(58 days)
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.
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.
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.
The provided document is a 510(k) premarket notification for a Medical Resonance Imaging Accessory, specifically the Insight 7000 Phased Array Torso Coil. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's standalone efficacy or conducting extensive clinical trials as might be seen for novel technologies.
Therefore, the study conducted is primarily a comparison of the new device's parameters and performance characteristics against a predicate device to establish that it is "substantially equivalent" in terms of safety and effectiveness for its intended use.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy for a diagnostic algorithm). Instead, the "acceptance criteria" can be inferred as "same as predicate device" across various functional and safety parameters. The reported device performance is presented as the characteristics of the Insight 7000 Phased Array Torso Coil itself.
| Parameter | Acceptance Criteria (Inferred: "Same as Predicate") | Reported Device Performance (Insight 7000 Phased Array Torso Coil) |
|---|---|---|
| Intended Use | Torso Imaging including abdomen, chest, hips (Phased Array Body Coil, Esteem 1.5T MRI System Elscint MR (K962677)) | Torso Imaging including abdomen, chest, hips |
| Indications for Use | Identical to routine MRI imaging (Phased Array Body Coil, Esteem 1.5T MRI System Elscint MR (K962677)) | Identical to routine MRI imaging |
| 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)) | ABS Plastic, Naughahyde and Cordura Plus (fabric material) |
| Coil Design | Four coil receive-only phased array design (Phased Array Body Coil, Esteem 1.5T MRI System Elscint MR (K962677)) | Four coil receive-only phased array design |
| Decoupling | RF Chokes with Switching Diodes (Phased Array Body Coil, Esteem 1.5T MRI System Elscint MR (K962677)) | RF Chokes with Switching Diodes |
| 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)) | 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. |
| 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)) | Coil is a receive only coil and does not transmit RF power |
| 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)) | Decoupling isolates coil elements from RF fields during RF transmission. Length of cable and stiffness does not allow permit looping. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a specific 'test set' with patient data or images in the context of a clinical performance evaluation. The substantial equivalence is based on engineering design, material specifications, and fundamental operating principles when compared to the predicate device. Therefore, details like sample size, country of origin, or retrospective/prospective nature of data are not applicable in this 510(k) summary as no such clinical testing is described for performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no clinical test set requiring expert ground truth establishment is described in this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study (assessing human reader improvement with AI assistance) is not relevant for an MRI accessory like a coil, which is a hardware component and not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only) Performance Study was done
No, a standalone performance study in the context of an algorithm's performance was not done. The device is an MRI accessory (a coil), not a software algorithm.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" here is the established safety and performance characteristics of the predicate device, against which the new device's engineering and functional parameters are compared for substantial equivalence. There is no clinical "ground truth" (e.g., pathology, outcomes data) as this is not a diagnostic algorithm.
8. The Sample Size for the Training Set
Not applicable, as this is a hardware device (MRI coil), not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this is a hardware device.
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(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, USATelephone: 216-442-5920; Fax: 216-442-5919. |
| 6. Performance Standard: | No applicable performance standards have been issuedunder 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 diagnosticimages of the torso region (chest, abdomen and hipsanatomy) in Magnetic Resonance Imaging Systems. Theindications for use are the same as for standard MRImaging. The Insight 7000 Phased Array Torso Coil isdesigned for use with the Esteem 1.5T MRI scannermanufactured by Elscint MR. |
| 8. Device Description: | The Insight 7000 Phased Array Torso Coil is a four loopreceive-only coil. The coil consists of two sections: anupper and lower section, which are positioned aboveand below the patient torso respectively. The bottomsection, which contains two loop coils and the accessorycoil electronics, is enclosed in a vacuum formed housingwhich is covered with a foam pad. The housing and foampad is entirely covered by a cover made of Naughahydeand Cordura Plus® ( fabric material). The upper section,which contains two upper loop coils, is covered by ajacket made of identical materials as the bottom section. |
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9. Safety and Effectiveness
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| Parameter | Insight 7000 Phased ArrayTorso Coil | Same as Predicate Device |
|---|---|---|
| Intended Use | Torso Imaging includingabdomen, chest, hips | Phased Array Body Coil, Esteem 1.5T MRI SystemElscint MR(K962677) |
| Indications for Use | Identical to routine MRIimaging | Phased Array Body Coil, Esteem 1.5T MRI SystemElscint MR(K962677) |
| Coil Material | ABS Plastic,Naughahyde and Cordura Plus(fabric material) | Phased Array Body Coil, Esteem 1.5T MRI SystemElscint MR(K962677)General Purpose Flex CoilPicker International(K944469) |
| Coil Design | Four coil receive-only phasedarray design | Phased Array Body Coil, Esteem 1.5T MRI SystemElscint MR(K962677) |
| Decoupling | RF Chokes with SwitchingDiodes | Phased Array Body Coil, Esteem 1.5T MRI SystemElscint MR(K962677) |
| Prevention of RFBurns | Does not transmit RF PowerDecoupling isolates the coilelements from RF fields duringRF transmissionCoil elements and circuitryare enclosed in a non-conductive housing. | Phased Array Body Coil, Esteem 1.5T MRI SystemElscint MR(K962677) |
| Radio FrequencyAbsorption | Coil is a receive only coil anddoes not transmit RF power | Phased Array Body Coil, Esteem 1.5T MRI SystemElscint MR(K962677) |
| Formation of ResonantLoops | Decoupling isolates coilelements from RF fields duringRF transmission.Length of cable and stiffnessdoes not allow permit looping | Flexible Phased Array Spine CoilPicker 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
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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) |
§ 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.