(13 days)
The QD Head Speeder with NV Speeder Attachment is designed to provide Magnetic Resonance Images of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest. The QD Head Speeder with NV Speeder Attachment is designed for use with the ExcelArt 1.5 MRI system manufactured by Toshiba Medical Systems, Inc. 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.
The QD Head Speeder with NV Speeder Attachment is a multi-element phased array, receive-only coil. The coil consists of three sections: a main coil base, a sliding head section, and a removable anterior coil section. The open, patient friendly 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.
The provided text describes a Magnetic Resonance Imaging (MRI) Accessory, specifically the QD Head Speeder with NV Speeder Attachment. It is a receive-only phased array RF coil intended for obtaining diagnostic images of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest.
However, the document is a 510(k) Premarket Notification Summary for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a specific study proving those criteria are met for the newly introduced device via quantitative metrics.
Therefore, the requested information regarding detailed acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies is not available in the provided text.
The summary focuses on comparing the new device's design, intended use, and functionality to previously cleared predicate devices (e.g., Millennium 9000 Phased Array Neurovascular Coil and Excalibur 9000 TotalSENSE™ Quad Array Head Coil) to establish substantial equivalence. The "Safety and Effectiveness" section is mentioned, but its content is not provided in the extract.
The document implicitly "proves" the device meets acceptance criteria by demonstrating its substantial equivalence to already approved devices, which are presumed to have met their own safety and effectiveness criteria.
Summary of available information based on the provided text:
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantitative performance metrics for the new device. The implicit acceptance criterion is substantial equivalence to predicate devices regarding intended use, indications for use, and design features.
- Reported Device Performance: Not quantified. The performance is described in terms of its intended function (imaging the brain, cervical spine, etc.) and its design features (receive-only phased array, specific materials, decoupling mechanism, RF absorption characteristics). The document states "The indicators for use are the same as for standard imaging," implying its performance should be comparable to standard MRI.
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Sample size used for the test set and the data provenance: Not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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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, as this is an MRI coil, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is an MRI coil. Its performance is inherent to the image acquisition, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. The "ground truth" for an MRI coil's performance typically refers to its ability to produce diagnostic quality images, which would be assessed by radiologists. However, specific details are absent.
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The sample size for the training set: Not applicable, as this is hardware, not a machine learning model.
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How the ground truth for the training set was established: Not applicable.
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K04 1487
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory | QD Head Speeder with NV SpeederAttachment | Comparison to predicate device or other 510(k)cleared products |
|---|---|---|---|
| 2. Proprietary Name : | QD Head Speeder with NV Speeder Attachment | Intended Use: Imaging of the brain,cervical spine, and soft tissue andvasculature of the head, neck, andupper chest. | -Similar to the Millennium 9000 Phased ArrayNeurovascular Coil manufactured by USAInstruments, Inc. (K001870)-Similar to the Excalibur 9000 TotalSENSE™ QuadArray Head Coil manufactured by USAInstruments, Inc. (K022582) |
| 3. Classification : | Class II | Indications for Use: Identical to routineMRI imaging. | -Similar to the Millennium 9000 Phased ArrayNeurovascular Coil manufactured by USAInstruments, Inc. (K001870)-Similar to the Excalibur 9000 TotalSENSE™ QuadArray Head Coil manufactured by USAInstruments, Inc. (K022582) |
| 4. Establishment Registration #: | 1529041 | Coil Enclosure Material:Flame-retardant Delrin-AcetalFlame-retardant PolyurethaneFlame-retardant Vinyl Coated EVAFoamFlame-retardant Polycarbonate | -Similar to the Excalibur 9000 TotalSENSE™ QuadArray Head Coil manufactured by USAInstruments, Inc. (K022582)-Similar to the Excalibur 9000 TotalSENSE™ QuadArray Head Coil manufactured by USAInstruments, Inc. (K022582)-Similar to the Spirit III TotalSENSE™ Cardiac Coilmanufactured by USA Instruments, Inc. (K024187) |
| 5. Manufacture Facility Location: | USA Instruments, Inc.,1515 Danner DriveAurora, Ohio 44202, USATelephone: 330-562-1000; Fax: 330-562-1422. | Coil Design: Receive-only phasedarray coil. | -Similar to the Excalibur 9000 TotalSENSE™ QuadArray Head Coil manufactured by USAInstruments, Inc. (K022582) |
| 6. Performance Standard: | No applicable performance standards have beenissued under Section 514 of the Food, Drug andCosmetic Act. | Decoupling: Switching diodedecoupling. | -Similar to the Excalibur 9000 TotalSENSE™ QuadArray Head Coil manufactured by USAInstruments, Inc. (K022582) |
| 7. Intended Use: | The QD Head Speeder with NV SpeederAttachment is a receive-only phased array RF coil,used for obtaining diagnostic images of the brain,cervical spine, and soft tissue and vasculature ofthe head, neck, and upper chest in MagneticResonance Imaging Systems. The QD HeadSpeeder with NV Speeder Attachment is designedfor use with the ExcelArt 1.5T MRI systemmanufactured by Toshiba Medical Systems, Inc. Theindications for use are the same as for standard MRImaging. | 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 Excalibur 9000 TotalSENSE™ QuadArray Head Coil manufactured by USAInstruments, Inc. (K022582) |
| 8. Device Description: | The QD Head Speeder with NV SpeederAttachment is a multi-element phased array,receive-only coil. The coil consists of three sections:a main coil base, a sliding head section, and aremovable anterior coil section. The open, patientfriendly 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. | Radio Frequency Absorption: Coil is areceive only coil and does not transmitRF power. | -Similar to the Excalibur 9000 TotalSENSE™ QuadArray Head Coil manufactured by USAInstruments, Inc. (K022582) |
| 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 Excalibur 9000 TotalSENSE™ QuadArray Head Coil manufactured by USAInstruments, Inc. (K022582) |
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- Safety and Effectiveness
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Mr. James J. Wrenn Manager, QA and Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K041487 Trade/Device Name: QD Head Speeder with NV Speeder Attachment Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: June 2, 2004 Received: June 4, 2004
Dear Mr. Wrenn:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becally of the device is substantially equivalent (for the indications felerenced above and have actering marketed predicate devices marketed in interstate for use stated in the encrosary to regally to regally the Medical Device Amendments, or to commerce prof to May 20, 1976, the clordance with the provisions of the Federal Food, Drug, devices that have occh resulted in accere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, market the Bet include requirements for annual registration, listing of general controls provisions of tactice, 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 If your device is classince (soo abore) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and t may be subject to such additional commons, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oods of reants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri s issuality of our device complies with other requirements of the Act that I DA has made a decernmances that your is a ministered by other Federal agencies. You must comply of ally I ederal statures and regulations and but not limited to: registration and listing (21 CFR Part with an the Act 3 requirements, merculary of actice requirements as set forth in the 80 //, labeling (21 CFR Part 820); and if applicable, the electronic product quality systems (QU) regulation (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) I his letter will anow you to ocgin nationing of substantial equivalence of your device to a legally premaired notification. The FDA mailing of casification 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 If you desire specific advice for your done 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 Additionally, for questions on the pro-Other of Complanoo at (2017) 221 Part 807.97) you may obtain. Other general by receive to premarked notified in (er the Act may be obtained from the Division of Small mormation on your responsional 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. Brydon
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): | K041487 |
|---|---|
| --------------------------- | --------- |
Device Name: QD Head Speeder with NV Speeder Attachment
Indications for Use: The QD Head Speeder with NV Speeder Attachment is designed to provide Magnetic Resonance Images of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest. The QD Head Speeder with NV Speeder Attachment is designed for use with the ExcelArt 1.5 MRI system manufactured by Toshiba Medical Systems, Inc.
Anatomic Regions: brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest 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) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal,and Radiological Devices | |
| 510(k) Number | K04487 |
§ 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.