, meaning it is performed on a living organism.
- Intended Use: The intended use is to produce images that provide information useful in the determination of a diagnosis when interpreted by a trained physician. This is consistent with medical imaging devices, not IVDs.
Therefore, the device described is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Picker Outlook 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 the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and 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 Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region.
Product codes
90 MOS
Device Description
The Large Phased Array Neck Coil is a receive-only coil for the 0.23T Outlook system, and is optimized to image the cervical spine. The sensitive region of the coil covers the base of the cerebellum to the third thoracic vertebra for greater than 98% of patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Neck, from the cerebellum to the upper thoracic spine 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)
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
JUL 3 / 1998
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: | Outlook Large Phased Array Neck 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 |
Intended Uses 2.
The Picker Outlook 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 the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and 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 Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region.
| Anatomic Regions: | Neck |
|---|---|
| Nuclei Excited: | Hydrogen |
3. Device Description
The Large Phased Array Neck Coil is a receive-only coil for the 0.23T Outlook system, and is optimized to image the cervical spine. The sensitive region of the coil covers the base of the cerebellum to the third thoracic vertebra for greater than 98% of patients.
| PICKER INTERNATIONAL, INC. | (LNECK) | 5/22/98 | I - |
|---|---|---|---|
| ---------------------------- | --------- | --------- | ----- |
1
Safety and Effectiveness 4.
୍କ ଦି
The Picker Large Phased Array Neck Coil is substantially equivalent in safety and effectiveness to the USA Instruments (USAI) Quadrature Volume Neck Coil and the Picker Phased Array Neck Coil. The following chart has been compiled to demonstrate the substantial equivalence of these devices.
| Parameter | Large Phased Array
Neck Coil | Predicate Device
Picker - Outlook Neck Coil (K964678)
USAI - Profile 7000 Neck Coil (K964531) |
|--------------------------------|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatibility | Picker 0.23T Outlook system | Hitachi 1.5T MRH-1500 system
(See K964531) |
| Enclosure Material | Same. | Royalite R59 ABS/PVC alloy
(See K964531) |
| Coil Design | Two-channel receive-only
phased array coil. | Two-channel receive-only quadrature coil
(See K964531). |
| Decoupling | Same. | Switching Diode decoupling.
(See K964531) |
| Formation of Resonant
Loops | Same. | Length of cable and stiffness does not
permit looping (See K964531 or K964678) |
| Potential for RF burns | Same. | Limited by the following:
- Does not transmit RF power
- Coil elements and circuitry encased in
non-conductive material. - Decoupling isolates the coil elements
from transmitted RF.
(See K964531 or K964678) |
| Radio Frequency
Absorption | Same. | Coil is receive-only and does not transmit
RF power. Power deposition during
imaging is limited by the system SAR
algorithm. (See K964531 or K964678) |
| Tuning Scheme | Same. | Automatically tuned for each patient.
(See K964678) |
(LNECK)
5/22/98
I - 2
2
| Parameter | Large Phased Array
Neck Coil | Predicate Device
Picker - Outlook Neck Coil (K964678)
USAI - Profile 7000 Neck Coil (K964531) |
|---------------------|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Same. | The Phased Array Neck Coil is indicated for
use in providing coverage of the neck, from
the cerebellum to the upper thoracic spine
region.
Anatomic Regions: Neck
Nuclei Excited: Hydrogen
(See K964678) |
| Intended Use | Same. | The Picker Outlook 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
the NMR parameters (proton density, flow
velocity, spin-lattice relaxation time (T1),
and 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.
(See K964678) |
PICKER INTERNATIONAL, INC.
ﻤﺴﺘﺸﻔﻪ
(LNECK)
:
11:40 PM IST
5/22/98
I - 3
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 31 1000
Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Cleveland, OH 44143
Re:
K981959 Outlook Large Phased Array Neck Coil Dated: June 2, 1998 Received: June 4, 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 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). 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 (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 (OS) 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 vito 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/dsmaldsmamain.html".
Sincerely yours,
William Yn
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K981959
Large Phased Array Neck Coil Device Name:
Indications for Use:
The Picker Outlook 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 the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and 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 Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region.
Anatomic Regions: Neck Nuclei Excited: Hydrogen
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
William
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K981959
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)