(101 days)
Not Found
No
The summary describes a standard MRI scanner and its imaging capabilities, without mentioning any AI or ML features for image processing, analysis, or workflow optimization. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
Explanation: The device is described as an imaging device used to produce diagnostic images, not to treat a condition.
Yes
The "Intended Use / Indications for Use" states that the device produces images that, "If interpreted by a medical expert, these images can provide diagnostically useful information." This indicates its role in the diagnostic process.
No
The device description clearly outlines hardware components like a superconducting magnet and discusses hardware-related performance studies (Peripheral Nerve Stimulation).
Based on the provided information, the Optima MR430s MR Scanner is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Optima MR430s Function: The Optima MR430s is an MRI scanner. It uses magnetic fields and radio waves to create images of the internal structure of the body directly. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a magnetic resonance imaging device that produces images of limbs and joints. These images are then interpreted by a medical expert. This is a form of in vivo (within the living body) imaging.
Therefore, the Optima MR430s MR Scanner falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Optima MR430s MRI Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique crosssectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The Optima MR430s MRI Scanner utilizes a superconducting magnet to acquire 2D single-slice and multi-slice and 3D volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, fast spin echo, 2D and 3D gradient echo acquisitions. Imaging options such as inversion recovery, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system is used as a stationary system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand
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)
As part of Verification testing, a non-significant risk study was performed to characterize onset levels for Peripheral Nerve Stimulation (PNS) in accordance with IEC 60601-2-33 for the change in the gradient slew rate (300 T/m/s). No nerve sensation was reported. As a result, with respect to PNS, the system is not capable of operating outside of the Normal Operating Mode. The sample DICOM images included in this submission were also collected as part of a non-significant risk study.
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.
0
p '/3
Image /page/0/Picture/1 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The design has a vintage or classic appearance, with slightly rough or textured lines, suggesting it may be an older version of the logo.
FEB 1 1 2011 、、・・・・・ .
•
GE Healthcare
301 Ballardvale Street
Wilmington, MA 01887
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: October 29, 2010
ﺎ
| Submitter: | GE Medical Systems, LLC (GE Healthcare)
301 Ballardvale Street, Suite 4
Wilmington, MA 01887 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Norma LeMay
Regulatory Affairs Leader, Specialty MR
GE Medical Systems, LLC (GE Healthcare)
Tel: (781) 262-5581
Fax: (978) 658-0898 |
| Secondary Contact Person: | Glen Sabin
Director of Regulatory Affairs, MR
GE Medical Systems, LLC (GE Healthcare)
3200 N Grandview Boulevard
Waukesha, WI 53188
Tel: (262) 521-6848
Fax: (262 521-6439 |
| Device:
Trade Name: | Optima MR430s MRI Scanner |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names: | Magnetic Resonance Diagnostic Device |
| Product Code:
Predicate Device(s): | LNH
K080048, MSK Extreme MRI Scanner |
1
Device Description: The Optima MR430s MRI Scanner utilizes a superconducting magnet to acquire 2D single-slice and multi-slice and 3D volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, fast spin echo, 2D and 3D gradient echo acquisitions. Imaging options such as inversion recovery, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system is used as a stationary system.
Indications for Use: The Optima MR430s MRI Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique crosssectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.
Technology: The Optima MR430s employs the same fundamental scientific technology as its predicate device (MSK Extreme, K080048).
Determination of Summary of Non-Clinical Tests: Substantial Equivalence:
The Optima MR430s complies with voluntary standards as detailed in Sections 9 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- · Risk Analysis
- Requirements Reviews .
- Design Reviews ●
- Design Verification Testing
- System Verification Testing .
- Performance testing (Verification) ●
- . Safety testing (Verification)
The results of all testing performed indicate that the Optima MR430s meets the acceptance criteria and is substantially equivalent to the currently cleared 1.5T MSK Extreme (predicate device, cleared through K080048).
Summary of Clinical Tests:
As part of Verification testing, a non-significant risk study was performed to characterize onset levels for Peripheral Nerve Stimulation (PNS) in accordance with IEC 60601-2-33 for the
2
K 103 238 p3/3
change in the gradient slew rate (300 T/m/s). No nerve sensation was reported. As a result, with respect to PNS, the system is not capable of operating outside of the Normal Operating Mode. The sample DICOM images included in this submission were also collected as part of a non-significant risk study. See Section 20 for more details of the studies performed.
GE Healthcare considers the Optima MR430s to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Ms. Norma J. LeMay Regulatory Affairs Leader GE Healthcare 301 Ballard Street, Suite 4 WILMINGTON MA 01887
FEB 25 2011
Re: K103238
Trade/Device Name: Optima MR430s 1.5T MR Scanner Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: January 31, 2011 Received: February 1, 2011
Dear Ms. LeMay:
This letter corrects our substantially equivalent letter of February 11, 2011.
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 (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 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); medical device reporting (reporting of medical
4
Page 2 - Ms. LeMay
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ull D'Othen for
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
5
KID3238
510(k) Number (if known):
Device Name: Optima MR430s 1.5T MR Scanner
Indications for Use:
The Optima MR430s MR Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knec, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Vinny Spattt
Division Sign-off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K163238
Page I of