← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K030317 # MODEL 1300GE-64: PEDIATRIC POSITIONER (K030317) _Midwest Rf, LLC · MOS · Mar 25, 2003 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K030317 ## Device Facts - **Applicant:** Midwest Rf, LLC - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Mar 25, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Pediatric ## Intended 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. ## Device Story The Model 1300GE-64 Pediatric Positioner is an accessory for GE Signa 1.5T MRI systems. It provides physical support and positioning for pediatric patients during MRI, MRA, and proton spectroscopy procedures of the head, body, and extremities. The device is used in clinical settings by radiology staff. It does not alter the MRI system's safety parameters, including RF power deposition, acoustic noise, or imaging performance (SNR, uniformity, spatial resolution). By stabilizing the patient, it facilitates high-quality diagnostic imaging, aiding clinicians in accurate diagnosis. ## Clinical Evidence Bench testing only. The device was evaluated for safety and effectiveness by comparing imaging performance parameters (SNR, image uniformity, geometric distortion, slice thickness/gap, and high-contrast spatial resolution) and safety parameters (RF power deposition, acoustic noise, biocompatibility) against the GE Signa 1.5T MRI system baseline. No changes in performance were observed. ## Technological Characteristics MRI accessory for pediatric positioning. Complies with UL-94 (flammability of plastic materials), IEC-60601-1 (general safety for medical electrical equipment), and IEC-60601-2-33 (safety for magnetic resonance equipment). Passive mechanical device; no electronic components or software. ## Regulatory 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). ## Special Controls *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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K030317](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K030317) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com