(136 days)
MrOpen 05 is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging, MrOpen 05 tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the examinations may be performed both in weight free (supine or seated position) 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 (72), chemical shift and flow velocity. When interpreted by a trained physician, these images en yield information that can be useful in the determination of a diagnosis,
Like the previously cleared device K101295, the actual MROpen 05 is a total body magnetic resonance imaging device characterized by high homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive proprietary technology. The magnet is "U" shaped with the opening upwards to host the patient preventing claustrophobic reactions. The pole plates limit laterally the FOV.
Modification of K101295 cleared device.
- . Remove the angiography limitation,
- . update software by adding a new angiography sequence and 3D viewer tool,
- update the receiving coils' set including some new coils. .
MROpen 05 is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MrOpen 05 tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position.
The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
The provided text describes a 510(k) premarket notification for the MrOpen 05, a Magnetic Resonance Diagnostic Device. The submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive clinical study with predefined endpoints.
Therefore, much of the requested information regarding acceptance criteria, specific study design (sample size, data provenance, ground truth, adjudication, MRMC study), and training set details are not explicitly present in the provided text, as these are typically part of a more extensive clinical trial report.
However, based on the available information, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" but focuses on demonstrating that the new angiography sequence and coils provide expected image quality and performance equivalent to or better than the predicate devices. The "reported device performance" is qualitative.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| New Angiography Sequence: Expected image quality for diagnostic use. | The images on healthy volunteers conform to the expected image quality. |
| New Coils: Equivalent or better image quality and/or patient comfort compared to previous models. | The use of these new receiving coils has been referred to the previous models for equivalent or better quality image, or patient comfort. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: "healthy volunteers" (number not specified, but plural indicates more than one).
- Data Provenance: The healthy volunteers were "available in our firm," suggesting prospective data collection at the company's location (likely Italy, given the submitter's address).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: The document states that the images are "interpreted by a trained physician," but no specific details about the number or qualifications of physicians involved in establishing ground truth for this particular demonstration are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence, not reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable, as this is a medical imaging device (MRI scanner), not an algorithm-only device. The device produces images that are then interpreted by a trained physician.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical tests (bench testing for standards) and healthy volunteer imaging: The "ground truth" for the new angiography sequence was qualitative, based on whether the images conformed to "expected image quality." For the new coils, it was assessed as "equivalent or better quality image, or patient comfort" compared to previous models. This suggests a form of expert visual assessment or comparison rather than a strict pathologist-confirmed or outcomes-based ground truth.
8. The sample size for the training set
- The document describes testing and comparison against predicate devices, not the training of an AI algorithm. Therefore, "training set" is not applicable in this context. The device's performance relies on its inherent hardware and software design, which would have been developed and refined (analogous to 'training') during its engineering phase, but not in the sense of an algorithmic training set with ground-truth labels.
9. How the ground truth for the training set was established
- Not applicable, as explained above.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three overlapping profiles of human faces. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Paramed S.r.1. % Ms. Luisella De Benedetti Quality Manager Corso F. M. Perrone 73R Genoa, 16152 ITALY
October 15, 2015
Re: K151466 Trade/Device Name: MrOpen 05 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: September 7, 2015 Received: September 10, 2015
Dear Ms. De Benedetti:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ochs
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for "PARAMed MEDICAL SYSTEMS". The word "PARAMed" is in a bold, sans-serif font, with the "ed" portion in a cursive style. Below it, in smaller letters, is the text "MEDICAL SYSTEMS".
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151466
Device Name MrOpen 05
Indications for Usa (Dascribe)
MrOpen 03 is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac intaging, no breast imaging, MrOpen 05 tomograph produces transverse, sagittal, coronal and oblique cross-sectional intages that display the internal structure of the examinations may be performed both in weight free (supine or seated position) and weight bearing position.
The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resoriance. The MR parameters that determine inage appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (72), chemical shift and flow velocity. When interpreted by a trained physician, these images en yield information that can be useful in the determination of a diagnosis,
| Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
Tol Parile Lives Converes (101) 411 1745 1245 EF
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PARAMed
MEDICAL SYSTEMS
7. 510(k) Summary (21 CFR 807.92)
Date: (month/day/year) _05/25 | 2015
807.92(a)(1) The submitter's name, address, telephone number, a contact
person, and the date the summary was prepared;
Submitter Information
| Name | Paramed Srl |
|---|---|
| Address | Corso Perrone 73R - 16152 Genova, Italy |
| Telephone n. | +39 010 6489 358 |
| Contact Person | Luisella De BenedettiParamed S.r.l.Corso F.M. Perrone 73R16152 Genova+39 010 6489 358luisella.debenedetti@paramed.it |
807.92(a)(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Name of the device | MrOpen 05 |
|---|---|
| Classification name | Total Body Magnetic Resonance DiagnosticDevice |
| Classification and class of device | 21 CFR 892.1000, class II |
| Classification Number | 90LNH |
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PARAMed
MEDICAL SYSTEMS
807.92(a)(3) An identification of the legally marketed device to which the submitter claims equivalence.
PRIMARY PREDICATE:
Paramed MrOpen 0.5T K101295 SECONDARY PREDICATE (FOR ANGIOGRAPHY APPLICATION) Toshiba OPART K990260 SECONDARY PREDICATE (FOR SPINE COIL USE) Paramed Spine COIL K123708 SECONDARY PREDICATE (FOR MATERIALS) Paramed Performance package K121249
807.92(a)(4) A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties;
Like the previously cleared device K101295, the actual MROpen 05 is a total body magnetic resonance imaging device characterized by high homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive proprietary technology. The magnet is "U" shaped with the opening upwards to host the patient preventing claustrophobic reactions. The pole plates limit laterally the FOV.
Modification of K101295 cleared device.
- . Remove the angiography limitation,
- . update software by adding a new angiography sequence and 3D viewer tool,
- update the receiving coils' set including some new coils. .
MROpen 05 is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MrOpen 05 tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position.
The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
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Image /page/5/Picture/0 description: The image shows the logo for "Paramed Medical Systems". The word "Paramed" is in a bold, sans-serif font, while "Medical Systems" is in a smaller, lighter font underneath. The word "Paramed" is in a stylized, cursive font.
The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (Tl), 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 modification reflected in this Traditional 510(k) for the MrOpen 05 Tomograph are to improve system performance. The modifications have not altered the scientific technology of the unmodified version MrOpen 05 K101295.
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PARAMed
MEDICAL SYSTEMS
807.92(a)(5) A statement of the intended use of the device that is the subject of the premarket notification submission, including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended. If the indication statements are different from those of the legally marketed device identified in paragraph (a)(3) of this section, the 510(k) summary shall contain an explanation as to why the differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and why the differences do not affect the safety and effectiveness of the device when used as labeled;
MrOpen 05 product is a Magnetic Resonance Diagnostic Device
MrOpen 05 is Total Body MRDD with the following limitation: no cardiac imaging, no breast imaging.
MrOpen 05 Tomograph produces transverse, sagittal, coronal and oblique crosssectional 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 vield information that can be useful in the determination of a diagnosis.
Intended population is for Patients less than 200 Kg
The new MrOpen 05 Tomograph can perform Angiography studies for this reason multiple predicates are addressed. Angiography is a well known diagnostic technique which does not rise safety and effectiveness issues different form the previously addressed ones when used as labeled.
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807.92(a)(6) If the device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device identified in paragraph (a) (3) of this section, a summary of the technological characteristics of the new device in comparison to those of the predicate device. If the device has different technological characteristics from the predicate device, a summary of how the technological characteristics of the device compare to a legally marketed device identified in paragraph (a)(3) of this section
Technological Characteristics
| General item | MrOpen 05 | Primary PredicateK101295 MrOpen 05 | SecondaryPredicateOpart K990260 |
|---|---|---|---|
| Anatomicalregions | Total body with thefollowinglimitation: nocardiac imaging, nobreast imaging. | Total body with thefollowing limitation: noangiography, no cardiacimaging, no breastimaging. | Total Body |
| Nucleus excited | Proton (hydrogen nucleus) | ||
| Diagnostic uses | Magnetic Resonance Diagnostic Device | ||
| Angiography | Yes | No | Yes |
The MrOpen 05 MRI system is substantially equivalent to
| General item | MrOpen 05 | Primary Predicate K101295 |
|---|---|---|
| MrOpen 05 | ||
| Magnetic system | • High homogeneity Open-sky Magnet, based on hightemperature cryogenless superconductive, horizontal field | |
| 0.5 Tesla | ||
| Mechanical | ||
| 28000 kg | ||
| 200x200x170 cm (HxDxW) | ||
| 4.0 x 4.6 x 3.6 m (Vertical x Transversal x Longitudinal) | ||
| <2 ppm FWHM over 30 cm DSV | ||
| Gantry | 56 cm lateral gap | |
| Gradient System | 20mT/m | |
| 0.6 msec (from 0 – 20 mT/m) | ||
| 33 mT/m/ms | ||
| RF amplifier | 9 kW |
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PARAMed
MEDICAL SYSTEMS
| ReceivingCoils' list | Code#autom.Recogn. digit | MrOpen 05 | PrimaryPredicateK101295MrOpen 05 | SecondaryPredicateSpine coil K123708 |
|---|---|---|---|---|
| Head | 03-2001-00#1 | Superseded by03-2001-01#1 | ||
| Body | 03-2002-00#2 | Superseded by03-2019-00#2 | ||
| C-Spine | 03-2003-00#7 | |||
| Knee | 03-2004-00#3 | Superseded by03-2018-00#3 | 1 | |
| Shoulder | 03-2005-00#9 | |||
| Hand | 03-2006-01#4 | |||
| MP-Loop | 03-2010-02#8 | 1 | ||
| Flex S | 03-2011-00#12 | ਹੈ | ||
| Flex L | 03-2012-00#13 | مما | ||
| MP Flat | 03-2015-02#14 | " | ||
| Spine | 03-2016-00#8 | V | ||
| Body | 03-2019-00#2 | Predicate code03-2002-00 | । | |
| Knee | 03-2018-00#3 | Predicate code03-2004-00 | ||
| Head | 03-2001-01 #1 | Predicate code03-2001-00 | ||
| Head/Neck | 03-2020-00#10 | Predicate code03-2001-00 |
(b) 510(k) summaries for those premarket submissions in which a
determination of substantial equivalence is also based on an assessment of performance data shall contain the following information:
A brief discussion of the nonclinical tests submitted, (1) referenced, or relied on in the premarket notification submission for a determination of substantial equivalence;
The MrOpen 05 has been evacuated to demonstrate substantial equivalence related to medical electrical equipment, risk management, software verification and image quality and has been found to conform to the following medical device safety standards (see also 3654 Forms).
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Image /page/9/Picture/0 description: The image shows the logo for PARAMED MEDICAL SYSTEMS. The word "PARAMED" is in a bold, textured font, while "MEDICAL SYSTEMS" is in a smaller, dotted font underneath. The "PARAMED" part of the logo is larger and more prominent than the "MEDICAL SYSTEMS" part.
According to our quality management system a report I issued if a standard changes, if the device changes or both. Not all the tests were newly performed where the above conditions did not apply
| Standard | FDARecog.number | Rationale for repeating/not repeatingtests | 510(k) ref |
|---|---|---|---|
| IEC 60601-1 | 19-4 | Standard revision - repeated | See belowsection 8 |
| IEC 60601-2-33 | 12-271 | Standard revision - repeated | See belowsection 8 |
| IEC 62304 | 13-8 | Software changes - repeated | See belowsection 8 |
| IEC 62471 | 12-249 | No change - Not repeated | K101295 |
| NEMA MS-1 | 12-188 | New coils - repeated | See belowsection 8 |
| NEMA MS-2 | 12-196 | No change - Not repeated | K101295 |
| NEMA MS-3 | 12-187 | New coils - repeated | See belowsection 8 |
| NEMA MS-4 | 12-232 | No change - Not repeated | K101295 |
| NEMA MS-5 | 12-231 | No change - Not repeated | K101295 |
| NEMA MS-6 | 12-195 | No single channel new coils - Notrepeated | K101295 |
| NEMA MS-8 | 12-192 | No change - Not repeated | K101295 |
| NEMA MS-9 | 12-264 | No change - Not repeated | K101295 |
| NEMA MS-10 | 12-158 | No change - Not repeated | K101295 |
| NEMA MS-12 | 12-234 | No change - Not repeated | K101295 |
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PARAMed
(2) A brief discussion of the clinical tests submitted, referenced, relied on in the premarket notification submission for a or determination of substantial equivalence. This discussion shall include, where applicable, a description of the subjects upon whom the device was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific reference to adverse effects and complications, and any other information from the clinical testing relevant to a determination of substantial equivalence; and
No clinical tests were performed.
Paramed supplies images of healthy volunteers who agreed to cooperate to demonstrate performance of the device on humans.
| Item tested | Result/remarks |
|---|---|
| New Angiography sequence | The images on healthy volunteers conform to the expected image quality |
| New coils | The use of this new receiving coils has been referred to the previous models for equivalent or better quality image, or patient comfort |
Only main changes were tested:
Population (healthy volunteers)
The healthy volunteers were adult male and female aged between 20 and 50 available in our firm.
(3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a) (3) of this section.
The non clinical (bench) and clinical (healthy volunteers) data demonstrate MrOpen to be as safe, as effective and performs as well than the predicates. MrOpen is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards.
§ 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.