(72 days)
Not Found
No
The document describes a standard MRI head coil and its intended use, focusing on hardware components and compatibility with existing MRI systems and technology (SENSE). There is no mention of AI, ML, image processing beyond standard MRI reconstruction, or any data training/testing related to AI/ML algorithms.
No
The device is described as being used for obtaining "diagnostic images" and to "yield information that can be useful in the determination of a diagnosis," indicating its purpose is for diagnosis, not therapy.
Yes
Explanation: The device is used to obtain diagnostic images that, when interpreted by a trained physician, "yield information that can be useful in the determination of a diagnosis."
No
The device description explicitly states it is a "transmit birdcage coil and a receive only 4 channel phased array RF coil" with a "rigid enclosure" and "coil elements and accessory electronics enclosed in a rigid plastic housing," indicating it is a hardware component of an MRI system, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is an accessory for an MRI system. Its function is to transmit and receive radiofrequency signals to create images of the internal structure of the body (brain, spine, neck).
- No Sample Analysis: The device does not analyze biological samples taken from the patient. It interacts directly with the patient's body to generate images.
- Imaging Modality: The input imaging modality is Magnetic Resonance Imaging, which is an in-vivo imaging technique, not an in-vitro diagnostic method.
The device is clearly described as a component of an MRI system used for obtaining diagnostic images of the body, not for analyzing samples from the body.
N/A
Intended Use / Indications for Use
The Gemini III Hybrid Tx/Rx 4 Channel Head Coil consists of a transmit birdcage coil and a receive only 4 channel phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissue of the neck and upper chest in Magnetic Resonance Imaging Systems. The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is compatible with SENSE technology and designed for use with the Allegra 3.0T MRI systems manufactured by Siemens Medical Solutions.
The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is designed for use with the Siemens Allegra 3.0T scanner manufactured by Siemens Medical Solutions, Inc.
Anatomic Regions: brain, upper cervical spine, and the soft tissues and vasculature of the head and neck Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 3.0T 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.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Gemini III Hybrid Tx/Rx 4 Channel Head Coil consists of a transmit birdcage coil and a receive only 4 channel phased array RF coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
brain, cervical spine, soft tissue of the neck and upper chest, head and neck, whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
trained physician
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)
Not Found
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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Ko3 3235
DEC 17 2003
.
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Gemini III Hybrid Tx/Rx 4 Channel Head Coil |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc. |
| 1515 Danner Drive | |
| Aurora, Ohio 44202, USA | |
| Telephone: 330-562-1000; Fax: 330-562-1422. | |
| 6. Performance Standard: | No applicable performance standards have been |
| issued under Section 514 of the Food, Drug and | |
| Cosmetic Act. | |
| 7. Intended Use: | The Gemini III Hybrid Tx/Rx 4 Channel Head Coil |
| consists of a transmit birdcage coil and a receive | |
| only 4 channel phased array RF coil, used for | |
| obtaining diagnostic images of the brain, cervical | |
| spine, soft tissue of the neck and upper chest in | |
| Magnetic Resonance Imaging Systems. The Gemini | |
| III Hybrid Tx/Rx 4 Channel Head Coil is compatible | |
| with SENSE technology and designed for use with | |
| the Allegra 3.0T MRI systems manufactured by | |
| Siemens Medical Solutions. | |
| 8. Device Description: | The Gemini III Hybrid Tx/Rx 4 Channel Head Coil |
| consists of a transmit birdcage coil and a receive | |
| only 4 channel phased array RF coil. The coil has a | |
| rigid enclosure. The open, patient friendly design | |
| eases patient handling and positioning 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. |
1
9. Safety and Effectiveness
| Gemini III Hybrid Tx/Rx 4 Channel Head
Coil product features | Comparison to predicate device or other 510(k)
cleared products |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the brain,
cervical spine, soft tissue of the head
and neck, | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) |
| Indications for Use: Identical to routine
MRI imaging | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) |
| Coil Enclosure Material:
Flame Retardant Polyurethane | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) |
| Coil Design: The coil design consists of a
transmit birdcage coil and a receive only
phased array coil. | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) |
| Decoupling: active and passive switching
diodes | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) |
| Prevention of RF Burns: The coil uses pin
diodes to isolate the receive elements from
the transmit coil; coil elements and circuitry
are enclosed in a non-conductive housing | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) |
| Radio Frequency Absorption: Power
deposition during imaging is limited by SAR
algorithm | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) |
| Formation of Resonant Loop: Active
diodes isolate the coil elements from RF
fields: length of cable and stiffness does not
permit looping | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) |
.
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 with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2003
Ms. Christie Shumaker Manager, QA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K033235
Trade/Device Name: Gemini III Hybrid Tx/Rx 4 Channel Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: September 29, 2003 Received: October 6, 2003
Dear Ms. Shumaker:
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 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) 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 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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
4
510(k) Number (if known): K033235
Device Name: Gemini III Hybrid Tx/Rx 4 Channel Head Coil
Indications for Use: The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is designed for use with the Siemens Allegra 3.0T scanner manufactured by Siemens Medical Solutions, Inc.
Anatomic Regions: brain, upper cervical spine, and the soft tissues and vasculature of the head and neck Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 3.0T 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) | ✓ | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|---|
| --------------------------------------- | ---------------------------------------- | ---- | ----------------------------------------------- |
| (Division Sign-Off) | Nancyc Brogdon |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K033235 |