(11 days)
The TEM 3000 head coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM 3000 head coil is compatible with the 3T Magnetom Trio MR scanner manufactured by Siemens Medical Systems.
The TEM 3000 Head Coil is a 15-element quadrature transmit/receive coil. The coil elements and associated circuitry are enclosed in a rigid housing to prevent any exposure to patient or environment. The coil housing employs a large open viewing window on the top. The coil design facilitates the scanning of patients with different window on the top: "Ifizes patient comfort and ease of use. Included with the coil housing is a Head Support/Coil Base. It allows the coil to be slid back for better patient access.
The provided text describes a 510(k) premarket notification for the TEM 3000 Head Coil and does not contain information about acceptance criteria or a study proving the device meets them. The document is from 2004 and is a regulatory submission for a medical device rather than a scientific study report.
Therefore, most of the requested information cannot be extracted from this document, specifically:
- 1. A table of acceptance criteria and the reported device performance: Not available. The document is a regulatory filing, not a performance study report.
- 2. Sample sized used for the test set and the data provenance: Not available. No "test set" in the context of a performance study is mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- 4. Adjudication method: Not available.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not indicated.
- 6. If a standalone was done: Not indicated.
- 7. The type of ground truth used: Not available.
- 8. The sample size for the training set: Not available.
- 9. How the ground truth for the training set was established: Not available.
What the document does indicate:
The document describes the TEM 3000 Head Coil as a 15-element quadrature transmit/receive coil intended for 'H high-resolution whole-head adult and pediatric imaging, including functional MRI, spectroscopy, and angiography. It is compatible with the Siemens 3T Magnetom Trio MR System.
The submission focuses on establishing substantial equivalence to a predicate device, the Magnetom Trio Head Coil (K021330), based on similar construction and operation, despite using TEM technology instead of "Birdcage" technology. Substantial equivalence in this context means the new device is as safe and effective as a legally marketed device. This is a regulatory pathway, not a clinical performance study with acceptance criteria as typically understood in a scientific evaluation.
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APR 2 3 2004
Image /page/0/Picture/2 description: The image shows the logo for MR Instruments Inc. The logo consists of the letters "mrii" in a stylized font, with the "o" in "mrii" filled with a textured pattern. Below the letters, the words "MR INSTRUMENTS INC" are printed in a simple, sans-serif font.
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
- MR Instruments, Inc. 1. Submitter's Name:
- 4802 Park Glen Road 2. Address: Minneapolis, MN 55416
-
- Telephone: 952.746.1435
- Gene Berghoff 4. Contact Person:
-
- Date Prepared: April 7, 2004
-
- Registration Number: Pending
B. Device
- TEM 3000 Head Coil 1. Name: TEM 3000 Head Coil 2. Trade Name: Common Name: Head Coil 3. Classification Name: Magnetic Resonance Diagnostic Device 4. 5. Product Code: 90MOS 6. Class: II 892.1000 7. Regulation Number:
SCO4
RA
II
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Image /page/1/Picture/1 description: The image shows the logo for MR Instruments INC. The logo consists of the letters 'mr' in a stylized font, with the 'm' and 'r' connected. Below the letters is the text 'MR INSTRUMENTS INC' in a smaller, sans-serif font. The logo is black and white.
C. Identification of Legally Marketed Devices
| 1. Name: | Magnetom Trio Head Coil |
|---|---|
| 2. K Number: | K021330 |
| 3. Date Cleared: | July 25, 2002 |
D. Description of the Device
The TEM 3000 Head Coil is a 15-element quadrature transmit/receive coil. The coil elements and associated circuitry are enclosed in a rigid housing to prevent any exposure to patient or environment. The coil housing employs a large open viewing window on the top. The coil design facilitates the scanning of patients with different window on the top: "Ifizes patient comfort and ease of use. Included with the coil housing is a Head Support/Coil Base. It allows the coil to be slid back for better patient access.
E. Intended Use Statement
The MR Instruments TEM 3000 Head Coil is intended for 'H high-resolution whole-I head adult and pediatric imaging. Typical applications include functional MRI, spectroscopy and angiography. It is compatible with the Siemens 3T Magnetom Trio MR System (K021330).
F. Technological Characteristics Summary
The TEM 3000 Head coil is similar to the predicate device, the USA Instruments 3T head coil manufactured for the Siemens Magnetom Trio system, in regard to its construction and operation. The key difference is the use of TEM (Transverse Electromagnetic) technology rather than the commonly used "Birdcage" technology. This means the coil develops the necessary RF field using "distributed" (transmission I mis momis the con as a responsible or discrete components. As a result, the TEM coil has the potential of being more efficient at higher frequencies.
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2004
MR Instruments, Inc. % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K040937
Trade/Device Name: TEM 3000 Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 8, 2004
Received: April 12, 2004
Dear Mr. Job:
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 such 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 I DA'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) I his letter will anow you've of substantial equivalence of your device to a legally premarket notification: - The PDF intally sition 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 acvies to: your 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, to: questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Othernation as ( notification" (21CFR Part 807.97) you may obtain. Other general of releveloo to premarited in 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. brigden
Nancv 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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Indication for Use Form
Koyo 937 510(k) Number:
Device Name: TEM 3000 Head Coil
Indications for Use: The TEM 3000 head coil is designed to provide Thurcations for 'Osci Images of the brain, soft tissues and Magnetic Resomation of the TEM 3000 head coil is vasculature of the nead. The TEAT 5000 head coanner manufactured by Siemens Medical Systems.
PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
OR
David A. Seyram
OVER-THE-COUNTER USE __ (optional Form 1-2-96)
/ 2007/2007
10
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KD40937
§ 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.