(72 days)
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.
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.
This document is a 510(k) premarket notification for a medical device called the "Gemini III Hybrid Tx/Rx 4 Channel Head Coil." This device is an accessory for Magnetic Resonance Imaging (MRI) systems. The provided text, however, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one might find for an AI/CADe device.
Therefore, many of the requested sections below cannot be fully extracted from the provided text as the nature of the document and the device itself (an MRI coil, not an image analysis algorithm) do not involve such a study design.
Here's an attempt to address your request based only on the provided information, highlighting where information is absent due to the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not define specific performance "acceptance criteria" or report quantitative "device performance" in terms of clinical accuracy (e.g., sensitivity, specificity, AUC) for the Gemini III Hybrid Tx/Rx 4 Channel Head Coil. Instead, it demonstrates substantial equivalence to a predicate device (Magnetom Trio 3.0T Head Coil, K021262) by comparing various features and safety aspects.
The table below summarizes the comparison points used to establish substantial equivalence, which serves as the "criteria" for this type of submission. The "reported device performance" here is that the features are "similar" to the predicate.
| Acceptance Criteria (Feature Comparison) | Reported Device Performance (Similarity Statement) |
|---|---|
| Intended Use: Imaging of the brain, cervical spine, soft tissue of the head and neck. | Similar to the Magnetom Trio 3.0T Head Coil |
| Indications for Use: Identical to routine MRI imaging. | Similar to the Magnetom Trio 3.0T Head Coil |
| Coil Enclosure Material: Flame Retardant Polyurethane. | Similar to the Magnetom Trio 3.0T Head Coil |
| Coil Design: Transmit birdcage coil and a receive only phased array coil. | Similar to the Magnetom Trio 3.0T Head Coil |
| Decoupling: Active and passive switching diodes. | Similar to the Magnetom Trio 3.0T Head Coil |
| Prevention of RF Burns: Pin diodes to isolate receive elements from transmit coil; coil elements and circuitry enclosed in non-conductive housing. | Similar to the Magnetom Trio 3.0T Head Coil |
| Radio Frequency Absorption: Power deposition limited by SAR algorithm. | Similar to the Magnetom Trio 3.0T Head Coil |
| Formation of Resonant Loop: Active diodes isolate coil elements from RF fields; cable length/stiffness prevents looping. | Similar to the Magnetom Trio 3.0T Head Coil |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document describes an MRI accessory (a head coil) and its technical features for substantial equivalence, not an algorithm that analyzes data or requires a test set of patient scans. Therefore, there is no mention of a "test set," sample size, or data provenance in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is not an diagnostic algorithm requiring ground truth established by experts for performance evaluation. Its safety and effectiveness are established through engineering design, material specifications, and comparison to an already cleared device.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" and no diagnostic challenge requiring adjudication in this type of submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or CADe devices to assess improved reader performance, which is not relevant for an MRI coil accessory.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This device is an MRI coil, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant.
7. The Type of Ground Truth Used
Not applicable. As this is an MRI coil and not a diagnostic algorithm, the concept of "ground truth" (e.g., pathology, outcomes data) for clinical decision-making is not applied in this submission. The "ground truth" for the device's acceptable performance is its adherence to safety standards and engineering principles, and its similarity to the predicate device in terms of intended use, materials, design, and mechanisms to ensure patient safety.
8. The Sample Size for the Training Set
Not applicable. There is no algorithm or "training set" mentioned or implied for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for it.
{0}------------------------------------------------
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 DriveAurora, Ohio 44202, USATelephone: 330-562-1000; Fax: 330-562-1422. |
| 6. Performance Standard: | No applicable performance standards have beenissued under Section 514 of the Food, Drug andCosmetic Act. |
| 7. Intended Use: | The Gemini III Hybrid Tx/Rx 4 Channel Head Coilconsists of a transmit birdcage coil and a receiveonly 4 channel phased array RF coil, used forobtaining diagnostic images of the brain, cervicalspine, soft tissue of the neck and upper chest inMagnetic Resonance Imaging Systems. The GeminiIII Hybrid Tx/Rx 4 Channel Head Coil is compatiblewith SENSE technology and designed for use withthe Allegra 3.0T MRI systems manufactured bySiemens Medical Solutions. |
| 8. Device Description: | The Gemini III Hybrid Tx/Rx 4 Channel Head Coilconsists of a transmit birdcage coil and a receiveonly 4 channel phased array RF coil. The coil has arigid enclosure. The open, patient friendly designeases patient handling and positioning 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. |
{1}------------------------------------------------
9. Safety and Effectiveness
| Gemini III Hybrid Tx/Rx 4 Channel HeadCoil product features | Comparison to predicate device or other 510(k)cleared products |
|---|---|
| Intended Use: Imaging of the brain,cervical spine, soft tissue of the headand neck, | -Similar to the Magnetom Trio 3.0T Head Coilmanufactured by USA Instruments, Inc. (K021262) |
| Indications for Use: Identical to routineMRI imaging | -Similar to the Magnetom Trio 3.0T Head Coilmanufactured by USA Instruments, Inc. (K021262) |
| Coil Enclosure Material:Flame Retardant Polyurethane | -Similar to the Magnetom Trio 3.0T Head Coilmanufactured by USA Instruments, Inc. (K021262) |
| Coil Design: The coil design consists of atransmit birdcage coil and a receive onlyphased array coil. | -Similar to the Magnetom Trio 3.0T Head Coilmanufactured by USA Instruments, Inc. (K021262) |
| Decoupling: active and passive switchingdiodes | -Similar to the Magnetom Trio 3.0T Head Coilmanufactured by USA Instruments, Inc. (K021262) |
| Prevention of RF Burns: The coil uses pindiodes to isolate the receive elements fromthe transmit coil; coil elements and circuitryare enclosed in a non-conductive housing | -Similar to the Magnetom Trio 3.0T Head Coilmanufactured by USA Instruments, Inc. (K021262) |
| Radio Frequency Absorption: Powerdeposition during imaging is limited by SARalgorithm | -Similar to the Magnetom Trio 3.0T Head Coilmanufactured by USA Instruments, Inc. (K021262) |
| Formation of Resonant Loop: Activediodes isolate the coil elements from RFfields: length of cable and stiffness does notpermit looping | -Similar to the Magnetom Trio 3.0T Head Coilmanufactured 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 |
§ 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.