(7 days)
Not Found
No
The document describes a hardware component (a head coil) for an MR system and does not mention any software or algorithms that would incorporate AI or ML.
No
The device is described as a head coil for magnetic resonance imaging, used to provide images for diagnostic purposes, not to treat a condition.
Yes
Explanation: The device is a head coil for an MR system, designed to provide "Magnetic Resonance Images of the brain, soft tissues and vasculature of the head." The creation of medical images for analysis is a key component of diagnostic processes.
No
The device description clearly states it is a "15-element, quadrature transmit/receive coil" enclosed in a "rigid housing," indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide Magnetic Resonance Images of the brain, soft tissues, and vasculature of the head. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, or tissue samples) outside of the body.
- Device Description: The description details a coil used within an MR system to generate images, not a reagent, instrument, or system intended for in vitro examination of specimens.
- Input Imaging Modality: The input is Magnetic Resonance, which is an in vivo imaging technique.
- Anatomical Site: The device is used on the head, which is an in vivo application.
IVD devices are specifically designed for testing biological samples outside of the body to provide information about a person's health. This device is used to create images of structures inside the body.
N/A
Intended Use / Indications for Use
The MR Instruments TEM 3000G Head Coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM 3000G Head Coil is designed for use with the GE Signa 3.0T Excite MR System manufactured by GE.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The TEM 3000G Head Coil is a 15-element, quadrature transmit/receive coil. The coil elements and associated circuitry are enclosed in a rigid housing to prevent rne exposure to patient or environment. The coil housing employs a large open any order on the top. The coil design facilitates the scanning of patients with different head sizes and maximizes patient comfort and ease of use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Images
Anatomical Site
brain, soft tissues and vasculature of the head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was completed to verify the design specifications necessary for the designed for use with the GE Healthcare Signa® 3.0T MR System necessary for the usershility of the GE based Head Coil. Test results modified.com and performance of the TEM 3000G Head Coil for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows a logo for MR Instruments Inc. The logo consists of the letters 'mrii' in a stylized font, with the 'm' and 'ii' in solid black and the 'r' in a dotted pattern. Below the letters, the words 'MR INSTRUMENTS INC' are written in a simple sans-serif font.
AUG 1 9 2005
TEM 3000G Head Coil
Section 2 - 510(k) Summary and Certification
[As required by 21 CFR 807.92(c)]
1. Contact Person
Mark Watson VP, Engineering Tel: (952) 746-1435 Fax: (952) 746-1437
MR Instruments, Inc., Inc. 4802 Park Glen Road Minneapolis, MN 55416
2. General Information
| Name: | TEM 3000G Head Coil |
|---|---|
| Trade Name: | TEM 3000 Head Coil |
| Common Name: | Head Coil |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Classification: | This device is classified by the Radiology |
| Panel into Class II, (21 CFR 892.1000) |
3. Device Description
The TEM 3000G Head Coil is a 15-element, quadrature transmit/receive coil. The coil elements and associated circuitry are enclosed in a rigid housing to prevent rne exposure to patient or environment. The coil housing employs a large open any order on the top. The coil design facilitates the scanning of patients with different head sizes and maximizes patient comfort and ease of use.
The predicate device, manufactured for General Electric Company, Milwaukee, WI (USA) by GE Medical Systems (India) Private LTD, Split Head Coil Assembly for G3 (K040444), is also quadrature transmit/receive coil. The TEM 3000G's fundamental construction and use of materials (as defined above) is similar to the predicate device. (See Attachment B for device drawings.)
4. Intended Use
The MR Instruments TEM 3000G Head Coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM
CONFIDENTIAL
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Image /page/1/Picture/0 description: The image shows the logo for MR Instruments INC. The logo consists of the letters 'm' and 'rii' in a stylized font. The letters are in black and the background is white. The text 'MR INSTRUMENTS INC' is written in a smaller font below the logo.
NNSTASMENTS
3000G Head Coil is designed for use with the GE Signa 3.0T Excite MR System manufactured by GE.
5. Substantial Equivalence Comparison
antial Equivalient o coil is substantially equivalent to the following device i with respect to intended use and design:
- GE Signa 3.0T Excite MR System (Split Head Coil Assembly for G3) . GE Signa 0.0 + Exection for General Electric Company (Milwaukee, WI, (114044) manufal Systems (India) Private LTD, Banagalore, India
The similarities between the two devices is that they are both quadrature transmit and receive RF coils designed to work with the GE Signa 3.0T Excite transmit and the similar in size, shape and construction.
The primary difference between the two devices is that the predicate utilizes The philary anterence as a transverse electromagnetic (TEM) technology, which requires less RF power to achieve high-resolution imaging.
6. Summary of Studies
Performance testing was completed to verify the design specifications necessary for the designed for use with the GE Healthcare Signa® 3.0T MR System necessary for the usershility of the GE based Head Coil. Test results modified.com and performance of the TEM 3000G Head Coil for its intended use.
7. Conclusion (statement of equivalence)
The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the TEM 300G Head Coil.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wavy lines emanating from its head, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2005
MR Instruments, Inc. % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K052200
Trade/Device Name: TEM 3000G Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: MOS Dated: August 10, 2005 Received: August 12, 2005
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 (Premarket Approval), 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 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the support of all and of also and securedaries to Jegal This letter will allow you to begin marketing your entress of your device to a legally premarket notification. The FDA Inding of Sabstantial of 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 device on our laboring numbers, based. on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, firstitution on your responsibilities under the Act from the 807.97). You may obtain other general miormation on Jour September Assistance at its toll-free number (800) DIVIsion of Billion (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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Image /page/4/Picture/0 description: The image contains handwritten text that appears to be a code or identifier. The text reads 'Kos 2200'. The characters are written in a cursive style, and the numbers are slightly larger than the letters.
Image /page/4/Picture/1 description: The image shows a logo for MR Instruments INC. The logo is black and white and features a stylized "m" followed by "rii". The text "MR Instruments INC" is below the logo in a smaller font.
Indications for Use Statement
Page 1 of 1
The MR Instruments TEM 3000G Head Coil is designed to provide Magnetic
t the MR Instruments TEM 3000 is and vasculature of the head. Th The MR Instruments TEM 3000C Head Coll is designed to processor to the head. The TEM
Resonance Images of the brain, soft tissues and vasculature of the MR System Resonance Images of the brain, son tissues and Vasualaria
3000G Head Coil is designed for use with the GE Signa 3.0T Excite MR System manufactured by GE.
Prescription Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
and Radiological Devices
510(k) Number July 29, 2005
Nancy C. Bropon
(Division Sign-Off)
Division of Reproductive, Abdominal,
CONFIDENTIAL
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