The MrJ 3300 is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the following joints: hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography).

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 (T1), 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.

Device Description

The MrJ 3300 is a magnetic resonance imaging device characterized by an open structure to minize claustrophobic reactions. The magnet is a permanent "C" shaped joke designed to minimize the installation area and the Controlled Access area in order to fit also very small hospital and clinics.

It is indicated for use as a diagnostic imaging device that produces transverse, sagittal. coronal and oblique cross-sectional images that display the internal structure of the following joints: hip, knee, ankle, foot; shoulder, elbow, wrist; hand, calf, thigh, arm, forearm. Temporo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography). ....

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 (Tl), 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. ... .

The MrJ 3300 has a 0,3 T magnet, which has a higher intensity than the predicate one (0,2T). Of course the new 0,3 T magnet with slightly different dimensions needs a new design of covers and some modest upgrades due to design ageing of the MrJ Inspire 01-2000-01 product.

New covers of the system have been designed by the same company which designed MRJ Inspire's covers and they have been manufactured using the same C-UL-US approved fire protection materials.

The MrJ 3300 employs both the positioning LED (K033507) and the positioning touch screen . (K100164) to give to the user the maximum chances to get rapidly to the correct patient of positioning.

The scanning sequences are the same employed in MrJ Inspire model (K100164) unless the FLAIR sequences which are equivalent to the same FLAIR sequences employed on the MrOpen 05 T K101295 device.

The MrJ 3300 is furnished with the Performance Package of new concept receiving coils . (code 06-0096-00) equivalent to the Performance Package K121249.

AI/ML Overview

The Paramd MrJ 3300 is a magnetic resonance imaging device.

Acceptance Criteria and Reported Device Performance:

The submission does not explicitly state "acceptance criteria" for clinical performance. Instead, it aims to demonstrate substantial equivalence to predicate devices, implying that if the device performs equivalently in a clinical setting, it meets the inherent acceptance criteria of a diagnostic MRI system whose predicates are already on the market. The study attempts to show that the MrJ 3300's generated images are "clinically acceptable" and equivalent to those from the predicate devices.

Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Image Quality	Clinically acceptable, equivalent to predicate devices	"Proposed images... are clinically acceptable as those presented for the same districts in previous 510(k) files to which equivalence is claimed."
Coils	Coils must be equivalent to those on predicate devices	All coils listed (Knee, Hip, Hand, Shoulder, TMJ, etc.) are "Equivalent" to corresponding coils on MrJ Inspire K100164.
Sequences	Sequences must be equivalent to those on predicate devices	All sequences listed (SCOUT, SE, E-RASE, DE, GFE, STIR, etc.) are "Equivalent" to corresponding sequences on MrJ Inspire K100164 or MrOpen 0.5T K101295.
Safety/Effectiveness	As safe and effective as predicate devices	"MrJ 3300 device is at least as safe and effective as the predicate devices." (based on non-clinical and clinical-like observations)

Sample Size and Data Provenance for the Test Set:

The document mentions "test images performed both on phantoms and on healthy volunteers" for the "clinical tests." However, it does not specify the sample size for these healthy volunteers, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective).
Number of Experts and Qualifications for Ground Truth:

The submission states that images should be "interpreted by a trained physician" or a "medical expert." It does not specify the number of experts used to establish ground truth for the test set, nor does it provide their specific qualifications (e.g., years of experience). The assessment of "clinical acceptability" appears to be an internal conclusion rather than an independent expert review with quantified metrics.
Adjudication Method for the Test Set:

No specific adjudication method (e.g., 2+1, 3+1) is mentioned or described for the assessment of the clinical images.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study design described does not involve human readers comparing performance with and without AI assistance or between this device and other devices. It focuses on demonstrating equivalency of image quality for diagnostic interpretation.
Standalone Performance Study:

Yes, a type of standalone (algorithm only) performance assessment was implicitly done for the device in terms of image quality. The claim is that the images produced by the MrJ 3300 are "clinically acceptable" on their own for diagnostic interpretation by a medical expert, equivalent to those from existing devices. The document does not describe a human-in-the-loop experiment designed to improve human reader performance using the device.
Type of Ground Truth Used:

The ground truth for the "clinical tests" appears to be based on the general "clinical acceptability" of the images as interpreted by medical experts, implying a form of expert consensus on diagnostic utility. No specific pathology, outcomes data, or definitive diagnostic truth is explicitly mentioned as being used to validate the images.
Sample Size for the Training Set:

The document does not mention a training set for an algorithm. This submission describes an MRI device itself, not an AI or algorithm that would require a distinct training set. The "clinical tests" refer to assessing the diagnostic imaging capabilities of the hardware and software for image generation.
How Ground Truth for the Training Set Was Established:

As there is no mention of an algorithm requiring a training set, the question of how ground truth was established for a training set is not applicable here.

Summary

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PARAMed
MEDICAL SYSTEMS

510(K) Summary

Date 05/07/2012

The following Special 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(c).

Manufacturer Information

Manufacturer:

Address:

Paramed Srl Corso Perrone 73R 16152 Genova, Italy 3004994584.

Establishment registration number:

807.92(a)(1)

Submitter Information Correspondent:

Contact Person

ichard Olson, Correspondent USA Paramed Medical Systems, Inc 6204 W. Oakton Street Morton Grove, IL 60053 Toll Free: 1 866 840-7565 T 1 847 470-0580nF 1 847 470-0612 Luisella De Benedetti Paramed S.r.l. Corso F.M. Perrone 73R 16152 Genova +39 010 6489 358 luisella.debenedetti@paramed.it

807.92(a)(2)

Classification Name(s):

Classification Number:

Trade Name:

Common Name:

MrJ 3300

Magnetic resonance diagnostic system System, Nuclear Magnetic Resonance Imaging 21 CFR 892.1000, class II Classification and class of device:

90LNH

807.92(a)(3)

Predicate Devices

Section A

Paramed	MrJ	K033507
Paramed	MrJ Inspire	K100164
Paramed	MrOpen 05T	K101295
Paramed	Performance Package	K121249

681245

DEC 0 6 2012

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807.92(a)(4)

ction A

The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.

New covers of the system have been designed by the same company which designed MRJ Inspire's covers and they have been manufactured using the same C-UL-US approved fire protection materials.

The MrJ 3300 employs both the positioning LED (K033507) and the positioning touch screen . (K100164) to give to the user the maximum chances to get rapidly to the correct patient of positioning.

The scanning sequences are the same employed in MrJ Inspire model (K100164) unless the FLAIR sequences which are equivalent to the same FLAIR sequences employed on the MrOpen 05 T K101295 device.

The MrJ 3300 is furnished with the Performance Package of new concept receiving coils . (code 06-0096-00) equivalent to the Performance Package K121249.

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807.92(a)(5)

Device Intended Use(s)

The intended use of Paramed's MrJ 3300 product is the same than the intended use of the predicate one: it is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography).

The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joint being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation i time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift), If interpreted by a medical expert, these images can provide diagnostically useful information.

807.92(a)(6)

Section A

Technological Characteristics

The MrJ 3300 MRI system is substantially equivalent to:

Paramed Mr Inspire K033507 for intended use. � architecture, software and positioning LED system. . . . . . ::::: .
Paramed Mr Inspire K100164 for intended use, covers' materials, and Touch panel positioning system.
Paramed MrOpen 05T K101295 for the FLAIR sequences
Paramed Performance Package K121249 (C-Spine coil, L-Spine coils, MP_wrap coil) complete equivalence except the working frequency which here is centered at 13 MHz due to the higher magnetic field.

10/? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?

Neither the intended use nor the technological characteristics of this model differ from those of the referenced models. A table is supplied later on regarding design similarities.

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807.92(b)(1)

The discussion of the nonclinical, tests submitted, referenced, or in the premarket notification submission for a determination of substantial equivalence.

The nonclinical tests are summarized in this submission.

The aim of the nonclinical test is to demonstrate performance towards the relevant standards listed in form 3514. :

Parameter	MrJ 3300	MrJ Inspire withExtended KitK100164
IEC 60601-1 Electrical safety	Conform	Conform
IEC 60601-1-2 Electromagneticcompatibility	Conform	Conform
IEC 60601-1-4 Programmable devices	ConformSw release n.1.A.3	ConformSw release n. 1.A.3
IEC 60601-2-33 Operation mode	Normal Controlled Operation Mode	Normal ControlledOperation Mode
IEC 60601-2-33 SARWhole Body	0.66 +/- 0.10 W/Kg	0,57 +/- 0,15 W/Kg
Head	0.9 +/- 0.6 W/Kg	-
Exposed Body	0.66 +/- 0.10 W/Kg	-
IEC 60601-2-33 max dB/dt	Conform19,8 T/s with $\tau$ = 600 $\mu$ sGradient coil diameter 850 mm	Conform19,8 T/s with $\tau$ = 600 $\mu$ sGradient coil diameter 850mm
IEC 60601-2-33 max Acoustic noiseLevel A-weighted L eq	Conform (<99dBA)89.8 +/- 0.5 dBA	Conform (<99dBA)79.0+/- 0.1 dBA
IEC 60601-2-33 max Acoustic noisePeak	Conform (<140 dB)(102.5 +/-0.5) dB	Conform (<140 dB).82.0+/- 0.1 dB
NEMA MS-1 SNR multichannel coils	Conform see Laboratory testing forthe results	Conform
NEMA MS-3 Image uniformity	Conform see Laboratory testing forthe results	Conform
NEMA MS-1 SNR for single channelcoils	Conform see Laboratory testing forthe results	Conform
NEMA MS-2 Geometric Distortion	Conform see Appendix L	Conform
NEMA MS-5 SLICE THICKNESS	Conform see Appendix L	Conform

The non clinical test demonstrate that the new tomograph respects the standards as the previous models did.

73315/295

Differences in the results are due to the new magnet adopted by this model.

Section A

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807.92(b)(2)

: : : :

A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a 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 on 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. .:.

The proposed images (see clinical output par.) are clinically acceptable as those presented for the same districts in previous 510 (k) files to which equivalence is claimed.

Coil	Limb	Standard/Optional coils available with MrJ 3300 confronted with corresponding coils available onMrJ Inspire K100164 system
Knee	Knee	Equivalent
Hip	Hip	Equivalent
Hand	Hand	Equivalent
Shoulder	Shoulder	Equivalent
TMJ	TMJ	Equivalent
Knee large	Knee large	Equivalent
VS	Hand	Equivalent
VL	Thigh	Equivalent
VXL	L-Spine small dimensions' patient	Equivalent
C-Spine	C-Spine	Equivalent
L-Spine small	L-Spine on small patient	Equivalent
L-Spine Large	L-Spine on big patient	Equivalent
MP Wrap	Knee	Equivalent

. : :

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Sequence usedwith MrJ3300	Sequence used withMrJ Inspire K100164	District	Decision with reference to MrJInspire
SCOUT	SCOUT	Knee	Equivalent
SE	SE	Knee	Equivalent
E-RASE	E-RASE	Hand	Equivalent
DE	DE	Knee	Equivalent
GFE	GFE	Knee	Equivalent
STIR	STIR	Knee	Equivalent
STIR GFE	STIR GFE	Knee	Equivalent
SE T2	SE T2	Hand	Equivalent
3D GFE	3D GFE	Hand	Equivalent
3D GFE SPOILED	3D GFE SPOILED	Knee	Equivalent
3D GFE EMIT	3D GFE EMIT	Knee	Equivalent
3D GBASS	3D GBASS	L-Spine	Equivalent
RISE T2	RISE T2	Hand	Equivalent
RIDE	RIDE	Shoulder	Equivalent
FAST RISE	FAST RISE	C-Spine	Equivalent
FIR	FIR	L-Spine	Equivalent
FWS GFE	FWS GFE	Knee	Equivalent

Sequence usedwith MrJ3300	Sequence used withMrOpen 05TK101295	District	Decision with reference toMrOpen 05T
FLAIR T1	FLAIR T1	C-Spine	Equivalent
FLAIR T2	FLAIR T2	C-Spine	Equivalent

807.92(b)(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. ... . . :: : ・・・・・・

On the basis of the internal final inspection data reports, summarized in the above 807.92(b)(1) and (b)(2) point and of the test images performed both on phantoms and on healthy volunteers, we declare that the MrJ 3300 device is at least as safe and effective as the predicate devices.

:::::::

71243

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a globe, with flowing lines suggesting movement or connection.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Paramed Srl % Ms. Luisella De Benedetti Quality Manager Paramed Srl Corso F.M. Perrone 73R 16152 Genova, Italy

December 6, 2012

Re: K122034

Trade/Device Name: MrJ 3300 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II · Product Code: LNH Dated: November 14, 2012 Received: November 19, 2012

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

{7}------------------------------------------------

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 Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please . note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

Janine M. Morris, M.S. Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

MrJ 3300 code 06-2000-00 Device Name:

Indications for Use:

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 (T), 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)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Michael D. O'Hara

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K122034

Page I of

Regulation Number and Section

§ 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.