(79 days)
The Neurovascular Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest extending to the cardiac region in Magnetic Resonance Imaging Systems. The Millennium 5000 Neurovascular Coil is designed for use with the Altaire 0.7T MRI system manufactured by Hitachi Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Millennium 5000 Phased Array Neurovascular Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest. The Millennium 5000 Phased Array Neurovascular Coil is designed for use with the Altaire 0.7T scanner manufactured by Hitachi Medical Systems.
The indications for use are the same as for standard imaging:
The 0.7T 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 Millennium 5000 Phased Array Neurovascular Coil is a 4-element quadrature phased array, receive-only coil. The coil consists of three sections: a main coil base, an open designed head former, and a detachable chest plate. The split-top, three piece design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
This document is a 510(k) premarket notification for a medical device called the "Millennium 5000 Phased Array Neurovascular Coil." It describes the device and claims substantial equivalence to previously cleared devices, rather than presenting a study to prove performance against specific acceptance criteria.
Therefore, the requested information elements related to a study (like sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets, clinical outcomes, etc.) are not available in this document.
The document primarily focuses on demonstrating that the new device has similar characteristics and intended use to existing devices, which is the basis for a 510(k) clearance, not a clinical performance study with predefined acceptance criteria.
However, I can extract information regarding the device's intended use, description, and comparison to predicate devices, which serves as the "performance" relevant to a 510(k) submission.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating similarity to predicate devices, and the "reported device performance" is a description of its features and intended use, aligning with those of the predicates.
| Feature / "Acceptance Criteria" Met by Similarity | Reported Device Performance (as described in the 510(k)) |
|---|---|
| Intended Use (Safety and Effectiveness) | Imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. (Similar to Millennium 9000 Neurovascular Coil K001870 and Medrad PA Neurovascular Coil K984257) |
| Indications for Use (Safety and Effectiveness) | Identical to routine MRI imaging (The 0.7T MRI system is indicated for use as an NMR device that produces images that correspond to the distribution of protons exhibiting NMR signal, depend upon NMR parameters, and display soft tissue structure to yield diagnostic information when interpreted by a trained physician). (Similar to Millennium 9000 Neurovascular Coil K001870) |
| Coil Enclosure Material (Safety) | Polyurethane, Polycarbonate. (Similar to Magna 5000 PA CTL Spine Coil K994345 & K000002 and Millennium 9000 Neurovascular Coil K001870) |
| Coil Design (Safety and Effectiveness) | Receive-only phased array coil. 4-element quadrature phased array. (Similar to Millennium 9000 Neurovascular Coil K001870) |
| Decoupling (Safety) | Switching diode decoupling. Decoupling isolates the coil elements from RF fields during RF transmission. (Similar to Millennium 9000 Neurovascular Coil K001870) |
| Prevention of RF Burns (Safety) | 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. (Similar to Millennium 9000 Neurovascular Coil K001870) |
| Radio Frequency Absorption (Safety) | Coil is a receive only coil and does not transmit RF power. (Similar to Millennium 9000 Neurovascular Coil K001870) |
| Formation of Resonant Loop (Safety) | Decoupling isolates the coil elements from RF fields during RF transmission; length of cable and stiffness does not permit looping. (Similar to Millennium 9000 Neurovascular Coil K001870) |
| Compatibility (Device Functionality) | Designed for use with the Altaire 0.7T MRI system manufactured by Hitachi Medical Systems, Inc. |
Regarding the other requested points, they are not applicable or estimable from the provided document as it is a 510(k) submission based on substantial equivalence, not a clinical performance validation study:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This document does not describe a test set or clinical study data. It relies on comparison 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 (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. No ground truth establishment is described for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No adjudication method is described.
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 provided. This is a hardware device (MRI coil), not an AI-assisted diagnostic product. No MRMC study was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No ground truth is described.
8. The sample size for the training set
- Not applicable/Not provided. There is no "training set" as this is not an AI or software device that undergoes training.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No training set or ground truth for it is relevant to this submission.
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Koz 1141
JUN 2 7 2002
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Millennium 5000 Phased Array Neurovascular Coil |
| 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 Neurovascular Coil is a receive-only phasedarray RF coil, used for obtaining diagnostic imagesof the brain, cervical spine, soft tissues andvasculature of the head, neck and upper chestextending to the cardiac region in MagneticResonance Imaging Systems. The Millennium 5000Neurovascular Coil is designed for use with theAltaire 0.7T MRI system manufactured by HitachiMedical Systems, Inc. The indications for use arethe same as for standard MR Imaging. |
| 8. Device Description: | The Millennium 5000 Phased Array NeurovascularCoil is a 4-element quadrature phased array,receive-only coil. The coil consists of three sections:a main coil base, an open designed head former,and a detachable chest plate. The split-top, threepiece design minimizes claustrophobic effects andmaximizes patient comfort. The coil elements andaccessory electronics are enclosed in a rigid plastichousing, which is fire rated and has a high impactand tensile strength. |
Please turn over
USA Instruments, Inc.
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9. Safety and Effectiveness
| Millennium 5000 Phased ArrayNeurovascular Coil product features | Comparison to predicate device or other 510(k)cleared products |
|---|---|
| Intended Use: Imaging of the brain,cervical spine, soft tissues andvasculature of the head, neck, andupper chest | -Similar to the Millennium 9000 Neurovascular Coilmanufactured by USA Instruments, Inc. (K001870)-Similar to the Medrad PA Neurovascular Coilmanufactured by Medrad, Inc.(K984257) |
| Indications for Use: Identical to routineMRI imaging | -Similar to the Millennium 9000 Neurovascular Coilmanufactured by USA Instruments, Inc. (K001870) |
| Coil Enclosure Material:PolyurethanePolycarbonate | -Similar to the Magna 5000 PA CTL Spine Coilmanufactured by USA Instruments, Inc.(K994345& K000002)-Similar to the Millennium 9000 Neurovascular Coilmanufactured by USA Instruments, Inc. (K001870) |
| Coil Design: Receive-only phasedarray coil | -Similar to the Millennium 9000 Neurovascular Coilmanufactured by USA Instruments, Inc. (K001870) |
| Decoupling: Switching diodedecoupling | -Similar to the Millennium 9000 Neurovascular Coilmanufactured by USA Instruments, Inc. (K001870) |
| Prevention of RF Burns: Does nottransmit RF power; decoupling isolatesthe coil elements from RF fields duringRF transmission; coil elements andcircuitry are enclosed in a non-conductive housing. | -Similar to the Millennium 9000 Neurovascular Coilmanufactured by USA Instruments, Inc. (K001870) |
| Radio Frequency Absorption: Coil is areceive only coil and does not transmitRF power. | -Similar to the Millennium 9000 Neurovascular Coilmanufactured by USA Instruments, Inc. (K001870) |
| Formation of Resonant Loop:Decoupling isolates the coil elementsfrom RF fields during RF transmission;length of cable and stiffness does notpermit looping | -Similar to the Millennium 9000 Neurovascular Coilmanufactured by USA Instruments, Inc. (K001870) |
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with three curved lines above them, resembling a stylized wing or banner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2002
Re: K021141
Trade/Device Name: Millennium 5000 Phased Arrav Neurovascular Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: April 8, 2002 Received: April 9, 2002
Dear Ms. Shumaker:
Ms. Christie Shumaker
USA Instruments, Inc ·
AURORA OH 44202
1515 Danner Drive
OA and Regulatory Manager
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 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 this 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" (21 CFR Part 807.97). 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 yours.
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: Millennium 5000 Phased Array Neurovascular Coil
Indications for Use: The Millennium 5000 Phased Array Neurovascular Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest. The Millennium 5000 Phased Array Neurovascular Coil is designed for use with the Altaire 0.7T scanner manufactured by Hitachi Medical Systems.
Anatomic Regions: Soft tissues and vasculature of the head, neck and upper chest. Hydrogen Nuclei Excited:
The indications for use are the same as for standard imaging:
The 0.7T 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.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | ✓ (Per 21 CFR 801.109) |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K021141 |
|---|---|
| --------------- | --------- |
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.