(43 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard MRI technology and pulse sequences.
No
The device is described as an imaging device used to produce diagnostically useful images, not to provide therapy.
Yes
The device produces images that, "If interpreted by a medical expert, can provide diagnostically useful information." This explicitly indicates its role in diagnosis.
No
The device description explicitly states it utilizes a superconducting magnet and is a stationary system, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
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 for diagnosis, monitoring, or screening.
- Device Function: The Optima MR430s MRI Scanner is an imaging device that produces images of internal body structures using magnetic resonance. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for producing images of limbs and joints for diagnostic information when interpreted by a medical expert. This is a form of in vivo (within the living body) imaging, not in vitro (in glass/outside the body) analysis.
Therefore, based on the provided information, the Optima MR430s MRI Scanner is a medical imaging device, not an In Vitro Diagnostic device.
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
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
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)
The modification that prompted this submission did not require clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circle. The letters and the circle are black, creating a strong contrast against the white background.
NOV 1 3 2012
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: September 19, 2012
GE Medical Systems, LLC (GE Healthcare) Submitter: 301 Ballardvale Street, Suite 4 Wilmington, MA 01887
Primary Contact Person:
Yuan Ma Regulatory Affairs Manager GE Medical Systems, LLC (GE Healthcare) Tel: (781) 262-5581 Fax: (414) 908-9390 yuan.ma@med.ge.com
Secondary Contact Person:
Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC) (262) 521-6848 (262) 364-2785 Glen.Sabin@med.ge.com
Establishment Registration Number:
3008193097
Optima MR430s Device Trade Name:
Common/Usual Name: Magnetic Resonance Imaging System
Classification 21 C.F.R. 892.1000 Magnetic Resonance Diagnostic Device · Names:Product Code: LNH
Predicate Device(s): K103238, Optima MR430s MRI Scanner
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.
1
Image /page/1/Picture/19 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular border. The border has decorative swirls or flourishes at regular intervals around the circle.
GE Healthcare
510(k) Premarket Notification Submission
Intended 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.
The modified Optima MR430s employs the same fundamental
scientific technology as the unmodified predicate device.
Technology:
Determination of Substantial Equivalence:
The Optima MR430s complies with voluntary standards as detailed in Sections 9 of this premarket submission. The following quality assurance measures were applied to the modification of the system:
- . Risk Analysis
- Requirements Reviews .
Summary of Non-Clinical Tests:
- . Design Reviews
- Performance Testing (Verification) ●
- System Validation Testing .
Summary of Clinical Tests:
The modification that prompted this submission did not require clinical testing.
Conclusion:
GE Healthcare considers the Optima MR430s to be as safe, as effective, and performance is substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
GE Medical Systems, LLC Speciality MR 301 Ballardvale Street Suite 4 Wilmington, MA 01887
NOV 1 3 2012
Re: K123068
Trade/Device Name: OPTIMA MR430s Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: October 01, 2012 Received: October 16, 2012
Dear Dr. Ma: .
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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Yuan Ma
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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely yours,
Michael D. O'hara 2012.11.09 15:33:15-05'00'
Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
K123068
510(k) Number (if known):
Device Name: Optima MR430s
Indications for Use:
The Optima MR430s MR 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 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.
X Prescription Use (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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 123068
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