(79 days)
The MR Open is indicated for use as a diagnostic total body imaging device with the following limitation: no angiography, no cardiac imaging, no breast imaging.
MR Open tomograph produces transverse, sagittal, coronal and oblique crosssectional images that display the internal structure of the body.
The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
The MR parameters that determine image appearance are proton density, spinlattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
The MrOpen 05 MRI system is substantially equivalent to Paramed MrOpen K073362 as a total body open structure superconducting MRI Scanner.
The provided text does not contain any information about acceptance criteria or a study proving device performance in the context of specific performance metrics.
This document is a 510(k) summary for a medical device (MrOpen 05 MRI system). 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance studies with statistical analysis as might be done for a novel device or a device with new performance claims.
Here's a breakdown of why the requested information cannot be extracted from this document:
- Acceptance Criteria and Reported Device Performance: The document lists IEC, UL, and FDA standards as compliance targets, but these are general safety and performance standards for MRI devices, not specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy for a particular condition). There is no table of acceptance criteria and reported device performance related to diagnostic accuracy.
- Sample Size and Data Provenance (Test Set): No information about a test set, its sample size, or data provenance is provided.
- Number of Experts and Qualifications (Ground Truth): No information about experts used to establish ground truth is mentioned.
- Adjudication Method: No adjudication method is described.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no mention of an MRMC study or any comparison of human readers with vs. without AI assistance. This device is an MRI scanner, not an AI-assisted diagnostic tool.
- Standalone Performance: As this is an MRI scanner, its "standalone performance" would relate to image quality parameters, signal-to-noise ratio, spatial resolution, etc., which are often demonstrated through technical evaluations and phantom studies rather than diagnostic performance studies in a 510(k) summary. However, these specific details are not provided here.
- Type of Ground Truth: No specific ground truth type (e.g., pathology, outcomes data, expert consensus) is discussed for any performance evaluation.
- Sample Size for Training Set: There is no mention of a training set, as this is a hardware device, not a machine learning algorithm.
- How Ground Truth for Training Set was Established: Not applicable, as there's no training set mentioned.
In summary, the provided document focuses on regulatory compliance (510(k) process) and establishing substantial equivalence to a predicate MRI device. It does not contain the detailed performance study information requested, which would typically be found in clinical study reports for devices making specific diagnostic claims or incorporating AI/algorithmic components.
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K101295
page 1/2
JUL 28 2010
: IEC standards: IEC 60601-1, International Electrotechnical Commission, Medical Electrical Equipment, Part 1: General Requirements for Safety IEC 60601-2-33 UL standards: UL 94 Tests for Flammability of Plastic Materials for Parts in Devices and Appliances FDA standards: Regulations under 21 CFR Subchapter J -Radiological Health Voluntary standards: DICOM 3.0
A.3.9 510(K) Summary of Safety and Effectiveness
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
Manufacturer Information
| Manufacturer: | Paramed Srl |
|---|---|
| Address: | Corso Perrone 73R16152 Genova, Italy |
| Establishment registration number: | 3004994584 |
807.92(a)(1)
Submitter Information
Correspondent: Correspondent
Richard R. Glasheen (from 2010-05-10 on),
39 High Street North Andover, MA 01845 USA. Ph. 978.975.7530 x4345 Fax: 978.975.9930
Contact person:
Richard R. Glasheen (from 2010-05-10 on),
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807.92(a)(2)
| Trade Name: | MrOpen 05 |
|---|---|
| Common Name: | Total Body Magnetic resonance diagnosticdevice |
| Classification Name(s): | System, Nuclear Magnetic Resonance Imaging |
| Classification and class of device: | 21 CFR 892.1000, class II |
| Classification Number: | 90LNH |
807.92(a)(3)
Predicate Devices
MrOpen Paramed
807.92(a)(5)
Device Intended Use(s)
The intended use of Paramed's MrOpen 05 product is indicated for use as a diagnostic total body imaging device with the following limitation: no angiography, no cardiac imaging, no breast imaging. MrOpen tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the anatomies. The examinations may be performed both in weight free (supine) and weight bearing position.
The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
807.92(a)(6)
Technological Characteristics
The MrOpen 05 MRI system is substantially equivalent to
- Paramed MrOpen K073362 as a total body open structure superconducting MRI . Scanner
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three overlapping human figures.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Paramed Srl % Mr. Richard R. Glasheen Correspondent 39 High Street NORTH ANDOVER MA 01845
JUL 2 8 2010
Re: K101295
Trade/Device Name: MR Open 0.5T Regulation Number: 21 CFR 892.1000 . Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNI Dated: April 28, 2010 Received: May 10, 2010
Dear Mr. Glasheen:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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 vours.
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K101295
JUL 2 8 2010
Device Name: MR Open 0.5T
Indications for Use:
"The MR Open is indicated for use as a diagnostic total body imaging device with the following limitation: no angiography, no cardiac imaging, no breast imaging.
MR Open tomograph produces transverse, sagittal, coronal and oblique crosssectional images that display the internal structure of the body.
The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
The MR parameters that determine image appearance are proton density, spinlattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis."
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Page 1 of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDBH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K101295
§ 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.