(58 days)
No
The description focuses on the physical components and intended use of an RF coil for MRI, with no mention of AI or ML for image processing or analysis.
No.
The device is used for obtaining diagnostic images and yields information for diagnosis, not for treating a condition.
Yes
The device is used to obtain diagnostic images, and these images, when interpreted by a trained physician, "yield information that can be useful in the determination of a diagnosis."
No
The device description explicitly details physical components like "four loop receive-only coil," "two sections," "vacuum formed housing," "foam pad," and "cover made of Naughahyde and Cordura Plus® ( fabric material)," indicating it is a hardware device.
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 Insight 7000 Phased Array Torso Coil is a component of a Magnetic Resonance Imaging (MRI) system. It is a receive-only RF coil used to acquire signals from the patient's body during an MRI scan.
- Intended Use: The intended use is to obtain diagnostic images of the torso region. 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 Insight 7000 Phased Array Torso Coil is a medical device used for in vivo diagnostic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Insight 7000 Phased Array Torso Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the torso region (chest, abdomen and hips anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Insight 7000 Phased Array Torso Coil is designed for use with the Esteem 1.5T MRI scanner manufactured by Elscint MR.
The Insight 7000 Phased Array Torso Coil is designed to provide Magnetic Resonance Images of the torso region. The Insight 7000 Phased Array Torso Coil is designed for use with the Elscint MR's Esteem 1.5T scanner.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Insight 7000 Phased Array Torso Coil is a four loop receive-only coil. The coil consists of two sections: an upper and lower section, which are positioned above and below the patient torso respectively. The bottom section, which contains two loop coils and the accessory coil electronics, is enclosed in a vacuum formed housing which is covered with a foam pad. The housing and foam pad is entirely covered by a cover made of Naughahyde and Cordura Plus® (fabric material). The upper section, which contains two upper loop coils, is covered by a jacket made of identical materials as the bottom section.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
torso region (chest, abdomen and hips anatomy)
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
(972340
SUMMARY OF SAFETY AND EFFECTIVENESS
AUG 21 1007
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Insight 7000 Phased Array Torso Coil |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 675-B Alpha Drive, |
| Highland Heights, Ohio 44143, USA | |
| Telephone: 216-442-5920; Fax: 216-442-5919. | |
| 6. Performance Standard: | No applicable performance standards have been issued |
| under Section 514 of the Food, Drug and Cosmetic Act. | |
| 7. Intended Use: | The Insight 7000 Phased Array Torso Coil is a receive- |
| only phased array RF coil, used for obtaining diagnostic | |
| images of the torso region (chest, abdomen and hips | |
| anatomy) in Magnetic Resonance Imaging Systems. The | |
| indications for use are the same as for standard MR | |
| Imaging. The Insight 7000 Phased Array Torso Coil is | |
| designed for use with the Esteem 1.5T MRI scanner | |
| manufactured by Elscint MR. | |
| 8. Device Description: | The Insight 7000 Phased Array Torso Coil is a four loop |
| receive-only coil. The coil consists of two sections: an | |
| upper and lower section, which are positioned above | |
| and below the patient torso respectively. The bottom | |
| section, which contains two loop coils and the accessory | |
| coil electronics, is enclosed in a vacuum formed housing | |
| which is covered with a foam pad. The housing and foam | |
| pad is entirely covered by a cover made of Naughahyde | |
| and Cordura Plus® ( fabric material). The upper section, | |
| which contains two upper loop coils, is covered by a | |
| jacket made of identical materials as the bottom section. |
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9. Safety and Effectiveness
)
ﻧﻤﺴﺔ
| Parameter | Insight 7000 Phased Array
Torso Coil | Same as Predicate Device |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Torso Imaging including
abdomen, chest, hips | Phased Array Body Coil, Esteem 1.5T MRI System
Elscint MR
(K962677) |
| Indications for Use | Identical to routine MRI
imaging | Phased Array Body Coil, Esteem 1.5T MRI System
Elscint MR
(K962677) |
| Coil Material | ABS Plastic,
Naughahyde and Cordura Plus
(fabric material) | Phased Array Body Coil, Esteem 1.5T MRI System
Elscint MR
(K962677)
General Purpose Flex Coil
Picker International
(K944469) |
| Coil Design | Four coil receive-only phased
array design | Phased Array Body Coil, Esteem 1.5T MRI System
Elscint MR
(K962677) |
| Decoupling | RF Chokes with Switching
Diodes | Phased Array Body Coil, Esteem 1.5T MRI System
Elscint MR
(K962677) |
| Prevention of RF
Burns | Does not transmit RF Power
Decoupling isolates the coil
elements from RF fields during
RF transmission
Coil elements and circuitry
are enclosed in a non-
conductive housing. | Phased Array Body Coil, Esteem 1.5T MRI System
Elscint MR
(K962677) |
| Radio Frequency
Absorption | Coil is a receive only coil and
does not transmit RF power | Phased Array Body Coil, Esteem 1.5T MRI System
Elscint MR
(K962677) |
| Formation of Resonant
Loops | Decoupling isolates coil
elements from RF fields during
RF transmission.
Length of cable and stiffness
does not allow permit looping | Flexible Phased Array Spine Coil
Picker International
(K960497) |
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Image /page/2/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" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, which is a common symbol of the United States government. The logo is black and white.
Food and Drug Administration · 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 1997
Rony Thomas . . . . . . . . . . . Manager, Regulatory Affairs USA Instruments, Inc. 675-B Alpha Drive Highland Heights, Ohio 44143
Re:
K972340 Insight 7000 Phased Array Torso Coil Dated: May 6, 1997 Received: June 24, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Thomas:
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 (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 requirement, 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 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 (2) CFR Part 801 and additionally 809.10 for in vitn 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/odth/dsmamain.html".
Sincerely yours,
ht 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
3
Page 1 of 1
510(k) Number (if known): K472340
Device Name: Insight 7000 Phased Array Torso Coil
Indications for Use: The Insight 7000 Phased Array Torso Coil is designed to provide Magnetic Resonance Images of the torso region. The Insight 7000 Phased Array Torso Coil is designed for use with the Elscint MR's Esteem 1.5T scanner.
Anatomic Regions: Torso Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Esteem 1.5T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, 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.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, ENT, | ||
| and Radiological Devices | ||
| 510(k) Number | K972340 | |
| Prescription Use | ||
| (Per 21 CFR 801.109) | ||
| ✓ | OR | Over-The-Counter Use |
| (Optional Format 1-2-96) |