(14 days)
The Signa® Profile EXCITE MR system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa® Profile EXCITE MR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa® Profile EXCITE MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Due to the 'open' design of the Signa® Profile EXCITE MR system may also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.
Signa® Profile EXCITE MR System is a modification to the 0.2T Signa® Profile/i MR System (K033168) which utilizes a permanent magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques
This document is a 510(k) summary for the GE Signa® Profile EXCITE MR System, submitted in 2004. It describes a modification to an existing MR system and focuses on demonstrating substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria or detailed device performance in a table format as might be expected for a machine learning or AI device. Instead, it relies on demonstrating compliance with established performance standards for Magnetic Resonance (MR) systems.
| Criteria Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety Standards | Compliance with: - IEC 60601-1 International Medical Equipment Safety standard - IEC 60601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis | The Signa® Profile EXCITE MR System was evaluated and found to comply with the specified safety standards. The conclusion states, "Usage of the Signa® Profile EXCITE MR System does not result in any new potential hazards." |
| Performance Standards | Compliance with appropriate NEMA (National Electrical Manufacturers Association) performance standards for MR systems. (Specific NEMA standards are not listed but are implied as "appropriate" for an MR system.) | The Signa® Profile EXCITE MR System was evaluated to the "appropriate NEMA performance standards." Implied performance is comparable to the predicate device, as the submission aims to show "substantial equivalence." |
| Substantial Equivalence to Predicate Device | Key differences (EXCITE technology, changed data acquisition hardware, new software version, gradient power supply) do not introduce new safety concerns or alter fundamental performance characteristics such that the device is no longer equivalent for its intended use. | The device is deemed "substantially equivalent to the currently marketed the 0.2T Signa® Profile/i MR system (K033168)." The changes enable "maximum gradient slew rate changes to 34 T/m/s with maximum hardware capability of 46 T/m/s," and maintain a maximum gradient amplitude of 19 mT/m, indicating performance improvements within the scope of the predicate. |
| Intended Use | The device should be able to produce diagnostic images for the specified body parts and systems, and be usable for interventional procedures with MR compatible devices. | The device is "indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems." It can also be "utilized for imaging during interventional procedures." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document describes a medical device (MR System), not an AI/machine learning algorithm that uses a "test set" in the computational sense. The evaluation is based on compliance with established engineering and medical device safety and performance standards (NEMA, IEC) and comparison to a predicate device. Therefore, there is no specific "test set" of patient data or images described in this summary. The evaluation focuses on the hardware and software modifications and their adherence to regulated standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As this is not an AI/ML device relying on image interpretation for its primary function, there is no "ground truth for a test set" in the context of expert review of images to train or validate an algorithm. The "ground truth" for an MR system's performance is its ability to produce images that meet physical and technical specifications and allow for diagnostic interpretation by a trained physician (as stated in the Indications for Use).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set of images requiring expert adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an MR imaging system, not an AI-assisted diagnostic tool for image interpretation. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm; it is a physical imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of evaluating a software algorithm. For an MR system, the implicit "ground truth" of its performance is its ability to acquire images that accurately represent the physical properties of the body (proton density, T1, T2, flow) as confirmed by physical phantom measurements and clinical observation, which are then used by trained physicians for diagnosis.
8. The sample size for the training set
Not applicable. This device is a hardware/software system, not an AI/ML algorithm that is "trained" on a dataset of patient images.
9. How the ground truth for the training set was established
Not applicable. No training set is described for this device.
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General Electric Company P.O. Box 414, Milwaukee, WI 53201
14043112
NOV 2 4 2004 510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
| Submitter: | GE HealthcarePO Box 414Milwaukee, WI 53201 |
|---|---|
| Contact Person: | Larry A. Kroger Ph.D.Senior Regulatory Programs Manager |
| Telephone: | 262- 544-3894 |
| Fax: | 262- 548-4768 |
| Date Prepared: | November 8, 2004 |
Device Name:
Signa® Profile EXCITE MR System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
Marketed Device:
Signa® Profile EXCITE MR System is substantially equivalent to the currently marketed the 0.2T Signa® Profile/i MR system (K033168) with the main differences of EXCITE technology with change of data acquisition hardware, host computer operated by new version software, and gradient power supply to AN8295Y, which enable maximum gradient slew rate changes to 34 T/m/s with maximum hardware capability of 46 T/m/s to allow for future customer upgrades. Maximum gradient amplitude is 19 mT/m.
Device Description:
Signa® Profile EXCITE MR System is a modification to the 0.2T Signa® Profile/i MR System (K033168) which utilizes a permanent magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques
Indications for Use:
The Signa® Profile EXCITE MR system is an open, whole body scanner designed to support imb olgha Frome Broting and shorter scan times. The Signa® Profile EXCITE MR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa® EXCITE MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a circular emblem with the letters 'GE' intertwined in the center. The letters are stylized and appear to be handwritten or calligraphic. The logo is black and white.
General Flectric Comnany P.O. Box 414, Milwaukee, WI 53201
time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Due to the 'open' design of the Signa® Profile EXCITE MR system may also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.
Comparison with Predicate Device:
The Signa® Profile EXCITE MR System is a modification of the Signa® Profile/i MR System (K033168) with the main differences of EXCITE technology with change of data acquisition hardware, host computer operated by new version software, and gradient power supply to AN8295Y. which enable maximum gradient slew rate changes to 34 T/m/s with maximum hardware capability of 46 T/m/s to allow for future customer upgrades. The Maximum gradient amplitude is 19 mT/m.
Summary of Studies:
The Signa® Profile EXCITE MR System was evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 International Medical Equipment Safety standard and IEC 60601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. The Signa® Profile EXCITE MR System is comparable to the currently marketed Signa® Profile/i MR System.
Conclusion:
It is the opinion of GE that the Signa® Profile EXCITE MR System is substantially equivalent to the Signa® Profile/i MR System. Usage of the Signa® Profile EXCITE MR System does not result in any new potential hazards.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2004
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager General Electric Company GE Healthcare P.O. Box 414, W-400 MILWAUKEE WI 53201
Re: K043112 Trade/Device Name: GE 0.2T Signa® Profile EXCITE MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: 90 LNH Dated: November 8, 2004 Received: November 10, 2004
Dear Dr. Kroger:
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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) r ms lotter notification. The FDA finding of substantial equivalence of your device to a legally prematicate 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 rr you atter Office of Compliance at one of the following 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 807.97). You may obtain other general information on your responsibilities under the Act 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
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GE Healthcare
General Electric Company P.O. Box 414, Milwaukee, WI 53201
STATEMENT OF INTENDED USE
K043112 510(k) Number (if known):
| Device Name: | GE 0.2T Signa ® Profile EXCITE MR System |
|---|---|
| -------------- | ----------------------------------------------------- |
Indications for Use
The Signa® Profile EXCITE MR system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa® Profile EXCITE MR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa® Profile EXCITE MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Due to the 'open' design of the Signa® Profile EXCITE MR system may also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number [K043112](https://510k.innolitics.com/device/K043112)
(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
§ 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.