(54 days)
Not Found
Not Found
No
The device is a pediatric positioner, an accessory for an MRI system, with no mention of software, algorithms, or any AI/ML related terms.
No
The device is described as an "MRI Accessory" and a "Pediatric Positioner" used for imaging, not for treating a disease or condition. Its intended use is for "Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA) and Proton Spectroscopy," which are diagnostic imaging modalities.
No
Explanation: The device is described as a "Pediatric Positioner" and "MRI Accessory." Its intended use is to position pediatric patients during MRI, MRA, and Proton Spectroscopy procedures. The "Summary of Performance Studies" focuses on imaging performance parameters like SNR, image uniformity, and geometric distortion, which relate to the quality of the image produced by the MRI system, not the interpretation or diagnosis of medical conditions. While it is used with imaging modalities that can be diagnostic, the device itself is an accessory that aids in the imaging process rather than performing a diagnostic function.
No
The device description explicitly states "Pediatric Positioner" and "MRI Accessory," indicating a physical hardware component used in conjunction with an MRI system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Pediatric Positioner" used in conjunction with an MRI system for imaging and spectroscopy. This is a device used during an imaging procedure on a patient, not a device used to test samples outside of the body (in vitro).
- Device Description: The description confirms it's an "MRI Accessory" and a "Pediatric Positioner."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to position a pediatric patient for an MRI scan, which is an imaging modality, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA) and Proton Spectroscopy of the pediatric head, body and extremities. This device is used in conjunction with a General Electric 1.5 Tesla MRI System. Proton Spectroscopy is used in conjunction with the PROBE (Proton Brain Exam) option.
Product codes
90MOS
Device Description
Model 1300GE-64 - Pediatric Positioner. Compatible with GE Signa 1.5T MRI Systems. An MRI Accessory.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA), Proton Spectroscopy
Anatomical Site
Pediatric head, body and extremities.
Indicated Patient Age Range
Pediatric
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
| 4.0 Attachment 2: | 510(K) Summary of Safety and Effectiveness |
|---|---|
| Device Name: | Model 1300GE-64 - Pediatric Positioner |
| Applicability: | Compatible with GE Signa 1.5T MRI Systems |
| Reason for 510(k): | New device |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Device Classification Panel: | Radiology |
| Device Classification Number: | 892.1000 |
| Product Code: | 90MOS |
| Common Name: | MRI Accessory |
| Proprietary Name: | Model 1300GE-64 - Pediatric Positioner |
| Establishment Registration | |
| Number: | 2134565 |
| Address of MFG Facility: | Midwest RF, LLC |
| 535 Norton Drive | |
| Hartland, WI 53029 | |
| Classification: | Class II |
| Intended Uses: | |
| Diagnostic Uses: | 2D, 3D imaging, proton density, T1 and T2 |
| weighted imaging, 2D, 3D time of flight, phase | |
| contrast imaging. Proton spectroscopy. | |
| Anatomic Regions: | Pediatric head, body and extremities. |
1
Standards:
Performance Standards: None established under Section 514 Voluntary Safety Standards: UL-94 Tests for Flammability of Plastic Materials for Parts in Devices and Appliances International Electrotechnical Commission. IEC-60601-1
- IEC-60601-2-33 International Electrotechnical Commission, Part 2: particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis
Requirements for Safety
Medical Electrical Equipment, Part 1: General
Overview
The Radiology Devices Panel considered potential concerns regarding the safe and effective operation of Magnetic Resonance Diagnostic Devices when thev recommended reclassification to Class II on July 27, 1987. After reclassification. the FDA's Center for Devices and Radiological Health (CDRH) released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. Due to considerable technological advances in MRDDs. CDRH issued an updated guidance document on November 14, 1998. The following is a summary of the information contained within this premarket notification that addresses these concerns:
The GE Signa 1.5T MRI System, operated with the Midwest RF Pediatric Positioner, is substantially equivalent to the GE Signa 1.5T MRI System operated with the legally market predicated devices listed in Attachment 8 of this PMN, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels:
Safety Parameters
Maximum Static Magnetic Field: No change
Rate of Magnetic Field Strength Change: No change
Pediatric Positioner
2
| RF Power Deposition: | No change when used in
accordance with operator
instructions |
|-----------------------------------|--------------------------------------------------------------------|
| Acoustic Noise Levels: | No change |
| Biocompatibility: | No change |
| Imaging Performance Parameters | |
| Specification Volume: | No change |
| Signal-to-Noise Ratio: | No change (within measurement
error) |
| Image Uniformity: | No change (within measurement
error) |
| Geometric Distortion: | No change |
| Slice Thickness and Gap: | No change |
| High Contrast Spatial Resolution: | No change |
General Safety and Effectiveness Concerns
The device contains detailed instructions for use. It includes indications for use, precautions, cautions, contraindications, warnings and quality assurance testing.
Substantial Equivalence Summary
The GE Signa 1.5T MRI System, operated with the Midwest RF Pediatric Positioner addressed in this PMN, has the same intended use and technological characteristics as the GE Signa 1.5T MRI System operated with the legally market predicated devices. The use of this device does not alter the GE Signa 1.5T MRI System safety parameter specifications.
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 stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Pediatric Positioner
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2003
Mr. Helmut Keidl CEO Midwest R.F., LLC 535 Norton Drive HARTLAND WI 53209 Re: K030317 Trade/Device Name: Model 1300GE-64
Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: January 28, 2003 Received: January 30, 2003
Dear Mr. Keidl:
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 r 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.
4
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
5
5.0 Statement of Indication for Use Attachment 3:
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Pediatric Positioner, Model # 1300GE-64 Device Name:
Indications For Use:
Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA) and Proton Spectroscopy of the pediatric head, body and extremities. This device is used in conjunction with a General Electric 1.5 Tesla MRI System. Proton Spectroscopy is used in conjunction with the PROBE (Proton Brain Exam) option.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-off)
Division of Reproductive, Abdominal, ENT,
| and Radiological Devices | |
|---|---|
| 510(K) Number |
Prescription Use (Per 21 CFR 801.109) OR Over-the Counter Use (Optional Format 1-2-96)
| Name | Nancy Brogdon |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K030317 |
Pediatric Positioner