(86 days)
The Insight Plus 9000 Phased Array Torso and Pelvis Coil is a receive only phased array RF coil, used for obtaining diagnostic images of the torso and pelvic regions, including the abdomen, chest, and hips, in Magnetic Resonance Imaging Systems. The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed for use with the Philips Infinion 1.5T MRI system manufactured by Philips Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed to provide Magnetic Resonance Images of the torso and pelvic regions, including the abdomen, chest, and hips. The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed for use with the Philips Intera 1.5T MRI scanner manufactured by Philips Medical Systems, Inc.
The 1.5T MRI 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 Plus 9000 Phased Array Torso and Pelvis Coil is an eight element receive only phased array coil. The coil elements and associated circuitry are enclosed in a semi-flexible housing, which is fire rated and has a high impact and tensile strength.
The provided text is a 510(k) summary for the "Insight Plus 9000 Phased Array Torso and Pelvis Coil," a Magnetic Resonance Imaging Accessory. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a performance study with detailed acceptance criteria and reported device performance metrics in the way that would typically be seen for a new algorithmic device or a device requiring a specific clinical outcome.
Therefore, the requested information, particularly regarding specific numerical acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not present in this document.
The document states that the device's acceptable performance is established through comparison to legally marketed predicate devices, meaning its capabilities are similar to existing devices that have already met safety and effectiveness standards.
Here's an analysis of the provided information in relation to your request:
1. Table of acceptance criteria and reported device performance
Not present in the document. The document establishes substantial equivalence by comparing the features and intended use of the new coil to predicate devices. It does not define specific performance metrics (e.g., signal-to-noise ratio, image quality scores) with corresponding acceptance criteria and then report the device's achievement of those criteria. Instead, it states the new device is "similar" for various features.
| Acceptance Criteria (Not Explicitly Stated as Numerical Criteria) | Reported Device Performance (as described in comparison to predicate) |
|---|---|
| Intended Use (Imaging of torso/pelvic regions, abdomen, chest, hips) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
| Indications for Use (Identical to routine MRI imaging) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
| Coil Enclosure Material (Flame Retardant Polyurethane, Vinyl Coated EVA Foam, Chlorinated Polyethylene Foam, Flame Retardant Polycarbonate) | Similar to the Mark 5000 Quadrature Shoulder coil (K013854) and Insight Plus 9000 Phased Array Torso and Pelvis Coil (K010730) |
| Coil Design (Receive-only phased array coil) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
| Decoupling (Switching diode decoupling) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
| Prevention of RF Burns (Does not transmit RF power, decoupling isolates coil elements, non-conductive housing) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
| Radio Frequency Absorption (Receive only, does not transmit RF power) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
| Formation of Resonant Loop (Decoupling isolates coil elements, cable length/stiffness prevents looping) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
2. Sample size used for the test set and the data provenance
Not applicable/Not present. This document does not describe a performance study with a test set of data in the context of an AI/ML device. The device is an MRI accessory (a coil), and its safety and effectiveness are established by demonstrating that its technical characteristics are substantially equivalent to existing, legally marketed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not present. As this is not a study requiring diagnostic accuracy assessment of images by experts, there is no mention of ground truth establishment by experts for a test set.
4. Adjudication method for the test set
Not applicable/Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable/Not present. This is not an AI/ML device, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not present. This is not an algorithmic device.
7. The type of ground truth used
Not applicable/Not present.
8. The sample size for the training set
Not applicable/Not present. This is not an AI/ML device, and no training set is mentioned.
9. How the ground truth for the training set was established
Not applicable/Not present.
In summary: The provided 510(k) summary (K023650) for the "Insight Plus 9000 Phased Array Torso and Pelvis Coil" demonstrates substantial equivalence to predicate devices based on its intended use, indications for use, materials, design, and safety features. It does not detail a performance study with specific numerical acceptance criteria, reported performance metrics, or data sets (test or training) in the manner expected for software or AI/ML devices. Therefore, most of the requested information is not available in this document.
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SUMMARY OF SAFETY AND EFFECTIVENESS
Ko23650
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Insight Plus 9000 Phased Array Torso and PelvisCoil |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc.1515 Danner DriveAurora, Ohio 44202, USATelephone: 330-562-1000; Fax: 330-562-1422. |
| 6. Performance Standard: | No applicable performance standards have beenissued under Section 514 of the Food, Drug andCosmetic Act. |
| 7. Intended Use: | The Insight Plus 9000 Phased Array Torso andPelvis Coil is a receive only phased array RF coil,used for obtaining diagnostic images of the torsoand pelvic regions, including the abdomen, chest,and hips, in Magnetic Resonance Imaging Systems.The Insight Plus 9000 Phased Array Torso andPelvis Coil is designed for use with the PhilipsInfinion 1.5T MRI system manufactured by PhilipsMedical Systems, Inc. The indications for use arethe same as for standard MR Imaging. |
| 8. Device Description: | The Insight Plus 9000 Phased Array Torso andPelvis Coil is an eight element receive only phasedarray coil. The coil elements and associatedcircuitry are enclosed in a semi-flexible housing,which is fire rated and has a high impact and tensilestrength. |
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9. Safety and Effectiveness
| Insight Plus 9000 Phased Array Torso andPelvis Coil Product Features | Comparison to predicate device or other 510(k)cleared products |
|---|---|
| Intended Use: Imaging of the torso andpelvic regions, including abdomen, chestand hips. | -Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209)-Similar to the Flow 7000 Peripheral Vascular Coilmanufactured by USA Instruments, Inc. (K010730) |
| Indications for Use: Identical to routineMRI imaging. | -Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209)-Similar to the Flow 7000 Peripheral Vascular Coilmanufactured by USA Instruments, Inc. (K010730) |
| Coil Enclosure Material:Flame Retardant PolyurethaneVinyl Coated EVA Foam | - Similar to the Mark 5000 Quadrature Shoulder coilmanufactured by USA Instruments, Inc. (K013854) |
| Chlorinated Polyethylene FoamFlame Retardant Polycarbonate | -Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil manufactured by USA Instruments, Inc.(K010730) |
| Coil Design: Receive-only phasedarraycoil. | -Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209)-Similar to the Flow 7000 Peripheral Vascular Coilmanufactured by USA Instruments, Inc. (K010730) |
| Decoupling: Switching diode decoupling. | -Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209)-Similar to the Flow 7000 Peripheral Vascular Coilmanufactured by USA Instruments, Inc. (K010730) |
| Prevention of RF Burns: Does not transmitRF power; decoupling isolates the coilelements from RF fields during RFtransmission; coil elements and circuitry areenclosed in a non-conductive housing. | -Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209)-Similar to the Flow 7000 Peripheral Vascular Coilmanufactured by USA Instruments, Inc. (K010730) |
| Radio Frequency Absorption: Coil is areceive only coil and does not transmit RFpower. | -Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209)-Similar to the Flow 7000 Peripheral Vascular Coilmanufactured by USA Instruments, Inc. (K010730) |
| Formation of Resonant Loop: Decouplingisolates the coil elements from RF fieldsduring RF transmission; length of cable andstiffness does not permit looping. | -Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209)-Similar to the Flow 7000 Peripheral Vascular Coilmanufactured by USA Instruments, Inc. (K010730) |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized emblem. The emblem consists of a symbol resembling a bird or an abstract human figure, composed of three curved lines, representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2003
Ms. Christie Shumaker Manager, OA and Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K023650
Trade/Device Name: Insight Plus 9000 Phased Array Torso and Pelvis Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 28, 2002 Received: October 30, 2002
Dear Ms. Shumaker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Insight Plus 9000 Phased Array Torso and Pelvis Coil
Indications for Use: The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed to provide Magnetic Resonance Images of the torso and pelvic regions, including the abdomen, chest, and hips. The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed for use with the Philips Intera 1.5T MRI scanner manufactured by Philips Medical Systems, Inc.
Anatomic Regions: Torso and pelvic regions, including the abdomen, chest, and hips. Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 1.5T MRI 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.
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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)
Nancy C. Srodon
Division of Reprodu and Radiological Devices 510(k) Number
§ 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.