(154 days)
No
The summary describes a physical coil for MR imaging and does not mention any software or algorithms that would incorporate AI or ML.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a spine coil for MR imaging, and its intended use is for diagnostic imaging, not therapeutic treatment.
No
The device is a coil for an MR imaging system used to acquire images of the spine, not to interpret or diagnose from those images. Its intended use is the same as for standard MR imaging, which is an imaging modality.
No
The device description explicitly details physical hardware components (solenoid, saddle coil element, flexible vinyl enclosure) and their function in patient positioning, indicating it is a hardware device, not software-only.
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 description clearly states that the Flexible Phased Array Spine Coil is a component used with an MR Imaging System to acquire images of the spine. It is a physical coil that interacts with the patient's body during the imaging process.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on substances taken from the body. Its purpose is to facilitate the acquisition of images.
Therefore, the Flexible Phased Array Spine Coil falls under the category of a medical device used for imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Flexible Phased Array Spine Coil is designed to provide coverage of the thoracic and lumbar spinal regions of the body. The indications for use are the same as for standard MR imaging.
Product codes
Not Found
Device Description
The Flexible Phased Array Spine Coil is a phased array coil package consisting of a solenoid and a saddle coil element. All elements and associated circuitry are enclosed in a flexible vinyl enclosure.
The patient is wrapped with the coil allowing for ease of patient positioning. The coil has a fixed circumference and attaches by snapping the ends together.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR Imaging
Anatomical Site
thoracic and lumbar spinal regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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): 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.
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
The - 5 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
1. General Information
Classification:
Class II Magnetic Resonance (MR) Imaging System
MRI Receive-Only Coil Common/Usual Name:
Proprietary Name:
Flexible Phased Array Spine Coil
Establishment Registration:
Manufacturer: Picker Nordstar, Inc. P.O. Box 33 FIN-0051 Helsinki, FINLAND Phone: +358-0-394 127 +358-0-146 2811 Fax: FDA Facility Registration #9680194
United States Representative: Picker International, Inc. 595 Miner Road Cleveland, OH 44143 FDA Owner Number: #1580240
Performance Standards
No applicable performance standards have been used under section 514 of the Food. Drug and Cosmetic Act.
2. Intended Uses
The Flexible Phased Array Spine Coil is designed to provide coverage of the thoracic and lumbar spinal regions of the body. The indications for use are the same as for standard MR imaging.
3. Device Description
The Flexible Phased Array Spine Coil is a phased array coil package consisting of a solenoid and a saddle coil element. All elements and associated circuitry are enclosed in a flexible vinyl enclosure.
The patient is wrapped with the coil allowing for ease of patient positioning. The coil has a fixed circumference and attaches by snapping the ends together.
PICKER INTERNATIONAL, INC. (FPASC) I-1 (2/1/96)
1
4. Safety and Effectiveness
SUBSTANTIAL EQUIVALENCE CHART
| PARAMETER | FLEXIBLE SPINE COIL | PREDICATE |
|---|---|---|
| Coil Enclosure Material | Vinyl fabric | Same as material uses in Picker |
| Extended Coverage Head Coil | ||
| (K893619) | ||
| Coil Design | Two-channel receive-only | |
| phased array coil | Outlook Body Coil is a receive- | |
| only phased array coil | ||
| (K945827) | ||
| Decoupling | Active PIN diode decoupling | Same as Body Coil for Outlook |
| (K945827) | ||
| Formation of Resonant | ||
| Loops | The length of the cable and its | |
| stiffness does not permit | ||
| looping. | N/A | |
| Potential for RF burns | Does not transmit RF power. | |
| Coil elements and associated | ||
| circuitry encased in non- | ||
| conductive material. | ||
| Decoupling isolates the coil | ||
| elements from transmitted RF. | Same as other Outlook Coils | |
| (K945827) | ||
| Radio Frequency | ||
| Absorption | Power deposition during | |
| imaging is limited by the SAR | ||
| algorithm. | Algorithm used on Outlook | |
| system (K945827) | ||
| Intended Use | Thoracic and Lumbar spine | |
| regions. | Body Coil for Outlook | |
| (K945827) | ||
| Indications for Use | Same as for standard MR | |
| imaging. | Body Coil for Outlook | |
| (K945827) |
PICKER INTERNATIONAL, INC.
(FPASC) (2/1/96) I-2