MRJ 3300

{0}------------------------------------------------ **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 | 10 681245 20 DEC 0 6 2012 {1}------------------------------------------------ ## 807.92(a)(4) ction A 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. {2}------------------------------------------------ ## 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. 12 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. {3}------------------------------------------------ ## 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 with<br>Extended Kit<br>K100164 | |------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | IEC 60601-1 Electrical safety | Conform | Conform | | IEC 60601-1-2 Electromagnetic<br>compatibility | Conform | Conform | | IEC 60601-1-4 Programmable devices | Conform<br>Sw release n.1.A.3 | Conform<br>Sw release n. 1.A.3 | | IEC 60601-2-33 Operation mode | Normal Controlled Operation Mode | Normal Controlled<br>Operation Mode | | IEC 60601-2-33 SAR<br>Whole 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 | Conform<br>19,8 T/s with $\tau$ = 600 $\mu$ s<br>Gradient coil diameter 850 mm | Conform<br>19,8 T/s with $\tau$ = 600 $\mu$ s<br>Gradient coil diameter 850<br>mm | | IEC 60601-2-33 max Acoustic noise<br>Level A-weighted L eq | Conform (<99dBA)<br>89.8 +/- 0.5 dBA | Conform (<99dBA)<br>79.0+/- 0.1 dBA | | IEC 60601-2-33 max Acoustic noise<br>Peak | Conform (<140 dB)<br>(102.5 +/-0.5) dB | Conform (<140 dB).<br>82.0+/- 0.1 dB | | NEMA MS-1 SNR multichannel coils | Conform see Laboratory testing for<br>the results | Conform | | NEMA MS-3 Image uniformity | Conform see Laboratory testing for<br>the results | Conform | | NEMA MS-1 SNR for single channel<br>coils | Conform see Laboratory testing for<br>the 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 {4}------------------------------------------------ # 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 on<br>MrJ 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 | . : : . {5}------------------------------------------------ | Sequence used<br>with MrJ3300 | Sequence used with<br>MrJ Inspire K100164 | District | Decision with reference to MrJ<br>Inspire | |-------------------------------|-------------------------------------------|----------|-------------------------------------------| | 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 used<br>with MrJ3300 | Sequence used with<br>MrOpen 05T<br>K101295 | District | Decision with reference to<br>MrOpen 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 {6}------------------------------------------------ ## 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 {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): MrJ 3300 code 06-2000-00 Device Name: Indications for Use: 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 (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