Who is the manufacturer of QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT?

Usa Instruments, Inc. filed the 510(k) submission for QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT (K041487).

What is the FDA product code for QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT?

MOS. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT?

510(k) clearance (submission type: Special).

What are the predicate devices for QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT?

Millennium 9000 Phased Array Neurovascular Coil (K001870); Excalibur 9000 TotalSENSE Quad Array Head Coil (K022582).

Who can help prepare an FDA 510(k) submission like QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT

K041487 · Usa Instruments, Inc. · MOS · Jun 17, 2004 · Radiology

Device Facts

Record ID	K041487
Device Name	QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
Applicant	Usa Instruments, Inc.
Product Code	MOS · Radiology
Decision Date	Jun 17, 2004
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

The QD Head Speeder with NV Speeder Attachment is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest in Magnetic Resonance Imaging Systems. The QD Head Speeder with NV Speeder Attachment is designed for use with the ExcelArt 1.5T MRI system manufactured by Toshiba Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.

Device Story

Multi-element phased array, receive-only RF coil; consists of main coil base, sliding head section, and removable anterior coil section. Used in MRI suites with Toshiba ExcelArt 1.5T systems. Operates by receiving MR signals from hydrogen nuclei; does not transmit RF power. Decoupling via switching diodes isolates elements during RF transmission. Rigid, fire-rated plastic housing; open design minimizes claustrophobia. Output is diagnostic MR images of head, neck, and upper chest. Used by radiologists/technicians to visualize soft tissue and vasculature; aids in clinical diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness supported by comparison to predicate devices and adherence to standard MRI coil design principles, including RF safety (decoupling) and material biocompatibility/flammability ratings.

Technological Characteristics

Receive-only phased array coil; switching diode decoupling. Materials: Flame-retardant Delrin-Acetal, Polyurethane, Vinyl Coated EVA Foam, Polycarbonate. Form factor: Multi-section (base, sliding head, removable anterior). Connectivity: Dedicated interface for Toshiba ExcelArt 1.5T MRI. Energy: Passive RF reception. No software algorithm.

Indications for Use

Indicated for patients requiring MRI of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest. Used with 1.5T MRI systems to produce images based on proton density, T1, and T2 parameters for diagnostic interpretation by a physician.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

Millennium 9000 Phased Array Neurovascular Coil (K001870)
Excalibur 9000 TotalSENSE Quad Array Head Coil (K022582)

Reference Devices

Spirit III TotalSENSE Cardiac Coil (K024187)

Related Devices

K042342 — MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL · Usa Instruments, Inc. · Sep 24, 2004
K022582 — EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL · Usa Instruments, Inc. · Oct 22, 2002
K083160 — 1.5T ATLAS SPEEDER HEAD-NECK COIL · Quality Electrodynamics · Nov 7, 2008
K083014 — ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A · Toshiba America Medical Systems, In.C · Oct 17, 2008
K052621 — 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL · Usa Instruments, Inc. · Oct 7, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ K04 1487 ## SUMMARY OF SAFETY AND EFFECTIVENESS | 1. Device Name : | Magnetic Resonance Imaging Accessory | QD Head Speeder with NV Speeder Attachment | 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 and vasculature of the head, neck, and upper chest. | -Similar to the Millennium 9000 Phased Array Neurovascular Coil manufactured by USA Instruments, Inc. (K001870) -Similar to the Excalibur 9000 TotalSENSE™ Quad Array Head Coil manufactured by USA Instruments, Inc. (K022582) | | 3. Classification : | Class II | Indications for Use: Identical to routine MRI imaging. | -Similar to the Millennium 9000 Phased Array Neurovascular Coil manufactured by USA Instruments, Inc. (K001870) -Similar to the Excalibur 9000 TotalSENSE™ Quad Array Head Coil manufactured by USA Instruments, Inc. (K022582) | | 4. Establishment Registration #: | 1529041 | Coil Enclosure Material: Flame-retardant Delrin-Acetal Flame-retardant Polyurethane Flame-retardant Vinyl Coated EVA Foam Flame-retardant Polycarbonate | -Similar to the Excalibur 9000 TotalSENSE™ Quad Array Head Coil manufactured by USA Instruments, Inc. (K022582) -Similar to the Excalibur 9000 TotalSENSE™ Quad Array Head Coil manufactured by USA Instruments, Inc. (K022582) -Similar to the Spirit III TotalSENSE™ Cardiac Coil manufactured by USA Instruments, Inc. (K024187) | | 5. Manufacture Facility Location: | USA Instruments, Inc., 1515 Danner Drive Aurora, Ohio 44202, USA Telephone: 330-562-1000; Fax: 330-562-1422. | Coil Design: Receive-only phased array coil. | -Similar to the Excalibur 9000 TotalSENSE™ Quad Array Head Coil manufactured by USA Instruments, Inc. (K022582) | | 6. Performance Standard: | No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act. | Decoupling: Switching diode decoupling. | -Similar to the Excalibur 9000 TotalSENSE™ Quad Array Head Coil manufactured by USA Instruments, Inc. (K022582) | | 7. Intended Use: | The QD Head Speeder with NV Speeder Attachment is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest in Magnetic Resonance Imaging Systems. The QD Head Speeder with NV Speeder Attachment is designed for use with the ExcelArt 1.5T MRI system manufactured by Toshiba Medical Systems, Inc. The indications for use are the same as for standard MR Imaging. | 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. | -Similar to the Excalibur 9000 TotalSENSE™ Quad Array Head Coil manufactured by USA Instruments, Inc. (K022582) | | 8. Device Description: | 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. | Radio Frequency Absorption: Coil is a receive only coil and does not transmit RF power. | -Similar to the Excalibur 9000 TotalSENSE™ Quad Array Head Coil manufactured by USA Instruments, Inc. (K022582) | | Formation of Resonant Loop: Decoupling isolates the coil elements from RF fields during RF transmission; length of cable and stiffness does not permit looping. | -Similar to the Excalibur 9000 TotalSENSE™ Quad Array Head Coil manufactured by USA Instruments, Inc. (K022582) | | | - 9. Safety and Effectiveness {1}------------------------------------------------ {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ | 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. (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use (Per 21 CFR 801.109) | <div style="text-align:left;">✓</div> | |------------------------------------------------------------------|---------------------------------------| | OR | | | Over-The-Counter Use (Optional Format 1-2-96) | | | (Division Sign-Off) | | | Division of Reproductive, Abdominal, and Radiological Devices | | | 510(k) Number | K04487 |